TriangleNCT04579757 · STUDY IN CONTEXT
Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) version (v)5.0,DLT was defined as any of the following AEs during DLT observation period: Nonhematologic toxicities:grade 3 or higher nonhematologic toxicity, except for grade 3 fatigue lasting \<7 days, grade 3 rash returning to baseline or ≤grade 1 within 7 days with treatment, grade 3 hypertension downgraded to ≤grade 1 within 7 days with therapy, grade 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolving to ≤grade 1 within 7 days, grade 3 or higher amylase or lipase elevation without symptoms of pancreatitis, grade 3 nausea/vomiting or diarrhea for \<72 hours with care, grade 3 or higher electrolyte abnormality lasting up to 72 hours and resolving with treatment. Hematologic toxicities: grade 3 or higher febrile neutropenia, grade 4 neutropenia and grade 4 thrombocytopenia lasting \>7 days, grade 3 thrombocytopenia with severe bleeding, and grade 4 anemia.
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- trial label
- Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 9
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0000
- source section id
- NCT04579757-om-0000
- source outcome index
- 0
- endpoint
- Dose Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs)
- endpoint definition
- According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) version (v)5.0,DLT was defined as any of the following AEs during DLT observation period: Nonhematologic toxicities:grade 3 or higher nonhematologic toxicity, except for grade 3 fatigue lasting \<7 days, grade 3 rash returning to baseline or ≤grade 1 within 7 days with treatment, grade 3 hypertension downgraded to ≤grade 1 within 7 days with therapy, grade 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolving to ≤grade 1 within 7 days, grade 3 or higher amylase or lipase elevation without symptoms of pancreatitis, grade 3 nausea/vomiting or diarrhea for \<72 hours with care, grade 3 or higher electrolyte abnormality lasting up to 72 hours and resolving with treatment. Hematologic toxicities: grade 3 or higher febrile neutropenia, grade 4 neutropenia and grade 4 thrombocytopenia lasting \>7 days, grade 3 thrombocytopenia with severe bleeding, and grade 4 anemia.
- time origin
- From the first dose of study drug (Day 1) up to Day 21 of Cycle 1 (cycle duration: 3 weeks)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The DLT-evaluable analysis set included all patients enrolled in dose escalation phase of the study who were evaluable for DLT assessment and received ≥85% of scheduled surufatinib and ≥67% of scheduled tislelizumab administration during the DLT assessment window and/or experienced a DLT.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0001
- source section id
- NCT04579757-om-0001
- source outcome index
- 1
- endpoint
- Dose Escalation Phase: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
- endpoint definition
- An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
- time origin
- From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- source section id
- NCT04579757-om-0002
- source outcome index
- 2
- endpoint
- Dose Expansion Phase: Objective Response Rate (ORR)
- endpoint definition
- ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
- time origin
- Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 37 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0003
- source section id
- NCT04579757-om-0003
- source outcome index
- 3
- endpoint
- Dose Escalation Phase: Objective Response Rate
- endpoint definition
- ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
- time origin
- Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0004
- source section id
- NCT04579757-om-0004
- source outcome index
- 4
- endpoint
- Dose Escalation and Dose Expansion Phases: Progression-free Survival (PFS)
- endpoint definition
- PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
- time origin
- Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0005
- source section id
- NCT04579757-om-0005
- source outcome index
- 5
- endpoint
- Dose Escalation and Dose Expansion Phases: Disease Control Rate (DCR)
- endpoint definition
- DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
- time origin
- Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 42 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
- regimen
- Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
- regimen
- Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
- regimen
- Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
- regimen
- Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Expansion Phase: Cohort A: CRC
- regimen
- Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose Expansion Phase: Cohort B1: Thoracic NETs
- regimen
- Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Dose Expansion Phase: Cohort B2: GEP NETs
- regimen
- Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Dose Expansion Phase: Cohort C: SCLC
- regimen
- Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- arm key
- OG004
- arm label
- Dose Expansion Phase: Cohort D: GC
- regimen
- Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0002#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- arm key
- OG005
- arm label
- Dose Expansion Phase: Cohort E2: UPS
- regimen
- Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0002#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0002
- arm key
- OG006
- arm label
- Dose Expansion Phase: Cohort F: ATC
- regimen
- Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0002#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
- regimen
- Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579757-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG000
- source section id
- NCT04579757-ae
- event group key
- EG000
- event group label
- Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
- serious affected
- 5
- serious at risk
- 6
- other affected
- 5
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG001
- source section id
- NCT04579757-ae
- event group key
- EG001
- event group label
- Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG002
- source section id
- NCT04579757-ae
- event group key
- EG002
- event group label
- Dose Expansion Phase: Cohort A: CRC
- serious affected
- 9
- serious at risk
- 15
- other affected
- 14
- other at risk
- 15
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG003
- source section id
- NCT04579757-ae
- event group key
- EG003
- event group label
- Dose Expansion Phase: Cohort B1: Thoracic NETs
- serious affected
- 5
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG004
- source section id
- NCT04579757-ae
- event group key
- EG004
- event group label
- Dose Expansion Phase: Cohort B2: GEP NETs
- serious affected
- 9
- serious at risk
- 20
- other affected
- 20
- other at risk
- 20
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG005
- source section id
- NCT04579757-ae
- event group key
- EG005
- event group label
- Dose Expansion Phase: Cohort C: SCLC
- serious affected
- 8
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG006
- source section id
- NCT04579757-ae
- event group key
- EG006
- event group label
- Dose Expansion Phase: Cohort D: GC
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG007
- source section id
- NCT04579757-ae
- event group key
- EG007
- event group label
- Dose Expansion Phase: Cohort E2: UPS
- serious affected
- 4
- serious at risk
- 9
- other affected
- 8
- other at risk
- 9
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-neuroendocrine-tumor-sandostatin-535c1e71
- nct id
- NCT04579757
- harm key
- EG008
- source section id
- NCT04579757-ae
- event group key
- EG008
- event group label
- Dose Expansion Phase: Cohort F: ATC
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase. All-cause mortality (deaths) were collected from signing of the informed consent form up to end of follow up, approximately 42 months.
- event definition
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice