TriangleNCT04579757 · OUTCOME
Dose Escalation and Dose Expansion Phases: Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 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
What was measured
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.
Analysis population: The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Groups in this outcome
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
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.
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
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.
Dose Expansion Phase: Cohort A: CRC
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.
Dose Expansion Phase: Cohort B1: Thoracic NETs
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.
Dose Expansion Phase: Cohort B2: GEP NETs
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.
Dose Expansion Phase: Cohort C: SCLC
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.
Dose Expansion Phase: Cohort D: GC
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.
Dose Expansion Phase: Cohort E2: UPS
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.
Dose Expansion Phase: Cohort F: ATC
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.
| Group | Source count |
|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 6 |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6 |
| Dose Expansion Phase: Cohort A: CRC | 15 |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 10 |
| Dose Expansion Phase: Cohort B2: GEP NETs | 20 |
| Dose Expansion Phase: Cohort C: SCLC | 15 |
| Dose Expansion Phase: Cohort D: GC | 3 |
| Dose Expansion Phase: Cohort E2: UPS | 9 |
| Dose Expansion Phase: Cohort F: ATC | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 1.5 | Not reported | 1.2 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure. |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6.0 | Not reported | 1.8 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure. |
| Dose Expansion Phase: Cohort A: CRC | 4.7 | Not reported | 2.7 | 5.4 | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 4.5 | Not reported | 0.3 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure. |
| Dose Expansion Phase: Cohort B2: GEP NETs | 7.4 | Not reported | 3.1 | 20.0 | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 1.4 | Not reported | 1.0 | 4.0 | Not reported |
| Dose Expansion Phase: Cohort D: GC | 9.6 | Not reported | 5.6 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure. |
| Dose Expansion Phase: Cohort E2: UPS | NA | Not reported | 1.3 | NA | NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure. |
| Dose Expansion Phase: Cohort F: ATC | 2.8 | Not reported | 1.2 | NA | NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 1.5
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- NA
- value
- 6.0
- group Id
- OG002
- lower Limit
- 2.7
- upper Limit
- 5.4
- value
- 4.7
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
- group Id
- OG003
- lower Limit
- 0.3
- upper Limit
- NA
- value
- 4.5
- group Id
- OG004
- lower Limit
- 3.1
- upper Limit
- 20.0
- value
- 7.4
- group Id
- OG005
- lower Limit
- 1.0
- upper Limit
- 4.0
- value
- 1.4
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
- group Id
- OG006
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 9.6
- comment
- NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
- group Id
- OG007
- lower Limit
- 1.3
- upper Limit
- NA
- value
- NA
- comment
- NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
- group Id
- OG008
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 20
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 3
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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.
- id
- OG000
- title
- Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
- description
- 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.
- id
- OG001
- title
- Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
- description
- 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.
- id
- OG002
- title
- Dose Expansion Phase: Cohort A: CRC
- description
- 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.
- id
- OG003
- title
- Dose Expansion Phase: Cohort B1: Thoracic NETs
- description
- 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.
- id
- OG004
- title
- Dose Expansion Phase: Cohort B2: GEP NETs
- description
- 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.
- id
- OG005
- title
- Dose Expansion Phase: Cohort C: SCLC
- description
- 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.
- id
- OG006
- title
- Dose Expansion Phase: Cohort D: GC
- description
- 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.
- id
- OG007
- title
- Dose Expansion Phase: Cohort E2: UPS
- description
- 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.
- id
- OG008
- title
- Dose Expansion Phase: Cohort F: ATC
- param Type
- MEDIAN
- population Description
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- reporting Status
- POSTED
- time Frame
- 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
- title
- Dose Escalation and Dose Expansion Phases: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice