TriangleNCT04579757 · OUTCOME
Dose Expansion Phase: Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- 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 37 months
What was measured
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.
Analysis population: The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Groups in this outcome
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 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 Expansion Phase: Cohort A: CRC | 6.7 | Not reported | 0.2 | 31.9 | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 0 | Not reported | NA | NA | NA indicates that upper and lower limits of confidence interval (CI) were not estimable as there were no patients with CR or PR in that disease cohort. |
| Dose Expansion Phase: Cohort B2: GEP NETs | 15.0 | Not reported | 3.2 | 37.9 | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 13.3 | Not reported | 1.7 | 40.5 | Not reported |
| Dose Expansion Phase: Cohort D: GC | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
| Dose Expansion Phase: Cohort E2: UPS | 44.4 | Not reported | 13.7 | 78.8 | Not reported |
| Dose Expansion Phase: Cohort F: ATC | 0 | Not reported | NA | NA | NA indicates that upper and lower limits of CI were not estimable as there were no patients with CR or PR in that disease cohort. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 31.9
- value
- 6.7
- comment
- NA indicates that upper and lower limits of confidence interval (CI) were not estimable as there were no patients with CR or PR in that disease cohort.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG002
- lower Limit
- 3.2
- upper Limit
- 37.9
- value
- 15.0
- group Id
- OG003
- lower Limit
- 1.7
- upper Limit
- 40.5
- value
- 13.3
- group Id
- OG004
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- group Id
- OG005
- lower Limit
- 13.7
- upper Limit
- 78.8
- value
- 44.4
- comment
- NA indicates that upper and lower limits of CI were not estimable as there were no patients with CR or PR in that disease cohort.
- group Id
- OG006
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 3
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- title
- Dose Expansion Phase: Cohort F: ATC
- param Type
- NUMBER
- 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 37 months
- title
- Dose Expansion Phase: Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of patients
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Preserved source evidence · Not medical advice