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NCT04579757 · OUTCOME

Dose Escalation and Dose Expansion Phases: Clinical Benefit Rate (CBR)

Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors · Source last updated 2025-05-08

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 42 months

What was measured

CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. 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.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab6
Dose Expansion Phase: Cohort A: CRC15
Dose Expansion Phase: Cohort B1: Thoracic NETs10
Dose Expansion Phase: Cohort B2: GEP NETs20
Dose Expansion Phase: Cohort C: SCLC15
Dose Expansion Phase: Cohort D: GC3
Dose Expansion Phase: Cohort E2: UPS9
Dose Expansion Phase: Cohort F: ATC3

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0Not reportedNANANA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab50.0Not reported11.888.2Not reported
Dose Expansion Phase: Cohort A: CRC20.0Not reported4.348.1Not reported
Dose Expansion Phase: Cohort B1: Thoracic NETs20.0Not reported2.555.6Not reported
Dose Expansion Phase: Cohort B2: GEP NETs40.0Not reported19.163.9Not reported
Dose Expansion Phase: Cohort C: SCLC13.3Not reported1.740.5Not reported
Dose Expansion Phase: Cohort D: GC33.3Not reported0.890.6Not reported
Dose Expansion Phase: Cohort E2: UPS44.4Not reported13.778.8Not reported
Dose Expansion Phase: Cohort F: ATC0Not reportedNANANA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      2. group Id
        OG001
        lower Limit
        11.8
        upper Limit
        88.2
        value
        50.0
      3. group Id
        OG002
        lower Limit
        4.3
        upper Limit
        48.1
        value
        20.0
      4. group Id
        OG003
        lower Limit
        2.5
        upper Limit
        55.6
        value
        20.0
      5. group Id
        OG004
        lower Limit
        19.1
        upper Limit
        63.9
        value
        40.0
      6. group Id
        OG005
        lower Limit
        1.7
        upper Limit
        40.5
        value
        13.3
      7. group Id
        OG006
        lower Limit
        0.8
        upper Limit
        90.6
        value
        33.3
      8. group Id
        OG007
        lower Limit
        13.7
        upper Limit
        78.8
        value
        44.4
      9. comment
        NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
        group Id
        OG008
        lower Limit
        NA
        upper Limit
        NA
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      20
    6. group Id
      OG005
      value
      15
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      9
    9. group Id
      OG008
      value
      3
    units
    Participants
description
CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. 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.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
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 42 months
title
Dose Escalation and Dose Expansion Phases: Clinical Benefit Rate (CBR)
type
SECONDARY
unit Of Measure
percentage of patients

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Preserved source evidence · Not medical advice