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NCT04579757 · OUTCOME

Dose Expansion Phase (Cohorts A and F): Overall Survival (OS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose of study treatment (Day 1) up to date of death due to any cause, up to approximately 42 months

What was measured

OS was defined as the time from the start of study treatment until the date of death due to any cause.

Analysis population: The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab. As pre-specified in the protocol and statistical analysis plan (SAP), OS was assessed only in Cohort A (CRC) and Cohort F (ATC) of the dose expansion phase.

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 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 Expansion Phase: Cohort A: CRC15
Dose Expansion Phase: Cohort F: ATC3

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Expansion Phase: Cohort A: CRC7.1Not reported4.811.8Not reported
Dose Expansion Phase: Cohort F: ATC5.3Not reported2.8NANA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.8
        upper Limit
        11.8
        value
        7.1
      2. 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
        2.8
        upper Limit
        NA
        value
        5.3
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      3
    units
    Participants
description
OS was defined as the time from the start of study treatment until the date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
    OG001
    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. As pre-specified in the protocol and statistical analysis plan (SAP), OS was assessed only in Cohort A (CRC) and Cohort F (ATC) of the dose expansion phase.
reporting Status
POSTED
time Frame
From the first dose of study treatment (Day 1) up to date of death due to any cause, up to approximately 42 months
title
Dose Expansion Phase (Cohorts A and F): Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice