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NCT04579757 · OUTCOME

Dose Expansion Phase: Number of Patients With Treatment-Emergent Adverse Events, Treatment-Emergent Serious Adverse Events and TEAEs Leading to Treatment Discontinuation

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 33 months

What was measured

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.

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 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 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

Any TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Expansion Phase: Cohort A: CRC14Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs10Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs20Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC15Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC3Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS9Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC3Not reportedNot reportedNot reportedNot reported
Any TESAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Expansion Phase: Cohort A: CRC9Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs5Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs9Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC8Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS4Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC1Not reportedNot reportedNot reportedNot reported
Any TEAEs leading to surufatinib treatment discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Expansion Phase: Cohort A: CRC3Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs2Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs5Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC5Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS2Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC0Not reportedNot reportedNot reportedNot reported
Any TEAEs leading to tislelizumab treatment discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Expansion Phase: Cohort A: CRC6Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs2Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs6Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC5Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS2Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        20
      4. group Id
        OG003
        value
        15
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        3
    title
    Any TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        1
    title
    Any TESAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
    title
    Any TEAEs leading to surufatinib treatment discontinuation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
    title
    Any TEAEs leading to tislelizumab treatment discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      20
    4. group Id
      OG003
      value
      15
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      3
    units
    Participants
description
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.
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 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
COUNT_OF_PARTICIPANTS
population Description
The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
reporting Status
POSTED
time Frame
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 33 months
title
Dose Expansion Phase: Number of Patients With Treatment-Emergent Adverse Events, Treatment-Emergent Serious Adverse Events and TEAEs Leading to Treatment Discontinuation
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice