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A Phase II Clinical Study of Surufatinib Combined With Sintilimab in the Treatment of Advanced Gastric Cancer

Primary Purpose

Gastric Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Surufatinib+Sintilimab
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must have the ability to understand and voluntarily sign informed consent;
  2. Age: 18-75 years old;
  3. Patients have histologically or cytologically confirmed advanced or recurrent gastric or gastroesophageal junction adenocarcinoma;
  4. NO previous therapy for advanced/metastatic disease of GC/GEJ and CPS≥1;
  5. Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
  6. Eastern Cooperative Group (ECOG) performance status of 0 to 2;
  7. Has adequate organ function;
  8. Expected survival period ≥ 3 months;
  9. Patients who not received a blood transfusion within 7 days of registration;
  10. Patients have recovered adverse events associated with chemotherapy, radiation and surgical operation as pretreatment to Grade 1 or lower with CTCAE v5.0 excluding stable symptoms (eg alopecia, peripheral sensory neuropathy, skin hyperpigmentation, dysgeusia etc.).
  11. Patients capable of taking oral medication;
  12. Female of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 6 months after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.

Exclusion Criteria:

  1. Patients who received prior anticancer treatment within 14 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs.
  2. Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment.
  3. Patients with a history of prior treatment with Lenvatinib or any anti-programmed death 1 (anti-PD-1), anti-programmed ligand death 1 (anti-PD-L1), or anti-programmed ligand death 2 (anti-PD-L2 agent).
  4. Patients with symptomatic brain metastasis.
  5. Patients with hypertension that is difficult to control (systolic blood pressure ≥150 mmHg and diastolic blood pressure ≥100 mmHg) despite treatment with several hypotensive agents.
  6. Those who have received live vaccination within 4 weeks before the start of treatment.
  7. Patients with active hepatitis.
  8. Patients with a history of human immunodeficiency virus (HIV).
  9. Patients were judged unsuitable as subject of this trial by investigator.

Sites / Locations

  • Cancer center of SunYat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surufatinib + Sintilimab

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

Secondary Outcome Measures

Disease control rate (DCR)
Progression-free survival (PFS)
Overall survival (OS)

Full Information

First Posted
February 9, 2022
Last Updated
August 8, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05235906
Brief Title
A Phase II Clinical Study of Surufatinib Combined With Sintilimab in the Treatment of Advanced Gastric Cancer
Official Title
An Open-label, Single Center, Phase II Study of Surufatinib Combined With Sintilimab in Patients With Advanced Adenocarcinoma of the Gastric or Gastrooesophageal Junction Adneocarcinoma Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The efficacy and safety of the use of Surufatinib in combination with Sintilimab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surufatinib + Sintilimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Surufatinib+Sintilimab
Intervention Description
Surufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Sintilimab injected intravenously 200mg per 3 weeks until disease progresses or unacceptable tolerability occurs.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Time Frame
up to 12 months
Title
Progression-free survival (PFS)
Time Frame
up to 12 months
Title
Overall survival (OS)
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have the ability to understand and voluntarily sign informed consent; Age: 18-75 years old; Patients have histologically or cytologically confirmed advanced or recurrent gastric or gastroesophageal junction adenocarcinoma; NO previous therapy for advanced/metastatic disease of GC/GEJ and CPS≥1; Patients have measurable disease as defined by RECIST 1.1 as determined by investigator; Eastern Cooperative Group (ECOG) performance status of 0 to 2; Has adequate organ function; Expected survival period ≥ 3 months; Patients who not received a blood transfusion within 7 days of registration; Patients have recovered adverse events associated with chemotherapy, radiation and surgical operation as pretreatment to Grade 1 or lower with CTCAE v5.0 excluding stable symptoms (eg alopecia, peripheral sensory neuropathy, skin hyperpigmentation, dysgeusia etc.). Patients capable of taking oral medication; Female of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 6 months after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment. Exclusion Criteria: Patients who received prior anticancer treatment within 14 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs. Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment. Patients with a history of prior treatment with Lenvatinib or any anti-programmed death 1 (anti-PD-1), anti-programmed ligand death 1 (anti-PD-L1), or anti-programmed ligand death 2 (anti-PD-L2 agent). Patients with symptomatic brain metastasis. Patients with hypertension that is difficult to control (systolic blood pressure ≥150 mmHg and diastolic blood pressure ≥100 mmHg) despite treatment with several hypotensive agents. Those who have received live vaccination within 4 weeks before the start of treatment. Patients with active hepatitis. Patients with a history of human immunodeficiency virus (HIV). Patients were judged unsuitable as subject of this trial by investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsheng Zhang, PhD
Phone
86-2087343795
Email
zhangdsh@sysucc.org.cn
Facility Information:
Facility Name
Cancer center of SunYat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongsheng Zhang, MD,PhD
Phone
86-2087343795
Email
zhangdsh@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

A Phase II Clinical Study of Surufatinib Combined With Sintilimab in the Treatment of Advanced Gastric Cancer

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