Loading clinical trials...

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

Efficacy and Safety of Conversion Therapy With Sintilimab in Combination With Chemotherapy and Apatinib in Patients With Stage IV Gastric Cancer

NCT04267549•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•gastric adenocarcinoma confirmed by gastroscopy and pathology (histologically/cytologically ) ;
•life expectancy of ≥3-month；
•unresectable patients who were initially diagnosed as stage IV (clinical stage, American Joint Committee on Cancer 8th edition);
•Eastern Cooperative Oncology Group performance status: 0-1;
•must have at least 1 of the following unresectable factors indicated by CT, MRI or positron emission tomography(PET)-CT:
•1. N3 lymphatic metastasis;
•2. Extensive or bulky lymph nodes;
•3. T4b;
•4. Hepatic metastasis: ≤5 lesions, total diameter of ≤8cm;
•5. Peritoneal metastasis (CY1, P1);
+4 more criteria

Exclusion Criteria

•prior use of any checkpoint inhibitor treatment, including PD-1, programmed cell death ligand-1(PDL-1), CTLA4 etc;
•Her-2 positive with willing to use herceptin treatment;
•prior active autoimmune disease or history of autoimmune disease;
•clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class \> 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) \< 50%;
•not controlled hypertension;
•prior systemic treatment to metastatic disease；
•previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency;
•history of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis ;
•patients who may receive vaccination during study period;
•mental disorders history, or psychotropic drug abuse history;
+1 more criteria

Locations (1)

Department of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 1, 2019

Primary Completion Date

December 1, 2022

Completion Date

August 30, 2023

Last Updated

July 6, 2023

Enrollment

ACTUAL participants

Conditions

Gastric Cancer Stage IV

Interventions

sintilimab

DRUG

apatinib

DRUG

Nab paclitaxel

DRUG

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

NCT06519591

Gastric Cancer Stage IVPeritoneal Metastases

View study

RECRUITINGPHASE1/PHASE2

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

NCT04592211

Gastric Cancer Stage IV

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

Inclusion Criteria

Exclusion Criteria

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric Cancer

Maintenance Treatment With S-1 in Gastric Cancer Patients