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Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability (MSS) Advanced or Metastatic Gastric (GC) or Gastroesophageal Junction (GEJ) Cancer

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Trial Identification

Brief Title: A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability (MSS) Advanced or Metastatic Gastric (GC) or Gastroesophageal Junction (GEJ) Cancer

Official Title: An Open-Label, Multi-Center, Phase II Study to Evaluate the Efficacy and Safety of PD-1 Antibody Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative MSS Advanced or Metastatic GC or GEJ Cancer

Study ID: NCT05216237

Study Description

Brief Summary: To evaluate the efficacy and safety of Sintilimab combined with apatinib and chemotherapy as First-line or second-line Therapy in Treatment of HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer. At the same time, the correlation between tissue programmed death ligand-1(PD-L1) expression and blood circulating tumor cell(CTC) counts and the efficacy of immune combination therapy was also explored.

Detailed Description: Participants receive Sintilizumab 200 mg, intravenously (IV) every 3 weeks(Q3W);plus Apatinib 250 mg twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days; plus Tegafur gimeracil oteracil potassium capsules (40mg for body surface area \< 1.25/m\^2, 50mg/m\^2 for body surface area 1.25-1.5m\^2, 60mg for body surface area \> 1.5/m\^2) BID by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus Oxaliplatin 85 mg/m\^2, IV Q3W; for 4-6 cycles followed by Cindilizumab plus Tegafur gimeracil oteracil potassium capsules.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Affiliated Hospital of Qinghai University, Xining, Qinghai, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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