Sintilimab Combined With Modified FLOT Regimen in the Treatment of Metastatic Gastric Cancer

Gastric Cancer Clinical Trial

Official title: PD-1 Antibody Sintilimab Combined With Modified FLOT Regimen in the Treatment of Metastatic Gastric Cancer: a Phase II Clinical Study

Status Recruiting

Clinical Trial Summary

This is a prospective, one-arm, single-center phase II study. The objective was to evaluate the efficacy and safety of domestic PD-1 antibody Sintilimab combined with modified FLOT regimen in the treatment of metastatic gastric cancer. To compare the time of maintenance of treatment after induction of chemotherapy with sintilimab combined with modified FLOT regimen until the reapplication of induction regimen with or without the combination of sintilimab, and the time of secondary progression after signing informed consent until the reapplication of induction regimen with or without the combination of sintilimab.

Clinical Trial Description

This study set up two cohorts, Cohort A: patients with HER2-negative advanced gastric cancer, and planned to enroll 87 patients with initially treated advanced gastric cancer. Thirty patients with ORR of more than 70% were enrolled in the first stage and then further enrolled. Cohort B: advanced gastric cancer patients with HER2 positive initial treatment, the number of enrolled is not specified. Patients with initially treated advanced gastric cancer who meet the inclusion criteria will be enrolled in this study to receive Sintilimab combined with mFLOT regimen. Trastuzumab was given to Cohort B. The results were repeated every 2 weeks and evaluated every 6 weeks. The examination methods were consistent with those at baseline. Patients without disease progression were treated for a maximum of 6 cycles, then switched to oral capecitabine monotherapy combined with the sintilimab until disease progression, intolerable adverse reactions, patient death, or withdrawal of informed consent. If intolerability toxicity of albumin paclitaxel or oxaliplatin occurs within 6 cycles, maintenance is advanced to sintilimab combined with capecitabine monotherapy. Patients were randomly assigned to Cohort A1 and Cohort A2 after maintaining treatment progress. Cohort A1: Cohort 1 combined with mFLOT; Cohort A2: mFLOT program Therapy. The regimen was repeated every 2 weeks and tumor efficacy was evaluated every 3 treatment cycles. Patients without disease progression were treated for a maximum of 6 cycles before being switched to monotherapy S-1 oral with or without sintilimab until disease progression, intolerable adverse reactions, patient death, or withdrawal of informed consent. The treatment should start within 1 week after the signing of informed consent, and the time from the signing of informed consent to the first progress should be PFS1; The time from the signing of informed consent to the progress of induction program back to the second progress is PFS2. In this study, peripheral blood and tissue samples of patients will be collected to analyze the correlation between biomarkers (such as Micro-RNA, cytokine expression levels, etc.) and efficacy and prognosis. The expected time of enrollment was 48 months, and the patients were observed clinically until disease progression and death. (PFS2 equals PFS1 if the induction regimen is applied again after the first disease progression and the first efficacy evaluation is the disease progression) ;

Related Conditions & MeSH terms

• Chemotherapy Effect
• Gastric Cancer
• Immune Checkpoint Inhibitor
• Stomach Neoplasms

• NCT number: NCT05982301
• Study type: Interventional
• Source: Fudan University
• Contact: WeiJian Guo, M.D.,Ph.D.
• Phone: 64175590
• Email: guoweijian1@hotmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: February 9, 2023
• Completion date: December 2025