drugset / Trial / NCT05982301

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

NCT05982301 ↗

Phase 2 Unknown 87 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-09
Primary completion
2025-01
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Paclitaxel-albumin Unknown 125 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject fluorouracil Small molecule 2.4 g Intravenous