Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer

Summary

The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the second-line therapy for patients diagnosed with HER2-negative unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is 5-month progression-free survival (PFS) rate. The investigators estimated that 27 patients were necessary. Secondary endpoints include overall survival, progression-free survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer. Exploratory endpoint is to detect the baseline ctDNA level of patients before initial treatment.

Timeline

Start

2026-06

Primary completion

2036-06

Completion

2036-06

Drugs

Indications

No indication recorded.