OncoMatch/Clinical Trials/NCT06365008
Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer
Is NCT06365008 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab+irinotecan+leucovorin folinate+fluorouracil for unresectable/metastatic gastric cancer.
Treatment: Sintilimab+irinotecan+leucovorin folinate+fluorouracil — 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 salvage therapy for patients diagnosed with 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 progression-free survival (PFS). The investigators estimated that 40 patients were necessary. Secondary endpoints include overall survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — first-line
Progression or toxicity intolerance of first-line treatment
Cannot have received: chemotherapy or biotherapy
Exception: within 28 days prior to the first use of the investigational drug
Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug
Cannot have received: immunotherapy
Exception: hyperprogression or immunotherapy related grade 3 or above adverse reactions during previous immunotherapy
The patient has experienced hyperprogression and immunotherapy related grade 3 or above adverse reactions during previous immunotherapy
Cannot have received: systemic hormone therapy for immunosuppressive purposes
Exception: dose >10mg/day prednisone or other therapeutic hormone within 14 days prior to initiation of study therapy
Immunosuppressive or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) within 14 days prior to initiation of study therapy
Cannot have received: radiation therapy
Exception: total area of previous bone marrow radiation therapy exceeds 30%; exception: if not the target lesion, palliative radiotherapy is allowed, and the radiotherapy area must be less than 25% of the bone marrow area
the total area of previous bone marrow radiation therapy exceeds 30%; the exception is that if it is not the target lesion, palliative radiotherapy is allowed, and the radiotherapy area must be less than 25% of the bone marrow area
Lab requirements
Blood counts
Hemoglobin ≥8g/dl, neutrophil absolute count ≥1000/μL, platelets ≥75,000/μL
Kidney function
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance >50mL/min (Cockcroft Gault formula)
Liver function
Total bilirubin ≤1.5 x ULN; alkaline phosphatase, AST (SGOT) and ALT (SGPT) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN); Serum albumin ≥2.8g/dl
Adequate organ and bone marrow function, as follows: Hemoglobin ≥8g/dl, neutrophil absolute count ≥1000/μL, platelets ≥ 75,000 /μL,Total bilirubin ≤1.5 x upper limit of normal (ULN), alkaline phosphatase, aspartate aminotransferase (AST (SGOT) and alanine aminotransferase (ALT (SGPT)) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN), Serum albumin≥2.8g/dl, Serum creatinine ≤1.5 x ULN or calculated creatinine clearance >50mL/min (calculated according to Cockcroft Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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