A Phase 2 interventional study of Sintilimab+irinotecan+leucovorin folinate+fluorouracil in Unresectable/Metastatic Gastric Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 2, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 27 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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Exclusion Criteria:
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.
Drug: Sintilimab+irinotecan+leucovorin folinate+fluorouracil
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.
5-month progression-free survival (PFS) rate
The 5-month PFS rate refers to the proportion of patients who do not experience tumor progression or all-cause death at the 5-month time point following initial treatment
Time frame: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days
Overall survival
OS is defined as the time from study enrollment to the date of death due to any cause, assessed up to 60 months.
Time frame: From the date of enrollment to the date of death from any cause, assessed up to 60 months.
Progression free survival
PFS is defined as the time from study enrollment to the first documentation of disease progression or all-cause death, whichever occurs first, assessed up to 60 months.
Time frame: From the date of enrollment to the first documentation of disease progression or all-cause death, whichever occurs first, assessed up to 60 months.
Objective response rate
ORR is defined as the percentage of patients relative to the total of enrolled subjects who achieve a complete response (CR) or partial response (PR) based on CT or MRI scan images
Time frame: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days
Disease control rate
DCR is defined as the percentage of patients relative to the total of enrolled subjects who achieve a complete response (CR) , partial response (PR) or stable disease (SD) based on CT or MRI scan images
Time frame: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days
Adverse Events
Assessment of Safety and tolerance for sintilimab plus FOLFIRI as salvage therapy in patients with unresectable/metastatic gastric cancer, including incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Time frame: from the date of the first medicine to 28±7 days after the last medicine
Baseline ctDNA level
Detection of circulating tumor DNA (ctDNA) levels in peripheral blood before the initial treatment
Time frame: At baseline, prior to initial treatment
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University