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.
Metastatic or locally advanced, unresectable HER2-negative gastric adenocarcinoma confirmed by histology or cytology
Progression or toxicity intolerance of first-line treatment
Patients aged ≥ 18 years
ECOG score 0-2
Pregnant and lactating women
The patient has experienced hyperprogression and immunotherapy related grade 3 or above adverse reactions during previous immunotherapy
Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug, 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
Suffering from other malignant tumors within the past 5 years or simultaneously
Single group
Sintilimab+irinotecan+leucovorin folinate+fluorouracil
Drugsintilimab 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
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.
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.
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
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
Baseline ctDNA level
Detection of circulating tumor DNA (ctDNA) levels in peripheral blood before the initial treatment
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