Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric C… (NCT06365008) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer
China27 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Estimated life expectancy of at least 12 weeks
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing sintilimab combined with FOLFIRI chemotherapy as a second-line treatment — does that mean I would need to have already tried a first-line treatment that didn't work, and would that fit where I am in my treatment journey?
2Since this is a Phase 2 trial, the main thing being measured is whether patients are still progression-free at 5 months — what does that tell us about how much is already known about whether this combination is safe and effective compared to standard second-line options?
3The trial isn't recruiting yet — do you know when it's expected to open, and is there a standard second-line treatment I should consider starting now rather than waiting?
4My cancer needs to be HER2-negative to be considered for this trial — has my tumor already been tested for HER2 status, and if not, should we do that testing regardless of this trial?
5The FOLFIRI chemotherapy regimen involves regular infusions on a specific schedule — given my current health and daily responsibilities, is the treatment schedule for this trial something that would realistically work for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
5-month progression-free survival (PFS) rate
Timeframe: Undergo imaging examination to evaluate efficacy every 8 weeks ±7 days
Trial details
NCT IDNCT06365008
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) \<1.5 x ULN (thromboembolic event must be ruled out if D-dimer is abnormal)
. Negative pregnancy test not more than 7 days before enrollment,Pregnancy tests can only be omitted in women who do not have any reproductive potential (e.g., postmenopausal women, i.e. amenorrhea ≥2 years or prior hysterectomy or bilateral oophorectomy). Fertile women and men must consent to the use of appropriate contraception at the time of enrollment and during study participation for at least 3 months after the last treatment
Exclusion criteria
. 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
. Suffering from severe neurological and psychiatric disorders
. Patients with uncontrolled or symptomatic brain metastases
. Patients with active autoimmune diseases
. 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