Actively Recruiting
Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-04-15
40
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic or locally advanced, unresectable gastric adenocarcinoma confirmed by histology or cytology
- Progression or intolerance to first-line treatment
- Age between 18 and 75 years old
- ECOG performance status score of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function as defined by specific blood count and chemistry levels
- International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) less than 1.5 times the upper limit of normal
- Negative pregnancy test within 7 days before enrollment unless woman is not of reproductive potential
- Fertile women and men must agree to use contraception during the study and for 3 months after last treatment
- Ability to understand study and provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- History of severe adverse reactions or hyperprogression during prior immunotherapy
- Received chemotherapy or biotherapy within 28 days before starting the study drug
- More than 30% of bone marrow previously irradiated; limited palliative radiotherapy allowed
- Other malignant tumors within past 5 years or concurrent
- Severe neurological or psychiatric disorders
- Uncontrolled or symptomatic brain metastases
- Active autoimmune diseases
- Use of immunosuppressive or systemic steroids above 10 mg/day prednisone equivalent within 14 days before treatment
- Allergies to study drugs or their components
- Uncontrolled hypertension, heart disease, heart failure, or arrhythmias beyond specified criteria
- Severe infections within 4 weeks before treatment or recent therapeutic antibiotic use within 2 weeks
- Congenital or acquired immune deficiencies such as HIV infection
- Receipt of live attenuated vaccines within 28 days before or expected during treatment or within 60 days after last dose of sintilimab
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Q
Qiong Yang, Doctor
CONTACT
Y
Yajing Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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