Actively Recruiting
Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab
Led by Fujian Cancer Hospital · Updated on 2025-02-27
51
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
CONDITIONS
Official Title
Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction
- With or without measurable lesions
- Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
- No serious systemic dysfunction and able to tolerate chemotherapy
- Normal marrow, liver, and renal function including hemoglobin 100g/L without recent blood transfusion, leucopenia count 4.0�d7109/L, platelet count 100�d7109/L, total bilirubin 1.5 times upper normal limit, creatinine 1.5 times upper normal limit, creatinine clearance rate 50 ml/min, and liver enzymes within specified limits
- Life expectancy of at least 3 months
- Normal electrocardiogram and no history of congestive heart failure
- Normal coagulation function (APTT, PT, INR each 1.5 times upper normal limit)
- Female participants of child-bearing potential must agree to contraceptive measures starting 1 week before first dose until 8 weeks after discontinuing study drug
- Male participants must agree to contraceptive measures during study and for 8 weeks after last dose
- Signed written informed consent
- Good compliance and agreement to follow-up of disease progression and adverse events
You will not qualify if you...
- History of another cancer within past 3 years except basal cell carcinoma of skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
- Brain or central nervous system metastases including leptomeningeal disease
- Pregnant or breastfeeding
- Serious, non-healing wounds, ulcers, or bone fractures
- Significant cardiac disease including unstable angina, NYHA grade II or greater, congestive heart failure, recent myocardial infarction within 6 months
- Evidence of bleeding disorders or coagulopathy
- History of stroke or cerebrovascular accident within 6 months
- Clinically significant peripheral vascular disease
- Inability to comply with study or follow-up procedures
- Any other medical condition or reason making the patient unstable for clinical trial participation according to investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian cancer hospital
Fuzhou, Fujian, China, 350500
Actively Recruiting
Research Team
L
lin rong bo, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here