Actively Recruiting
Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab
Led by Fujian Cancer Hospital · Updated on 2025-02-27
51
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a combination treatment involving Irinotecan and paclitaxel with 5-fluorouracil, leucovorin, oxaliplatin, and Tislelizumab for patients with advanced unresectable gastric or gastroesophageal junction adenocarcinoma. This phase I/II study aims to determine the maximum dose patients can tolerate and assess the overall response, progression-free survival, and overall survival over two years. The treatment regimen includes sequential dosing of Irinotecan and paclitaxel at increasing levels on day 1 of each 14-day cycle. Oxaliplatin and Levo-leucovorin are given on day 1, followed by a 46-hour infusion of 5-fluorouracil using an ambulatory pump. Tislelizumab is administered at a fixed dose every 14 days. Dose-limiting toxicities are monitored during the first four weeks to guide dose escalation, with specific criteria to define when to stop increasing doses. Participants will receive regular treatments every two weeks and undergo monitoring for safety and treatment response. Researchers will evaluate the maximum tolerated dose after one month and follow patients for up to two years to track treatment outcomes. Safety assessments include blood tests, organ function tests, and performance status evaluations. The total study duration spans from the start date until the planned end date in late 2025.
CONDITIONS
Brief 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.
- Patients with or without measurable lesions.
- Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Patients must have normal marrow, liver, and renal function meeting specified laboratory thresholds.
- Life expectancy of at least 3 months.
- Normal electrocardiogram results and no history of congestive heart failure.
- Normal coagulation function with specified laboratory values.
- Female subjects of child-bearing potential must agree to use contraceptives starting 1 week before first dose until 8 weeks after stopping study drug; males must also agree to contraceptive use during and 8 weeks after study.
- Written informed consent signed voluntarily by patients or their legal representatives.
- Good compliance and agreement to follow-up for disease progression and adverse events.
You will not qualify if you...
- History of another cancer within the past three years, except certain skin, cervical, or prostate cancers.
- Brain or central nervous system metastases, including leptomeningeal disease.
- Pregnant or breastfeeding women.
- Serious, non-healing wounds, ulcers, or bone fractures.
- Significant cardiac disease including unstable angina, congestive heart failure, recent myocardial infarction.
- Evidence of bleeding disorders or coagulopathy.
- History of stroke within 6 months.
- Clinically significant peripheral vascular disease.
- Inability to comply with study or follow-up procedures.
- Any other medical condition making participation unsafe or unstable as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles with evaluation during the first 4 weeks for dose limiting toxicities
Participants receive a combination of chemotherapy drugs and immunotherapy every 14 days in repeated cycles. The drugs include irinotecan, paclitaxel, oxaliplatin, levo-leucovorin, 5-fluorouracil, and tislelizumab. Treatment continues with dose adjustments based on tolerance and safety assessments.
Visits every 14 days for treatment administration
Trial Site Locations
Total: 1 location
1
Fujian cancer hospital
Fuzhou, Fujian, China, 350500
Actively Recruiting
Research Team
L
lin rong bo, bachelor
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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