Combining Irinotecan and Tislelizumab for Advanced Gastric Cancer

Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab

This study is testing a new combination of treatments for people with advanced stomach cancer to see if it is safe and effective.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (other gov)
• Drugs / interventions: Tislelizumab, chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05319639 on ClinicalTrials.gov

What this trial studies

This phase I/II study aims to evaluate the safety and efficacy of a combination treatment involving Irinotecan, Paclitaxel, and Tislelizumab in patients with advanced unresectable gastric cancer. The study will assess the tolerability of this regimen in patients with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction. Participants will be monitored for their performance status and various health parameters to ensure they can tolerate the chemotherapy involved in the treatment.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced unresectable gastric or gastroesophageal junction adenocarcinoma who meet specific health criteria.

Not a fit: Patients with serious systemic dysfunction or those who cannot tolerate chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastric cancer, potentially improving survival rates.

How similar studies have performed: Other studies have explored similar combinations of chemotherapy and immunotherapy, showing promising results, but this specific combination is novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
2. With or without measurable lesions.
3. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
4. Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
5. Life expectancy ≥3 months.
6. With normal electrocardiogram results and no history of congestive heart failure.
7. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
8. Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
9. With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
10. With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

1. Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
2. Patients with brain or central nervous system metastases, including leptomeningeal disease.
3. Pregnant (positive pregnancy test) or breast feeding.
4. Serious, non-healing wound, ulcer, or bone fracture.
5. Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
6. History of a stroke or CVA within 6 months.
7. Clinically significant peripheral vascular disease.
8. Inability to comply with study and/or follow-up procedures.
9. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.

Where this trial is running

Fuzhou, Fujian

• Fujian cancer hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: lin rong bo, bachelor

Conditions: Gastric Cancer Stage IV