NCT06197438

Phase II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab in Advanced Gastric Cancer

PD-1 Antibody(Tislelizumab) Plus Irinotecan Combined With POF in Treatment Naive Advanced Gastric Cancer: A Phase II Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single center, phase II study, to evaluate the effectiveness and safety of PD-1 Antibody(Tislelizumab) Plus Irinotecan Combined With POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the first-line treatment for patients with advanced/metastatic gastric cancer.

Detailed description

This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to compare that ORR of patients with Tislelizumab plus Irinotecan and POF for advanced/metastatic gastric cancer. In treatment period, patients will be administrated Tislelizumab plus Irinotecan and POF, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination. The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab will be administered on day 1 of each cycle at 200mg once every 21 days.
DRUG	Oxaliplatin	Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
DRUG	Levo-Leucovorin	Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
DRUG	5-fluorouracil	5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
DRUG	Irinotecan Hydrochloride	Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 once every 14 days.
DRUG	Paclitaxel	Paclitaxel will be administered on day 1 of each cycle at 90 mg/m2 once every 14 days.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-04-11
• Completion: 2025-04-01
• First posted: 2024-01-09
• Last updated: 2024-01-09