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

Sponsor
Fujian Cancer Hospital
Study ID
NCT06197438
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Jan 2024
Primary completion
Apr 11, 2024
Completion
Apr 1, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: POFI and Tislelizumab

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: From enrollment to 12 month ]

Central Contacts

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