Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab

Sponsor
Fujian Cancer Hospital
Study ID
NCT05319639
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Gastric Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Paclitaxel — DRUG
    Paclitaxel will be administered on day 1 of each cycle at 45mg/m2 at dose level 1; 67.5 mg/m2 at dose level 2 ; 90 mg/m2 at dose level 3; 112.5 mg/m2 at dose level 4 once every 14 days.
  • Irinotecan — DRUG
    Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 at dose level 1; 150 mg/m2 at dose level 2 once every 14 days.
  • Tislelizumab — DRUG
    Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Study Details

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.

Key Dates

Start date
Feb 16, 2023
Status verified
Jan 2025
Primary completion
Oct 31, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: POFI and Tislelizumab
    This study will include a sequential evaluation of 3 subjects per cohort. Irinotecan 135 → 150 and paclitaxel 45 → 67.5 → 90 mg/m2 on day 1. The rest of regimen is that oxaliplatin (85 mg/m2) and Lev-leucovolin (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. Tislelizumab 200mg，repeating the cycle every 14 days. A dose limiting toxicity (DLT) event is defined as any of the following events in the first 4-week period: CTCAE Grade 4 event (except for neutropenia lasting for ≤ 5 days); Grade 3 non-hematologic toxicity (except for nausea and vomiting that could be improved with optimal supportive care, escalation of alkaline phosphatase) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If 2 DLTs are experienced in any cohort, the dose escalation ceased. The MTD was defined as the dose having at most two out of six patients experience DLT.

Primary Outcome Measure

The maximum dose tolerated [ Time Frame: 1 month ]

Central Contacts