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

NCT05319639 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-02-27

No results posted yet for this study

Summary

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.

Conditions

  • Gastric Cancer Stage IV

Interventions

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

Paclitaxel

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.

DRUG

Irinotecan

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.

DRUG

Tislelizumab

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-16
Primary Completion
2024-10-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319639 on ClinicalTrials.gov