RecruitingPhase 1Phase 2NCT05319639

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

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


Sponsor

Fujian Cancer Hospital

Enrollment

51 participants

Start Date

Feb 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase I/II study tests a new chemotherapy combination (irinotecan plus POF — paclitaxel, oxaliplatin, and 5-FU) in patients with advanced biliary tract cancer (cancers of the bile ducts or gallbladder) that has stopped responding to standard treatment. **You may be eligible if...** - You have advanced biliary tract cancer (bile duct or gallbladder cancer) - Your cancer has progressed on at least one prior line of chemotherapy - You are 18 or older - You are in reasonably good physical condition (ECOG 0-2) - Your organ function is adequate **You may NOT be eligible if...** - You have severe nerve damage (neuropathy) from prior chemotherapy - You have active brain metastases - You are pregnant or breastfeeding - You have had a prior bone marrow transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxaliplatin

Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.

DRUGLevo-Leucovorin

Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.

DRUG5-fluorouracil

5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.

DRUGPaclitaxel

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.

DRUGIrinotecan

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.

DRUGTislelizumab

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


Locations(1)

Fujian cancer hospital

Fuzhou, Fujian, China

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NCT05319639


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