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RECRUITING
NCT07364305
PHASE2

HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC

Sponsor: Eastern Hepatobiliary Surgery Hospital

View on ClinicalTrials.gov

Summary

Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.

Official title: HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-01-01

Completion Date

2028-01-01

Last Updated

2026-01-23

Healthy Volunteers

Yes

Interventions

DRUG

PD-L1 inhibitor

PD-L1 inhibitor Drug: Durvalumab OR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab: During combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 200 mg Q4W

PROCEDURE

HAIC

Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic arterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: Cisplatin 20mg/m2, maintained for 3 hours. Gemcitabine 0.6g/m2, maintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles was determined by the investigator according to the patient's condition).

Locations (1)

Shanghai Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China