RecruitingPhase 2NCT07364305

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

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


Sponsor

Eastern Hepatobiliary Surgery Hospital

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called HAIC and a drug called PD-L1 inhibitor for people with advanced cancer and icc. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

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

DRUGPD-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

PROCEDUREHAIC

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

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NCT07364305


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