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RecruitingPhase 2NCT07364305

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

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Trial Parameters

ConditionICC
SponsorEastern Hepatobiliary Surgery Hospital
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment50
SexALL
Min Age18 Years
Max Age75 Years
Start Date2025-01-01
Completion2028-01-01
All Conditions
Interventions
PD-L1 inhibitorHAIC

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Brief 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 Criteria

Inclusion Criteria: 1. Age: Age ≥ 18 years old. 2. Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging. 3. Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria). 4. Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1. 5. Expected lifespan: Expected lifespan ≥ 3 months. 6. Liver function: Child Pugh classification A or B. 7. Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol. 8. Not receiving relevant treatment: Not receiving systematic treatment for ICC. Exclusion Criteria: 1. Previous treatment: Previously received systemic treatment for ICC. 2. Poor physical condition: ECOG physical condition score ≥ 2. 3. Poor liver function: Child Pugh grading\>8. 4. Short life expectancy: Life expectancy is less than 3 months. 5. Merge with other malignant tumors: have other malignant tumors or

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