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

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.

Hepatic arterial infusion chemotherapy (HAIC)-GC（Gemcitabine+Cisplatin） combined with Durvalumab OR Pembrolizumab

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 a history of other malignant tumors.
6. Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.
7. Drug allergy or intolerance: Allergic to the investigational drug or its excipients.
8. Other: Other situations that the researcher deems unsuitable to participate in this study