Overview
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.
Description
Hepatic arterial infusion chemotherapy (HAIC)-GC（Gemcitabine+Cisplatin） combined with Durvalumab OR Pembrolizumab
Eligibility
Inclusion Criteria:
- Age: Age ≥ 18 years old.
- Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.
- Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).
- Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.
- Expected lifespan: Expected lifespan ≥ 3 months.
- Liver function: Child Pugh classification A or B.
- Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.
- Not receiving relevant treatment: Not receiving systematic treatment for ICC.
Exclusion Criteria:
- Previous treatment: Previously received systemic treatment for ICC.
- Poor physical condition: ECOG physical condition score ≥ 2.
- Poor liver function: Child Pugh grading\>8.
- Short life expectancy: Life expectancy is less than 3 months.
- Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors.
- Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.
- Drug allergy or intolerance: Allergic to the investigational drug or its excipients.
- Other: Other situations that the researcher deems unsuitable to participate in this study