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
Eastern Hepatobiliary Surgery Hospital
50 participants
Jan 1, 2025
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
Inclusion Criteria8
- 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 Criteria8
- 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
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Interventions
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
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)
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NCT07364305