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

Naval Military Medical University (Second Military Medical University)

Status and phase: Enrolling; Phase 2

Conditions: Advanced Cancer; ICC

Treatments: Drug: PD-L1 inhibitor; Procedure: HAIC

Study type: Interventional

Funder types: Other

Identifiers

NCT07364305

Lalo

20241130 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

HAIC combined with PD-L1 inhibitor

Experimental group

Description:

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). 2. 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

Treatment:

Procedure: HAIC

Drug: PD-L1 inhibitor