Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2028

Conditions
Intrahepatic Cholangiocarcinoma (Icc)HAICDurvalumab
Interventions
DRUG

Durvalumab

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

DRUG

hepatic arterial infusion chemotherapy (HAIC)

hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: cisplatin 60 mg/m2 on the first day, arterial infusion for half an hour, gemcitabine 1000 mg/m2 on the first day, arterial infusion for half an 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).

DRUG

Lenvatinib

Lenvatinib 8mg (weight \<60 kg) or 12mg (weight ≥60 kg) oral QD, during combination therapy, starting on day 3 of each 3-week cycle (determined by the investigator)

Trial Locations (1)

Unknown

RECRUITING

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER