Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01)

PHASE2RecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

March 15, 2027

Study Completion Date

March 15, 2028

Conditions
Intrahepatic Cholangiocellular Carcinoma
Interventions
DRUG

Tislelizumab

Tislelizumab will be administered by IV, 200 mg on day 1 of each 21 day cycle.

DRUG

Lenvatinib

Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily

PROCEDURE

cryoablation

Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone. Lenvatinib plus Tislelizumab will be administered 1-3 days after cryoablation.

DRUG

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

FOLFOX chemotherapy was administered intravenously every 2 weeks for a maximum of 12 cycles (oxaliplatin 85 mg/m², leucovorin, 400 mg/m2, fluorouracil 400 mg/m² \[bolus\], and fluorouracil 2400 mg/m² as a 46-h continuous intravenous infusion

Trial Locations (1)

200032

RECRUITING

Zhongshan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER