RecruitingPhase 2NCT06860477

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

Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01): a Multicenter, Randomized, Phase 2 Study


Sponsor

Fudan University

Enrollment

92 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus Tislelizumab compared with FOLFOX in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing cryoablation (a technique that uses extreme cold to destroy tumors) combined with lenvatinib plus tislelizumab (targeted therapy + immunotherapy) against standard FOLFOX chemotherapy in patients with advanced bile duct cancer (intrahepatic cholangiocarcinoma) that has not responded to one prior treatment. **You may be eligible if...** - You are 18 or older - You have confirmed unresectable or metastatic intrahepatic cholangiocarcinoma - Your cancer has progressed or was intolerable on 1 prior systemic treatment - You have at least one measurable tumor on imaging - Your general health score (ECOG) is 2 or below and life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have clinically significant heart disease or had significant GI bleeding in the past 4 weeks - You had a stroke, deep vein thrombosis, or pulmonary embolism in the past 6 months - You previously received cryoablation, lenvatinib, or other targeted therapies - You had radiation or other ablation treatment within 4 weeks of study start Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

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

DRUGLenvatinib

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

PROCEDUREcryoablation

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.

DRUGFOLFOX (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


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06860477