RecruitingPhase 2NCT07070700

Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma

Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-02): A Single-arm, Multi-cohort, Phase 2 Trial


Sponsor

Fudan University

Enrollment

56 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus QL1706 (iparomlimab/tuvonralimab) 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 tests a combination approach for advanced bile duct cancer inside the liver (intrahepatic cholangiocarcinoma): freezing the tumor (cryoablation) combined with two drugs — lenvatinib (a targeted therapy) and QL1706 (a dual immunotherapy drug). This is for patients whose cancer has progressed after at least one prior treatment. **You may be eligible if...** - You are 18 or older - You have unresectable or metastatic bile duct cancer (intrahepatic cholangiocarcinoma) confirmed by biopsy - Your cancer progressed after at least one prior systemic treatment regimen **You may NOT be eligible if...** - You have never tried any prior systemic treatment - You have significant liver disease or poor health - You are pregnant or breastfeeding - You have autoimmune conditions that could be worsened by immunotherapy 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGQL1706 (bispecific antibody targeting PD-1 and CLTA-4)

QL1706 will be administered by IV, 5 mg/kg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

DRUGLenvatinib

Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

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 QL1706 will be administered 1-3 days after cryoablation.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07070700


Related Trials