NCT07070700

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Two cohorts will be recruited. Cohort A will recruit advanced ICC who have progressed after GemCis plus PD1/PD-L1 inhibitor. Cohort B will recruit advanced ICC who have progressed after GemCis plus PD1/PD-L1 inhibitor and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors. Both cohorts will receive cryoablation combined with lenvatinib plus QL1706.

Conditions

• Intrahepatic Cholangiocarcinoma (Icc)

Interventions

Type	Name	Description
DRUG	QL1706 (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.
DRUG	Lenvatinib	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.
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 QL1706 will be administered 1-3 days after cryoablation.

Timeline

• Start date: 2025-08-20
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-07-17
• Last updated: 2025-08-12

Locations

1 site across 1 country: China