NCT07147088

Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma.

Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-03): A Single-arm, Phase 2 Trial.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (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 SHR-1701, a bifunctional fusion protein targeting PD-L1 and TGF-β, plus famitinib, a multi-targeted receptor tyrosine kinase inhibitor, in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.

Detailed description

This study will recruit advanced ICC who have progressed after GemCis plus PD1/PD-L1 inhibitor. The participant will receive cryoablation combined with SHR-1701 plus famitinib.

Conditions

• Advanced Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	SHR-1701	SHR-1701 will be administered by IV, 1200mg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
DRUG	Famitinib	Famitinib will be administered at 15 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. SHR-1701 plus famitinib will be administered 1-3 days after cryoablation.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: China