At a glance
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A Phase II Study of Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-01)
In Brief
A Phase 2 clinical trial evaluating cryoablation, Sintilimab, and 1 other intervention for Intrahepatic Cholangiocarcinoma. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic Cholangiocarcinoma after progression on first line systemic therapy.
Study Details
Timeline
Interventions
Cryoablation treatment starts at day 0.
Sintilimab will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.