Combined DEB-TACE, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma
NCT06192784 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2024-01-09
Summary
This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of drug eluting beads-transcatheter arterial chemoembolization combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.
Conditions
- Cholangiocarcinoma Non-resectable
Interventions
- PROCEDURE
-
DEB-TACE
transcatheter arterial chemoembolization with doxorubicin embedded eluting beads- was performed every 3 weeks through the tumor feeding arteries.
- DRUG
-
Lenvatinib plus pucotenlimab
lenvatinib (8mg, qd) plus pucotenlimab (200mg, q3w)
Sponsors & Collaborators
-
Geneplus-Beijing Co. Ltd.
collaborator INDUSTRY -
Chinese Cooperative Group of Liver Cancer
collaborator OTHER -
Tongji Hospital
lead OTHER
Principal Investigators
-
Ze-yang Ding, M.D. · Tongji Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-09
- Primary Completion
- 2025-01-31
- Completion
- 2025-06-30
Countries
- China
Study Locations
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