JS014 Combined With Toripalimab and TACE in Unresectable HCC: a Phase Ib Study
NCT06882876 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-09-19
Summary
This is an open-label, single-center, single-arm phase Ib clinical trial. The aim of this study is to assess the safety and efficacy of JS014 in combination with Toripalimab and transarterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (HCC). The primary endpoint is the safety and tolerability, while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), time to progression (TPP), progression-free survival (PFS), and overall survival (OS).
Conditions
- Hepatocellular Carcinoma (HCC)
Interventions
- DRUG
-
JS014 Combined With Toripalimab and TACE
JS014 (60μg/kg,QW)+Toripalimab (240mg , Q3W)+ dTACE (60mg/m2)
Sponsors & Collaborators
-
Shanghai Junshi Bioscience Co., Ltd.
collaborator OTHER -
Xiangya Hospital of Central South University
lead OTHER
Principal Investigators
-
Liangrong Shi, M.D. · Xiangya Hospital of Central South University
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
- 2025-07-10
- Primary Completion
- 2027-01-01
- Completion
- 2029-07-30
Countries
- China
Study Locations
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