drugset / Trial / NCT06882876
JS014 Combined With Toripalimab and TACE in Unresectable HCC: a Phase Ib Study
Phase 1
Enrolling by invitation
20 enrolled
Xiangya Hospital of Central South University
Shanghai Junshi Bioscience Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2025-07-10
- Primary completion
- 2027-01-01
- Completion
- 2029-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JS014 | Protein / enzyme biologic | 60 ug/kg | — |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |