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JS014 Combined With Toripalimab and TACE in Unresectable HCC: a Phase Ib Study

StatusEnrolling by Invitation
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Primary completion date: Jan 1, 2026 to Jan 1, 2027
    • Start date changed from estimate of Mar 20, 2025 to Jul 10, 2025
    • Study completion date: May 30, 2027 to Jul 30, 2029
    • Site contact updated
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06882876
Lead Sponsor Xiangya Hospital of Central South University
Collaborators: Shanghai Junshi Bioscience Co., Ltd.
Conditions
(from sponsor)		 Hepatocellular Carcinoma (HCC)
Related terms Carcinoma, Hepatocellular
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov