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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06882876 on ClinicalTrials.gov