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

NCT06882876 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: JS014-F01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

JS014; Toripalimab; BCLC Stage B Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• The rate of adverse events

  Safety and tolerability

  Two years

Secondary Outcomes (6)

• ORR (RECIST 1.1)

  Two years

• DCR

  Two years

• PFS

  Two years

• TTP

  Two years

• OS

  Two years

Study Arms (1)

JS014 combined With Toripalimab and TACE

EXPERIMENTAL

Drug: JS014 Combined With Toripalimab and TACE

Interventions

JS014 Combined With Toripalimab and TACE DRUG

JS014 (60μg/kg,QW)+Toripalimab (240mg , Q3W)+ dTACE (60mg/m2)

JS014 combined With Toripalimab and TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form, voluntarily participate in this study, good compliance and follow-up cooperation.
• Histologically or pathologically confirmed unresectable hepatocellular carcinoma;
• Male or female patients aged 18-75 years;
• Eastern Cooperative Oncology Group (ECOG) PS score of 0-1;
• Child-Pugh score of ≤7;
• BCLC/B stage; not previously treated with anti-cancer therapy; at least one measurable lesion (according to RECIST 1.1 criteria).
• Sufficient organ function in vital organs (excluding serious functional impairment in the heart, lung, liver, kidney, bone marrow, nervous system, and endocrine systems).

You may not qualify if:

• Diagnosed with fibrolamellar carci-noma of liver, intrahepatic cholangiocarcinoma, and mixed carcinoma;
• Within 28 days prior to the start of the study, the participant received treatment with another investigational drug or participated in another clinical study for a different therapeutic indication.;
• Based on the investigator's judgment, the patient is expected to live for less than 12 weeks;
• Uncontrolled pleural effusion, pericardial effusion, or ascites of moderate volume or more;
• Current or past history of central nervous system metastasis;
• Have a history of psychotropic drug abuse or drug use;
• Hereditary or acquired tendency towards bleeding and thrombosis, a thromboembolic event occurred within the past 6 months;
• Have a history of severe allergy to any monoclonal antibody, Toripalimab , JS014 and other ingredients of this study;
• Pregnant or breastfeeding women;
• Subjects with other factors that, in the judgment of the investigator, may cause the study to be prematurely terminated.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Liangrong Shi, M.D.

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: March 19, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 30, 2029
• Last Updated: September 19, 2025

Record last verified: 2024-09

Locations

CN (1)