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

Phase 1

Not yet recruiting

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Drug: JS014 Combined With Toripalimab and TACE

• Registration Number: NCT06882876
• Lead Sponsor: Xiangya Hospital of Central South University

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).

Detailed Description

There is already existing evidence indicating that the efficacy of PD-1/PD-L1 therapy is closely associated with the immune response status within the tumor microenvironment. Researchers are now embarking on exploring immune-activating treatment approaches that can synergize with immunotherapy in the battle against cancer. This includes local treatments such as radiation therapy and local ablation therapy, which can induce local inflammation and release antigens to activate anti-tumor immune responses and enhance the efficacy of PD-1 antibodies. Multiple preclinical studies have confirmed that transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) can induce immunogenic necrosis and activate anti-tumor immune responses. This study is designed to investigate the safety and efficacy of TACE combined with JS014 and Toripalimab in the treatment of advanced liver cancer. It is an open-label, single-center, single-arm phase Ib clinical trial.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Start: 2025-03-20
• Primary Completion: 2026-01-01
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JS014 combined With Toripalimab and TACE	JS014 Combined With Toripalimab and TACE	-

Primary Outcome Measures

Name	Time	Method
The rate of adverse events	Two years	Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
TTP	Two years	time to progress
ORR (RECIST 1.1)	Two years	Objective response rate
DCR	Two years	disease control rate
PFS	Two years	Progression free survival
OS	Two years	Overall survival
ORR(mRECIST)	Two years	Objective response rate

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China