Status:
ENROLLING_BY_INVITATION
JS014 Combined With Toripalimab and TACE in Unresectable HCC: a Phase Ib Study
Lead Sponsor:
Xiangya Hospital of Central South University
Collaborating Sponsors:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 chemoemb...
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 embar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06882876
Start Date
July 10 2025
End Date
July 30 2029
Last Update
September 19 2025
Active Locations (1)
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1
Xiangya Hospital
Changsha, Hunan, China