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

Launched by XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial, called JS014 Combined With Toripalimab and TACE in Unresectable HCC, is studying a new treatment approach for patients with a type of liver cancer known as hepatocellular carcinoma (HCC) that cannot be surgically removed. The researchers want to find out if the combination of two medications, JS014 and Toripalimab, along with a procedure called transarterial chemoembolization (TACE), is safe and effective. The trial will measure how well patients respond to the treatment and how long they can live without the cancer getting worse.

To participate in this study, patients must be between 18 and 75 years old and have been diagnosed with unresectable HCC. They should not have received previous cancer treatments, and their overall health must allow them to participate (as determined by specific health criteria). If you or someone you know is interested, it’s important to discuss it with a healthcare provider to see if they meet the eligibility requirements. The study is not currently recruiting participants, but it will provide valuable information about potential new therapies for liver cancer in the future.

Gender

ALL

Eligibility criteria

• 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.