NCT06882876Enrolling by invitationPhase 1
JS014 Combined With Toripalimab and TACE in Unresectable HCC: a Phase Ib Study
Phase Ib Exploratory Study on the Combination of JS014 and Toripalimab in Combination With Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma.
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 10 Jul 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Xiangya Hospital of Central South University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06882876
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 10 Jul 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.;
Other illness
- 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;
Other
- Diagnosed with fibrolamellar carci-noma of liver, intrahepatic cholangiocarcinoma, and mixed carcinoma;
- 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;
- Pregnant or breastfeeding women;
- Subjects with other factors that, in the judgment of the investigator, may cause the study to be prematurely terminated.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.