Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JS014 Combined With Toripalimab and TACE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JS014 combined With Toripalimab and TACE
- interventionNames
- Drug: JS014 Combined With Toripalimab and TACE
Primary outcomes (1)
- measure
- The rate of adverse events
- timeFrame
- Two years
- description
- Safety and tolerability
Secondary outcomes (6)
- measure
- ORR (RECIST 1.1)
- timeFrame
- Two years
- description
- Objective response rate
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available