Hepatocellular Carcinoma (HCC)Phase 1NCT06882876
JS014 Combined With Toripalimab and TACE in Unresectable HCC: a Phase Ib Study
A Phase 1 study testing JS014 Combined With Toripalimab and TACE in people with Hepatocellular Carcinoma (HCC), run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- JS014 Combined With Toripalimab and TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 30 Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase Ib Exploratory Study on the Combination of JS014 and Toripalimab in Combination With Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma.
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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- JS014 Combined With Toripalimab and TACE
- Keywords
- JS014, Toripalimab, BCLC Stage B Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS014 Combined With Toripalimab and TACEDrug
JS014 (60μg/kg,QW)+Toripalimab (240mg , Q3W)+ dTACE (60mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| JS014 combined With Toripalimab and TACE | Experimental | Not described Receives: Drug: JS014 Combined With Toripalimab and TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of adverse events
Safety and tolerability
Measured: Two years
Secondary outcomes (6)
ORR (RECIST 1.1)
Objective response rate
Measured: Two years
DCR
disease control rate
Measured: Two years
PFS
Progression free survival
Measured: Two years
TTP
time to progress
Measured: Two years
OS
Overall survival
Measured: Two years
ORR(mRECIST)
Objective response rate
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 Jul 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Liangrong Shi, M.D., Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882876
- Sponsor's protocol ID
- JS014-F01
- Status last verified
- Sep 2024
- First submitted
- 21 Nov 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Exploratory Study on the Combination of JS014 and Toripalimab in Combination With Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT06882876
- Acronym / sponsor ID
- JS014-F01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- JS014, Toripalimab, BCLC Stage B Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JS014 combined With Toripalimab and TACE | Experimental | Drug: JS014 Combined With Toripalimab and TACE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS014 Combined With Toripalimab and TACEJS014 (60μg/kg,QW)+Toripalimab (240mg , Q3W)+ dTACE (60mg/m2) | Drug | JS014 combined With Toripalimab and TACE |
Primary outcome
The rate of adverse events
Time frame: Two years
Safety and tolerability
6 secondary outcomes
ORR (RECIST 1.1)
Time frame: Two years
DCR
Time frame: Two years
PFS
Time frame: Two years
TTP
Time frame: Two years
OS
Time frame: Two years
ORR(mRECIST)
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liangrong Shi, M.D. principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS014 Combined With Toripalimab and TACE in people with Hepatocellular Carcinoma (HCC), run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of adverse events (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.