Hepatocellular CarcinomaPhase 3NCT07823348
JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer
A Phase 3 study testing JS207, JS007 and Toripalimab in people with Hepatocellular Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, randomized, open-label, controlled Phase III clinical study designed to evaluate the efficacy and safety of JS207 in combination with JS007 versus toripalimab in combination with bevacizumab as first-line treatment in participants with advanced HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- JS207, JS007 and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesChina
- Study dates
- 8 Oct 2026to 30 Oct 2031
- Phase
- Phase 3
- 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
- Voluntarily participate and sign a written informed consent form.
- Aged 18-75 years, regardless of sex.
- Histologically/cytologically confirmed HCC, or cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
- No prior systemic therapy for HCC.
- At least one measurable lesion per RECIST v1.1 criteria.
- Child-Pugh liver function grade A or grade B with a score ≤7, and no history of hepatic encephalopathy.
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
- Expected survival ≥ 12 weeks.
- Adequate hematologic and end-organ function.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use a highly effective contraceptive method during the study and for at least 6 months after the last dose. Female participants of childbearing potential must have a negative blood HCG test within 7 days prior to study enrollment and must not be breastfeeding.
Who cannot join
- Concomitant with the following study disease states: Known intrahepatic cholangiocarcinoma (ICC) or mixed-type liver cancer, sarcomatoid hepatocellular carcinoma, and fibrolamellar carcinoma of the liver; Presence of HCC central nervous system metastasis.
- Prior treatment-related toxicity not recovered to ≤ CTCAE Grade 1.
- Severe infection at screening.
- Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically apparent moderate or greater ascites at screening.
- -≥ Grade 3 (NCI-CTCAE v6.0) gastrointestinal or non-gastrointestinal fistula at screening.
- Severe unhealed wounds, active ulcers, or untreated fractures at screening.
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- Severe cardiovascular or cerebrovascular disease:
- History of gastrointestinal bleeding within 6 months prior to the first dose, or definite tendency for gastrointestinal bleeding.
- Other obvious bleeding tendency or evidence of major coagulation disorders:
- Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
- Malignancy other than HCC within 5 years prior to the first dose.
- Confirmed or suspected moderate-to-severe pulmonary disease severely affecting pulmonary function.
- Active tuberculosis.
- Co-infection with hepatitis B and hepatitis C.
- Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or solid organ transplantation, or other immunodeficiency.
- Known history of severe allergy to any monoclonal antibody.
- Other factors that, in the investigator's judgment, may affect study results or lead to forced premature termination of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng, Ph.D., +86 15134569619, ztsgcp@126.com
Tongsen Zheng, Ph.D.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jia Fan, Ph.D., +86 021 64041990, fan.jia@zs-hospital.sh.cn
Guoming Shi, Ph.D., +86 13916969578, shi.guoming@zs-hospital.sh.cn
About this study
Official title: A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of JS207 in Combination With JS007 Versus Toripalimab in Combination With Bevacizumab as First-line Treatment for Advanced Hepatocellular Carcinoma
This is a multicenter, randomized, open-label, controlled Phase III clinical study designed to evaluate the efficacy and safety of JS207 in combination with JS007 versus toripalimab in combination with bevacizumab as first-line treatment in participants with advanced HCC.
All study participants have unresectable locally advanced, recurrent, or metastatic HCC and have not previously received systemic anti-tumor therapy for advanced disease.
Approximately 560 participants are planned to be enrolled in this study. The JS207 + JS007 group (experimental group) and the toripalimab + bevacizumab group (positive control group) are each planned to enroll 280 participants.
Read the detailed description
This is a multicenter, randomized, open-label, active-controlled Phase III study in participants with unresectable locally advanced, recurrent, or metastatic hepatocellular carcinoma.Tumor images will be assessed by investigator and blinded independent central review (BICR). Treatment will continue until protocol-defined discontinuation criteria are met, for a maximum of 2 years. Participants will undergo tumor assessments, safety assessments, and survival follow-up.
Anti-tumor activity will be assessed by determining best overall response (BOR), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (BICR-PFS and INV Safety will be assessed through AEs, laboratory variables, physical examination findings, vital signs, 12-lead electrocardiogram, echocardiography, and ECOG performance status. The severity of AEs will be graded per NCI-CTCAE v6.0.
Participants in the JS207 + JS007 group (experimental group) will undergo plasma concentration assessments and immunogenicity assessments for JS207 and JS007.
The EORTC QLQ-C30, EORTC QLQ-HCC18, and EQ-5D-5L questionnaires will be used to assess participants' health-related quality of life (HRQOL).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- JS207, JS007, Toripalimab, Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS207Drug
PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
JS007Drug
CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
ToripalimabDrug
PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
BevacizumabDrug
VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| JS207 plus JS007 | Experimental | Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion Receives: Drug: JS207; Drug: JS007 |
| Toripalimab plus bevacizumab | Active comparator | Drug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion Receives: Drug: Toripalimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
Time from randomization to the first documented disease progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
Measured: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Overall Survival (OS)
Time from randomization to death from any cause. After safety follow-up, survival status is assessed every 2 months until death, loss to follow-up, withdrawal of consent, or study termination.
Measured: From randomization to death from any cause; assessed up to 66 months.
Secondary outcomes (10)
Progression-Free Survival Assessed by the Investigator (INV-PFS)
Time from randomization to first documented disease progression assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first. Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
Measured: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Objective Response Rate Assessed by BICR (ORR)
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR). Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
Measured: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Objective Response Rate Assessed by the Investigator (ORR)
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR). Responses and progression are assessed by the investigator per RECIST v1.1.
Measured: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Disease Control Rate Assessed by BICR (DCR)
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD). Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
Measured: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Disease Control Rate Assessed by the Investigator (DCR)
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD). Responses and progression are assessed by the investigator per RECIST v1.1.
Measured: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Duration of Response Assessed by BICR (DoR)
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders. Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
Measured: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Duration of Response Assessed by the Investigator (DoR)
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders. Responses and progression are assessed by the investigator per RECIST v1.1.
Measured: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Number of Participants With Adverse Events
Adverse events (AEs) are summarized by incidence, severity, and outcome. Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Measured: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Number of Participants With Serious adverse events (SAEs)
Serious adverse events (SAEs) are summarized by incidence, severity, and outcome. Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Measured: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Number of Participants With Immune-related AEs
Immune-related AEs are summarized by incidence, severity, and outcome. Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Measured: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 560 participants will be randomized 1:1 to JS207 plus JS007 or toripalimab plus bevacizumab (approximately 280 participants per arm).
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823348
- Sponsor's protocol ID
- JS207-017-III-HCC
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of JS207 in Combination With JS007 Versus Toripalimab in Combination With Bevacizumab as First-line Treatment for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07823348
- Acronym / sponsor ID
- JS207-017-III-HCC
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 16 Sep 2026 (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 a multicenter, randomized, open-label, controlled Phase III clinical study designed to evaluate the efficacy and safety of JS207 in combination with JS007 versus toripalimab in combination with bevacizumab as first-line treatment in participants with advanced HCC.
All study participants have unresectable locally advanced, recurrent, or metastatic HCC and have not previously received systemic anti-tumor therapy for advanced disease.
Approximately 560 participants are planned to be enrolled in this study. The JS207 + JS007 group (experimental group) and the toripalimab + bevacizumab group (positive control group) are each planned to enroll 280 participants.
Detailed description
This is a multicenter, randomized, open-label, active-controlled Phase III study in participants with unresectable locally advanced, recurrent, or metastatic hepatocellular carcinoma.Tumor images will be assessed by investigator and blinded independent central review (BICR). Treatment will continue until protocol-defined discontinuation criteria are met, for a maximum of 2 years. Participants will undergo tumor assessments, safety assessments, and survival follow-up.
Anti-tumor activity will be assessed by determining best overall response (BOR), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (BICR-PFS and INV Safety will be assessed through AEs, laboratory variables, physical examination findings, vital signs, 12-lead electrocardiogram, echocardiography, and ECOG performance status. The severity of AEs will be graded per NCI-CTCAE v6.0.
Participants in the JS207 + JS007 group (experimental group) will undergo plasma concentration assessments and immunogenicity assessments for JS207 and JS007.
The EORTC QLQ-C30, EORTC QLQ-HCC18, and EQ-5D-5L questionnaires will be used to assess participants' health-related quality of life (HRQOL).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 560 participants will be randomized 1:1 to JS207 plus JS007 or toripalimab plus bevacizumab (approximately 280 participants per arm).
| Arm | Type | Receives |
|---|---|---|
| JS207 plus JS007 | Experimental | Drug: JS207, Drug: JS007Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion |
| Toripalimab plus bevacizumab | Active comparator | Drug: Toripalimab, Drug: BevacizumabDrug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily participate and sign a written informed consent form.
- Aged 18-75 years, regardless of sex.
- Histologically/cytologically confirmed HCC, or cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
- No prior systemic therapy for HCC.
- At least one measurable lesion per RECIST v1.1 criteria.
Key exclusion criteria (17 listed)
- Concomitant with the following study disease states: Known intrahepatic cholangiocarcinoma (ICC) or mixed-type liver cancer, sarcomatoid hepatocellular carcinoma, and fibrolamellar carcinoma of the liver; Presence of HCC central nervous system metastasis.
- Prior treatment-related toxicity not recovered to ≤ CTCAE Grade 1.
- Severe infection at screening.
- Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically apparent moderate or greater ascites at screening.
- -≥ Grade 3 (NCI-CTCAE v6.0) gastrointestinal or non-gastrointestinal fistula at screening.
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 |
|---|---|---|
| JS207PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion. | Drug | JS207 plus JS007 |
| JS007CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion. | Drug | JS207 plus JS007 |
| ToripalimabPD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion. | Drug | Toripalimab plus bevacizumab |
| BevacizumabVEGF monoclonal antibody supplied as an injectable solution for intravenous infusion. | Drug | Toripalimab plus bevacizumab |
Primary outcome
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
Time frame: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Time from randomization to the first documented disease progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
Overall Survival (OS)
Time frame: From randomization to death from any cause; assessed up to 66 months.
Time from randomization to death from any cause. After safety follow-up, survival status is assessed every 2 months until death, loss to follow-up, withdrawal of consent, or study termination.
10 secondary outcomes
Progression-Free Survival Assessed by the Investigator (INV-PFS)
Time frame: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
Objective Response Rate Assessed by BICR (ORR)
Time frame: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Objective Response Rate Assessed by the Investigator (ORR)
Time frame: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Disease Control Rate Assessed by BICR (DCR)
Time frame: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Disease Control Rate Assessed by the Investigator (DCR)
Time frame: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
Duration of Response Assessed by BICR (DoR)
Time frame: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Duration of Response Assessed by the Investigator (DoR)
Time frame: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
Number of Participants With Adverse Events
Time frame: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Number of Participants With Serious adverse events (SAEs)
Time frame: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
Number of Participants With Immune-related AEs
Time frame: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Jia Fan, Ph.D. principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JS207, JS007 and Toripalimab in people with Hepatocellular Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 2 sites 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 10 inclusion and 17 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Jiazheng Yan, Project Manager (+86 158 2259 6147, jiazheng_yan@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS) (time frame: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.). The study lists 2 primary outcomes in all. 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 16 Sep 2026.