JS207: PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
JS007: CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Toripalimab: PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Bevacizumab: VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.
Study 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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
* 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.
Primary outcome measure(s)
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS) — 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) — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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