🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07823348
Starting soon Phase 3

JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer

NCT07823348 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Phase
Phase 3
Started
2026-10-08
Last updated
2026-09-16

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

JS207JS007ToripalimabBevacizumab

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)

Trial sites (2)

FacilityCityRegionStatus
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality

On this site

📄 Avastin (bevacizumab) drug profile →

More Shanghai Junshi Bioscience Co., Ltd. trials in China

Other trials for the same condition

Official registry record

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.

View NCT07823348 on ClinicalTrials.gov ↗ ← All trials in China