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

NCT07823348 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: JS207-017-III-HCC
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From randomization to death from any cause; assessed up to 66 months.

Secondary Outcomes (10)

• Progression-Free Survival Assessed by the Investigator (INV-PFS)

  From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.

• Objective Response Rate Assessed by BICR (ORR)

  From randomization to the end of tumor assessment follow-up; assessed up to 24 months.

• Objective Response Rate Assessed by the Investigator (ORR)

  From randomization to the end of tumor assessment follow-up; assessed up to 24 months.

• Disease Control Rate Assessed by BICR (DCR)

  From randomization to the end of tumor assessment follow-up; assessed up to 24 months.

• Disease Control Rate Assessed by the Investigator (DCR)

  From randomization to the end of tumor assessment follow-up; assessed up to 24 months.

Other Outcomes (9)

• Blood Concentrations of JS207

  Up to 27 months

• Immunogenicity of JS207 assessed by the presence of antidrug antibodies (ADAs) for JS207

  Up to 27 months

• Immunogenicity of JS207 assessed by the presence of antidrug antibodies (NAb) for JS207

  Up to 27 months

Study Arms (2)

JS207 plus JS007

EXPERIMENTAL

Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion

Drug: JS207; Drug: JS007

Toripalimab plus bevacizumab

ACTIVE COMPARATOR

Drug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion

Drug: Toripalimab; Drug: Bevacizumab

Interventions

JS207 DRUG

PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.

JS207 plus JS007

JS007 DRUG

CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.

JS207 plus JS007

Toripalimab DRUG

PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.

Toripalimab plus bevacizumab

Bevacizumab DRUG

VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.

Toripalimab plus bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

toripalimab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jia Fan, Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiazheng Yan, Project Manager

CONTACT

+86 158 2259 6147; jiazheng_yan@junshipharma.com

Feng Li

CONTACT

+86 186 2772 1499; feng_li@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Approximately 560 participants will be randomized 1:1 to JS207 plus JS007 or toripalimab plus bevacizumab (approximately 280 participants per arm).

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2031
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)