JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma

This open-label, multicenter phase II study was designed to evaluate the safety and efficacy of JS207 alone or in combination with JS007 as first-line treatment in subjects with advanced HCC. The subjects were all subjects with unresectable, locally advanced, recurrent, or metastatic HCC who had not received previous systemic therapy. Planned to enroll 43 to 72 subjects.The study was divided into two stages, dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).After the dose exploration phase, a dose group was selected to enter the randomized expansion phase based on comprehensive discussion and evaluation of DLT, AE, dose adjustment, PK parameters and preliminary efficacy results in each dose group.

NCT Number	NCT06954467
Lead Sponsor	Shanghai Junshi Bioscience Co., Ltd.
Conditions	Hepatocellular Carcinoma
Enrollment	72 participants
Start Date	2025-05-29
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-02