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.
Willing to participate and sign a written informed consent form.
Age ≥ 18 years, male or female.
Patients with histologically/cytologically confirmed HCC or Hepatic cirrhosis meeting the criteria of the American Association for the Study of Liver Diseases (AASLD) can be enrolled.
HCC classified as Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage) or stage C (advanced stage), or stage IIa/IIb or IIIa/IIIb as defined by the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition), prior to lymph node clearance, and deemed unsuitable for surgical and/or local treatment.
Received major surgery (requiring general anesthesia and >24 hours of hospitalization, excluding diagnostic biopsy), live vaccination, or investigational drug treatment within 4 weeks prior to the first dose, or received palliative radiotherapy for localized bone/brain lesions within 2 weeks prior to the first dose.
Patients who are receiving chronic systemic corticosteroid therapy (daily dose >10 mg prednisone or other glucocorticoid with the same effect) or other immunosuppression therapy within 7 days prior to the first dose.
Hepatic tumor burden > 50% of total hepatic volume at screening.
Invasion of portal vein main trunk (Vp4) by cancer thrombus (more than 1/2 of lumen) as confirmed by CT/MRI examination.