A Phase II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma（HCC）
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.
• No systemic therapy for HCC prior to study entry (mainly including systemic chemotherapy, targeted therapy, immunotherapy, etc.; adjuvant/neoadjuvant administration of small molecule anti-angiogenic drugs, such as lenvatinib, sorafenib, and donafenib, is allowed, but the last dose of these drugs must be administered ≥90 days prior to the first dose of the study drug).
• Having ≥1 measurable lesion according to RECIST v1.1. Requirement: The selected target lesion had not been subjected to local therapy previously, or the selected target lesion was located in the area of previous local therapy, but later determined to be progressed through imaging examination according to RECIST v1.1.
• Child-Pugh liver function class A or B ≤ 7 without history of Hepatic encephalopathy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
• Life expectancy ≥12 weeks.
⁃ Major organ function meets the following requirements, without transfusion, hematopoietic stimulating factors (including G-CSF, GM-CSF, EPO and TPO, etc.) or human Albumin preparations within 14 days prior to screening:
⁃ Females of childbearing potential and males whose partners are of childbearing age are required to use highly effective contraceptive measures during the trial and for at least 6 months after the last dose (Appendix 5). Female patients of childbearing potential must have a negative serum HCG test within 7 days before study entry and must be non-lactating.