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.
Parallel
JS207
Drug10 mg/kg q3W or adjust the dose (e.g. 15 mg/kg) based on accumulated data on the safety and efficacy of JS207 from clinical studies.
JS007
DrugDose exploration stage: C1-C4, group 1:3 mg/kg, C1D1 once (single dose); Group 2:3 mg/kg, D1, Q6W; Group 3:1 mg/kg,D1, Q3W; ≥C5, 1 mg/kg, Q6W; Dose expansion stage: according to the group medication confirmed in the dose exploration stage.
AE
All adverse events, regardless of relationship to the study drug, were reported from the time the study drug was started until 90 days after the last dose or the subject started a new antineoplastic therapy, whichever occurred first.
SAE
Only those resulting from interventions required by the protocol were reported from the time of ICF signing until the first dose. All were reported from the time of the first dose until 90 days after the last dose or initiation of a new antineoplastic therapy, after which, those considered to be related to previous study treatment were reported.
DLT
Dose-limiting toxicity
ORR
Objective remission rate
PFS
Progression free survival
DCR
Disease control rate
DOR
Duration of response
OS
Overall survival
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