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

Korábbi kezelés

• 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.
• History of gastrointestinal bleeding within 6 months prior to the first dose, or definite tendency for gastrointestinal bleeding.
• 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.
• Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or solid organ transplantation, or other immunodeficiency.

Más betegség

• 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 cardiovascular or cerebrovascular disease:
• Other obvious bleeding tendency or evidence of major coagulation disorders:
• 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 severe allergy to any monoclonal antibody.

Egyéb

• Severe unhealed wounds, active ulcers, or untreated fractures at screening.
• Other factors that, in the investigator's judgment, may affect study results or lead to forced premature termination of the study.

• 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.