A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC

Prior treatment

• Occurred arteriovenous thromboembolic events within 6 months before the first administration.
• Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
• Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.

Other illness

• The main portal vein and the left and right primary branches were clogged with cancer thrombus
• History of hepatic encephalopathy or liver transplantation
• Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
• Inadequately controlled hypertension.
• Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
• Severe infections.

Lab values

• Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.

Other

• Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc
• For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions
• Unable to receive an enhanced CT or MRI scan of the liver.

• Signed written informed consent form voluntarily.
• Histologically or cytologically documented hepatocellular carcinoma.
• CNLC IIa IIb or IIIa
• The main portal vein was not completely obstructed,
• Child-Pugh A or B
• At least one measurable lesion according to RECIST criteria
• ECOG PS 0-1
• Adequate organ function
• Estimated life expectancy of ≥3 months
• For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent