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

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.

• Occurred arteriovenous thromboembolic events within 6 months before the first administration.

• Inadequately controlled hypertension.

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

• Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.

• Severe infections.

• 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.

• Unable to receive an enhanced CT or MRI scan of the liver.