A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Collaborator: Akeso Pharmaceuticals, Inc.
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

• Signed written informed consent form voluntarily.

• Histologically or cytologically documented hepatocellular carcinoma.

• BCLC stage C, and non-resectable BCLC stage B .

• At least one measurable lesion according to RECIST criteria.

• ECOG of 0 or 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.

• History of hepatic encephalopathy or liver transplantation.

• Clinical significance of hydrothorax, ascites or pericardial effusion.

• Central nervous system metastases and/or carcinomatous meningitis.

• 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.

• Tumor volume > 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.

• Inadequately controlled arterial 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.