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

Akeso

Status and phase: Active, not recruiting; Phase 2

Conditions: Unresectable, Non-metastatic Hepatocellular Carcinoma

Treatments: Procedure: TACE; Biological: AK104; Drug: Lenvatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05319431

AK104-216

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

AK104+Lenvatinib+TACE

Experimental group

Description:

Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.

Treatment:

Drug: Lenvatinib

Biological: AK104

Procedure: TACE