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

NCT ID: NCT05319431

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2025-06-30

Brief Summary

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

Conditions

Unresectable, Non-metastatic Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK104+Lenvatinib+TACE

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.

Group Type: EXPERIMENTAL

AK104

Intervention Type: BIOLOGICAL

Subjects will receive AK104 until disease progression or for a maximum of 24 months

Lenvatinib

Intervention Type: DRUG

Subjects will receive lenvatinib until disease progression or for a maximum of 24 months

TACE

Intervention Type: PROCEDURE

On demand TACE

Interventions

AK104

Subjects will receive AK104 until disease progression or for a maximum of 24 months

Intervention Type: BIOLOGICAL

Lenvatinib

Subjects will receive lenvatinib until disease progression or for a maximum of 24 months

Intervention Type: DRUG

TACE

On demand TACE

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guoliang Shao, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

The First Hospital of Beijing University

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shandong Cancer Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

AK104-216

Identifier Type: -

Identifier Source: org_study_id