A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma

Akeso

Status and phase: Enrolling; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lenvatinib; Procedure: TACE; Drug: AK104; Other: Placebo for AK104; Other: Placebo for Lenvatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06371157

AK104-308

Details and patient eligibility

About

A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma

Enrollment: 469 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
2. No evidence of metastasis
3. Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
4. Child Pugh score class A
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. Measurable disease by RECIST 1.1
7. Adequate organ function

Exclusion criteria

1. History of liver transplantation
2. History of hepatic encephalopathy
3. Uncontrolled arterial hypertension
4. Deep venous thrombosis within 3 months before first treatment
5. Bleeding events within the last 6 months
6. Co-infection with HBV and HCV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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469 participants in 3 patient groups, including a placebo group

Arm A

Experimental group

Description:

AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)

Treatment:

Procedure: TACE

Drug: AK104

Drug: Lenvatinib

Arm B

Placebo Comparator group

Description:

Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE

Treatment:

Other: Placebo for Lenvatinib

Other: Placebo for AK104

Procedure: TACE

Arm C

Other group

Description:

AK104 + Placebo for Lenvatinib in Combination With TACE

Treatment:

Other: Placebo for Lenvatinib

Procedure: TACE

Drug: AK104