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

NCT05319431 | Active Not Recruiting Phase 2

• 1 other identifier: AK104-216
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.

  Up to 2 years

Secondary Outcomes (4)

• Objective response rate (ORR

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Number of participants with adverse events (AEs)

  the time of informed consent signed through 90 days after the last dose

Study Arms (1)

AK104+Lenvatinib+TACE

EXPERIMENTAL

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.

Biological: AK104; Drug: Lenvatinib; Procedure: TACE

Interventions

AK104 BIOLOGICAL

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

AK104+Lenvatinib+TACE

Lenvatinib DRUG

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

AK104+Lenvatinib+TACE

TACE PROCEDURE

On demand TACE

AK104+Lenvatinib+TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (5)

The First Hospital of Beijing University

Beijing, Beijing Municipality, 100034, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

MeSH Terms

Interventions

lenvatinib

Study Officials

• Guoliang Shao, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: June 28, 2022
• Primary Completion: August 15, 2023
• Study Completion: June 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (5)