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Clinical Trials in China / NCT05319431
Active, not recruiting Phase 2

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

NCT05319431 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 2
Started
2022-06-28
Last updated
2025-03-12

Condition(s) studied

Unresectable, Non-metastatic Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

AK104 →Lenvatinib →TACE

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

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

TACE: On demand TACE

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
The First Hospital of Beijing University Beijing Beijing Municipality
Nanfang Hospital, Southern Medical University Guangzhou Guangdong
Henan Cancer Hospital Zhengzhou Henan
Hunan Cancer Hospital Changsha Hunan
Shandong Cancer Hospital Jinan Shandong

On this site

📄 Lenvima (lenvatinib) drug profile →

More Akeso trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05319431 on ClinicalTrials.gov ↗ ← All trials in China