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

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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)

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

Trial contacts and locations

5

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Central trial contact

Ting Liu, MD

Data sourced from clinicaltrials.gov

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