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

Sponsor
Akeso (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05319431
Collaborator
(none)
60
Enrollment
5
Locations
1
Arm
36.1
Anticipated Duration (Months)
12
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AK104 Plus Lenvatinib and TACE in the Treatment of Unresectable, Non-metastatic Hepatocellular Carcinoma
Actual Study Start Date :
Jun 28, 2022
Anticipated Primary Completion Date :
Apr 17, 2023
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

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

Procedure: TACE
On demand TACE

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [Up to 2 years]

    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.

Secondary Outcome Measures

  1. Objective response rate (ORR [Up to 2 years]

    ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.

  2. Disease control rate (DCR) [Up to 2 years]

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

  3. Duration of response (DoR) [Up to 2 years]

    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first

  4. Number of participants with adverse events (AEs) [the time of informed consent signed through 90 days after the last dose]

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Hospital of Beijing University Beijing Beijing China 100034
2 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515
3 Henan Cancer Hospital Zhengzhou Henan China 450003
4 Hunan Cancer Hospital Changsha Hunan China 410013
5 Shandong Cancer Hospital Jinan Shandong China 250117

Sponsors and Collaborators

  • Akeso

Investigators

  • Principal Investigator: Guoliang Shao, MD, Zhejiang Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akeso
ClinicalTrials.gov Identifier:
NCT05319431
Other Study ID Numbers:
  • AK104-216
First Posted:
Apr 8, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib

Study Results

No Results Posted as of Aug 15, 2022