Back to resultsA Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
Primary Purpose
Unresectable, Non-metastatic Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK104
Lenvatinib
TACE
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable, Non-metastatic Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- The First Hospital of Beijing University
- Nanfang Hospital, Southern Medical UniversityRecruiting
- Henan Cancer HospitalRecruiting
- Hunan Cancer HospitalRecruiting
- Shandong Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AK104+Lenvatinib+TACE
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective response rate (ORR
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Disease control rate (DCR)
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.
Duration of response (DoR)
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
Number of participants with adverse events (AEs)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05319431
Brief Title
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
April 17, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable, Non-metastatic Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AK104+Lenvatinib+TACE
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
AK104
Intervention Description
Subjects will receive AK104 until disease progression or for a maximum of 24 months
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
Subjects will receive lenvatinib until disease progression or for a maximum of 24 months
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
On demand TACE
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR
Description
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Time Frame
Up to 2 years
Title
Disease control rate (DCR)
Description
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.
Time Frame
Up to 2 years
Title
Duration of response (DoR)
Description
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
Time Frame
Up to 2 years
Title
Number of participants with adverse events (AEs)
Description
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.
Time Frame
the time of informed consent signed through 90 days after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Liu, MD
Phone
(0760)89873999
Email
clinicaltrials@akesobio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoliang Shao, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Beijing University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
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