Back to resultsTACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lenvatinib
TACE
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Transarterial Chemoembolization, lenvatinib
Eligibility Criteria
Inclusion Criteria:
- 1. Histopathologically or clinically confirmed unresectable hepatocellular carcinoma.
2. Age ≥ 18 years at time of study entry. 3. Child-Pugh scores <7. 4. Performance status (PS) ≤ 2 (ECOG scale). 5. BCLC stage B, some patients in stage C (Vp2-3). 6. The patient and/or his family agreed to join the clinical trial and sign the informed consent form.
Exclusion Criteria:
1. Have received TACE or other local treatment for liver cancer (except bridged liver transplantation).
2. Main portal vein tumor thrombus or complicated with extrahepatic metastasis. 3. Tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
4. Have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy.
5. Estimated life expectancy of <3 months. 6. There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil<1.5×109/L, PLT<50×109/L. The INR>2.3.
7. Renal dysfunction：serum creatinine (SCR) >176.8 μmol/L（2 mg/dL）or creatinine clearance rate (Ccr) <30 mL/min.
8. Serious heart, lung, brain or other important organ diseases. 9. Pregnant or lactating women. 10. cannot cooperate with TACE operation and sign informed consent form.
Sites / Locations
- Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TACE Combined with Lenvatinib
Arm Description
Outcomes
Primary Outcome Measures
Time to progression（TTP）
The time from the beginning of randomization to the tumor progression of the patient
Objective remission rate（ORR）
ORR according to modified RECIST for Hepatocellular Carcinoma
Secondary Outcome Measures
Adverse Events
Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)
Overall survival
the survival time after randomization
Full Information
NCT ID
NCT04490694
First Posted
July 26, 2020
Last Updated
September 23, 2021
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04490694
Brief Title
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
Official Title
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
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
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.
Detailed Description
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Transarterial Chemoembolization, lenvatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE Combined with Lenvatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
Lenvatinib treatment
Intervention Description
Intervention Description：lenvatinib will be administered daily (for patients <60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transcatheter arterial chemoembolization
Intervention Description
Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.
Primary Outcome Measure Information:
Title
Time to progression（TTP）
Description
The time from the beginning of randomization to the tumor progression of the patient
Time Frame
2 years
Title
Objective remission rate（ORR）
Description
ORR according to modified RECIST for Hepatocellular Carcinoma
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)
Time Frame
2 years
Title
Overall survival
Description
the survival time after randomization
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 1. Histopathologically or clinically confirmed unresectable hepatocellular carcinoma.
2. Age ≥ 18 years at time of study entry. 3. Child-Pugh scores <7. 4. Performance status (PS) ≤ 2 (ECOG scale). 5. BCLC stage B, some patients in stage C (Vp2-3). 6. The patient and/or his family agreed to join the clinical trial and sign the informed consent form.
Exclusion Criteria:
1. Have received TACE or other local treatment for liver cancer (except bridged liver transplantation).
2. Main portal vein tumor thrombus or complicated with extrahepatic metastasis. 3. Tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
4. Have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy.
5. Estimated life expectancy of <3 months. 6. There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil<1.5×109/L, PLT<50×109/L. The INR>2.3.
7. Renal dysfunction：serum creatinine (SCR) >176.8 μmol/L（2 mg/dL）or creatinine clearance rate (Ccr) <30 mL/min.
8. Serious heart, lung, brain or other important organ diseases. 9. Pregnant or lactating women. 10. cannot cooperate with TACE operation and sign informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiping Yan, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma
We'll reach out to this number within 24 hrs