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Trial Title:
TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
NCT ID:
NCT05555316
Condition:
Liver Tumor
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Conditions: Keywords:
Large hepatocellular carcinoma
Lenvatinib
TACE
Microwave ablation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TACE combined with Lenvatinib
Description:
Three days after the first TACE treatment, when the liver function was evaluated as grade
A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day
(body weight equal to or more than 60kg). Lenvatinib reduction standard: 8mg / day; 4mg /
day; 4mg, the next day.
Arm group label:
TACE combined with Lenvatinib
Other name:
lenvima
Summary:
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the
treatment of advanced liver cancer. After successful down-stage, radical microwave
ablation was further performed.
Detailed description:
The purpose of this study is to explore the objective effective rate of TACE combined
with Lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new
idea for the radical microwave ablation treatment mode after the decline of locally
advanced liver cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of
at least 3 months;
- Number of tumors ≤ 3;
- Large hepatocellular carcinoma with tumor diameter ≥ 7 cm;
- Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and
cholangiocarcinoma thrombus;
- Although there is arteriovenous fistula or arterioportal fistula, it can be
completely blocked;
- Child Pugh grade A or B of liver function; ECoG physical fitness score < 2;
- No bleeding tendency, normal coagulation function or coagulation dysfunction can be
corrected after treatment;
- Leukocyte count ≥ 3.0 × 109/L；
- Hemoglobin ≥ 8.5g/dl;
- Platelet count ≥ 50 × 109/L；
- The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin
time (PT) does not exceed the upper limit of normal control for 3 seconds;
- Serum creatinine was less than 1.5 times of the upper limit of normal;
- Patients and / or family members agree to join the clinical trial and sign the
informed consent form
Exclusion Criteria:
- Diffuse hepatocellular carcinoma;
- Portal vein tumor thrombus;
- Combined with tumor thrombus of hepatic vein and inferior vena cava;
- Patients with lymph node metastasis and extrahepatic distant metastasis;
- The liver function was classified as child Pugh C and could not be improved by liver
protection treatment;
- Arteriovenous fistula or arterioportal fistula with ineffective intervention;
- Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with
obvious bleeding tendency;
- Intractable massive ascites;
- ECoG physical fitness score > 2 points;
- Combined with active infection, especially bile duct inflammation;
- Serious heart, lung, kidney, brain and other important organ diseases;
- Note: see attached table 1 for child Pugh classification of liver function; See
attached table 2 for ECoG physical fitness score
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinhua Huang, Ph.D
Phone:
0086-20-87343447
Email:
huangjh@sysucc.org.cn
Investigator:
Last name:
Jinhua Huang, Ph.D
Email:
Principal Investigator
Start date:
November 10, 2019
Completion date:
November 2023
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555316
