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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05555316
Other study ID # TALEM
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 10, 2019
Est. completion date November 2023

Study information

Verified date September 2022
Source Sun Yat-sen University
Contact Jinhua Huang, Ph.D
Phone 0086-20-87343447
Email huangjh@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date November 2023
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TACE combined with Lenvatinib
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.

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Down stage rate if the patient achieve any of these three criteria: ? the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ? Liver function reaches child Pugh grade A or B; ? The patient is in good health and can tolerate ablation. 4 months
Secondary RFS Recurrence free survival indicates the length of time after MWA for a cancer ends that the patient survives without any signs or symptoms of HCC 3 years
Secondary Objective response rate Change of the tumor size according to the modified response evaluation criteria in solid tumors (mRECIST) [see attached table 3], the efficacy is defined as CR (complete remission), PR (partial remission), SD (stable) and PD (Progress) 3 years
Secondary Changes of liver and kidney function Changes of liver and kidney function index from blood biochemistry compared to baseline 3 years
Secondary TACE frequency and ablation frequency To access the times and frequency of TACE and ablation 3 years
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