TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma

NCT ID: NCT05555316

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2023-11-30

Brief 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.

Conditions

Liver Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

TACE combined with Lenvatinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

lenvima

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Huang Jinhua

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinhua Huang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinhua Huang, Ph.D

Role: CONTACT

huangjh@sysucc.org.cn

0086-20-87343447

Facility Contacts

Jinhua Huang, Ph.D

Role: primary

huangjh@sysucc.org.cn

0086-20-87343447

Other Identifiers

TALEM

Identifier Type: -

Identifier Source: org_study_id