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

Last updated: September 23, 2022
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Cancer

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05555316
TALEM
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18-75 years with hepatocellular carcinoma have an expected survival ofat 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 andcholangiocarcinoma thrombus;
  • Although there is arteriovenous fistula or arterioportal fistula, it can be completelyblocked;
  • Child Pugh grade A or B of liver function; ECoG physical fitness score < 2;
  • No bleeding tendency, normal coagulation function or coagulation dysfunction can becorrected 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 theinformed consent form

Exclusion

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 liverprotection treatment;
  • Arteriovenous fistula or arterioportal fistula with ineffective intervention;
  • Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obviousbleeding 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; Seeattached table 2 for ECoG physical fitness score

Study Design

Total Participants: 46
Study Start date:
November 10, 2019
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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