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

NCT05555316 | Unknown Phase 2

• 1 other identifier: TALEM
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Tumor

Keywords

Large hepatocellular carcinoma; Lenvatinib; TACE; Microwave ablation

Outcome Measures

Primary Outcomes (1)

• Down stage rate

  if the patient achieve any of these three criteria： ① 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). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation.

  4 months

Secondary Outcomes (4)

• RFS

  3 years

• Objective response rate

  3 years

• Changes of liver and kidney function

  3 years

• TACE frequency and ablation frequency

  3 years

Study Arms (1)

TACE combined with Lenvatinib

EXPERIMENTAL

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).

Drug: TACE combined with Lenvatinib

Interventions

TACE combined with Lenvatinib 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.

Also known as: lenvima

TACE combined with Lenvatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jinhua Huang, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhua Huang, Ph.D

CONTACT

0086-20-87343447; huangjh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: September 26, 2022
• Study Start: November 10, 2019
• Primary Completion: January 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)