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

Phase 2

Recruiting

• Conditions: Liver Tumor
• Interventions: Drug: TACE combined with Lenvatinib

• Registration Number: NCT05555316
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2019-11-10
• Study First Submitted: 2022-01-20
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-23
• Last Update Submitted: 2022-09-23
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-01
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TACE combined with Lenvatinib	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).

Primary Outcome Measures

Name	Time	Method
Down stage rate	4 months	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.

Secondary Outcome Measures

Name	Time	Method
TACE frequency and ablation frequency	3 years	To access the times and frequency of TACE and ablation
Objective response rate	3 years	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)
RFS	3 years	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
Changes of liver and kidney function	3 years	Changes of liver and kidney function index from blood biochemistry compared to baseline

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China