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

Liver Tumor Clinical Trial

Official title:

Prospective Single Arm Phase II Study of TACE Combined With Lenvatinib and MWA After Down-stage in the Treatment of Locally Advanced Large Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555316
• Other study ID #: TALEM
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Tumor

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