Clinical trial NCT05555316: TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Tumor
Keywords: Large hepatocellular carcinoma
Lenvatinib
TACE
Microwave ablation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Down stage rate
timeFrame: 4 months
Secondary outcomes:
measure: RFS
timeFrame: 3 years
measure: Objective response rate
timeFrame: 3 years
measure: Changes of liver and kidney function
timeFrame: 3 years
measure: TACE frequency and ablation frequency
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jinhua Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: