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
Overview
- Phase
- Phase 2
- Intervention
- TACE combined with Lenvatinib
- Conditions
- Liver Tumor
- Sponsor
- Sun Yat-sen University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Down stage rate
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Huang Jinhua
Professor
Sun Yat-sen University
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；
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;
Arms & Interventions
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).
Intervention: TACE combined with Lenvatinib
Outcomes
Primary Outcomes
Down stage rate
Time Frame: 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 Outcomes
- Objective response rate(3 years)
- TACE frequency and ablation frequency(3 years)
- RFS(3 years)
- Changes of liver and kidney function(3 years)