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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Lenvatinib

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