TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Anhui Provincial Hospital; Changhai Hospital; Chinese PLA General Hospital; Dalian University affiliated Zhongshan Hospital; Eastern Hepatobiliary Surgery Hospital; First Affiliated Hospital of Xinjiang Medical University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Henan Cancer Hospital; Hunan Provincial People's Hospital; Jiangsu Cancer Institute & Hospital; Jilin Provincial Tumor Hospital; LanZhou University; Nanfang Hospital of Southern Medical University; Qilu Hospital; Qilu Hospital of Shandong University; Shandong Tumor Hospital; Shanghai Cancer Hospital, China; Shengjing Hospital; Sichuan Cancer Hospital and Research Institute; Sun Yat-sen University; The Affiliated Zhongshan Hospital of Dalian University; The First Affiliated Hospital of Anhui Medical University; The First Hospital of Lanzhou University; The Third Affiliated Hospital of Harbin Medical University; Wuhan Union Hospital, China; Xijing Hospital; Zhejiang Cancer Hospital
• Treatments: Epirubicin; Ethiodized Oil

Criteria

Inclusion Criteria:

1. Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;

2. Patients with large HCC (>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);

3. Patients with no thrombus in main portal vein (PV)

4. Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;

5. Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;

6. White blood cell count ≥ 3.0×10^9/L;

7. Hemoglobin ≥ 8.5g/dl;

8. Platelet ≥ 50×10^9/L;

9. INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;

10. Blood creatinine less than 1.5 times of upper limit of reference;

11. Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.

Exclusion Criteria:

1. Patients with diffuse type of liver cancer;

2. Cholangiocellular carcinoma

3. Patients with main PV thrombus;

4. Patients with hepatic vein thrombus;

5. Patients with lymph node or distant metastasis outside of liver;

6. Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;

7. Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;

8. Patients with intractable massive ascites;

9. Patients' ECOG PS >2;

10. Patients complicated with active infection, especially cholangitis;

11. Patients with severe disorders of heart, lungs, kidneys, or brain;

12. Patients and/or their relatives refuse to anticipate this study.