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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Other: Gelatin sponge articles; Drug: EADM; Drug: Ultra-fluid lipiodol; Procedure: Thermal Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02630108

B2015-146R

Details and patient eligibility

About

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.

Full description

It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (>5cm in diameter) and huge HCC (>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

280 participants in 2 patient groups

Thermal Ablation & TACE

Experimental group

Description:

Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Treatment:

Procedure: Thermal Ablation

Drug: Ultra-fluid lipiodol

Other: Gelatin sponge articles

Drug: EADM

TACE alone

Active Comparator group

Description:

Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Treatment:

Drug: Ultra-fluid lipiodol

Other: Gelatin sponge articles

Drug: EADM