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

Phase 3

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: Thermal Ablation; Drug: EADM; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles

• Registration Number: NCT02630108
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18
• Primary Completion: 2017-12
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermal Ablation & TACE	Ultra-fluid lipiodol	Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Thermal Ablation & TACE	Thermal Ablation	Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Thermal Ablation & TACE	EADM	Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Thermal Ablation & TACE	Gelatin sponge articles	Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
TACE alone	EADM	Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
TACE alone	Ultra-fluid lipiodol	Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
TACE alone	Gelatin sponge articles	Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Primary Outcome Measures

Name	Time	Method
Overall Survival	From the date of randomization until the date of death from any cause, assessed up to 26 months

Secondary Outcome Measures

Name	Time	Method
Time-to-Disease Progression	From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months	TTDP follow-up is done at three months interval after lesions defined as stable with treatment of TACE or ablation combined with synchronous TACE six months after enrollment until lesions are defined as disease progression.
Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups	From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation)	Serious or mild adverse events after treatment
Objective response rate (ORR)	Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.	The ratio of CR plus PR. The efficacy is defined as complete regression (CR), partial regression (PR), stable disease (SD) and progressive disease (PD) according to modified Response Evaluation Criteria in Solid Tumors (mRESIST)
Progression free survival(PFS)	From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months.
Numbers of TACE and TACE combined with ablation cycles	From the date of randomization until the date of death, assessed up to 26 months.	The times of the subjects undergoing TACE or TACE combined with ablation

Trial Locations

Locations (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China