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

NCT02630108 | Unknown Phase 3

• 1 other identifier: B2015-146R
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Keywords

HCC; TACE; Thermal Ablation; Safety/Efficacy

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From the date of randomization until the date of death from any cause, assessed up to 26 months

Secondary Outcomes (5)

• 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

• Objective response rate (ORR)

  Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.

• 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.

• 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)

Study Arms (2)

Thermal Ablation & TACE

EXPERIMENTAL

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

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

TACE alone

ACTIVE COMPARATOR

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

Drug: EADM; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles

Interventions

Thermal Ablation PROCEDURE

Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.

Also known as: Radiofrequency ablation, Microwave ablation

Thermal Ablation & TACE

EADM DRUG

EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.

Also known as: Epirubicin

TACE alone; Thermal Ablation & TACE

Ultra-fluid lipiodol DRUG

Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .

Also known as: lipiodol

TACE alone; Thermal Ablation & TACE

Gelatin sponge articles OTHER

Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

TACE alone; Thermal Ablation & TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;
• Patients with large HCC (\>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);
• Patients with no thrombus in main portal vein (PV)
• Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;
• Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;
• White blood cell count ≥ 3.0×10\^9/L;
• Hemoglobin ≥ 8.5g/dl;
• Platelet ≥ 50×10\^9/L;
• INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;
• Blood creatinine less than 1.5 times of upper limit of reference;
• Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.

You may not qualify if:

• Patients with diffuse type of liver cancer;
• Cholangiocellular carcinoma
• Patients with main PV thrombus;
• Patients with hepatic vein thrombus;
• Patients with lymph node or distant metastasis outside of liver;
• Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;
• Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;
• Patients with intractable massive ascites;
• Patients' ECOG PS \>2;
• Patients complicated with active infection, especially cholangitis;
• Patients with severe disorders of heart, lungs, kidneys, or brain;
• Patients and/or their relatives refuse to anticipate this study.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Xijing Hospital: collaborator
• Changhai Hospital: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Shanghai Cancer Hospital, China: collaborator
• Shengjing Hospital: collaborator
• The Third Affiliated Hospital of Harbin Medical University: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• Henan Cancer Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Shandong Tumor Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Chinese PLA General Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• LanZhou University: collaborator
• Sun Yat-sen University: collaborator
• Hunan Provincial People's Hospital: collaborator
• Affiliated Zhongshan Hospital of Dalian University: collaborator

Study Sites (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Transurethral Resection of Prostate; Radiofrequency Ablation; Epirubicin; Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Jianhua Wang, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Wang, MD

CONTACT

+8613611759557; wang.jianhua@zs-hospital.sh.cn

Rong Liu, MD

CONTACT

+8613681971563; liu.rong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 15, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

CN (1)