TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial

NCT03636620 | Completed Phase 3 DMC

• 1 other identifier: LC-TACE+RFA/MV
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• overall survival

  up to 46 months

Secondary Outcomes (1)

• objective response rate

  up to 46 months

Study Arms (2)

TACE group

ACTIVE COMPARATOR

Transcatheter arterial chemoembolization

Device: Transcatheter arterial chemoembolization

TACE+RFA/MV group

EXPERIMENTAL

Transcatheter arterial chemoembolization and radiofrequency /microwave ablation

Device: Transcatheter arterial chemoembolization; Device: radiofrequency ablation/microwave ablation

Interventions

Transcatheter arterial chemoembolization DEVICE

Transcatheter arterial chemoembolization

Also known as: TACE

TACE group; TACE+RFA/MV group

radiofrequency ablation/microwave ablation DEVICE

radiofrequency ablation/microwave ablation

Also known as: RFA/MW

TACE+RFA/MV group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diganosed with hepatocellualr carcinoma beyond Milan criteria
• the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
• Child-Pugh A or B
• ECOG score 0-1;
• prothrombin time ≤16 s;
• white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl

You may not qualify if:

• expected survival time \< 12 months before random assignment;
• received anticancer surgery or procedure within one month before assignment;
• concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
• existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
• upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

liver cancer institute ,Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

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)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• zheng-gang Ren, doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: TACE vs.TACE+RFA

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 17, 2018
• Study Start: June 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)