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CompletedNCT03636620TACE+RFAUpdated Aug 17, 2018

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

A Phase 3 interventional study of Transcatheter arterial chemoembolization and radiofrequency ablation/microwave ablation in Hepatocellular Carcinoma, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 2 months after the study started (first participant enrolled Jun 2013, registered Aug 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 110 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Active comparator
    TACE group

    Transcatheter arterial chemoembolization

    Device: Transcatheter arterial chemoembolization

  • Experimental
    TACE+RFA/MV group

    Transcatheter arterial chemoembolization and radiofrequency /microwave ablation

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

Interventions

  • DeviceTranscatheter arterial chemoembolization

    Transcatheter arterial chemoembolization

    Also known as: TACE

  • Deviceradiofrequency ablation/microwave ablation

    radiofrequency ablation/microwave ablation

    Also known as: RFA/MW

06

What researchers measure

Primary outcomes

  1. overall survival

    Time frame: up to 46 months

Secondary outcomes

  1. objective response rate

    Time frame: up to 46 months

07

Study locations

1 site
  • liver cancer institute ,Fudan University
    Shanghai, 200032, China
08

References and documents

Individual participant data

Plan to share: No — no plan to make individual paticipant data available to other researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03636620
Lead sponsor
Fudan University
Responsible party
Zheng-Gang Ren (professor, Fudan University) — Principal investigator
First posted
Aug 17, 2018
Start date
Jun 2013
Primary completion
Aug 2018
Completion
Aug 2018
Last update
Aug 17, 2018

Study contacts

zheng-gang Ren, doctor
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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