Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2006-12-31

Brief Summary

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Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.

Detailed Description

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To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes.

The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response.

Conditions

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Hepatocellular Carcinoma

Keywords

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Hepatocellular carcinoma,treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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chemoembolization ,Radiofrequency ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Eligibility criteria were:

1. Not indicated for resection,
2. Liver function of Child-Pugh class A or B,
3. 3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter,
4. No portal vein involvement or extrahepatic metastasis,
5. Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct,
6. Platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and
7. No previous HCC treatment.

Exclusion Criteria

1. Encephalopathy,
2. Refractory ascites,
3. Active gastrointestinal bleeding,
4. Renal failure.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Wang Qi Liang, MD,PhD

Role: STUDY_CHAIR

Dept. of Radiology

References

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Cheng BQ, Jia CQ, Liu CT, Fan W, Wang QL, Zhang ZL, Yi CH. Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm: a randomized controlled trial. JAMA. 2008 Apr 9;299(14):1669-77. doi: 10.1001/jama.299.14.1669.

Reference Type DERIVED

PMID: 18398079 (View on PubMed)

Other Identifiers

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03BS035

Identifier Type: -

Identifier Source: secondary_id

2001HCC