Targeted Internal Radiation Therapy in Advanced HCC Patients.

NCT ID: NCT02724267

Last Updated: 2016-03-31

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

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced HCC patients.

Detailed Description

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Conditions

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Internal Radiation Advanced Hepatocellular Carcinoma

Keywords

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131I-chTNT-1/B treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transcatheter arterial chemoembolization

Patients will be treated with TACE only.

Group Type ACTIVE_COMPARATOR

131I-chTNT-1/B

Intervention Type BIOLOGICAL

29.6 MBq/kg,intravenous administration in 1 hour,1-3 course of treatment

internal radiation group

Patients will be treated with TACE combined with internal radiation.

Group Type EXPERIMENTAL

131I-chTNT-1/B

Intervention Type BIOLOGICAL

29.6 MBq/kg,intravenous administration in 1 hour,1-3 course of treatment

Interventions

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131I-chTNT-1/B

29.6 MBq/kg,intravenous administration in 1 hour,1-3 course of treatment

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma
2. mRECIST estimation: necrosis region in HCC
3. Negative iodine allergy test
4. Liver function :Child-Pugh A/B

Exclusion Criteria

1. reject to attend;
2. impossible to come to our hospital for physical examination regularly.
3. Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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ZD201208002-P1

Identifier Type: -

Identifier Source: org_study_id