Targeted Internal Radiation Therapy in Advanced HCC Patients.

Eastern Hepatobiliary Surgery Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Internal Radiation Advanced Hepatocellular Carcinoma

Interventions

131I-chTNT-1/BBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Overall Survival

Time frame: 3 years

Secondary Outcomes

Time to Progression

Time frame: 3 years

Data from ClinicalTrials.gov

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