Targeted Internal Radiation Therapy in Advanced HCC Patients.

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Internal Radiation; Advanced Hepatocellular Carcinoma

Treatments: Biological: 131I-chTNT-1/B

Study type: Interventional

Funder types: Other

Identifiers

NCT02724267

ZD201208002-P1

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

transcatheter arterial chemoembolization

Active Comparator group

Description:

Patients will be treated with TACE only.

Treatment:

Biological: 131I-chTNT-1/B

internal radiation group

Experimental group

Description:

Patients will be treated with TACE combined with internal radiation.

Treatment:

Biological: 131I-chTNT-1/B