Liver Cancer HepaSphere Combined With Cryosurgery

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Liver Cancer

Treatments: Procedure: HepaSphere combined with cryosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02545556

Liver hepaSphere cryosurgery

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.

Full description

By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） combined with cryosurgery for liver cancer.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age:18-80
2. Karnofsky performance status >60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion criteria

1. Patients with other primary tumor except liver cancer
2. History of coagulation disorders or anemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

HepaSphere combined with cryosurgery

Experimental group

Description:

liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery

Treatment:

Procedure: HepaSphere combined with cryosurgery

control

Placebo Comparator group

Description:

liver cancer patients received traditional therapy

Treatment:

Procedure: HepaSphere combined with cryosurgery