Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma

Soochow University

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Procedure: Radiofrequency ablation; Biological: Cytokine-induced killer cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02482454

chol001

Details and patient eligibility

About

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.

Full description

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.

Enrollment: 50 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed cholangiocarcinoma
• Primary lesions (cholangiocarcinoma) are not resected
• Serum bilirubin level of 2.0 mg/dl or less.
• Performance status of 0 or 1.
• Expected survival of 1 year or more.
• Informed consent from the patient.

Exclusion criteria

• With extrahepatic metastases
• With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

RFA alone

Other group

Description:

Patients undergo radiofrequency ablation alone.

Treatment:

Procedure: Radiofrequency ablation

RFA+CIK

Experimental group

Description:

Autologous cytokine-induced killer cells were transfer via venous one week after RFA

Treatment:

Biological: Cytokine-induced killer cells

Procedure: Radiofrequency ablation