Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases

Soochow University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colorectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02419677

FirstPHChangzhou

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 colorectal cancer liver metastases (CRCLM).

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed adenocarcinoma
• Primary lesions (colorectal cancer) are resected
• Must have undergone prior complete resection of the primary tumor; liver metastases
• Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
• 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 colorectal cancer.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 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:

Procedure: Radiofrequency ablation

Biological: Cytokine-induced killer cells