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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Radiofrequency ablation; Biological: Cytokine-induced killer cells

• Registration Number: NCT02419677
• Lead Sponsor: The First People's Hospital of Changzhou

Brief Summary

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).

Detailed Description

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

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-14
• Last Update Submitted: 2015-04-14
• Study First Posted: 2015-04-17
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA alone	Radiofrequency ablation	Patients undergo radiofrequency ablation alone.
RFA+CIK	Radiofrequency ablation	Autologous cytokine-induced killer cells were transfer via venous one week after RFA.
RFA+CIK	Cytokine-induced killer cells	Autologous cytokine-induced killer cells were transfer via venous one week after RFA.

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	One year	Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.

Secondary Outcome Measures

Name	Time	Method
Adverse events	4 weeks	Adverse events related to RFA and CIK treatments.

Trial Locations

Locations (1)

The First People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China