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

Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: Cytokine-induced killer cells; Procedure: Radiofrequency ablation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • The First People's Hospital Of Changzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RFA alone; Patients undergo radiofrequency ablation alone.	Procedure: Radiofrequency ablation; Radiofrequency ablation is performed percutaneously under CT/US guidance.; Other Names: RFA
Experimental: RFA+CIK; Autologous cytokine-induced killer cells were transfer via venous one week after RFA.	Biological: Cytokine-induced killer cells; The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.; Other Names: CIK; Procedure: Radiofrequency ablation; Radiofrequency ablation is performed percutaneously under CT/US guidance.; Other Names: RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	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.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events related to RFA and CIK treatments.	4 weeks

Collaborators and Investigators

• Sponsor: The First People's Hospital of Changzhou

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: radiofrequency ablation; cytokine-induced killer cells; colorectal cancer iver metastases
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: FirstPHChangzhou