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

NCT ID: NCT02419677

Last Updated: 2015-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RFA alone

Patients undergo radiofrequency ablation alone.

Group Type OTHER

Radiofrequency ablation

Intervention Type PROCEDURE

Radiofrequency ablation is performed percutaneously under CT/US guidance.

RFA+CIK

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

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type PROCEDURE

Radiofrequency ablation is performed percutaneously under CT/US guidance.

Cytokine-induced killer cells

Intervention Type BIOLOGICAL

The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Interventions

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Radiofrequency ablation

Radiofrequency ablation is performed percutaneously under CT/US guidance.

Intervention Type PROCEDURE

Cytokine-induced killer cells

The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Intervention Type BIOLOGICAL

Other Intervention Names

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RFA CIK

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First People's Hospital of Changzhou

OTHER

Sponsor Role lead

Responsible Party

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Liangrong Shi

Director of Science and Education Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Changping Wu, M.D.

Role: STUDY_DIRECTOR

The First People's Hospital of Changzhou

Locations

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The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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FirstPHChangzhou

Identifier Type: -

Identifier Source: org_study_id

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