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

February 21, 2016 updated by: The First People's Hospital of Changzhou
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 ovarian carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. patients diagnosed with FIGO stage II ovarian carcinoma;
  2. cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed;
  3. medical records maintain comprehensive data on treatment and follow-up;
  4. no history of previous malignancies.

Exclusion Criteria:

  1. neoadjuvant chemotherapy applied;
  2. less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed;
  3. medical records maintain incomplete data on treatment or follow-up;
  4. history of previous malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: RFA alone
Patients undergo radiofrequency ablation alone.
Experimental: RFA+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions
Procedure: Radiofrequency ablation
Radiofrequency ablation is performed percutaneously under CT/US guidance
Other Names:
  • RFA
Biological: Cytokine-induced killer cells
The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
Other Names:
  • CIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 1 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First People's Hospital of Changzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2038

Study Completion (Anticipated)

June 1, 2040

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 21, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ovarian001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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