Radiofrquency Ablation Combined With Cytokine-induced Kil... | NCT02487693

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

NCT02487693

Sponsor

The First People's Hospital of Changzhou

Status

Active, not recruiting

Last Update Posted

Feb 23, 2016Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Ovarian Carcinoma

Interventions

Radiofrequency ablation
Cytokine-induced killer cells

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jun 2038Estimated

Completion Date

Jun 2040Estimated

First Submitted Date

Jun 29, 2015

First Submission Date that Met QC Criteria

Jun 30, 2015

First Posted Date

Jul 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2016

Last Update Posted Date

Feb 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 ovarian carcinoma.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RFA alone	No Intervention	Patients undergo radiofrequency ablation alone.
RFA+CIK	Experimental	Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions	Procedure: Radiofrequency ablation Biological: Cytokine-induced killer cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency ablation	Procedure	Radiofrequency ablation is performed percutaneously under CT/US guidance	RFA+CIK

Outcomes Module

Primary Outcomes

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.	1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided