Radiofrquency Ablation Combined With Cytokine-induced Kil... | NCT02482454

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

NCT02482454

Sponsor

The First People's Hospital of Changzhou

Status

Active, not recruiting

Last Update Posted

Aug 1, 2017Actual

Enrollment

50Actual

Phase

Phase 2Phase 3

Conditions

Cholangiocarcinoma

Interventions

Radiofrequency ablation
Cytokine-induced killer cells

Countries

China

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 2017

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 2012

Primary Completion Date

Jul 2030Estimated

Completion Date

Jul 2033Estimated

First Submitted Date

Jun 24, 2015

First Submission Date that Met QC Criteria

Jun 24, 2015

First Posted Date

Jun 26, 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

Jul 31, 2017

Last Update Posted Date

Aug 1, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

peng du, Director of Science and Education Division, The First People's Hospital of ChangzhouPrincipal Investigator

Lead Sponsor

The First People's Hospital of ChangzhouOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 cholangiocarcinoma.

Detailed Description

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

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RFA alone	Other	Patients undergo radiofrequency ablation alone.	Procedure: Radiofrequency ablation
RFA+CIK	Experimental	Autologous cytokine-induced killer cells were transfer via venous one week after RFA	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 alone 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 with histologically confirmed cholangiocarcinoma
Primary lesions (cholangiocarcinoma) are not resected
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 cholangiocarcinoma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Changping Wu, M.D.	The First People's Hospital of Changzhou	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First People's Hospital of Changzhou		Changzhou	Jiangsu		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

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