Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular... | NCT03235167

Studies
Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy

NCT03235167

Sponsor

Dalian University

Status

Unknown status

Last Update Posted

Sep 18, 2017Actual

Enrollment

100Estimated

Phase

Phase 1

Conditions

Hepatocellular Carcinoma

Interventions

CpG DNA
transcatheter arterial chemoembolization
Placebo - Concentrate

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2017Estimated

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Jul 27, 2017

First Submission Date that Met QC Criteria

Jul 27, 2017

First Posted Date

Aug 1, 2017Actual

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

Sep 14, 2017

Last Update Posted Date

Sep 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

to observe the outcome of hepatocellular carcinoma patients under the combination treatment of transcatheter arterial chemoembolization (TACE) and CpG DNA

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CpG DNA	Experimental	CpG DNA concentrate	Drug: CpG DNA Procedure: transcatheter arterial chemoembolization
placebo	Placebo Comparator	placebo concentrate	Procedure: transcatheter arterial chemoembolization Drug: Placebo - Concentrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CpG DNA	Drug	CpG DNA concentrate	CpG DNA
transcatheter arterial chemoembolization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival time		5 years
metastasis free survival time		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

TNM (tumor node metastasis ) staging with non distant metastasis; no other tumors

Exclusion Criteria:

having received previous treatment for liver cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
haoren wang	Contact	86-041162893507		haoren_wang@yahoo.com

Overall Officials

Name	Affiliation	Role
xiaolin Yuan	Affiliated Zhongshan Hospital of Dalian University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

age, gender, cancer staging

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

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