Back to resultsCytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CpG DNA
transcatheter arterial chemoembolization
Placebo - Concentrate
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CpG DNA
placebo
Arm Description
CpG DNA concentrate
placebo concentrate
Outcomes
Primary Outcome Measures
survival time
metastasis free survival time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235167
Brief Title
Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy
Official Title
Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to observe the outcome of hepatocellular carcinoma patients under the combination treatment of transcatheter arterial chemoembolization (TACE) and CpG DNA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CpG DNA
Arm Type
Experimental
Arm Description
CpG DNA concentrate
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo concentrate
Intervention Type
Drug
Intervention Name(s)
CpG DNA
Intervention Description
CpG DNA concentrate
Intervention Type
Procedure
Intervention Name(s)
transcatheter arterial chemoembolization
Intervention Description
transcatheter arterial chemoembolization (TACE) therapy for liver cancer
Intervention Type
Drug
Intervention Name(s)
Placebo - Concentrate
Intervention Description
CpG DNA vehicle
Primary Outcome Measure Information:
Title
survival time
Time Frame
5 years
Title
metastasis free survival time
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
haoren wang
Phone
86-041162893507
Email
haoren_wang@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaolin Yuan
Organizational Affiliation
The Affiliated Zhongshan Hospital of Dalian University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
age, gender, cancer staging
Learn more about this trial
Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy
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