NCT03235167

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_1 hepatocellular-carcinoma

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

5 years

First QC Date

July 27, 2017

Last Update Submit

September 14, 2017

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • survival time

    5 years

  • metastasis free survival time

    5 years

Study Arms (2)

CpG DNA

EXPERIMENTAL

CpG DNA concentrate

Drug: CpG DNAProcedure: transcatheter arterial chemoembolization

placebo

PLACEBO COMPARATOR

placebo concentrate

Procedure: transcatheter arterial chemoembolizationDrug: Placebo - Concentrate

Interventions

CpG DNADRUG

CpG DNA concentrate

CpG DNA
transcatheter arterial chemoembolizationPROCEDURE

transcatheter arterial chemoembolization (TACE) therapy for liver cancer

CpG DNAplacebo
Placebo - ConcentrateDRUG

CpG DNA vehicle

placebo

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • having received previous treatment for liver cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • xiaolin Yuan

    Affiliated Zhongshan Hospital of Dalian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

haoren wang

CONTACT

86-041162893507haoren_wang@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

September 18, 2017

Record last verified: 2017-09