NCT02509169

Brief Summary

An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

July 19, 2015

Last Update Submit

July 23, 2015

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

  • overall survival

    overall survival will be follow up to 2 years

    2 years

Secondary Outcomes (2)

  • immuno-reaction (lymphocyte counts and subgroup ratios)

    3 months

  • progression free survival

    2 years

Study Arms (2)

TAE plus p53 gene

EXPERIMENTAL

Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month

Drug: TAE plus P53 gene

TAE

ACTIVE COMPARATOR

Trans-catheter embolization (TAE) will be given once per month

Other: TAE

Interventions

TAE plus P53 geneDRUG

Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy

TAE plus p53 gene
TAEOTHER

Trans-catheter embolization

TAE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histopathologically diagnosed unresectable HCC
  • over 18 years old
  • with an Eastern Cooperative Oncology Group (ECOG) score of 0-2
  • with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C
  • with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function
  • signed the informed consent form.

You may not qualify if:

  • hypersensitive to study drug
  • With an abnormal coagulation condition or bleeding disorder
  • infections
  • with serious conditions which prevent using the study treatment
  • pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

first affiliated hospital in Dalian University

Dalian, Liaoning, China

RECRUITING

MeSH Terms

Interventions

Genes, p53

Intervention Hierarchy (Ancestors)

Genes, Tumor SuppressorGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGenes, Recessive

Central Study Contacts

Yuewei Zhang, MD and Ph D

CONTACT

zhangyuewei1121@sina.com

Gui Gao, MD, Ph D

CONTACT

scottgao1110@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2015

First Posted

July 27, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 27, 2015

Record last verified: 2015-07

Locations

CN(1)