NCT02418988

Brief Summary

Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients' poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC. But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has multiple anticancer functions and does not have any of the immune-inhibitory effects of chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced 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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2014

Typical duration for phase_2

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

July 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

March 25, 2015

Last Update Submit

April 13, 2015

Conditions

Advanced Adult Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • overall survival

    overall survival

    tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later

Secondary Outcomes (2)

  • safety as assessed by adverse events, vital sign, lab tests, ECG and physical examination

    from the first study treatment to the 30 days after the last treatment (on an average of 6 months from the start treatment)

  • progression-free survival

    tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later

Study Arms (2)

TACE plus rAd-p53

EXPERIMENTAL

TACE plus rAd-p53 artery injection'

Drug: TACE plus rAd-p53 artery injection

TACE

ACTIVE COMPARATOR

TACE will be applied alone

Drug: TACE

Interventions

TACE plus rAd-p53 artery injectionDRUG

Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days

Also known as: no other name
TACE plus rAd-p53
TACEDRUG

Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days

Also known as: no other name
TACE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histopathologically diagnosed HCC;
  • unresectable;
  • 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; 8. signed the informed consent form.

You may not qualify if:

  • Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
  • have serious heart, lung function abnormalities or severe diabetes patients;
  • active infection;
  • liver function Child-Pugh grade C;
  • secondary and diffuse hepatocellular carcinoma patients;
  • extensive metastasis;
  • severe atherosclerosis;
  • AIDS patients;
  • serious thrombotic or embolic events within 6 months;
  • renal insufficiency requiring hemodialysis or peritoneal dialysis;
  • \. pregnant or lactating women;
  • \. mental disorder or disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of the Fourth Military Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

Central Study Contacts

Xinming Zhou, MD

CONTACT

0118613991201878zhouxmm@fmmu.edu.cn

Scott Gao, Ph.D, MD

CONTACT

086-13923759810scottgao1110@gmail.com

Study Design

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

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 17, 2015

Study Start

July 1, 2014

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

April 17, 2015

Record last verified: 2015-03

Locations

CN(1)