NCT00518557

Brief Summary

The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.

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 P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Apr 2007

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

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

First QC Date

August 16, 2007

Last Update Submit

January 21, 2009

Conditions

Hepatocellular Carcinoma

Keywords

liver cancerinterventional radiologyChemoembolizationSafetyEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability, Mortality

    6 months

Secondary Outcomes (1)

  • Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival

    2 years

Study Arms (2)

1

EXPERIMENTAL

All patients of this arm are treated by TACE together with Andostatin.

Procedure: Transcatheter Arterial Chemoembolization

2

ACTIVE COMPARATOR

All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin.

Procedure: Transcatheter Arterial Chemoembolization

Interventions

Transcatheter Arterial ChemoembolizationPROCEDURE

The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.

Also known as: TAE
12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cytologically or histologically documented HCC, who are candidates for TACE
  • Child-Pugh Child A or B
  • Age \>= 18
  • Measurable disease by RECIST criteria;
  • Performance status ECOG 0-2
  • Previous local therapy completed \> 4 weeks
  • Written informed consent signed
  • Normal organ and marrow function defined as:
  • Haematopoietic:
  • WBC ≥ 3,000/µlplatelet count \> 80,000/mm3
  • haemoglobin \> 9g/dL
  • Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT \< 5 x ULN
  • Renal: creatinine \< 1.5 x ULN

You may not qualify if:

  • Metastases
  • Prior or concomitant chemotherapy or radiation therapy
  • VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
  • Severe and/or uncontrolled medical conditions:
  • Congestive heart failure, serious cardiac arrhythmia, active coronary artery
  • Severe renal impairment
  • Patients who anticipate receiving major surgery during the course of the
  • Pregnant or breastfeeding patients
  • Evidence of bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Interventional Radiology, Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gao-Jun Teng, MD, Ph.D

    Zhongda Hospital, Southeast University, Nanjing, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Chen, MD

CONTACT

+86 25 83272121noriko0706@sohu.com

Gang Deng, MD, Ph.D

CONTACT

+86 25 83272118dmm1996@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

April 1, 2007

Study Completion

December 1, 2009

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

CN(1)