NCT00921531

Brief Summary

Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver. Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall survival and time to progression.

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
200

participants targeted

Target at P25-P50 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Jun 2009

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

June 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 19, 2011

Status Verified

June 1, 2009

Enrollment Period

3.5 years

First QC Date

June 15, 2009

Last Update Submit

April 18, 2011

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomathalidomideTACEChild-Pugh Class A or B

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    primary outcome is defined as overall survival. overall survival is calculated from the time of undergo treatment (TACE) to time of patients death.

    36 months

Secondary Outcomes (1)

  • time to progression

    36 months

Study Arms (2)

Thalidomide and TACE

EXPERIMENTAL

Thalidomide is used for adjuvant therapy for TACE

Drug: ThalidomideDrug: TACE

TACE only

ACTIVE COMPARATOR
Drug: TACE

Interventions

ThalidomideDRUG

Thalidomide is used for adjuvant therapy for TACE Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day.

Thalidomide and TACE
TACEDRUG

TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.

TACE onlyThalidomide and TACE

Eligibility Criteria

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

You may qualify if:

  • Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
  • Age ≥ 18 years and ≤ 80 years
  • At least one tumor nodule with one uni-dimension of ≥ 2 cm
  • Child-Pugh Class A or B
  • Total bilirubin ≤ 1.5 x upper limit of normal
  • ALT and AST ≤ 2.0 x the upper limit of normal
  • PT-INR\<2.3,PTT \< 1.5 x upper limit of normal
  • Serum creatinine ≤ 1.5x upper limit of normal
  • Peripheral white blood cell count of or more than 3×10(9)/L
  • Peripheral platelet of or more than 50×10(9)/L
  • Expected survival time not less than 3 months
  • ECOG score 0-2

You may not qualify if:

  • Tumor thrombi in main branch of portal vein
  • Tumor involvement more than 70% of whole liver
  • With extrahepatic metastasis
  • Prior systemic chemotherapy or chemoembolization
  • Congestive heart failure \> NYHA class 2
  • History of HIV infection
  • Active clinically serious infections (\> 2 NCI-CTC Version 3.0)
  • Recurrence of HCC after liver transplantation
  • Pregnant or breast-feeding
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
  • Known or suspected allergy to any agent given in association with this trial
  • Patients unable to swallow oral medication
  • Inclined to thrombosis
  • Inclined to hemorrhage or active hemorrhage with 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Cancer Institute

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Zheng-Gang Ren, Ph.D

CONTACT

0086-021-64041990ren.zhenggang@zs-hospital.sh.cn

Ju-Bo Zhang, Ph.D

CONTACT

0086-021-64041990zhang.jubo@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

April 19, 2011

Record last verified: 2009-06

Locations

CN(1)