Phase III Trial of Oral Thalidomide in Advanced Hepatocel... | NCT00225290

Studies
Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve

NCT00225290

Sponsor

TTY Biopharm

Status

Terminated

Last Update Posted

Oct 12, 2011Estimated

Enrollment

230Estimated

Phase

Phase 3

Conditions

Carcinoma, Hepatocellular

Interventions

Thalidomide(Thado)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slowly recruitment rate

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2011

Last Update Posted Date

Oct 12, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Name	Type	Description	Arm Group Labels	Other Names
Thalidomide(Thado)	Drug

Measure	Description	Time Frame
overall survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
The diagnosis of HCC should be established either by cyto/histology
Patients must be > 20 years of age.
ECOG score < 2.
Signed informed consent.
Female patients at child-bearing age must have negative pregnancy test.

Exclusion Criteria:

Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
Patients with advanced second primary malignancy are not eligible.
Patients with active infection are not eligible.
Patients with pregnancy or breast-feeding are not eligible.
Patients with brain metastases are not eligible.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Li-Tzong Chen, M.D Ph.D.	Division of Cancer Research, National Health Research Institute Ward 191	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taiwan Cooperative Oncology Group		Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided