Adjuvant Therapy With Thalidomide for Chemoembolization i... | NCT00921531

Studies
Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

NCT00921531

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 19, 2011Estimated

Enrollment

200Estimated

Phase

Phase 3

Conditions

Hepatocellular Carcinoma

Interventions

Thalidomide
TACE

Countries

China

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

ID	Type	Description	Link
LCI-09-06-15

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2012Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Jun 15, 2009

First Submission Date that Met QC Criteria

Jun 15, 2009

First Posted Date

Jun 16, 2009Estimated

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

Apr 18, 2011

Last Update Posted Date

Apr 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thalidomide and TACE	Experimental	Thalidomide is used for adjuvant therapy for TACE	Drug: Thalidomide Drug: TACE
TACE only	Active Comparator		Drug: TACE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thalidomide	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
time to progression	time to progression is defined as from the time of treatment (TACE) to the time of patient's progression. the progression is defined as disease progression based on RECIST criteria.	36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zheng-Gang Ren, Ph.D	Contact	0086-021-64041990	2137	ren.zhenggang@zs-hospital.sh.cn
Ju-Bo Zhang, Ph.D	Contact	0086-021-64041990	2136	zhang.jubo@zs-hospital.sh.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liver Cancer Institute	Recruiting	Shanghai	Shanghai Municipality	200032	China

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

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids