Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00921531
• Other study ID #: LCI-THALIDOMIDE
• Secondary ID: LCI-09-06-15
• Status: Recruiting
• Phase: Phase 3
• First received: June 15, 2009
• Last updated: April 18, 2011
• Start date: June 2009
• Est. completion date: April 2013

Study information

• Verified date: June 2009
• Source: Fudan University
• Contact: Zheng-Gang Ren, Ph.D
• Phone: 0086-021-64041990
• Email: ren.zhenggang[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Thalidomide
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.
• TACE
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.

Locations

Country	Name	City	State
China	Liver Cancer Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Fudan University,Shanghai,China
•   Zhongshan Hospital,Fudan University,Shanghai,China