Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis

Hepatocellular Carcinoma Clinical Trial

— TACE HCC  

Official title:

Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00518557
• Other study ID #: SIMCERE-123456
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2007
• Last updated: January 21, 2009
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Southeast University, China
• Contact: Xiao-Hui Chen, MD
• Phone: +86 25 83272121
• Email: noriko0706[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Transcatheter Arterial Chemoembolization
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.

Locations

Country	Name	City	State
China	Department of Interventional Radiology, Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability, Mortality		6 months
Secondary	Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival		2 years

External Links

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