Hepatocellular Carcinoma
Conditions
Keywords
liver cancer, interventional radiology, Chemoembolization, Safety, Effectiveness
Brief 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.
Interventions
PROCEDURETranscatheter 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.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, Mortality | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival | 2 years |
Countries
China
Contacts
Primary ContactXiao-Hui Chen, MD
Backup ContactGang Deng, MD, Ph.D
Outcome results
None listed