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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability, Mortality

Outcome Time Frame:

6 months

Principal Investigator

Gao-Jun Teng, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhongda Hospital, Southeast University, Nanjing, China

Authority:

China: Food and Drug Administration

Study ID:

SIMCERE-123456

NCT ID:

NCT00518557

Start Date:

April 2007

Completion Date:

December 2009

Related Keywords:

  • Hepatocellular Carcinoma
  • liver cancer
  • interventional radiology
  • Chemoembolization
  • Safety
  • Effectiveness
  • Carcinoma
  • Carcinoma, Hepatocellular

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