Status:
COMPLETED
Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
TACE is considered the standard treatment for unresectable HCC and is widely used as a palliative treatment. However there is no consensus of the protocol of TACE.One of the variation is does the stab...
Detailed Description
Transcatheter arterial chemoembolization is currently the mainstays of palliative treatments worldwide for patients with unresectable HCC. However there is no standard protocol exists for TACE current...
Eligibility Criteria
Inclusion
- Male or female patients \> 18 years and \<=70 years of age with a diagnosis of HCC
- BCLC B stage disease
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. The lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not pregnant or breast-feeding patients
- No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
- The following laboratory parameters:
- Platelet count ≥ 60,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
- ASL and AST ≤ 5 x upper limit of normal
- Serum creatinine ≤ 1.5 x upper limit of normal
- INR ≤ 1.5 or PT/APTT within normal limits
- Absolute neutrophil count (ANC) \>1,500/mm3
- Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Known central nervous system tumors including metastatic brain disease
- severe Arterioportal Shunts or Arteria vein Shunts
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
812 Patients enrolled
Trial Details
Trial ID
NCT01259414
Start Date
January 1 2011
End Date
January 1 2017
Last Update
March 6 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China