Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Embolization; Other: Infusion of anticancer agent; Other: Infusion of mixture of anticancer agent and lipiodol

• Registration Number: NCT01229839
• Lead Sponsor: Sun Yat-sen University

Brief Summary

TACE is considered the standard treatment for unresectable HCC on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Study Start: 2013-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

• Adults patients with a diagnosis of HCC which is not amenable 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. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.

• No serious concurrent medical illness

• Unresectable BCLC stage A-B disease

• No cirrhosis or cirrhotic status of Child-Pugh class A

• No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis

• No current infections requiring antibiotic therapy

• Not on anticoagulation or suffering from a known bleeding disorder

• No unstable coronary artery disease or recent MI

• 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 Criteria

• Known history of HIV
• History of organ allograft
• Pregnant or breast-feeding patients
• 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 Arteriavein Shunts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
lipiodol chemotherapy group	Embolization	Infusion of mixture of anticancer agent and lipiodol followed by Embolization
infusion group	Embolization	Infusion of anticancer agent followed by Embolization
infusion group	Infusion of anticancer agent	Infusion of anticancer agent followed by Embolization
lipiodol chemotherapy group	Infusion of mixture of anticancer agent and lipiodol	Infusion of mixture of anticancer agent and lipiodol followed by Embolization

Primary Outcome Measures

Name	Time	Method
overall survival	3 year

Secondary Outcome Measures

Name	Time	Method
Time to progression	3 year

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China