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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Other: Infusion of mixture of anticancer agent and lipiodol; Other: Infusion of anticancer agent; Other: Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT01229839

HCC_S010

Details and patient eligibility

About

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.

Enrollment: 668 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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668 participants in 2 patient groups

infusion group

Experimental group

Description:

Infusion of anticancer agent followed by Embolization

Treatment:

Other: Embolization

Other: Infusion of anticancer agent

lipiodol chemotherapy group

Experimental group

Description:

Infusion of mixture of anticancer agent and lipiodol followed by Embolization

Treatment:

Other: Embolization

Other: Infusion of mixture of anticancer agent and lipiodol