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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

668 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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infusion group

Infusion of anticancer agent followed by Embolization

Group Type EXPERIMENTAL

Embolization

Intervention Type OTHER

embolization with lipiodol and polyvinyl alcohol particles (PVA)

Infusion of anticancer agent

Intervention Type OTHER

infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water

lipiodol chemotherapy group

Infusion of mixture of anticancer agent and lipiodol followed by Embolization

Group Type EXPERIMENTAL

Embolization

Intervention Type OTHER

embolization with lipiodol and polyvinyl alcohol particles (PVA)

Infusion of mixture of anticancer agent and lipiodol

Intervention Type OTHER

infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water

Interventions

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Embolization

embolization with lipiodol and polyvinyl alcohol particles (PVA)

Intervention Type OTHER

Infusion of anticancer agent

infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water

Intervention Type OTHER

Infusion of mixture of anticancer agent and lipiodol

infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No