Chemoembolization for Hepatocellular Carcinoma

NCT ID: NCT02821533

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-08-31

Brief Summary

The aim of the current study is to study the safety and effectiveness of TACE using a high dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and it improves the therapeutic effect of conventional TACE.

Detailed Description

Most patients with HCC are diagnosed at an intermediate and advanced stage when the tumors become unresectable, transcatheter arterial chemoembolisation (TACE) has been widely accepted as a standard treatment for them in most international management protocols. The therapeutic effect of TACE in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. Internationally, high doses and combination of chemotherapeutic agents are being routinely and widely used for TACE in major medical centers. Locally, a low dose of cisplatin (10mg) has been used as the chemotherapeutic agent for TACE in Hong Kong. There is evidence showing that the component of chemotherapeutic agent in TACE does play a significant role in the treatment effect of TACE. In an attempt to improve the treatment effect of TACE, the investigators propose a formulation of TACE using a high dose of cisplatin as chemotherapeutic agent.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE using a high dose of cisplatin

Two consecutive treatments at two months apart will be given. A delay in the second treatment is allowed if patients do not recover to an acceptable state for subsequent cycle of treatment. Two treatment sessions at one month apart may be required for each complete treatment to cover all lesions when the lesions are diffusely distributed and involving both lobes.

Group Type: OTHER

TACE

Intervention Type: PROCEDURE

TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.

Cisplatin

Intervention Type: DRUG

Cisplatin will be mixed with a mixture of Lipiodol and ethanol (LEM), which consists of 33% ethanol by volume in Lipiodol, in a ratio of 2mg cisplatin per mL of LEM, and delivered through catheters or microcatheters to the tumors until there is flow reduction at the tumor feeders. The total dose of cisplatin given in each treatment session is limited to 100mg (50mL LEM) in each treatment session. The usual volume of LEM delivered will be 20 - 30 mL.

Interventions

TACE

TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.

Intervention Type: PROCEDURE

Cisplatin

Cisplatin will be mixed with a mixture of Lipiodol and ethanol (LEM), which consists of 33% ethanol by volume in Lipiodol, in a ratio of 2mg cisplatin per mL of LEM, and delivered through catheters or microcatheters to the tumors until there is flow reduction at the tumor feeders. The total dose of cisplatin given in each treatment session is limited to 100mg (50mL LEM) in each treatment session. The usual volume of LEM delivered will be 20 - 30 mL.

Intervention Type: DRUG

Other Intervention Names

chemotherapeutic agent

Eligibility Criteria

Inclusion Criteria

Patient factor

1. Age > 18

2. Child-Pugh A or B cirrhosis

3. ECOG performance status Grade 2 or below

4. No serious concurrent medical illness

5. No prior treatment for HCC except for liver resection

6. Creatinine clearance >55ml/min.

Tumor factor

1. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.

2. Unresectable and locally advanced disease without extra-hepatic disease

3. Massive expansive tumor type with measurable lesion on CT

4. Total tumor mass < 50% liver volume

5. Largest tumor of greatest dimension ≤ 15cm

Exclusion Criteria

Patient factor

1. Serum creatinine level > 130 umol/L

2. Presence of biliary obstruction not amenable to percutaneous drainage

3. Child-Pugh C cirrhosis

Evidence of impaired liver function

1. History of hepatic encephalopathy, or

2. Intractable ascites not controllable by medical therapy, or

3. History of variceal bleeding within last 3 months, or

4. Serum total bilirubin level > 40 umol/L, or

5. Serum albumin level < 30g/L, or

6. INR > 1.3

Tumor factor

1. Presence of extrahepatic metastasis

2. Infiltrative lesion

3. Diffuse lesion

Vascular complications

1. Hepatic artery thrombosis, or

2. Partial or complete thrombosis of the main portal vein, or

3. Tumor invasion of portal branch of contralateral lobe, or

4. Hepatic vein tumor thrombus, or

5. Significant arterioportal shunt, or

6. Significant arteriovenous shunt

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Yu

Role: PRINCIPAL_INVESTIGATOR

DIIR, CUHK, Hong Kong

Locations

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

VIR-13-04

Identifier Type: -

Identifier Source: org_study_id