Overview

Chemoembolization for Hepatocellular Carcinoma

Status:
Terminated

Trial end date:
2017-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chinese University of Hong Kong

Treatments:

Antineoplastic Agents
Cisplatin

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