Chemoembolization for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Chemoembolization for Hepatocellular Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02821533
• Other study ID #: VIR-13-04
• Status: Terminated
• Phase: Phase 2
• First received: June 7, 2016
• Last updated: August 18, 2017
• Start date: February 2012
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Drug:
• 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.

Locations

Country	Name	City	State
Hong Kong	Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response	CT scan abdomen will be performed 3 months after the first treatment. Tumor response by CT was classified into complete response (CR), partial response (PR), static disease (SD, and progressive disease (PD) according to European Association for the Study of the Liver (EASL) necrosis guidelines,	3 months after treatment
Secondary	overall survival	No further treatment was given when there was deterioration in liver function or performance status meeting the exclusion criteria	30 days after treatment