Chemoembolization for Hepatocellular Carcinoma

August 18, 2017 updated by: Simon Yu, Chinese University of Hong Kong
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
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.
Other Names:
  • chemotherapeutic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: 3 months after treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 30 days after treatment
No further treatment was given when there was deterioration in liver function or performance status meeting the exclusion criteria
30 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (ESTIMATE)

July 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIR-13-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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