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Chemoembolization for Hepatocellular Carcinoma

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Terminated
CT.gov ID
NCT02821533
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
66
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Chemoembolization for Hepatocellular Carcinoma
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tumor response [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,

    Secondary Outcome Measures

    1. overall survival [30 days after treatment]

      No further treatment was given when there was deterioration in liver function or performance status meeting the exclusion criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Simon Yu, DIIR, CUHK, Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Simon Yu, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT02821533
    Other Study ID Numbers:
    • VIR-13-04
    First Posted:
    Jul 1, 2016
    Last Update Posted:
    Aug 22, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Cisplatin
    Antineoplastic Agents

    Study Results

    No Results Posted as of Aug 22, 2017