ClinicalTrials.gov
ClinicalTrials.gov Menu

Chemoembolization for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02821533
Recruitment Status : Terminated (Poor case accrual)
First Posted : July 1, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Simon Yu, Chinese University of Hong Kong

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
Hepatocellular Carcinoma Procedure: TACE Drug: Cisplatin 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemoembolization for Hepatocellular Carcinoma
Study Start Date : February 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
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 Name: chemotherapeutic agent




Primary Outcome Measures :
  1. 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,


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821533


Locations
Hong Kong
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

Responsible Party: Simon Yu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02821533     History of Changes
Other Study ID Numbers: VIR-13-04
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Cisplatin
Antineoplastic Agents