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Chemoembolization for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
TACE
Cisplatin
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TACE using a high dose of cisplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2016
Last Updated
August 18, 2017
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02821533
Brief Title
Chemoembolization for Hepatocellular Carcinoma
Official Title
Chemoembolization for Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor case accrual
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACE using a high dose of cisplatin
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
chemotherapeutic agent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor response
Description
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,
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
overall survival
Description
No further treatment was given when there was deterioration in liver function or performance status meeting the exclusion criteria
Time Frame
30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient factor Age > 18 Child-Pugh A or B cirrhosis ECOG performance status Grade 2 or below No serious concurrent medical illness No prior treatment for HCC except for liver resection Creatinine clearance >55ml/min. Tumor factor HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology. Unresectable and locally advanced disease without extra-hepatic disease Massive expansive tumor type with measurable lesion on CT Total tumor mass < 50% liver volume Largest tumor of greatest dimension ≤ 15cm Exclusion Criteria: Patient factor Serum creatinine level > 130 umol/L Presence of biliary obstruction not amenable to percutaneous drainage Child-Pugh C cirrhosis Evidence of impaired liver function History of hepatic encephalopathy, or Intractable ascites not controllable by medical therapy, or History of variceal bleeding within last 3 months, or Serum total bilirubin level > 40 umol/L, or Serum albumin level < 30g/L, or INR > 1.3 Tumor factor Presence of extrahepatic metastasis Infiltrative lesion Diffuse lesion Vascular complications Hepatic artery thrombosis, or Partial or complete thrombosis of the main portal vein, or Tumor invasion of portal branch of contralateral lobe, or Hepatic vein tumor thrombus, or Significant arterioportal shunt, or Significant arteriovenous shunt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Yu
Organizational Affiliation
DIIR, CUHK, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Chemoembolization for Hepatocellular Carcinoma

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