Chemoembolization for Hepatocellular Carcinoma

Phase 2

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Drug: Cisplatin

• Registration Number: NCT02821533
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-01
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TACE using a high dose of cisplatin	TACE	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.
TACE using a high dose of cisplatin	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong