Chemoembolization for Hepatocellular Carcinoma

The Chinese University of Hong Kong

Status and phase: Terminated; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Cisplatin; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT02821533

VIR-13-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

TACE using a high dose of cisplatin

Other group

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.

Treatment:

Procedure: TACE

Drug: Cisplatin