Chemoembolization for Hepatocellular Carcinoma

NCT02821533 | Terminated Phase 2 DMC

• 1 other identifier: VIR-13-04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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,

  3 months after treatment

Secondary Outcomes (1)

• overall survival

  30 days after treatment

Study Arms (1)

TACE using a high dose of cisplatin

OTHER

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; Drug: Cisplatin

Interventions

TACE PROCEDURE

TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.

TACE using a high dose of cisplatin

Cisplatin DRUG

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.

Also known as: chemotherapeutic agent

TACE using a high dose of cisplatin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cisplatin; Antineoplastic Agents

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Simon Yu

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: July 1, 2016
• Study Start: February 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)