Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

Pfizer73 enrolled

Overview

To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

Irinotecan plus capecitabineDRUG

Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma * Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement) * Eastern Cooperative Oncology Group performance status of ?2 Exclusion Criteria: * Decompensated cirrhosis or stage C (Index\>10) according to the Child-Pugh Classification * Current history of chronic diarrhoea * Reproductive potential not using adequate contraceptive measures

Locations (9)

Pfizer Investigational Site

Shanghai, China

Pfizer Investigational Site

Hong Kong SAR, Hong Kong

Pfizer Investigational Site

Seoul, South Korea

Pfizer Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Overall response rate

Time frame: Week 6