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

A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635323

Enrollment

Registered

2008-03-13

Start date

2002-11-30

Completion date

2005-05-31

Last updated

2008-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Brief summary

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

Interventions

DRUGIrinotecan plus capecitabine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall response rate	Week 6

Secondary

Measure	Time frame
Duration of overall response	Weeks 6, 12, 18, 24, 36, and 1 year
Overall tumour growth control rate	Weeks 6, 12, 18, 24, 36, and 1 year
Overall survival	Weeks 6, 12, 18, 24, 36, and 1 year
Time to progression	Weeks 6, 12, 18, 24, 36, and 1 year
Physical exam	Weeks 6, 12, 18, 24, 36, and 1 year
Laboratory tests	Weeks 6, 12, 18, 24, 36, and 1 year
Adverse events	Weeks 6, 12, 18, 24, 36, and 1 year

Countries

China, Hong Kong, South Korea, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026