Clinical trial · Interventional
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
NCT00635323CI-TRIAL-00001392completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan plus capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Irinotecan plus capecitabine
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Week 6
Secondary outcomes (7)
- measure
- Time to progression
- timeFrame
- Weeks 6, 12, 18, 24, 36, and 1 year
- measure
- Duration of overall response
- timeFrame
- Weeks 6, 12, 18, 24, 36, and 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.