Clinical trial · Interventional
Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer
Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients
NCT01322152CI-TRIAL-00010676completedPhase 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)
The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan, capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- wXELIRI regimen
- interventionNames
- Drug: irinotecan, capecitabine
Primary outcomes (1)
- measure
- Rate of Diarrhea
- timeFrame
- eight weeks
Secondary outcomes (5)
- measure
- Progression free survival
- timeFrame
- eight weeks
- measure
- Response rate
- timeFrame
- eight weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Histologically confirmed colorectal cancer * Age 18-70 years old * Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before * Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * ECOG 0-1 * Life expectancy of more than 3 months. * Normal laboratory values: hemoglobin \> 90g/dl, neutrophils \> 1.5×10\^9/L, platelets \> 100×10\^9/L, serum creatinine \< 1.5×upper limit of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN, AKP \< 4×ULN Exclusion Criteria: * Pregnant or lactating patients * Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety * Active or uncontrolled infection * Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure * Patients could not swallow the tablets * Concomitant with brain metastases
References
Publications (1)
- DERIVEDLi W, Xu J, Shen L, Liu T, Guo W, Zhang W, Chen Z, Zhu X, Li J. Phase II study of weekly irinotecan and capecitabine treatment in metastatic colorectal cancer patients. BMC Cancer. 2014 Dec 19;14:986. doi: 10.1186/1471-2407-14-986. PMID 25527007