Clinical trial · Observational
Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
NCT01912443CI-TRIAL-00014356unknownClinicalTrials.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 assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic 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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Bevacizumab Plus Chemotherapy
- interventionNames
- Drug: bevacizumab
Primary outcomes (4)
- measure
- Incidence, nature and severity of adverse events of special interest
- timeFrame
- Four years
- description
- Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria
- measure
- Incidence, nature and severity of bevacizumab related serious adverse events
- timeFrame
- Four years
- measure
- Onset time of adverse event associated with bevacizumab
- timeFrame
- Four years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * with histologically confirmed metastatic colorectal cancer * patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment * Written informed consent * Unlimited line of treatment (first-line or second line is not limited) Exclusion Criteria: Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert: * Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood * Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours \* * The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is ≥2g/24 hours. * Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds * Pregnant or lactating women * Excluding patients known to be allergic to bevacizumab or any of the excipients
References
Publications (0)
Data not yet available
No reference posted for this study.