Clinical trial · Observational
An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer
A Multi-center Observational Study of Bevacizumab Plus 5-FU Based Chemotherapy as First Line and Second Line Treatment for Chinese Patients With Metastatic Colorectal Cancer (ML25391)
NCT01319877CI-TRIAL-00023791completedResults postedClinicalTrials.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)
This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- First Line Treatment
- description
- Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
- label
- Second Line Treatment
- description
- Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Primary outcomes (5)
- measure
- Percentage of Participants With Adverse Events
- timeFrame
- 36 months
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
- measure
- Percentage of Participants With Serious Adverse Events
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult Chinese participants, \>/= 18 years of age * Histologically confirmed and previously untreated metastatic colorectal cancer * Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert * Documented participant with medical records Exclusion Criteria: * Recent history of serious hemorrhage or hemoptysis of \>/= 1/2 teaspoon of red blood * Proteinuria at baseline (\>/=2 grams / 24 hours) * Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.