Clinical trial · Interventional
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
ONO-4578 Phase I Study An Open-label, Uncontrolled Study of First-line Combination Therapy of ONO-4578 and ONO-4538 With Standard Therapy XELOX Plus Bevacizumab or FOLFOX Plus Bevacizumab in Patients With Unresectable, Advanced or Recurrent Colorectal Cancer
- 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 tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Calcium Levofolinate Hydrateb | Drug | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| ONO-4538 | Drug | Nivolumab | ALIAS |
| ONO-4578 | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-4578+ONO-4538+XELOX plus bevacizumab
- interventionNames
- Drug: ONO-4578
- Drug: ONO-4538
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- ONO-4578+ONO-4538+FOLFOX plus bevacizumab
- interventionNames
- Drug: ONO-4578
- Drug: ONO-4538
- Drug: Oxaliplatin
- Drug: Fluorouracil
- Drug: Calcium Levofolinate Hydrateb
- Drug: Bevacizumab
Primary outcomes (9)
- measure
- Incidence and severity of AEs and SAEs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable colorectal cancer * Life expectancy of at least 3 months * Patients with ECOG performance status 0 or 1 Exclusion Criteria: * Patients with severe complication * Patients are unable to swallow oral medications
References
Publications (0)
Data not yet available