Clinical trial · Interventional
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
NCT05854498CI-TRIAL-00107200recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Liposomal irinotecan | Drug | — | UNRESOLVED |
| TAS102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Metastatic or Unresectable Colorectal Cancer
- description
- Male and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer.
- interventionNames
- Drug: Liposomal irinotecan
- Drug: TAS102
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- up to 2 years
- description
- PFS is defined as the time from D1 of treatment with the study combination until the criteria for disease progression is met as defined by RECIST 1.1 criteria or death as a result of any cause.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1. * Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable. * The cancer must be mismatch repair proficient. * Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy. Exclusion Criteria: * Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy. * Patients whose cancers possess BRAF V600 mutations are excluded. * Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy. * Patients must not have mismatch repair deficient or microsatellite instability high cancers. * Patients must not have received prior TAS102.
References
Publications (0)
Data not yet available
No reference posted for this study.