Clinical trial · Interventional
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study
- 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 is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bevacizumab | — | UNRESOLVED | — |
| Colo-rectal Cancer | Colon Neoplasm | PROBABILISTIC | 0.70 |
| TAS 102 | — | UNRESOLVED | — |
| Third-line and Beyond Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trifluridine/tipiracil (TAS-102) plus bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Trifluridine/tipiracil 17.5 mg/m2 bid. po. d1-10, q2w Bevacizumab 5mg/kg ivgtt. d1 q2w
- interventionNames
- Drug: Trifluridine/tipiracil (TAS-102) plus bevacizumab
Primary outcomes (1)
- measure
- 6-month progression-free survival rate
- timeFrame
- 6 months
- description
- Defined as the proportion of patients who remain free from disease progression (as per RECIST criteria) or death for at least 6 months following initiation of study treatment.
Secondary outcomes (4)
- measure
- Adverse events
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. age over 60 years old, male and female 2. histologically confirmed adenocarcinoma of the colon or rectum 3. patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen 4. with or without measurable lesions 5. ECOG 0 to 2, expected survival time over 3 months 6. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN. 7. Signed informed consent and willing to follow the study protocol Exclusion Criteria: 1. symptomatic metastases of central nervous system 2. other primary malignancies 3. uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease 4. organ functions that cannot tolerate study treatment 5. bowel obstruction or other conditions affecting oral administration 6. allergic to study medication 7. other conditions that patients are unsuitable for this study assessed by the investigators
References
Publications (0)
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