NCT07085169RecruitingPhase 2
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 · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07085169
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Aug 2025 to the primary completion date, 1 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- other primary malignancies
- uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease
- bowel obstruction or other conditions affecting oral administration
- allergic to study medication
- other conditions that patients are unsuitable for this study assessed by the investigators
Other
- symptomatic metastases of central nervous system
- organ functions that cannot tolerate study treatment
Who the study is looking for
- age over 60 years old, male and female
- histologically confirmed adenocarcinoma of the colon or rectum
- patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen
- with or without measurable lesions
- ECOG 0 to 2, expected survival time over 3 months
- 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.
- Signed informed consent and willing to follow the study protocol
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SanMing First Hospital Coordinator of this site? Confirm its status | Sanming | China | Recruiting |
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.