Patients with metastatic colorectal cancer who had received two or more previous chemotherapy regimens
Conditions
Interventions
Study group:Trifluridine/tipiracil (17.5 mg/m^2/dose, twice daily, days 1–10, every 2 weeks)
Bevacizumab (5 mg/kg/dose, day 1, every 2 weeks)
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 60 years, male or female; 2. Histologically confirmed colorectal adenocarcinoma; 3. Metastatic or locally advanced patients who have failed second-line or higher standard therapy, are intolerant to standard therapy, or have no standard therapy available; 4. With or without measurable lesions; 5. ECOG performance status 0-2, with an expected survival time >= 3 months; 6. Adequate organ function, including hematologic: WBC >= 3.5×10^9/L; NE >= 1.5×10^9/L; Hb >= 80 g/L; Plt >= 75×10^9/L; hepatic function (bilirubin <= 1.5×ULN, AST and ALT <= 2.5×ULN; in patients with liver metastasis, AST and ALT may be <= 5×ULN); and renal function (serum creatinine <= 1.5×ULN); 7. Signed informed consent form, good compliance, and able to cooperate with related examinations, treatment, and follow-up.
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment: History taking and recording of adverse reactions performed each cycle, graded according to CTCAE version 5.0.;Objective response rate (ORR): Assessed according to RECIST criteria (version 1.1).;Progression-free survival (PFS);Overall survival (OS);Exploratory analysis of peripheral blood biomarkers; | — |
Countries
China
Contacts
Public ContactZhou Chenfei
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed