colorectal cancer
Conditions
Interventions
Experimental:Fluorouracil and tiopurine 35mg/m^2, twice daily, from day 1 to day 5, and from day 8 to day 12, repeated every 4 weeks
Fuyanitrien 4mg, once daily
take the medication continuously for 3 weeks, then stop for 1 week, and repeat every 4 weeks.
Control :Fluorouracil and tiopurine 35mg/m^2, administered twice daily on days 1-5 and days 8-12, repeated every 4 weeks
Bevacizumab 5mg/kg, administered on day 1, once every 2 weeks.
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All study participants will be required to sign an informed consent form before starting study-related operations; 2. aged 18-75 years old, male or female; 3. histologically confirmed unresectable colorectal cancer; 4. Known RAS status (mutant or wild-type); 5. Failure or intolerance of at least 2 previous treatment regimens (fluoropyrimidine-containing, oxaliplatin- and irinotecan-based chemotherapy, anti-vascular endothelial growth factor (VEGF) therapy and/or anti-epidermal growth factor receptor (EGFR) therapy); 6. have at least one measurable lesion based on RECIST v1.1; 7. be able to swallow oral tablets; 8. life expectancy >= 12 weeks; 9. ECOG PS 0-1; 10. normal major organ function (within 7 days prior to randomisation): Absolute neutrophil count >= 1.5 x 10^9/L; Platelet count >= 75 x 10^9/L; Haemoglobin >= 90g/L (no history of blood transfusion within 7 days); Creatinine clearance >=60ml/min (Cockcroft-Gault formula); Total bilirubin level <= 1.5 times the upper limit of normal (ULN); Glutamate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 times the ULN ,AST and ALT levels <= 5 times the ULN in patients with liver metastases; Urine protein <=1+ on routine urinalysis or <1g on 24-hour urine protein quantification; International Normalised Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN (if the study participant is receiving anticoagulation, as long as the PT is within the range formulated by the anticoagulant); 11. Women of childbearing potential with a negative serum pregnancy test at screening (within 7 days prior to randomisation); all study participants and their sexual partners agree to use a highly effective method of contraception for the duration of the trial and for at least 6 months after dosing
Exclusion criteria
Exclusion criteria: 1. prior treatment with travofluridine tepidopyrimidine or furazetinib drugs or other anti-vascular endothelial growth factor receptor inhibitors (e.g., apatinib, regorafenib, and amiloride, etc.); 2. pregnancy, lactating females, or the possibility of pregnancy during the study; 3. patients who are receiving or have received anticancer therapy within 4 weeks prior to randomisation; 4. have not recovered from clinically relevant non-haematological CTCAE >= Grade 3 toxicity from prior anti-cancer therapy prior to randomisation (with the exception of alopecia and skin pigmentation); 5. symptomatic CNS metastases, neurological instability or need for increased steroid doses to control CNS disease; 6. have severe or uncontrolled acute or chronic active infections; 7. have active or interstitial lung disease and/or a history of pneumonia or pulmonary hypertension 8. have any clinically significant active hepatitis, including, but not limited to, hepatitis B or hepatitis C; 9. known carriers of HIV antibodies; 10. confirmation of uncontrolled arterial hypertension (defined as systolic blood pressure >= 150 mm Hg and/or diastolic blood pressure >= 100 mm Hg) or uncontrolled or symptomatic cardiac arrhythmias; 11. deep arterial thromboembolic event, including cerebrovascular accident or myocardial infarction, within 6 months prior to randomisation; 12. patients who have undergone major surgery within 4 weeks prior to randomisation (surgical incisions should be fully healed prior to study drug administration) or who have not recovered from the side effects of previous surgery, or who may require major surgery during the study period; 13. radiotherapy within 2 weeks prior to randomisation, except for short courses of radiotherapy as symptomatic relief only; 14. other clinically significant diseases; 15. other malignant tumours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactSHirong Cai
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed