Colorectal cancer
Conditions
Interventions
Experimental Group:1. Fludarabine Tepipirine:
p.o. , 35mg/m^2, twice daily, from days 1-5 and days 15-19, every 28 days as one cycle
2. Bevacizumab:
5mg/kg, intravenous, on day 1 and day 15, every 28 days as one cycle
The study treatment continued until the occurrence of the termination event as specified in the protocol. An imaging examination was conducted every 8 weeks (±14 days) to evaluate the efficacy until d
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology; 3. Confirmed CR, PR or SD according to RECIST 1.1 assessment after prior induction therapy with standard chemotherapy (FOLFOX, FOLFIRI or CAPEOX) combined with bevacizumab second-line induction therapy; 4. Have at least 1 measurable lesion (RECIST 1.1); If there are no measurable lesions, but there are evaluable non-target lesions or complete response (CR) after induction, they can also be enrolled and described and treated separately in statistical analysis (e.g., only PFS/OS analysis is included, no ORR analysis); 5. ECOG score of 0-2 points; 6. Expected survival >=12 weeks; 7. Able to swallow oral tablets; 8. Major organ function meets the treatment requirements (appropriate supportive care is allowed and documented at the discretion of the investigator): (1) Routine blood examination: a. Hemoglobin >=90g/L b. Absolute neutrophil count >=1.5×10^9/L c. Platelets>=100×10^9/L; (2) Biochemical examination: a. Serum albumin >=30g/L; b. ALT and AST=40mL/min; (The Cockcroft-Gault formula is as follows): Male: Cr clearance = (140-age) ×weight)/(72×blood Cr) Females: Cr clearance = (140-age) ×body weight)/(72×blood Cr) ×0.85 Weight unit: kg; Blood Cr unit: mg/dL; (3) INR=2, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification <2.0g can be enrolled); 9. Women of childbearing potential should use effective contraception from signing the informed consent form to at least 6 months after the last dose; Male subjects/their partners should use effective contraception and refrain from sperm donation (sperm donation is recommended) from signing the informed consent form until at least 6 months after the last dose; 10. Subjects voluntarily participate in this study, sign the informed consent form, and are expected to be able to comply with the study visit and follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Toxicity caused by previous treatment that has not recovered to CTCAE 160 mmHg and/or diastolic blood pressure >100 mmHg after treatment); 4. High risk of bleeding/thrombosis: a. Active bleeding or clinically significant coagulation abnormalities; b. Serious thrombotic/embolic events (such as cerebral infarction, myocardial infarction, pulmonary embolism) within 3 months before the start of study treatment, or unstable in the judgment of the investigator, with extremely high risk of recurrence; c. Therapeutic anticoagulation or thrombolysis is still required 10 mg/day and continuous >14 days), and cannot be reduced; c. Other conditions judged by the investigator to have progressive or severe immunodeficiency leading to an unacceptable risk of infection/bleeding; 8. Active hepatitis (Reference: Active hepatitis B: HBsAg positive and HBV DNA>=2000IU/mL or ALT/AST continues to rise; Active hepatitis C: HCV RNA positive and viral load higher than the upper limit of normal in our center); 9. Active brain metastases (those who are stable after local therapy and do not need steroids are allowed to be discussed on a case-by-case basis); 10. Active uncontrolled infection or unexplained fever >38.5°C within 2 weeks before the first dose (tumor-related fever as judged by the investigator may be an exception); 11. Acute or subacute intestinal obstruction, active or uncontrolled chronic inflammatory bowel disease; 12. Severe, unstable or recent cardiovascular disease (e.g., cardiac insufficiency above NYHA II; Myocardial infarction within the last 6 months; LVEF<50%; severe arrhythmias that require clinical intervention); 13. Other malignant tumors (except basal cell carcinoma or carcinoma in situ of the cervix) within 5 years prior to enrollment, unless the tumor has been cured and there is no risk of recurrence; 14. Pregnant or lactating women; 15. Previous treatment with trifluridine tepiridine; 16. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the start of study treatment; 17. Other conditions that the investigator assesses as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Objective response rate;Overall survival;Duration of Overall Response; | — |
Countries
China
Contacts
Public ContactLiu Yibing
The Fourth Hospital of Hebei Medical University
Outcome results
None listed