colorectal cancer
Conditions
Interventions
Group 1:Bevacizumab combined with TAS-102
Sponsors
Medical Oncology Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender is not limited; 2. Colon or rectal adenocarcinoma confirmed by histology or cytopathology; 3. Previously received first-line and second-line chemotherapy containing oxaliplatin, irinotecan, 5-fluorouracil, and capecitabine (combined or not combined with anti-VEGF therapy, anti-EGFR therapy) failed (within 6 months after the end of adjuvant chemotherapy) relapse is regarded as first-line treatment failure); 4. Confirmed by CT or MRI, there is at least one measurable lesion (non-radiotherapy field) that meets the RECIST 1.1 standard; 5. Physical condition score ECOG 0-2; 6. Expected survival period >= 12 weeks; 7. Voluntarily sign the written informed consent; 8. The functions of vital organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the screening examination): (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (2) Platelets >= 90 × 10^9/L; (3) Hemoglobin >= 10 g/dL; (4) Total bilirubin <= 1.5 times ULN, ALT and AST <= 2.5 times ULN; if there is liver metastasis, ALT and AST <= 5 times ULN; (5) Creatinine clearance rate = 50mL/min (calculated according to the Cockcroft-Gault formula); (6) International normalized ratio (INR) <= 2 times ULN, or activated partial thromboplastin (APPT) <= 1.5 times ULN (except for patients receiving anticoagulant therapy); 9. Subjects with reproductive potential must accept effective medical contraceptive measures (no matter male or female subjects, until 3 months after the last study administration); 10. Good compliance.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or allergic reaction to any component of the study treatment; 2. Any life-threatening bleeding events occurred within the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, and continuous drug therapy; 3. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy; 4. Patients with intestinal obstruction or incomplete intestinal obstruction (surgical intervention required); 5. The researcher's judgment or other evidence shows that the subject has any unstable systemic diseases, including but not limited to: active infection, unstable angina, angina that started in the last 3 months, congestive failure ( New York Heart Association [NYHA] >= ? grade), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 6. Any of the following occurred within 3 months before enrollment: gastric or duodenal ulcer resistant to treatment, erosive esophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/bleeding/hematochezia, gastric Intestinal perforation/fistula, deep vein thrombosis and pulmonary embolism or other uncontrolled thromboembolic events; 7. Uncontrollable hypertension, systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 8. Grade >= 2 toxicity caused by any unrecovered previous treatment (CTCAE 5.0 standard, excluding anemia, hair loss, skin pigmentation); 9. Pregnant or lactating women; 10. The investigator judges that the subject has other factors that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;disease progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Quality of Life;disease control rate;objective response rate; | — |
Countries
China
Contacts
Public ContactXiaoyan Lin
Fujian Medical University Union Hospital
Outcome results
None listed