Colorectal cancer
Conditions
Interventions
case group:bevacizumab combined with TAS-102 (Suyuan) and irinotecan
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged from 18 to 75 years old; 2. Adenocarcinoma of the colon or rectum confirmed by tissue or cytopathology; 3. Failure of previous first-line fluorouracil and oxaliplatin-based chemotherapy (with or without anti-VEGF therapy, anti-EGFR therapy) (relapse within 6 months after the end of adjuvant chemotherapy 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 RECIST1.1 standard; 5. ECOG score is 0 or 1; 6. The estimated survival period is not less than 12 weeks; 7. Voluntarily sign a written informed consent form; 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 start of the screening test): (1)Absolute neutrophil count >=1.5x10^9/L (2)Platelet>=90x10^9/L; (3)Hemoglobin >=10g/dL; (4)Total bilirubin = 50mL/min (calculated according to Cockcroft-Gault formula); (6)International normalized ratio <= 2 times ULN, or when partial thromboplastin (APPT) is activated <= 1.5 times ULN (except for patients receiving anticoagulant therapy); 9. Subjects with fertility must receive 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. There are any CTCAE grade 2 or above toxicity that has not subsided due to previous treatment (excluding anemia, hair loss, skin pigmentation and chemotherapy-induced neurotoxicity); 2. Poorly controlled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure> 100 mmHg), and subjects who have a history of hypertensive crisis or hypertensive encephalopathy; 3. Have bleeding tendency, high bleeding risk or coagulation dysfunction; 4. Known brain and/or pial metastasis. Subjects with neurological symptoms should undergo brain CT/MRI to exclude brain metastases; 5. Have active infection or fever of unknown cause within 2 weeks before the first medication> 38.5? (according to the judgment of the investigator, the subject can be included in the group for fever caused by the tumor); 6. Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease; 7. Patients suffering from other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix; 8. Women during pregnancy or lactation; 9. After being evaluated by the investigator, it is deemed inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactHe Yifu
Anhui Provincial Cancer Hospital
Outcome results
None listed