Colorectal cancer
Conditions
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged =18 years old; 2. Postoperative recurrent or unresectable metastatic colorectal adenocarcinoma confirmed by histology or cytology; 3. Patients who had not received previous systemic therapy for metastatic lesions and had received adjuvant or neoadjuvant chemotherapy more than 6 months after the end of treatment were eligible; 4. At least one measurable lesion according to RECIST 1.1 criteria; 5.ECOG PS score: 0-2; 6. The expected survival time is more than 3 months; 7. There was no severe hematopoietic dysfunction, and the heart, lung, liver, and kidney functions were basically normal: A) bone marrow reserve (14 days not received blood transfusions or hematopoietic stimulating factor (treatment), 90 g/dL or higher hemoglobin, white blood cell count 3000 cells/mm3, neutrophils acuity or 1500 cells/mm3 and platelet 90000 cells/mm3 or higher; b) Coagulation function: both international normalized ratio (INR) and activated partial thromboplastin time (APTT) =1.5×ULN (upper limit of normal); c) Renal function: creatinine clearance (Ccr) =50ml/min (calculated according to Cockcroft-Gault formula); D) liver function: the total bilirubin (TBIL) 1.5 x ULN, cereal third transaminase (ALT) or less acuities were 2.5 x ULN and aspertate aminotransferase (AST) 2.5 x ULN or less (with liver metastasis, TBIL 2 x ULN, ALT or less 5 or less x ULN and AST 5 x ULN) or less. e) left ventricular ejection fraction (LVEF) =50%; 8.The subjects voluntarily joined the study, signed the informed consent form, and the compliance was good.
Exclusion criteria
Exclusion criteria: 1. Confirmed allergy to the trial drug and/or its excipients; 2. Pregnant or lactating women; 3. The adverse reactions of previous treatment have not recovered to CTCAE 5.0 grade =1 (except for toxicity without safety risk judged by investigators such as alopecia); 4. Incomplete recovery from major surgery (excluding needle biopsy) within 4 weeks before the first dose; 5. The presence of serious psychological or mental disorders that affect the compliance of the subjects to participate in the clinical study; 6. History of severe cardio-cerebrovascular disease, including but not limited to uncontrolled hypertension; Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and ?-? degree atrioventricular block requiring clinical intervention; Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events occurred within 6 months before the first dose; 7.Patients who were deemed by the investigators to be ineligible for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;OS;AE; | — |
Countries
China
Contacts
Public ContactLv jing
The Affiliated Hospital of Qingdao University
Outcome results
None listed