metastasis Colorectal Cancer
Conditions
Interventions
Group1:Fruquintinib:None
Group2:bevacizumab:None
Sponsors
Ningbo No.2 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old (when signing the informed consent form); (1).ECOG PS score: 0-2 points; (2).Expected survival is more than 3 months; 2.Patients with histologically confirmed advanced colorectal cancer adenocarcinoma who have failed standardized first-line and second-line therapy in the past; 3. Able to provide previously stored tumor tissue specimens or perform biopsies to collect tumor lesion tissues for detection of k-ras, N-ras, BRAF, MSI/MMR expression; 4. Presence of at least 1 measurable lesion according to RECIST1.1 criteria; 5. Good organ function (no blood transfusion, no use of hematopoietic stimulating factors, no transfusion of albumin or blood products within 14 days prior to randomization), and laboratory tests meet the following criteria: a. Hemoglobin >=80g/L;Absolute neutrophil count (ANC) >= 1.5×10^9/L;Platelets>= 80×10^9/L; ALT and AST = 50ml/min; Serum albumin>=30g/L;International normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT) =50%. 7.Female subjects of childbearing potential should agree that highly effective contraception must be used during the study and for 6 months after the end of the study; Negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject. Male subjects should agree to use contraception for the duration of the study and for 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1.Comorbid diseases and medical history: (1). Have had or currently have other malignant tumors within 3 years. The following may be enrolled: cured carcinoma in situ of the cervix, skin cancer of non-melanoma, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor-infiltrating basal membrane)]; (2). There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); (3). Gastrointestinal bleeding or perforation within or with a tendency to occur within 4 weeks prior to enrollment; (4). Patients with ulcerative colitis, Crohn's disease, and patients with active inflammatory bowel disease within 4 weeks prior to enrollment; (5). Uncontrollable pleural effusion, ascites, and pericardial effusion of moderate or higher amounts requiring repeated drainage; (6). Unresolved toxic reactions greater than CTC AE 1 grade or higher due to any prior therapy, excluding alopecia; (7).Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to enrollment (except for tissue biopsy under gastrointestinal endoscopy) (8)Patients with symptoms of hematemesis, hematochezia, or any bleeding event >=CTC AE grade 3 within 3 months prior to screening, or patients with any signs of bleeding or medical history judged by the investigator to be unsuitable for enrollment; (9).Presence of unhealed wounds, ulcers, or fractures; (10). Those who have a history of psychotropic drug abuse and cannot be stopped; (11).Subjects with any severe and/or uncontrolled disease, including: 1). Uncontrolled hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg after standard antihypertensive therapy); 2). Suffering from unstable angina>= grade 2 cardiogenic chest pain;Myocardial infarction within = grade 2 heart failure (New York Heart Association (NYHA) classification);restrictive heart disease;>= grade 2 atrioventricular block, arrhythmias that cannot be stably controlled with medications [including QTc =450 ms for males and QTc >= 470 ms for females], and arrhythmias that may have a potential impact on the trial treatment; 3). active infection (>= CTC AE grade 2 infection); 4). Decompensated cirrhosis, active hepatitis;(Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA positive (> 2500 copies/ml or >500 IU/ml); Hepatitis C reference: HCV antibody positive, and HCV viral titer test value exceeds the upper limit of normal value); Note: Those who meet the enrollment conditions. Subjects who are positive for hepatitis B surface antigen or core antibody, and patients with hepatitis C, require continuous antiviral therapy to prevent viral activation. ) 5). Patients with renal failure who require hemodialysis or peritoneal dialysis; 6). Those with a history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7). Those whose urine routine showed that the urine protein was >=++, and the 24-hour proteinuria was confirmed to be > 1.0g; 8). Those with a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and require treatment. 2. Subjects who are not suitable for enrollment according to the judgment of the investigator or believe that there are other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Quality of life scores;Overall survival;Duration of remission;Objective response rate; | — |
Countries
China
Contacts
Public ContactChen Zhang
Ningbo No.2 Hospital
Outcome results
None listed