colorectal cancer
Conditions
Interventions
experimental group:chemotherapy combined with bevacizumab
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients must fully understand the study,voluntarily sign the informed consent,and are willing to follow and able to complete all the trial procedures. 2.Male or female, age 18-75 years old (including the boundary value). 3.Advanced or metastatic colorectal adenocarcinoma which was confirmed by pathology without receiving radiotherapy, chemotherapy or immunotherapy. 4.At least one measurable and extracranial lesion,according to RECIST v1.1. 5.Unresectable. 6.RAS mutation, regardless of BRAF. 7.The Eastern United States Oncology Collaborative Group (ECOG) score was 0-1 in physical status. 8.Patients with asymptomatic Central Nervous System (CNS) metastases, or asymptomatic CNS metastases after treatment,who should be examined by computed tomography (CT) or magnetic resonance imaging (MRI) to be free of disease progression, stable for at least 3 months, and free of steroid therapy for at least 4 weeks. 9.The laboratory test results within the first two weeks of enrollment meet the following conditions: Absolute count of neutrophils (ANC) >= 1.5 x 10^9/L. Absolute white blood cell count (WBC) >= 3.0 x 10^9/L. Platelet >= 100 x 10^9/L. Hemoglobin >= 90g/L. Serum creatinine <= 1.5 times of the upper limit of normal (ULN). AST and ALT <= 2.5 times of ULN, liver metastasis <= 5 times of ULN. Serum total bilirubin (TBIL) <= 1.5 times ULN. International standardized ratio (INR) <= 2 times of ULN, or activated partial thromboplastin (APPT) <= 1.5 times of ULN (except in patients receiving anticoagulant therapy). 9.Male patients and female patients of childbearing age shall agree to use effective contraceptive measures from the time of signing the informed consent until 3 months after the last dosing.
Exclusion criteria
Exclusion criteria: 1.Patients who developed a second or more malignant tumors within 5 years before enrollment, except cured cervical carcinoma in situ and cured basal cell carcinoma of the skin. 2.The adverse reactions of previous treatments failed to recover to CTCAE V5.0 grade 3). 8.Previous clear neurological or mental disorders, such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders. 9.Patients with symptomatic brain metastases. 10.Pregnant or lactating women. 11.Subjects considered by the investigator to be unsuitable for participation in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Quality of Life;Adverse Events; | — |
Countries
China
Contacts
Public ContactYifu He
Anhui Provincial Cancer Hospital
Outcome results
None listed