metastatic colorectal cancer
Conditions
Interventions
experimental group:mFOLFOX6 +half-dose Bevacizumab (BYVASDA)
control group:mFOLFOX6 + half-dose Bevacizumab (Avastin)
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients can sign a written informed consent form, and can understand and agree to follow the planned visit, treatment, laboratory examination and other research requirements; 2.Patients with colorectal adenocarcinoma confirmed by histopathology or cytology, excluding all other histological types; 3.Patients with metastatic lesions (not able to take R0 surgical resection); 4.Patients aged >= 18 years; 5.Meet one of the following conditions: (1) Has not received systematic treatment(include chemotherapy, EGFR inhibitors such as cetuximab or panizumab, VEGF inhibitors such as bevacizumab, Immune checkpoint inhibitors such as PD-1 or PD-L1, CTLA-4 )for advanced or metastatic colorectal cancer in the past; (2) For patients with metastasis or recurrence after radical surgery, those who did not received adjuvant chemotherapy within 6 months before entering the study; 6.With an Eastern Cooperative Oncology Group (ECOG) performance status of = 3 x 10^9/L; (2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (3) Platelets >= 75 x 10^9/L; (4) Total bilirubin <= 1.5 x upper limit of normal (UNL); (5) ASAT (SGOT) and/or ALAT (SGPT) <= 2.5 x UNL (<= 5 x UNL if liver metastases); 9. The estimated survival time is at least 12 weeks; 10. Women with fertility must voluntarily take effective contraceptive measures during the study period and within 3 months after the last administration of the study drug, and the urine or serum pregnancy test results are negative within 7 days before enrollment. Male subjects who have not been sterilized must voluntarily take effective contraceptive measures during the study period and within 3 months after the last administration of study drug.
Exclusion criteria
Exclusion criteria: 1.Have received first-line systemic therapy for metastatic colorectal cancer, including chemotherapy, targeted therapy, biological therapy or other study therapy; 2.Previous or simultaneous existence of other malignant tumors (except malignant tumors that have been cured for more than 5 years or cured carcinoma in situ); 3.Patients with digestive tract diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction or other conditions that may cause gastrointestinal bleeding or perforation; 4.Patients with thrombus or embolism events within 12 months before the study, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep venous thrombosis; 5.Patients with the following conditions within 12 months before the study: myocardial infarction, severe / unstable angina pectoris, cardiac insufficiency above NYHA grade 2, clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure; 6.Patients with active infections requiring systemic treatment; 7.Patients with pleural effusion, ascites or pericardial effusion that could not be controlled after effective treatment within 14 days before the study; 8.Patients with level 2 or above (NCI-CTCAE version 5.0) unresolved adverse events caused by previous treatment (excluding alopecia); 9.Patients with interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia); 10.Patients with HIV infection or syphilis infection or active hepatitis B or hepatitis C. If HBsAg is positive, hepatitis B virus DNA will be tested. If the test result is >= 1 x 10^3 copies/ml, Patient cannot be enrolled in this study. If the test result is < 1 x 10^3 copies/ml, hepatitis B activity monitoring should be carried out after enrollment; 11.Known or suspected history of allergy to any related drugs used in the study; 12.Women during pregnancy or lactation; 13.Women of childbearing age(less than 2 years after their last menstruation) or men who are not willing to take non-hormonal contraceptive measures; 14.Participate in another therapeutic clinical trial within 30 days before screening; 15.Patients with other serious physical or mental disorders or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, or researchers did not consider the patient appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Overall Survival, OS;Disease Control Rate, DCR;Safety;EORTC Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30); | — |
Countries
China
Contacts
Public ContactJin Yongdong
Sichuan Cancer Hospital
Outcome results
None listed