Ras wild colorectal cancer
Conditions
Interventions
1:SHR1316,cetuximab and chemotherapy
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70, both male and female; 2. Patients with ECoG score 0-1; 3. Patients with metastatic or advanced colorectal cancer have not been treated; 4. Patients whose Ras / BRAF gene is wild type; 5. According to recist1.1, patients have at least one measurable lesion; 6. Patients whose expected survival time is more than or equal to 12 weeks; 7. Patients with normal function of main organs and bone marrow should meet the following requirements: (1) Patients with hemoglobin >= 90g / L (no blood transfusion within 14 days); (2) Patients with absolute neutrophil count >= 1.5 x 10 ^ 9 / L; (3) Platelet count >= 90 x 10 ^ 9 / L; (4) Patients with total bilirubin = 50%; QTc < 450ms in male and < 470ms in female; 8. International normalized prothrombin time ratio (INR) <= 1.5, partial thromboplastin time (APTT) <= 1.5 ULN in patients who have not received anticoagulant therapy. Patients receiving full dose or parenteral anticoagulant therapy need to keep the dosage of anticoagulant stable for at least 2 weeks before entering the clinical study, and the results of coagulation test are within the limits of local treatment; For women of childbearing age, appropriate contraceptive drugs should be given within 3 months or after the end of pregnancy; 10. Patients whose toxicity has recovered to <= 1 grade after previous treatment (if there is operation, the wound has been completely healed); 11. The patient voluntarily participated in and signed the informed consent form, which is expected to have good compliance and can cooperate with the study according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who had received any form of anti-tumor therapy within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another interventional clinical trial; 2. Patients who underwent major surgery within 4 weeks before enrollment (except minor outpatient surgery, such as placement of vascular access); 3. Patients with clinical symptoms and effusion in the third space that can not be controlled by drainage or other methods (such as large amount of pleural effusion or ascites); 4. Patients with poor control of hypertension even after drug treatment (continuous increase of systolic blood pressure = 150mmhg or diastolic blood pressure >= 100mmhg); 5. Patients with uncontrolled cardiac clinical symptoms or diseases, such as (1) Patients with NYHA II or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within one year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. 6. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); patients with childhood asthma who have been completely relieved without any intervention or vitiligo in adults Patients who need bronchodilator for medical intervention can not be included; 7. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of analysis method), or co infection of hepatitis B and hepatitis C; 8. Patients with severe infection within 2 weeks before the first administration (e.g. requiring intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown origin > 38.5 degrees C during screening / before the first administration; 9. Arteriovenous thrombosis events occurred in the first 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc.; 10. Patients who have suffered from or accompanied with other systemic malignant tumors in the past five years, except for the cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian carcinoma; 11. Patients known to be allergic to any test drug; 12. Pregnant and lactating patients, patients with reproductive capacity are not willing to take effective contraceptive measures; 13. Patients with a clear history of neurological or mental disorders, including epilepsy and dementia; 14. Patients with known uncontrollable or symptomatic active central nervous system (CNS) metastasis presented with clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and / or progressive growth; 15. Patients who are unable to swallow the study drug, such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), intestinal obstruction and other factors that affect the drug use and absorption; 16. Other situations considered unsuitable by the researcher. If accompanied by family or social factors, it will affect the safety of the subjects, or the collec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;PFS;OS; | — |
Countries
China
Contacts
Public ContactYong Gao
Shanghai East Hospital
Outcome results
None listed