Ras wild colorectal cancer
Conditions
Interventions
1:Camrelizumab, Cetuximab, and chemotherapeutics.
2:Camrelizumab, Cetuximab and chemotherapeutics.
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old, male or female; 2. ECOG 0-1; 3. Histologically confirmed advanced colorectal cancerdisease progression while on first-line chemotherapy or patient cant tolerate first-line chemotherapy; 4. Histologically confirmed kras wildtype; 5. According to therapeutic effect evaluation standard of solid tumor (RECIST1.1), with at least one measurable lesions; 6. The expected survival period is greater than 12 weeks; 7. The function of vital organs and bone marrow meet the following requirements; a.Hemoglobin >= 9 gram per deciliter (without transfusions); b.Absolute Neutrophil Count (ANC) >= 1.5 x 10^9 /Liter; c.Platelets >= 90 x 10^9 /Liter; d.Total bilirubin = 50%male QTc < 450msfemale Qtc < 470ms; 8. Partial thromboplastin time (PTT) <= 1.5x ULN and international normalized ratio (INR) <= 1.5 , unless participant is on full dose or parenteral anticoagulation therapy; patients on full-dose or parenteral anticoagulation are eligible if the following criteria are met: the dose of anticoagulation is stable for more than 2 weeks before the start of trial treatment entry, and the result of coagulation test is within the institutional ULN; 9. Women with fertility should be carried out within 14 days of urine or serum pregnancy test before accepting first study drug dosage, and prove to negative, and willing to use effective methods of contraception to the last dose of study drugs after three months during the study. For male subjects with a partner of childbearing age, effective method of contraception should be adopted during the study and within three months of the last dose of study drugs; 10. Participant must have the ability to understand and the willingness to sign a written informed consent document and be willing to comply with study and/or follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any anti-tumor therapy within 4 weeks before the start of trial treatment entry, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or any investigational Intervention clinical trial; 2. Previous treatment with any major surgery within 4 weeks before the start of trial treatment entry (except t for minor outpatient operations, such as placement of vascular access); 3. The third space effusion with clinical symptoms, cannot be controlled by drainage or other methods, such as large amount of hydrothorax or ascites; 4. Uncontrolled hypertension, defined as systolic blood pressure (BP) >= 150 millimeters of mercury (mmHg) or diastolic BP >= 100 mmHg with or without antihypertensive dication; 5. Subjects Have failed to control the heart of the clinical symptoms or disease, such as: (1) the NYHA class II heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Patients with clinically significant ventricular or ventricular arrhythmia requiring clinical intervention; 6. Subjects have a history of any active autoimmune disease or autoimmune disease(e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, myocarditis, nephritis, thyroid function, thyroid function decrease (hormone replacement therapy after the normal accepted)). Patients with vitiligo or asthma in childhood have been fully relieved and adults without any intervention can be included, Patients with asthma who need bronchial amplifiers for medical intervention are not included; 7. Subjects with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis b (hbv-dna is greater than 104 copies/ml) or hepatitis c (positive for hepatitis c antibody, and HCV-RNA is higher than the reference value of analytical method) or co infection with hepatitis B and C; 8. Severe infection within 2 weeks before the first application (e.g,Intravenous antibiotics, antifungal or antiviral drugs are needed), or unexplained fever > 38.5 dgree C occurred during the screening or before the first time to give medicine; 9. Arterial or venous thrombotic events within 2 weeks before enrollmentsuch as cerebrovascular accident(including transient ischemic attack, cerebral hemorrhage and cerebral infarction)deep vein thrombosis and pulmonary embolism; 10. Subjects has been diagnosed as other malignant tumor five years before first use of the study drug, except for cured basal cell carcinoma of the skincervical carcinoma in situ and ovarian cancer; 11. Known to be allergic to any study drug; 12. Women during pregnancy or lactationor men/women who are unwilling to take effective contraceptive measures; 13. Definitive history of neurological or psychiatric disordersincluding epilepsy and dementia; 14. Can not be controlled in the central nervous system (CNS) metastasisincluding clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth; 15. Inability to swallow oral medicationswith many factors that affect drug administration and absorption, such as chronic diarrhea(including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis)and intestinal obstruction; 16. Judged by investigator, the subjects had other factors that could lead to the termination of the study such as family and social factors maybe affect the safety or data co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;safety; | — |
Countries
China
Contacts
Public ContactYong Gao
Shanghai East Hospital
Outcome results
None listed