colorectal cancer
Conditions
Interventions
Case series:No
Sponsors
Quanzhou First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, gender is not limited; 2. Advanced metastatic colorectal cancer confirmed by pathology (including histology or cytology); 3. Newly diagnosed patients who have not received other systemic treatments such as surgery, radiotherapy and chemotherapy, targeted therapy or immunotherapy; 4. According to the RECIST1.1 standard, the patient has at least one target lesion with measurable diameter (the long diameter of the CT scan of the tumor lesion is >=10mm, the short diameter of the CT scan of the lymph node lesion is >=15mm, and the scan slice thickness is 5mm); 5. ECOG score: 0-2 points; 6. Expected survival period >= 3 months; 7. Major organ function is normal and meets the following criteria: (1) The standard of blood routine examination must meet: (no blood transfusion within 14 days) 1) HB>=90g/L, 2) WBC>=3.0x10^9/L 3) ANC>=1.5x10^9/L, 4) PLT>=80x10^9/L. (2) The biochemical examination shall meet the following standards: 1) BIL 50ml/min (Cockcroft-Gault formula). 8. Women of childbearing age must have a negative pregnancy test (serum) within 7 days before enrollment, and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the trial drug; for men, surgical sterilization or Agree to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the trial drug; 9. Not participating in other clinical research before and during treatment; 10. Voluntarily join the study and receive first-line treatment with camrelizumab.
Exclusion criteria
Exclusion criteria: 1. Those with a history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ; 2. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug, or a drug that targets another T-cell receptor that stimulates or synergistically inhibits (eg, CTLA-4, OX-40, CD137) ; 3. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 4. Patients with massive pleural effusion or ascites requiring drainage within 2 weeks of the first medication; 5. The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which can manifest as clinical symptoms, cerebral edema, spinal cord compression meningitis, leptomeningeal disease, and/or progressive growth. CNS metastases are adequately treated and neurological symptoms are able to return to baseline levels at least 2 weeks prior to randomization (residual signs or symptoms associated with CNS treatment can be enrolled in the study. In addition, patients under observation must be Discontinue corticosteroids or receive 450ms in men and >470ms in women) and cardiac insufficiency; (2) Patients with hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure>140mmHg, diastolic blood pressure>90mmHg); (3) Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L); (4) Patients with positive urine protein (urine protein test 2+ or above, or 24-hour urine protein quantification >1.0g); (5) Patients with uncontrolled epilepsy, central nervous system disease or mental disorder; (6) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, occurred within 6 months before the selected treatment; (7) There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinically active interstitial lung disease; (8) There is an active or uncontrolled infection that requires whole blood therapy; (9) Active pulmonary tuberculosis; (10) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (11) There are clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction. 7. Pregnant or breastfeeding women; 8. Patients with concurrent autoimmune diseases or a history of chronic or recurrent immune diseases, including a history of immunodeficiency such as HIV positive test or a history of organ transplantation and allogeneic bone marrow transplantation; 9. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center); Not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Disease control rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactLin hongyue
Quanzhou First Hospital
Outcome results
None listed