Colorectal cancer
Conditions
Interventions
Test group :Camrelizumab + radiotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Colorectal cancer confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan >=10mm, meeting RECIST 1.1 criteria); 3. Known RAS and BRAF gene expression status; 4. Expected survival > 3 months; 5. ECOG PS score: 0-2 points; 6. Not previously treated with immune checkpoint inhibitors; 7. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors during screening): absolute neutrophil count >=1.5x10^9/L; platelets >= 75 x 10^9/L; Hemoglobin >= 8.5g/dL; Thyroid-stimulating hormone (TSH) <= 1 times ULN (if abnormal, T3 and T4 levels should be investigated at the same time, if T3 and T4 levels are normal, they can be included in the group); bilirubin <= 2 times ULN; ALT and AST <= 5 times ULN; serum creatinine <= 1.5 times ULN; 8. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women of childbearing age and men (having sex with women of childbearing age) must agree to use effective without interruption during treatment and for 6 months after the last therapeutic dose contraceptive measures; 9. The subjects voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Breastfeeding women; 2. Suffering from other malignant tumors in the past 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled; 3. Uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function 5. Subjects with active, known or suspected autoimmune disease, hypothyroidism only receiving hormone replacement therapy, skin diseases (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment can be selected; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack within 6 months; 7. Serious active infection requiring intravenous antibiotic treatment occurred during enrollment; 8. Those who are allergic to the test drug; 9. Have been vaccinated or will be vaccinated with live vaccines within 30 days before the administration of camrelizumab; 10. Known history of HIV infection; 11. Active bleeding or abnormal coagulation function (PT > 16s, APTT > 43s, INR > 1.5 x ULN), or bleeding tendency or undergoing thrombolytic therapy; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 13. The researchers believe that it is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate ;Disease control rate ;Overall survival;survival rate;Safety; | — |
Countries
China
Contacts
Public ContactQiao Wenbo
Harbin Medical University Cancer Hospital
Outcome results
None listed