Colorectal cancer
Conditions
Interventions
single arm:Pd-l1 monoclonal antibody and lenalidomide
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have signed informed consent; 2. Patients aged 18-75 years; 3. Patients with advanced colorectal cancer diagnosed by pathology and imaging.Note: the presence of distant metastases should be confirmed by a CT or MR scan.Bone scan should be performed if bone metastases are suspected.Local radiotherapy for pain relief is permitted for bone metastases. 4. Patients with measurable lesions based on response evaluation criteria in solid tumors (RECIST) 1.1. and patients without local radiotherapy for target lesions. 5. Advanced colorectal cancer patients with PMMR / MSS who have progressed after the failure of current standard three-line treatment or are intolerant to three-line treatment; 6. ECOG 1 minute or less; 7. Patients who can provide tumor samples that can be used to detect PD-L1, MSI, B-Raf and K-ras status. This test requires the patients to provide paraffin embedded biopsy specimens or white slices. 8. Leukocyte >= 4 x10^9/L, platelet >= 100 x 10^9/L without blood transfusion, neutrophil absolute value (ANC) >= 1.5x 10^9/L without granulocyte stimulating factor treatment, and hemoglobin >= 90 g/L. 9. Bilirubin 45 ml/min; 11. Serum albumin >= 25 g/L (2.5g /dL); 12. INR or APTT <= 1.5 times ULN; 13. Hepatitis b/hepatitis c surface antigen positive patients need to be tested for hepatitis b/hepatitis c DNA virus quantitative test, only the < normal detection value of the upper limit of patients can be included in the group, and long-term use of anti-hepatitis b/hepatitis c drugs; 14. Drug elution time: 28 days or 5 half-lives from the last medication.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergy to any experimental drug or its excipients, or have history of severe allergy; 2. Have a history of autoimmune disease or are active; 3. Patients who have previously received allogeneic bone marrow transplantation or organ transplantation; 4. With congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or ct-confirmed active pneumonia; 5. With tested positive for HIV; 6. With active hepatitis b or hepatitis c (HCV and HCV are quantified higher than normal); 7. With active TB; 8. With uncontrolled cancer pain; 9. Patients who have received live attenuated vaccine within 4 weeks before the start of the study, or who are expected to receive live attenuated vaccine in the trial or within 5 months after the end of the trial; 10. Patients who have previously used immunotherapy, including CTLA4, anti-PD-1, or anti-PD-L1 mAb; 11. Patients with pulmonary active inflammation indicated by CT; 12. Systemic administration of glucocorticoids or immunosuppressants 2 weeks prior to trial initiation.Inhaled corticosteroids and halocorticoids are allowed.Use of hormones is contraindicated; 14. With severe cardiovascular disease, myocardial infection, arteriovenous thrombosis or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial; 15. An uncontrollable increase in blood pressure or blood sugar; 16. With histories of other malignancies up to 5 years ago, except for carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer; 17. Peripheral neuropathy >= NCI CTCAE grade 2; 18. Serum albumin less than 2.5 g/dL; 19. With uncontrolled or symptomatic hypercalcemia; 20. With infection requiring antibiotics within 14 days before the trial; 21. With chronic enteritis; 22. With clinically significant active gastrointestinal bleeding; 23. Patients who had non diagnostic surgery within 4 weeks before the start of the trial; 24. With any other disease for which there is evidence of a need to limit the use of experimental drugs; 25. Patients who participated in other trials or planned to participate in other trials within 30 days before the start of the trial; 26. Patients receiving other investigational drugs within 28 days before the start of the trial; 27. Women who are pregnant or nursing, or who plan to become pregnant within five months of the end of treatment.Women of childbearing age should undergo a blood pregnancy test 7 days before the start of the trial; 28. Patients who are contraindicated to use PD-L1 mAb or lenalidomide; 29. MSI-H/dMMR in patients with advanced colorectal cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security;Tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary efficacy; | — |
Countries
China
Contacts
Public ContactLuo Suxia/Li Ning
He'nan Cancer Hospital
Outcome results
None listed