Colorectal Cancer
Conditions
Interventions
Experimental Arm:Tislelizumab and cetuximab and irinotecan
Control Arm:Standard Treatment
Sponsors
Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Be able to provide written informed consent and understand and comply with the requirements and evaluation schedule of this study; 2. Be at least 18 years of age (or the legal age of commitment in the jurisdiction where the study takes place) on the date of signing the informed consent; 3. RAS wild-type colorectal cancer, histologically confirmed, with metastatic or recurrent foci that cannot be cured by surgery; 4. Have received at least second-line systemic anti-tumor therapy failure for metastatic colorectal cancer, among which chemotherapy drugs can include fluorouracil, oxaliplatin and irinotecan, and targeted drugs can include cetuximab and bevacizumab; 5. ECOG score = 1; 6. At least one measurable lesion as defined by RECIST version 1.1; 7. Organ function was good = 7 days before randomization, as shown in the following laboratory test values: A. Patients have not received blood, platelet transfusion or growth factor support therapy within 14 days or less before blood sample collection during the screening period, and should meet the following requirements: I. Neutrophils = 1.5 x 10^9/L Ii. Platelet =75 x 10^9/L Iii. Hemoglobin = 90 g/L B. Serum creatinine =1.5 times normal upper limit (ULN) C. ST and ALT=2.5 ULN (=5 ULN if liver metastasis occurs) D. Serum total bilirubin =1.5 ULN E. International standardized ratio (INR) =1.5 or prothrombin time =1.5 ULN F. Activated partial thrombin time (aPTT) =1.5 ULN G. Serum albumin =30 g/L 8. The research is not received within 4 weeks before the start of a major operation, 2 weeks prior to the start of the study was not received chemotherapy, radiotherapy and endocrine therapy, targeted therapy, or previous drug use more than 5 half-life (in short), and has set up a recovering from treatment of acute toxicity reaction before (if you have surgery, the wound has healed completely); Toxicity from previous anticancer therapy did not improve to level 1 or return to baseline, except for AE that were not identified as a safety risk (e.g., hair loss, neuropathy, and specific laboratory abnormalities); 9. Fertile women must agree to use highly effective contraception during the study period and =120 days after the last dose of the study drug and to have a negative serological pregnancy test =7 days before the first dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Any previous histological or hematological ctDNA test showed mismatch repair gene deletion (dMMR), microsatellite instability (MSI-H), or BRAF mutation; 2. Prior immunotherapy, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or any cellular immunotherapy; 3. Presence of active pia meningeal disease or poorly controlled brain metastases. In patients with previously treated BMS, if radiographically stable, that is, repeat radiographs confirm no progression for at least 4 weeks (note that repeat radiographs should be performed during the study screening period); 4. Active autoimmune disease or a history of autoimmune disease that may recur Note: Patients with the following diseases cannot be excluded and can be further screened: A. Well controlled type 1 diabetes B. Hypothyroidism (which can be controlled only with hormone replacement therapy) C. Well-controlled celiac disease D. Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, hair loss) E. Any other disease that is not expected to recur without an external trigger 5. Any active malignancy less than 5 years prior to the first administration of the study drug, excluding the specific cancers studied in the study and any locally recurrent cancers that have received radical therapy (e.g. excised basal or squamous cell skin cancer, cervical or breast carcinoma in situ); 6. Any systemic treatment with corticosteroids (prednisone or equivalent >10 mg/ day) or other immunosuppressive agents =14 days before the first administration of the study drug Note: Current or previous use of any of the following steroid regimens is not excluded: A. Adrenal replacement steroid (prednisone or equivalent =10 mg/ day) B. Inhaled corticosteroids with minimal local, ocular, intra-articular, intranasal, or systemic absorption C. Short-term (=7 days) prophylactic use of corticosteroids (e.g. for contrast agent allergies) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity from contact allergens) 7. Uncontrolled diabetes, grade =3 hypoalbuminemia, or grade >1 abnormal blood potassium, sodium, or calcium in laboratory tests despite standard drug therapy =14 days before the first administration of the study drug; 8. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled disease, including pulmonary fibrosis, acute lung disease, etc. 9. Urine routine indicated urine protein =++, and the 24-hour urine protein quantity was confirmed to be > 1.0g by quantitative urine protein detection; 10. Severe chronic or active infections (including tuberculosis, etc.) requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to initial administration of the study drug note: Patients with viral hepatitis are permitted to receive antiviral therapy; 11. Active psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, etc.). Depression under treatment with antidepressants was not excluded; 12. Known history of human immunodeficiency virus (HIV) infection; 13. Untreated carriers of chronic hepatitis B or chronic hepatitis B virus (HBV) (HBV DNA > 500 IU/mL) or active CARRIERS with DETECTABLE HCV RNA. Remarks: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) can be included; 14. Any major surgery requiring general anesthesia =28 days before the first administrati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;Disease control rate;Duration of response;overall survival; | — |
Countries
China
Contacts
Public ContactLiu Tianshu
Outcome results
None listed