Colorectal cancer
Conditions
Interventions
control group:Treated with anlotinib
experimental group:Treated with anlotinib in combination with tislelizumab
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. mss colorectal cancer subjects diagnosed by pathology, recurrent or ineffective after multi-line therapy; 3. ECOG score: 0 or 1; 4. Adequate organ and bone marrow function meets the following definitions: (1) Blood routine (no blood transfusion, no granulocyte colony-stimulating factor (G-CSF), no other drug correction within 14 days before treatment) : WBC>=2000/µL; Neutrophils >=1500/µL; Platelets >=100 x 10^3/µL; Hemoglobin >=9.0 g/dL; (2) Blood biochemistry: serum creatinine 50 mL/ min (using Cockcroft/Gault formula, the formula is as follows); AST<=3 x ULN; ALT<= 3 x ULN; Total bilirubin <=1.5xULN; 5. Life expectancy greater than 12 weeks; 6. Female subjects may participate in the study if they are not pregnant or lactating, and if at least one of the following conditions is met: non-fertile women or fertile women who have agreed to take contraceptive measures as required by the protocol during treatment and within 5 months after the last study drug administration; 7. Male subjects must agree to use contraception during treatment and for 5 months after the last study drug administration and must not donate sperm during this period; 8. With the subject's consent and signed informed consent, the planned visit, study and treatment, laboratory tests and other test procedures should be followed.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors; 2. Patients with neurological metastases; 3. Patients with known or suspected active autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions that are not expected to recur in the absence of external triggers are allowed to be included; 4. Previous treatment with anlotinib, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug that specifically targets T cell costimulation or checkpoint pathways; 5. Patients who received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents 14 days before administration of the study drug; 6. Severe interference (CTC AE>2) occurred within 4 weeks before administration of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection (unexplained fever >38.5 degrees) within 14 days before the first administration of the study drug, or the need for oral or intravenous antibiotic treatment; 7. All toxicities attributable to previous anticancer therapy (other than nephropathy, neuropathy, hearing loss, alopecia, and fatigue) did not return to grade 1 (NCI CTCAE, version 4.03) or baseline before study drug administration. Patients who developed toxicity attributable to previous anticancer therapy that was not expected to be remitted and resulted in lasting sequelae (e.g., peripheral neuropathy after platinum-based therapy) were allowed to be included. Peripheral neuropathy must be in remission to grade 2 (NCI CTCAE version 4.03); 8. According to the researcher's judgment, there may increase the risk of study participation, drug dosage related or can damage the ability of test solution treatment in patients with any serious or not get control of medical problems (such as poorly controlled hypertension, poorly controlled diabetes, poor control of neurological or psychiatric disease, etc.) or active infection; 9. A known positive history of human immunodeficiency virus (HIV) testing or known acquired immunodeficiency syndrome (AIDS); 10. Patients who received live/attenuated vaccine within 4 weeks prior to administration of the study drug; 11. Any positive test result for hepatitis B virus or hepatitis C virus indicating the presence of virus, such as hepatitis B surface antigen (HBsAg, Australian antigen) positive or hepatitis C antibody (anti-HCV) positive (except HCV-RNA negative); 12. History of allergy or hypersensitivity to study drug ingredients; 13. History of severe hypersensitivity reaction to any monoclonal antibody; 14. Patients with a history of substance abuse and inability to abstain or mental disorders; 15. A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. Patients who are enrolled in other clinical trials or have been enrolled in other clinical trials for less than 4 weeks; 17. Patients with BMI < 18.5mg/m^2 or weight loss greater than 10% before screening; 18. Other circumstances that the investigator believes will affect the progress of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (Progression Free Survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| OS (Overall Survival);ORR (Objective Response Rate);AER (Adverse Effects Rate);DCR (Disease Control Rate); | — |
Countries
China
Contacts
Public ContactZhong Shaoyang
Army Medical Center of PLA
Outcome results
None listed