Colorectal cancer
Conditions
Interventions
Colorectal cancer:tislelizumab+fruquintinib+decitabine
Sponsors
Oncology Department, Chongqing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in the study, signed the informed consent, and had good compliance; 2. At least 18 years old; 3. Cytology or histology confirmed colorectal adenocarcinoma with distant metastasis; 4. Failure to receive standard second-line chemotherapy (including fluorouracil drugs and oxaliplatin or irinotecan), disease progression or recurrence; 5. The patient must have at least one measurable lesion (RECIST1.1); 6. ECOG physical condition =2 points; 7. Expected survival =12 weeks; 8. Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value =1.5×109/L, platelet =100×109/L, hemoglobin concentration =9g/dL); 2) Liver function test (aspartate aminotransferase and glutamic aminotransferase =3×ULN, bilirubin =1.5×ULN; In the presence of liver metastasis, AST and ALT=5×ULN); 3) Renal function (serum creatinine =1.5×ULN, or creatinine clearance (CCr)=60ml/min); 4) Coagulation, International standardized ratio (INR) =1.5, prothrombin time (PT) and activated partial thrombin time (APTT) =1.5×ULN; 5) Thyroid function: FT3, FT4 and TSH. If FT3 and FT4 cannot be obtained, T3 and T4 can also be accepted. 9. Women of childbearing age must use effective contraceptive methods; 10. Subject is capable of understanding, agreeing, and signing the study Informed Consent Form (ICF) prior to initiating any project-related procedures; Subject may express consent with parental/guardian consent (if applicable).
Exclusion criteria
Exclusion criteria: 1. Had a surgical procedure within the first 4 weeks of treatment; Received radiation therapy, radiofrequency, chemotherapy, immunoor molecular targeted therapy or other investigational drugs for tumors within 2 weeks prior to treatment; 2. Previously received anti-vascular small-molecule targeted drug therapy, such as fuquinitinib, Regofenib, etc. (excluding large-molecule targeted drug therapy, such as bevacizumab, etc.); 3. Previously received immunosuppressive therapy, such as PD-1 monoclonal antibody and CTLA-4 monoclonal antibody; 4. A history of severe intolerance to decitabine or tirelizol (i.e., grade 4 toxicity of one of the drugs; Class 3-4 toxicity of other co-administered drugs is not excluded); 5. Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable). 6. Have hypertension that is not well controlled by antihypertensive medications (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); 7. Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (bleeding within 3 months > 30mL, hematemesis, black feces, blood in the stool), hemoptysis (within 4 weeks > 5mL fresh blood), etc. Or treatment of venous/venous thrombosis events occurring within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin =300mg/ day or clopidogrel =75mg/ day) is required; 8. Active heart disease, including myocardial infarction, severe/unstable angina, occurs 6 months before treatment. Left ventricular ejection fraction by echocardiography 1.0 g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;Duration of Response;safety; | — |
Countries
China
Contacts
Public ContactNianweiqi
Chongqing Hospital of Traditional Chinese Medicine
Outcome results
None listed