Colorectal cancer
Conditions
Interventions
Combined therapy group:Tislelizumab +TAS-102+ bevacizumab + stereotactic body radiotherapy
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Subjects with histologically or cytologically proven colorectal cancer b. subjects with evidence of stage IV metastatic disease, with baseline measurable lesions according to RECIST 1.1 c. Tumor tissue detection suggested MSS subtype (PCR or sequencing could be used). d. received standard first-line and second-line treatment for advanced colorectal cancer. e. age =18 years old, gender is not limited, ECOG score 0-1 f. the expected survival time is more than 6 months g. The subjects should meet the following hematological indicators: g1. Neutrophil count =1.5×109/L g2. Hemoglobin =10g/dL g3. Platelet count =100×109/L h. Subjects should meet the following biochemical indicators: h1. Total bilirubin =1.5× Upper limit of normal (ULN) h2. AST and AL T < 1.5×ULN h3. Creatinine clearance =60ml/min i. Subjects of childbearing age should take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial. j. Ability to swallow, inhale, and absorb oral medications k. Informed consent has been signed. l. Be able to follow the study protocol and follow-up procedures
Exclusion criteria
Exclusion criteria: a. Simultaneously participating in other clinical trials b. Subjects with active bacterial or fungal infections (>=Level 2 NCI-CTC, 3rd edition) c. The subjects have HIV, HCV, HBV infections, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease, or other diseases deemed by the researchers to be non enrollable d. The subject has a concurrent or previous history of other tumors e. The subject has an autoimmune disease or immune deficiency and is treated with immunosuppressive drugs. f. Pregnant and lactating women. Women of childbearing age must test negative for pregnancy test within 7 days before enrollment g. Drug abuse, clinical, psychological, or social factors that affect informed consent or research implementation h. A history of chronic inflammatory bowel disease requiring medical intervention (immunomodulatory or immunosuppressive drugs or surgery) within = 12 months prior to randomization i. Individuals who may be allergic to the medication treatment drugs involved in this experiment j. Researchers believe that it is not suitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mPFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;mOS;Adverse reaction; | — |
Countries
China
Contacts
Public ContactXiaoping Qian
Nanjing Drum Tower Hospital
Outcome results
None listed