Renal cell carcinoma
Conditions
Interventions
experimental group:Combination of multi-omics study and FasterPDTX artificial microenvironment guides individual precise treatment
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent to comply with the agreement; 2. Advanced metastatic renal clear cell carcinoma confirmed by histopathology; 3. Aged >= 18 years old, =1.5 x 10^9 / L): ANC >= 75 x 10^9 / L, HB >= 90 g / L (within 14 days without blood transfusion or colony stimulating factor); (2) liver function: TBIL = 50ml/min (calculated according to Cockcroft-Gault formula); (4) Coagulation function: activated partial thromboplastin time (APTT) = 20mL / min (Cockcroft-Gault formula); 9. Women should agree that contraceptive measures (such as intrauterine device [IUD], contraceptive or condom) must be used during the study and within 6 months after the end of the study; serum or urine pregnancy tests are negative within 7 days before the study, and must be non-lactation patients. Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 10. The subjects must have informed consent to this study before the experiment and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1. Pregnant and lactating women. 2, Major surgery is performed within 4 weeks before enrollment, or major surgery is expected to be required in the course of the study, rather than diagnosis. 3. Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other antineoplastic drugs within 4 weeks before the first use of research drugs (except nitrosourea, mitomycin C, oral fluorouracil, small molecular targeted drugs, traditional Chinese medicine with anti-tumor indications). 4. Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer), and the traditional Chinese medicine with anti-tumor indications is within 2 weeks before the first use of the study drug. 5. Patients receiving therapeutic oral or intravenous (IV) antibiotics within 14 days of enrollment are eligible to receive prophylactic antibiotics (for example, to prevent urinary tract infections or chronic obstructive pulmonary disease). 6. A live attenuated vaccine is given within 4 weeks prior to registration or is expected to be needed during the study. Prior to registration, systemic immune stimulants (including, but not limited to, interferon or IL-2) were used within 4 weeks or 5 half-lives of the drug, whichever is the shorter. 7. Severe infections occurred within 4 weeks before being enrolled in the study, including, but not limited to, hospitalization for complications of infection, bacteremia or severe pneumonia. 8. Major cardiovascular diseases, such as heart disease of the New York Heart Association (II or higher), myocardial infarction, unstable arrhythmia or unstable angina pectoris within the first 3 months of enrollment. 10. History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonia, tissue pneumonia (i.e. bronchiolitis obliterans, cryptogenic tissue pneumonia), or evidence of active pneumonia on chest CT scans. 11. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as HBsAg test negative and a hepatitis B core antigen positive antibody [anti-HBc] antibody test) were eligible. 12. Patients with positive hepatitis C virus (HCV) antibodies are eligible only when polymerase chain reaction (PCR) is negative for HCV RNA. 13. Evidence of significant uncontrolled concomitant diseases may affect compliance with the program or interpretation of results, including significant liver disease, positive HIV tests, active pulmonary tuberculosis, and a history of gastrointestinal diseases (medical diseases or extensive surgery) that may interfere with drug absorption. 14. Uncontrolled hypercalcemia (> 1.5 mmol / L ionic calcium or Ca > 12 mg / dL or corrected serum calcium > institutional ULN) or symptomatic hypercalcemia should continue to be treated with bisphosphonate or denosumab. 15. Patients who received bisphosphonate therapy or denosumab-specific prevention of bone events and had no clinically significant history of hypercalcemia were eligible. 16. Patients who receive denosumab before entering the group must be willing and eligible to receive bisphosphonates during the study. 17. History of autoimmune diseases, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, va
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug sensitivity of tumor tissue;objective response rate;Adversre events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactHailiang Zhang
Fudan University Shanghai Cancer Center
Outcome results
None listed