Renal cell carcinoma
Conditions
Interventions
Trial group:Toripalimab combined with TKI
Sponsors
SIR RUN RUN SHAW Hospital affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who have fully understood and voluntarily signed the informed consent; age >= 18 years old; 2. Patients with renal cell carcinoma confirmed by histology or cytology; according to AJCC TNM stage (8th Edition, 2017), the clinical stage was III-IV; 3. According to clinical diagnosis and treatment, patients need to use TKI drugs (including pezopanib, acetinib, sunitinib); 4. Patients with an estimated survival time of more than 3 months; 5. Patients who are willing and able to comply with the visit, treatment, laboratory tests and other research procedures of the study plan; 6. Patients with adequate organ function; 7. Patients who have not received immunotherapy before; 8. If the subject is a fertile woman, the following conditions must be met: contraceptive measures should be taken, or the prohibition of heterosexual intercourse should be the preferred way of daily life (long-term continuous abstinence). A highly sensitive pregnancy test (urine or serum test according to local regulations) was conducted 72 hours before the first administration of the study intervention, and the results should be negative.
Exclusion criteria
Exclusion criteria: 1. Patients with severe active infection or severe diseases of heart, liver, kidney and hematopoietic system; and those whose physical conditions are not suitable for relevant tests (judged by the researchers); 2. The patient had no measurable or evaluable lesions; 3. Patients with poor compliance; patients who are easy to lose follow-up; 4. Patients who have received immunotherapy in the past; patients who have received neoadjuvant therapy or relapsed after renal cell carcinoma surgery; 5. Patients who stopped using other TKI and chemotherapy drugs after enrollment; other clinical trial drugs were stopped for less than 4 weeks; 6. Patients during the study period, i.e. from the start of screening visit to 120 days after surgery, were pregnant or in lactation, or planned to become pregnant or become a father; 7. Patients with a history of organ transplantation or requiring long-term corticosteroid therapy; hypothyroidism, adrenal gland or hypophysis, type I diabetes, psoriasis or vitiligo that can be controlled only with hormone replacement therapy can participate in this study; 8. Patients with active infection requiring systematic treatment, human immunodeficiency virus (HIV) infection (known HIV antibody positive), active HBV or HCV infection (HBsAg positive, or HBcAb positive but HBsAg negative) need to be tested for DNA quantification, and those whose results do not exceed the upper limit of the laboratory normal value in the research center can participate in this study; HCV? RNA in the screening period of previous HCV infected patients should be included If the test results are negative, they can participate in this study); 9. Patients vaccinated with live vaccines within the first 30 days, including but not limited to mumps, rubella, measles, varicella / zoster (varicella), yellow fever, rabies, BCG and typhoid vaccines, excluding inactivated virus vaccines; 10. Patients with severe drug allergy history; those who are allergic to the experimental drug or have drug contraindications; 11. Within the first 7 days, or expected to take after enrollment, known as strong CYP3A4 / 5 inhibitors and CYP3A4 / 5 inducers (including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and Hypericum perforatum, etc.) or drugs that may cause arrhythmia (including but not limited to terfenadine, quinidine, procainamide, propylamine, sotalol, probucol, etc.) And bepril, etc.); 12. According to the investigator's judgment, the subject has a history or current evidence of any disease, treatment or laboratory abnormality that may confuse the test results, interfere with the subject's participation in the whole trial, or is not in the best interest of the subject to participate in the trial; 13. Vulnerable groups include, but are not limited to, mental patients, critically ill patients, pregnant women, minors, cognitive impairment, students of researchers, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactChen Yicheng
SIR RUN RUN SHAW Hospital affiliated to Zhejiang University School of Medicine
Outcome results
None listed