Bladder cancer
Conditions
Interventions
trial group:Camrelizumab and Pyrotinib
Sponsors
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria are eligible to participate in the trial: 1. Male or female >= 18 years old and = 3 months; 9. The main organs are functioning normally (14 days before enrollment), which means they meet the following criteria: 10. Routine blood examination standards must meet (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days before enrollment): HB >= 90 g/L; ANC >= 1.5 x 10^9 /L; PLT >= 100 x 10^9 /L; 11. Non-functional organic diseases must meet the following standards: T-BIL 50ml/min (Cockcroft-Gault formula); International normalized ratio (INR), activated partial thromboplastin time (aPTT): = 1 year)], must be in the trial process Use highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptives, sexual control or barrier contraception combined with spermicide), and continue contraception for 12 months after the end of treatment; 14. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions will be excluded from the trial: 1. Have received anti-PD-1, anti-PD-L1, anti-PD-L2, and anti-HER-2 therapy in the past, including adjuvant therapy stage; 2. Those who are known to be allergic to carrelizumab, pyrrotinib and their components; 3. Those who have received other anti-tumor treatments (including corticosteroid therapy, immunotherapy) or participated in other interventional clinical studies within 4 weeks before the start of the study treatment, or the toxicity of previous anti-tumor treatments has not recovered to CTCAE 0-1 (Except hair loss); 4. Pregnant or lactating women; 5. The HIV test result is positive; 6. Patients with active hepatitis B or C; i. HBV DNA must be tested during research screening for patients with HBsAg or HBcAb positive; if HBV DNA is detected at the same time (more than 500IU/ml); ii. Patients with positive HCV antibody test results can only be selected for this study if the HCV RNA PCR test result is negative. 7. Have a clear history of active tuberculosis; 8. There are active autoimmune diseases that require systemic treatment in the past 2 years (such as the use of disease-modifying drugs, corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or renal or pituitary insufficiency) are allowed Physiologic corticosteroid replacement therapy); 9. Other serious and uncontrollable concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, uncontrollable diabetes, and cardiovascular disease (New York Heart Association classification Defined grade III or IV heart failure, heart block above II degree, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or lung Disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm); 10. Exclude subjects with active central nervous system (CNS) metastasis. Patients who have previously received treatment for brain or meningeal metastases, such as clinical stability has been maintained for at least 3 months, and have stopped systemic hormone therapy (dose>10mg/day prednisone or other curative hormones) for more than 4 weeks can be included. If the subjects CNS metastasis can be adequately treated to meet the requirements specified by the enrollment criteria, and the subjects neurological symptoms can be restored to a level less than or equal to CTCAE1 before enrollment (except for residual signs or symptoms related to CNS treatment) At least 2 weeks, you can participate in the research; 11. Received live vaccination within 4 weeks before the start of treatment; 12. Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 13. Major surgery (excluding diagnostic surgery) within 4 weeks before the start of treatment; 14. Those who have a history of psychotropic drug abuse and cannot be quit or have a history of mental disorders; 15. Large amounts of pleural fluid or ascites accompanied by clinical symptoms or requiring symptomatic treatment; 16. People who have had other malignant tumors in the past 2 years that have not healed, but do not include malignant tumors that have been obviously cured, or curable cancers, such as skin basal cell carcinoma or squamous cell skin c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;SAE;rate of AE;rate of SAE;PFS;DCR;CSS;OS; | — |
Countries
China
Contacts
Public ContactLianhua Zhang
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed