Phase
Condition
Carcinoma
Urothelial Carcinoma
Treatment
N/AClinical Study ID
Ages > 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Volunteer to participate in this clinical trial, understand the study procedures, andbe able to sign a written informed consent.
- Age of 25 years old at the time of signing the informed consent (or the age rangespecifically required by the regulatory agency or ethics), without gender limitation;
- By histologically confirmed, surgical unresectable local advanced or metastaticurothelial cancer patients, can be accompanied by other histological typedifferentiation (including adenoid, squamous or other types)
- The ECOG PS (performance status) score is 0-1 point;
- The estimated survival period of 3 months;
- Good organ function level meets the following laboratory examination requirements, andthe examination results should be obtained within 14 days before the firstadministration of the study treatment
- Fertility female or male subjects must agree to use a medically approved contraceptivemeasure during the study treatment and within 6 months after the end of the studytreatment period; fertile female subjects must have a negative blood β -hCG testwithin 7 days before the first dose and must be non-lactating;
Exclusion
Exclusion Criteria:
- Known allergic to AZD4547 tablets or components; allergic to monoclonal antibody drugsand fusion protein drugs.
- Patients with imaging progression after previously receiving selective FGFR inhibitorsor receiving immune checkpoint inhibitors
- Subjects with a history of an active autoimmune disease or a possible recurrence of anautoimmune disease, as judged by the investigator, should be excluded. Patients areadmitted for the following diseases: hypothyroidism that can be controlled by hormonereplacement therapy only, skin diseases without systemic treatment
- A history of idiopathic pulmonary fibrosis (including pneumonia), drug-relatedpneumonia, organic pneumonia
- Subjects requiring systemic treatment with corticosteroids (prednisone or similardrug> 10 mg / day) or other immunosuppressive agents within 14 days prior toenrollment.a)
- Other malignant tumors requiring treatment were present within 6. 3 years
7 The electrolyte disorders that cannot be corrected and affect serum potassium, bloodcalcium or blood phosphorus levels. 8. Unstable or symptomatic CNS transfer 9. The researchers judge that the subject has factors that significantly affect theabsorption of oral drugs.
10 Current active infection or fever of unknown origin> 38.5℃ 11. Previous allograft or stem cell transplantation or organ transplantation. 12. Use of any live or attenuated vaccine against infectious diseases (e. g., influenza,chickenpox, etc.) 13. End time of other anti-tumor treatment from first study drug: 14. Patients with reversible adverse events caused by previous antitumor therapy, notreturning to grade CTCAE
15 Patients are using, or are using, the following drugs or foods within 7 days before thefirst administration of the study treatment: CYP3A4 and CYP2D6 strong inhibitors orinducers. 16. Presence of uncontrolled cardiovascular disease or medical history, including: a)Congestive heart failure 17. Any abnormal corneal or retinal changes that may increase the risk of ocular toxicityduring screening, including: 18. Human immunodeficiency virus (HIV) infection (HIV antibody serotest positive) orpreviously acquired / hereditary immunodeficiency disease
19 Patients with refractory / uncontrolled ascites or pleural effusion. Patients wereallowed to use an indwelling catheter.
20 Severe unhealed skin / mucosal ulcers, chronic ulcers of the lower extremities, knowngastric ulcers, or incisions are present. 21. Any other medical treatment (e. g., respiratory, metabolic, infectious, immune,congenital, endocrine, or central nervous system diseases), mental or social factors thatmay sign informed consent, cooperation, participate in clinical studies or affect theinterpretation of the research results.
Study Design
Study Description
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaActive - Recruiting

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