Cadonilimab Plus Nab-Paclitaxel for Recurrent or Metastatic Muscle Invasive Bladder Cancer

Inclusion Criteria:

1. Sign a written informed consent form before joining the group.
2. Age>18 years old.
3. Patients with advanced metastatic bladder cancer confirmed histologically orpathologically.
4. Have not received systemic treatment.
5. Have measurable lesions (according to RECIST 1.1 standard, non lymph node lesions havea CT scan length of ≥ 10 mm, and lymph node lesions have a CT scan short diameter of ≥ 15 mm).
6. ECOG PS score: 0-1.
7. The expected survival period is greater than 12 weeks.
8. The functions of important organs meet the following requirements (excluding the useof any blood components and cell growth factors within 14 days):

(1) Blood routine: Neutrophils ≥ 1.5 × 10^9/L;Platelet count ≥ 100 × 10^9/L;Hemoglobin ≥ 90g/L.

(2) Liver and kidney function:Serum creatinine (SCr) ≤ 1.5 times the upper limit of normalvalue (ULN) or creatinine clearance rate ≥ 50 ml/min (Cockcroft Fault formula);Liverfunction: Aspartate aminotransferase (AST) ≤ 2.5 x ULN, alanine liver aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastasis; ALT and AST<5 x ULN in livermetastasis subjects.;Total serum bilirubin (TBIL) ≤ 1.5 x ULN (excluding Gilbert syndromewhere TBIL<3.0 mg/dL);Urinary protein<2+;If the urine protein is ≥ 2+, the 24-hour urineprotein quantitative display must be ≤ 1g. 9. Normal coagulation function, no active bleeding or thrombosis disease

1. International standardized ratio INR ≤ 1.5 × ULN;
2. Partial thromboplastin time APTT ≤ 1.5 × ULN;
3. Prothrombin time PT ≤ 1.5 × ULN. 10. Non surgical sterilization or reproductive agefemale patients are required to use a medically approved contraceptive method (such asan intrauterine device, contraceptive pill, or condom) during the study treatmentperiod and within 3 months after the end of the study treatment period. Non surgicallysterilized female patients of childbearing age must have a negative serum or urine HCGtest within 7 days before enrollment in the study. And it must be non lactating.
4. The subjects voluntarily joined this study with good compliance, safety, and survivalfollow-up.

Exclusion Criteria:

1. The subject has previously or simultaneously suffered from other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
2. The subject is known to have previous allergies to macromolecular protein formulationsor known to be allergic to the drug components used.
3. The subject has any active autoimmune disease or a history of autoimmune disease (Forexample, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis,enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism,decreased thyroid function, who have undergone thyroid surgery in the past cannot beincluded. subjects with vitiligo or complete remission of childhood asthma, who do notrequire any intervention in adulthood, can be included. subjects who requirebronchodilators for medical intervention) Asthma cannot be included).
4. The subject is currently using immunosuppressive agents or systemic or absorbablelocal hormone therapy to achieve immunosuppressive effects (dosage>10mg/day ofprednisone or other therapeutic hormones), and continues to use them within 2 weeksbefore enrollment.
5. Ascites or pleural effusion with clinical symptoms require therapeutic puncture ordrainage.
6. Patients with clinically uncontrollable cardiac symptoms or diseases, such as: (1)NYHA grade 2 or above heart failure, (2) unstable angina pectoris, (3) myocardialinfarction within 1 year, (4) clinically significant supraventricular or ventriculararrhythmias that require treatment or intervention.
7. The subject has an active infection or an unexplained fever>38.5 degrees Celsiusduring the screening period or before the first administration (according to theresearcher's judgment, the subject's fever caused by the tumor can be included in thegroup).
8. Patients with past and current history of pulmonary fibrosis, interstitial pneumonia,pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment oflung function with objective evidence.
9. Subjects have congenital or acquired immune deficiency, such as HIV infected persons,or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis Breference: HBV DNA ≥ 1000 IU/ml. hepatitis C reference: HCV RNA ≥ 1000 IU/ml). Chronichepatitis B virus carriers with HBV DNA<2000 IU/ml must receive antiviral treatmentsimultaneously during the trial period before they can be enrolled.
10. Live vaccines may be administered less than 4 weeks before the study medication orduring the study period.
11. The subject is known to have a history of psychotropic substance abuse, alcoholism, ordrug abuse.
12. Accepted Chinese herbal medicine or traditional Chinese patent medicines and simplepreparations with anti-tumor indications within 2 weeks before the firstadministration.
13. The researcher believes that it should be excluded from this study. For example, basedon the researcher's judgment, the subject may have other factors that may cause thestudy to be terminated midway, such as other serious diseases (including mentalillness) requiring concurrent treatment, serious laboratory test abnormalities,accompanied by family or social factors, which may affect the safety of the subject,or the collection of data and samples.