An Open ,Single Arm, Prospective, Phase II Clinical Study on the First-line Treatment of Recurrent or Metastatic Muscle Invasive Bladder Cancer With Cadonilimab(AK104) Plus Nab-Paclitaxel
The goal of this clinical trial is to evaluate the efficacy and safety of Cadonilimab(AK104) combined with Nab -Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder. Eligible participants will receive AK104 (up to 24 months) plus Nab-Paclitaxel (for 6 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.
• Sign a written informed consent form before joining the group.
• Age\>18 years old.
• Patients with advanced metastatic bladder cancer confirmed histologically or pathologically.
• Have not received systemic treatment.
• Have measurable lesions (according to RECIST 1.1 standard, non lymph node lesions have a CT scan length of ≥ 10 mm, and lymph node lesions have a CT scan short diameter of ≥ 15 mm).
• ECOG PS score: 0-1.
• The expected survival period is greater than 12 weeks.
• The functions of important organs meet the following requirements (excluding the use of 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 normal value (ULN) or creatinine clearance rate ≥ 50 ml/min (Cockcroft Fault formula);Liver function: 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 liver metastasis subjects.;Total serum bilirubin (TBIL) ≤ 1.5 x ULN (excluding Gilbert syndrome where TBIL\<3.0 mg/dL);Urinary protein\<2+;If the urine protein is ≥ 2+, the 24-hour urine protein quantitative display must be ≤ 1g.
⁃ 9\. Normal coagulation function, no active bleeding or thrombosis disease
• International standardized ratio INR ≤ 1.5 × ULN;
• Partial thromboplastin time APTT ≤ 1.5 × ULN;
• Prothrombin time PT ≤ 1.5 × ULN. 10. Non surgical sterilization or reproductive age female patients are required to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period. Non surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before enrollment in the study. And it must be non lactating.
⁃ 11\. The subjects voluntarily joined this study with good compliance, safety, and survival follow-up.