Bladder Cancer
Conditions
Interventions
Experimental group:Penpulimab combined with concurrent chemoradiotherapy
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years old; 2. ECOG physical condition 0 or 1; 3. Pathologically diagnosed patients with muscle-invasive bladder cancer (MIBC), staged cT2-T4aN0M0, who are not suitable for or refuse to receive radical treatment; 4. The expected survival time exceeds 12 months; 5. The subject has not received systemic chemotherapy or immunotherapy; 6. Important laboratory inspection indicators meet: (1) Hemoglobin (HB) >= 90g/L; (2) White blood cells (WBC)>=4.0*10^9/L; (3) Absolute neutrophil count (ANC) >= 1.5*10^9/L; (4) Platelet (PLT)>=100*10^9/L (5) ALT = 50ml/min; (8) Normal or abnormal coagulation function (PT, APTT, TT, Fbg) has no clinical significance; (9) Left ventricular ejection fraction (LVEF) >= 50%.
Exclusion criteria
Exclusion criteria: 1. In addition to primary muscle-invasive urothelial carcinoma, patients with other tumors or other malignant tumors in the past 5 years, cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder Tumors were excluded [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)]; 2. Received systemic chemotherapy, targeted or other immune checkpoint inhibitor drugs (including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD) before receiving piamplimumab and neoadjuvant chemotherapy -L1 or anti-PD-L2 antibody) treated patients; 3. Patients with allergies to therapeutic drugs or hypersensitivity constitution, patients with autoimmune diseases; 4. Patients with muscle-invasive urothelial carcinoma with distant metastasis suggested by imaging examination (abdominal CT scan + enhanced, chest CT plain scan, ECT-bone scan, PET-CT, MRI, etc.); 5. There are uncontrollable concurrent diseases, including but not limited to persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea tract disease, or a psychiatric/social condition that would limit its compliance with study requirements, greatly increase the risk of causing AEs or impair the patient's ability to give written informed consent; 6. Received live attenuated vaccine or had severe infection one month before enrollment; 7. Treatment with systemic corticosteroids or corticosteroids within 12 weeks before enrollment fails to be reduced to = 500IU/mL; hepatitis C: HCV RNA positive and abnormal liver function); combined hepatitis B and hepatitis C co-infection; human immunodeficiency virus (HIV); 9. According to the judgment of the investigator, the patient may have other factors that may cause the study to be terminated halfway, such as other serious diseases or serious laboratory abnormalities or other factors that may affect the safety of the subjects, or the experimental data. Factors such as family or society are collected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete remission rate, cCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate, pCR;Implementation rate of salvage surgery;2 years bladder retention DFS;Quality of Life;Safety; | — |
Countries
China
Contacts
Public ContactJiang Shichun
Mianyang Central Hospital
Outcome results
None listed