penile cancer
Conditions
Interventions
Treatment:disitamab vedotin combined with toripalimab
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent voluntarily and follow the program requirements. 2. There is no age limit. 3. Expected survival =8 weeks. 4. Penile squamous cell carcinoma confirmed by histopathology. 5. Participants had advanced metastatic penile squamous cell carcinoma who had received triple chemotherapy with paclitaxel, ifosfamide and cisplatin (TIP) or docetaxel, cisplatin and 5-fluorouracil (TPF) and had disease progression or recurrence during or after the most recent treatment. Neoadjuvant/adjunctive therapies containing these drugs that relapsed in situ or progressed after treatment ended were also eligible for inclusion. Participants with renal function eGFR30ml/min • No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) = 50% (ECHO confirmed); • Coagulation function: International Normalized ratio (INR) =1.5×ULN, and active partial thromboplastin time (APTT) =1.5×ULN (except for those receiving therapeutic anticoagulants).
Exclusion criteria
Exclusion criteria: 1. Central nervous system (CNS) metastatic and/or cancerous meningitis; 2. In the investigator's judgment, any severe or uncontrolled systemic disease, including poorly controlled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), uncontrolled diabetes (subject's HBA1C =8% in the 3 months prior to the first dose of the study treatment), And active bleeding signs; 3. Expected survival =8 weeks; 4. Have uncontrolled heart disease, including NYHA grade 2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment, and prolonged QT syndrome, such as QTc > 450 ms; 5. Evidence of active infection including but not limited to hepatitis B (HBV DNA = 2000 IU/mL), hepatitis C (HCV antibody positive), hepatitis B (HBV DNA = 2000 IU/mL), hepatitis C (HCV antibody positive). HCV RNA positive) or human immunodeficiency virus (HIV) infection; 6. History or combination of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.; 7. Patients with previous severe atopic dermatitis; 8. Peripheral neuropathy > Grade 2; 9. A history of cirrhosis (Child-Pugh grade B, C); 10. Have an active autoimmune disease or history of autoimmune disease, are taking immunosuppressants, or systemic hormone therapy (dose >10 mg/ day of prednisone or other equivalent hormone), and continue to use within 2 weeks prior to enrollment; 11. Renal function: eGFR<30ml/min; 12. Uncontrolled tumor-related emergency spinal cord compression. A bone stabilization regimen must have been received at the time of initial dosing. 13. Other conditions deemed unsuitable for participation in this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactFang Yuan
Chongqing University Cancer Hospital
Outcome results
None listed