Penile cancer
Conditions
Interventions
Intervention group:Albumin taxol + Cisplatin + Bleomycin+Tislelizumab Injection
Sponsors
Beijing Chaoyang Huanxing Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed as penile squamous cell carcinoma, locally advanced and metastatic penile cancer ( such as clinical stage T (2-4) N (1-3) M1, T (3-4) N0M0, TxN3Mx and inoperable ); 2. No prior chemotherapy and/or immunotherapy and/or radiotherapy; 3. Aged between 18 and 70 years; 4. ECOG score 0-1; 5. Good organ function: (1) Hemoglobin >=90g/L, white blood cell >=3.5x10^9/L, neutrophil >=1.5x10^9/L, platelet >=100x10^9/L; (2) Creatinine <=1.0 UNL; The creatinine clearance rate was greater than 60ml/min; (3) Alanine aminotransferase (ALT) <=1.5 UNL, aspartate aminotransferase (AST) <=1.5 UNL; Alkaline phosphatase (ALP) <=1.5 UNL; (4) Total bilirubin (TBIL) <=1.5 UNL; 6. No history of autoimmune diseases; 7. Did not receive systemic corticosteroid therapy within 4 weeks before treatment; 8. The reproducible patient must use a highly effective contraceptive method (such as oral contraceptive, intrauterine contraceptive device, abstinence from libido or barrier contraceptive combined with spermicide) during the course of the trial and continue to use contraception for 12 months after the end of treatment; 9. Subjects voluntarily participate in the study, sign the informed consent form, have good compliance and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1) There is no distant metastasis at the first diagnosis or inguinal and pelvic lymph node metastasis can be completely removed by surgery; 2) Patients with cirrhosis caused by any cause; 3) cardiac function NYHA degree >I degree; 4) A history of previous myocardial infarction, unstable angina pectoris, stroke, and uncontrolled arrhythmia; 5) With any chemotherapy and immune contraindications; 6) those who have previously received chemotherapy and/or radiotherapy; 7) Have received any anti-PD-1, anti-PD-L1 /L2 antibody, anti-CTLA-4 antibody and other immunotherapy before; 8) Those who have received other anti-tumor therapy before; 9) Previous history of other tumors; 10) Concomitant with medical diseases that do not meet the conditions for chemotherapy; 11) Patients during pregnancy and lactation; 12) A history of mental illness; 13) Poor compliance; 14) Active central nervous system metastasis or cancerous meningitis; 15) Persons with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year before the first medication; 16) Human immunodeficiency virus (HIV) infection (HIV1/2 antibody positive); 17) Active hepatitis B and C. Patients with acute or chronic active hepatitis b or hepatitis c infection, hepatitis b virus (HBV) DNA>2000IU/ml or 104 copies /ml; Hepatitis c virus (HCV) RNA> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody are both positive; 18) Patients with previous autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, chronic lymphocytic thyroiditis, hyperthyroidism, polyarteritis nodosa, autoimmune hemolytic anemia, etc. 19) Receive live attenuated vaccine within the previous 4 weeks or plan to receive live attenuated vaccine during the study period; 20) Uncontrolled metabolic disorders or other non-malignant organ or systemic disease or cancer secondary reactions that can lead to higher medical risks and/or uncertainty in the assessment of survival; 21) Participating in other clinical trials; 22) Patients with other acute or chronic conditions, mental illness, or abnormal laboratory test values that may result in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable lesion;Measurable lesion;ORR;Progressive free survival time, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time, OS; | — |
Countries
China
Contacts
Public ContactHu Linjun
Beijing Chaoyang Huanxing Cancer Hospital
Outcome results
None listed