Penile cancer
Conditions
Interventions
Test group:Camrelizumab combined with TIP protocol
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced penile cancer with inguinal lymph node or/and pelvic lymph node metastases after resection of the primary tumor of penile cancer (the American Joint Committee on Cancer TNM Staging System for Penile Cancer 2017); 8th edition, TX, N2-N3, M0); 2. Have not received systemic therapy in the past; 3. Patients with penile squamous cell carcinoma confirmed by histology; 4. Patients with positive percutaneous lymph node biopsy; due to consideration of the occurrence of false negative lymph node biopsy, patients with positive biopsy need to be repeated; 5. Have measurable lesions that meet RECIST 1.1 criteria for evaluation; 6. Aged 25-75 years, male; 7. Expected survival > 3 months; 8. ECOG PS score: 0-1 points; 9. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors during screening): Absolute neutrophil count >= 1.5x10^9/L; Platelets >= 80x10^9/L; Hemoglobin >= 8.5g/dL; Thyroid-stimulating hormone (TSH) 50 ml/min; 10. Subjects with childbearing potential must agree to take a medically approved contraceptive method for contraception during the study period and within 6 months after the end of the study treatment period; 11. Subjects voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. There are other malignant tumors in the past five years; 2. Allergies for any test drugs and their excipients, have serious allergies or subject contraindications; 3. Continuous two urinary proteins 2 + -3 +, or proteinuria 4+, requiring additional 24-hour urinary protein to quantify, 24-hour urinary protein quantification> 1 g of patients 4. Uncontrolled, symptomatic brain transfer or misconduct histopathic or severe intelligence or cognitive dysfunction; 5. Pulmonary fibrosis, interstitial pneumonia, dust lung, radioactive pneumonia, drug-related pneumonia and lung function seriously damaged; 6. Subjects that have active, known or suspicious autoimmune diseases, only the thyroid dysfunction of hormone replacement treatment, no need for skin diseases (such as vitiligo, psoriasis or hair loss) without systemic treatment Can be selected; 7. Congestive heart failure, difficult arrhythmia, myocardial infarction, unstable angina, stroke or historional ischemic attack within 6 months; 8. Severe active infection of antibiotic intravenous injection during income; 9. Inoculated or subjected to vaccines within 30 days before Carrieli gabit. 10. History of known HIV infections; 11. Patients who cannot follow the test scheme or cannot be followed; 12. Researchers believe that it is not advisable to participate in this test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| event free survival;overall survival;objective response rate;disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactChen Yongsheng
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed