Penile cancer
Conditions
Interventions
Observation group:None
Sponsors
The First Central Hospital of Tianjin
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male, age 18-75 years; 2) ECOG score of 0-2; 3) Histologically or cytologically confirmed locally advanced squamous cell carcinoma of the penis (T4, N3, N1-2 with lymph nodes greater than 4cm); 4) For patients who have not used any chemotherapy drugs in the past for newly diagnosed or relapsed patients; 5) Patients who plan to use sintilimab in combination with cisplatin + nab-paclitaxel or paclitaxel liposomes in the perioperative period; 6) Objectively measurable lesions according to RECIST 1.1 criteria; 7) No history of autoimmune diseases; 8) Subjects voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Participation in other clinical trials within 4 weeks of the first treatment; 2) patients who have received prior immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, PD-L2 drugs, or CTLA-4); 3) diagnosed with immunodeficiency or requiring systemic steroid therapy (> 10 mg of prednisone, or other equivalent doses of hormonal drugs) at the time of initial treatment; 4) Vaccination with a live vaccine within 30 days prior to the first dose of study drug. Live vaccines include, but are not limited to: measles, mumps, fractional needle, varicella/zoster, rabies, BCG, typhoid vaccine, etc.; Seasonal influenza vaccines for injection are generally inactivated virus vaccines and are allowed to be used; 5) The patient is known to have other malignancies, is progressing or requires active treatment within the past 3 years (except for carcinoma in situ or localized prostate cancer made up by PSA testing); 6) Clinically relevant or prior interstitial lung disease; 7) Severe unhealed wounds, ulcers or fractures; 8) Autoimmune disease requiring systemic treatment within the past 2 years; 9) unstable systemic concomitant diseases (active phase of infection, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina, congestive heart failure, history of myocardial infarction, cerebrovascular accident, pulmonary embolism or untreated grade 3 deep vein thrombosis (DVT) occurring within 6 months, severe psychiatric disorders requiring drug control, hepatic, renal or other metabolic diseases, neuropsychiatric disorders such as Alzheimer's disease); 10) According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease Control Rate;Surgical conversion rate and R0 surgical resection rate;Safety; | — |
Countries
China
Contacts
Public ContactZhao Zhigang
The First Central Hospital of Tianjin
Outcome results
None listed