Stage IB–IV penile cancer
Conditions
Interventions
Group B- control group:Paclitaxel Polymer Micelles for Injection + Cisplatin + Ifosfamide
Group B- experimental group:Paclitaxel Polymer Micelles for Injection + Cisplatin + Ifosfamide + Suvemcitug + Envafolimab + Cetuximab ß
Group A:Paclitaxel Polymer Micelles for Injection + Cisplatin + Ifosfamide + Suvemcitug + Envafolimab + Cetuximab ß
Sponsors
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Informed Consent: Written informed consent must be signed prior to enrollment; 2.Age and Gender: Male patients, aged 18–75 years; 3.Diagnosis and Staging: Cytologically or pathologically confirmed penile cancer, Stage IB–IV (Stage IV is restricted to N3M0 patients only); 4.Histological Subtype: Confirmed Squamous Cell Carcinoma (SCC) by histology or cytology, with no evidence of neuroendocrine differentiation or small cell features. 5.EGFR Status: Immunohistochemistry (IHC) results showing EGFR positivity (EGFR+), which can be confirmed via IHC, gene amplification, or mutation testing. 6.Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria (non-nodal lesions with a long diameter >=10 mm on CT;nodal lesions with a short diameter >=15 mm on CT); 7.Surgical Eligibility: Evaluated as operable,willing to receive neoadjuvant therapy (combined EGFR-targeted therapy and bispecific antibody immunotherapy) followed by surgery and expresses a desire for organ-sparing treatment; 8.Cohort A Specification: Patients in Cohort A must be assessed by the investigator as initially ineligible for penis-sparing surgery or at high risk for such procedures; 9.Performance Status: ECOG Performance Status (PS) score of 0–1; 10.Compliance: Voluntary participation with good compliance,able to follow the study protocol and agree to post-operative follow-up. 11.Adequate Organ Function:(1) Blood routine: absolute neutrophil count (ANC) >=1.5 × 10^9/L, platelet (PLT) >= 100 × 10^9/L, hemoglobin (HB) >= 90g/L; (2) Liver function: serum total bilirubin (TBIL) = 50 ml/mi (using the standard Cockcroft Gault formula): (4) cardiac function: left ventricular ejection fraction (LVEF) >= 50% (confirmed by echocardiography or other appropriate cardiac function evaluation methods); (5) Coagulation function: international normalized ratio (INR) = 6 months;
Exclusion criteria
Exclusion criteria: 1.History of other malignancies, unless the tumor has been fully treated for at least 5 years with no signs of recurrence; 2. History of hypersensitivity to neoadjuvant therapy drugs (e.g., EGFR-targeted drugs, immunotherapy, or anti-angiogenic agents) or other related medications; 3. Patients unable to tolerate neoadjuvant therapy or surgery; 4.Prior treatment with radiotherapy, chemotherapy, immunotherapy, or targeted therapy;History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;Currently receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy (dosage >10 mg/day of prednisone or equivalent) that continued within 2 weeks prior to the first dose; 5.Positive for Syphilis antibody (Anti-TP);positive for Hepatitis C virus (HCV) antibody and HCV RNA;positive for Hepatitis B surface antigen (HBsAg) and HBV DNA (HBsAg-positive patients require further testing;HBV DNA >=200 IU/ml or >=10^3 copies/ml); 6.Uncontrolled medical conditions, including cardiovascular diseases (e.g., heart failure, myocardial infarction, severe coronary heart disease), pulmonary diseases, or hepatic/renal insufficiency; 7.Active infection or unexplained fever >38.5°C during screening or before the first dose (patients with tumor-related fever may be enrolled at the investigator's discretion); 8.Vaccination with live vaccines within 4 weeks prior to study drug administration or likely during the study period; 9.Known history of psychotropic drug abuse, chronic alcoholism, or drug addiction; 10.Inability to understand the study purpose, protocol, or informed consent due to mental illness or cognitive impairment; 11.Concurrent participation in other clinical trials; 12. Ineligible for the study as judged by the investigator, or presence of other conditions that may interfere with the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;Penis-sparing surgery completion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological downstaging rate;Overall survival;Objective Response Rate;Disease-free survival;Safety and tolerability;Pathological Complete Response(Queue A);Penis-sparing surgery completion rate(Queue B); | — |
Countries
China
Contacts
Public ContactNianzeng Xing
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed