penile squamous cell carcinoma
Conditions
Interventions
Treatment group:QL1706 plus Disitamab Vedotin
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in the clinical study; fully understand and be informed of this study and sign the Informed Consent Form (ICF); be willing to follow and capable of completing all trial procedures; 2.Aged 18 years or older; 3.Pathologically confirmed as penile squamous cell carcinoma by the Pathology Department of our hospital (based on the 8th Edition of the International Penile Cancer TNM Staging Criteria), excluding those with other heterologous differentiation types; 4.Having paraffin-embedded tumor tissue samples available for HER2 immunohistochemistry and other examinations (HER2 immunohistochemistry detection is independently conducted by the Pathology Department of Sun Yat-sen University Cancer Center and interpreted in accordance with the Chinese Clinical and Pathological Expert Consensus on Human Epidermal Growth Factor Receptor 2 Detection in Urothelial Carcinoma); 5.Locally advanced or metastatic penile squamous cell carcinoma that is not eligible for radical surgical resection (pT4, pN3, or M1); 6.Patients who have previously received first-line platinum-containing chemotherapy with ineffective response or disease progression (such as TIP, PF regimens) or are intolerant to platinum-containing chemotherapy regimens (according to EORTC criteria) for subsequent-line treatment; The EORTC criteria are as follows: WHO or ECOG PS of 2 or Karnofsky PS of 60%-70%; Creatinine clearance rate below 60 mL/min; CTCAE grade >= 2 hearing loss; CTCAE grade >= 2 peripheral neuropathy; Elderly patients with severe underlying cardiovascular and cerebrovascular diseases; Patients with New York Heart Function Class lower than Grade III heart failure; 7.ECOG performance status score of 0-2; expected survival time >= 6 months; 8.Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) >= 90 g/L; White blood cell count (WBC) >= 3×10?/L; Absolute neutrophil count (ANC) >= 1.5×10?/L; Platelet count (PLT) >= 80×10?/L; Total bilirubin (TBIL) = 30 ml/min.
Exclusion criteria
Exclusion criteria: 1.Pathologically complicated with other non-squamous carcinoma components, such as rare pathological types like glandular differentiation, small cell carcinoma, neuroendocrine carcinoma, clear cell carcinoma, and sarcoma; 2.Lesions eligible for radical resection and patients tolerating radical surgery; 3.Patients who have previously received treatments targeting anti-HER2 or anti-CTLA4 related targets; 4.Patients participating in other relevant clinical drug studies targeting penile cancer; 5.Patients with severe internal diseases, such as severe infection, uncontrolled diabetes, cardiovascular diseases (including Grade III or IV heart failure as defined by the New York Heart Association classification, second-degree or higher heart block, myocardial infarction within the past 1 month, unstable arrhythmia or unstable angina, cerebral infarction within 1 month, etc.), severe lung diseases (interstitial pneumonia, severe obstructive pulmonary disease, and a history of symptomatic bronchospasm), or a history of clinically symptomatic liver, kidney, hematological, endocrine, or neuropsychiatric diseases; 6.Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the study drug;The use of physiological doses of glucocorticoids (<=10mg/day of prednisone or equivalent drugs) is allowed; 7.Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV1/2 antibodies); 8.Untreated active hepatitis B; however, hepatitis B subjects meeting the following criteria are also eligible for inclusion (HBV viral load must be <1000 copies/ml (200IU/ml) before the first administration, and subjects should receive anti-HBV treatment throughout the study chemotherapy period to avoid virus reactivation. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, prophylactic anti-HBV treatment is not required, but close monitoring for virus reactivation is necessary); 9.Having received a live vaccine within 30 days before the first administration (Cycle 1, Day 1) (Note: inactivated viral vaccines for seasonal influenza administered via injection are allowed within 30 days before the first administration, but intranasal attenuated live influenza vaccines are not allowed); 10.Complicated with other active cancers, or a history of other malignant tumors within the past 5 years. Exceptions include: ? cured non-malignant melanoma of the skin; ? curable tumors including carcinoma in situ of the cervix and superficial bladder cancer; ? other solid tumors that have received radical treatment with no recurrence or metastasis for 5 years or more; 11.A clear history of neurological or psychiatric disorders, such as epilepsy, dementia, or poor compliance; 12.A history of drug abuse or substance abuse; 13.Other severe, acute, or chronic diseases or abnormal laboratory findings that may increase the risk of participating in the study and using the study drug, or may interfere with the interpretation of study results; 14.Patients deemed unsuitable for participating in the study by the researcher for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression free survival;Safety; | — |
Countries
China
Contacts
Public ContactKai Yao
Sun Yat-sen University Cancer Center
Outcome results
None listed