advanced malignant melanoma
Conditions
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for inclusion in this study: 1) Voluntarily participate in the study, demonstrate good compliance, be able to complete observations and follow-up as required by the trial, and sign an informed consent form. 2) Age = 18 years, any gender. 3) Histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) cutaneous and acral malignant melanoma. 4) ECOG PS score of 0 or 1. 5) All subjects must have at least one evaluable lesion (per RECIST 1.1) that, based on the assessment of the clinical investigator, is determined to potentially benefit from palliative radiotherapy to relieve or prevent pain, luminal obstruction, bleeding, or other symptoms. 6) No prior radiation therapy. 7) Expected life expectancy = 12 weeks. 8) Normal organ and bone marrow function.
Exclusion criteria
Exclusion criteria: 1) BRAF V600 mutation-positive melanoma eligible for standard targeted therapy as first-line treatment for advanced or metastatic disease (e.g., BRAF/MEK inhibitors, either alone or in combination). 2) Previous receipt of immunotherapy (e.g., anti-CTLA-4, anti-PD-1 treatment, or interferon) as adjuvant or neoadjuvant therapy, with recurrence within 6 months during or after immunotherapy. 3) Presence of active central nervous system metastasis or injury. 4) History of immunodeficiency or presence of other acquired or congenital immunodeficiency diseases or organ transplant history. 5) History of thyroid dysfunction that cannot be maintained within the normal range despite medication. 6) Severe, non-healing or ruptured wounds, active ulcers, or untreated fractures. 7) Inadequate control of arterial hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg) (based on the average of = 2 readings obtained from blood pressure measurements), allowed if achieved through antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy. 8) Severe cardiovascular disease within the past 3 months (such as New York Heart Association Class II or above heart disease, myocardial infarction, or cerebrovascular accidents), unstable arrhythmias, or unstable angina. 9) Use of systemic immunosuppressive drugs within 2 weeks before the first dose of study medication (including, but not limited to, glucocorticoids [> 10 mg/day prednisone or equivalent physiologic dose of other corticosteroids], cyclophosphamide, azathioprine, methotrexate, salazopyrine, and anti-tumor necrosis factor-alpha [TNF-a] agents), or anticipated need for systemic immunosuppressive drugs during the study treatment. 10) Receipt of systemic non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, etc.) within 2 weeks before the first dose of study medication. 11) Vaccination within 30 days before the first dose of study medication or anticipated need for vaccination during the study treatment or within 5 months after the last dose. 12) Known active tuberculosis (TB) or suspected active TB requiring clinical evaluation to exclude it; known active syphilis infection. 13) HIV-positive; HCV-positive; HBsAg or HBcAb-positive subjects with positive HBV DNA copies (quantitative detection limit of 500 IU/ml). 14) Pregnant or breastfeeding women or sexually active women of childbearing potential who are not using contraception. 15) Presence of active infections requiring systemic treatment. 16) Coexistence of known progressing or actively treated other malignancies. 17) Participation in other clinical trials simultaneously. 18) Known allergy to any study drug or excipient. 19) History of substance abuse with an inability to stop or individuals with psychiatric disorders. 20) Other conditions deemed unsuitable for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactZhengyun Zou
Nanjing Drum Tower Hospital
Outcome results
None listed