Mucosal melanoma
Conditions
Interventions
Experimental group:Adebrelimab + Bevacizumab (q3w, 4 cycles) ? Adebrelimab + Bevacizumab (q3w) + Radiotherapy ? Adebrelimab + Bevacizumab (q3w), and the cumulative maximum of adebrelimab was not more
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old, gender unlimited; 2) Subjects with histologically or radiographically confirmed non-resection (stage III) or metastatic (stage IV) mucosal malignant melanoma; 3) ECOG PS 0 or 1 points; 4) At least one evaluable lesion (RECIST 1.1); 5) Subjects with asymptomatic or stable brain metastases after treatment were allowed to be included; 6) Life expectancy =12 weeks; 7) Normal organ and bone marrow function.
Exclusion criteria
Exclusion criteria: 1) Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 2) The thyroid function is abnormal in the past, and the thyroid function cannot be maintained within the normal range under the condition of drug treatment; 3) Pregnant or lactating women; 4) Bleeding diathesis or significant evidence of coagulation dysfunction (no anticoagulant therapy); 5) Bleeding events due to untreated or inadequately treated esophageal and/or gastric varices within 6 months prior to the first dose; 6) Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) occurs within 6 months before the first medication; 7) Inadequate control of arterial hypertension (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg) (based on the average of BP readings obtained from =2 measurements), allowing the above parameters to be achieved through the use of antihypertensive therapy; Hypertensive crisis or hypertensive encephalopathy in the past; 8) Significant uncontrolled or symptomatic hypercalcemia (ionic calcium > 1.5 mmol/L, calcium > 12 mg/dL, or corrected serum calcium > ULN); 9) Severe cardiovascular disease (such as New York Heart Association Class II or higher heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina within 3 months; 10) severe, non-healing or open wounds, active ulcers or untreated fractures; 11) Hollow needle biopsy or other minor surgery within 3 days prior to the first dose, excluding placement of vascular access devices; 12) Major surgery was performed within 4 weeks prior to initial medication, or major surgery is expected to be required during the study period; 13) Systemic immunosuppressive drugs (including but not limited to glucocorticoids) are used within 2 weeks prior to initial medication. 10 mg/ day of prednisone or equivalent pharmacophysiological doses of other corticosteroids], cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor-a [TNF-a] preparations), or systemic immunosuppressive agents are expected to be required during the study treatment; 14) Subjects who have received or will receive a live vaccine within 30 days prior to the first dose, or who require the vaccine during expected treatment or within 5 months after the last dose; 15) Known allergy to any investigational drug or excipient; 16) Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 17) Other conditions determined by the investigator to be unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year target lesion control rate;Overall survival;Security;objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactZhengyun Zou
Nanjing Drum Tower Hospital
Outcome results
None listed