acral melanoma
Conditions
Interventions
Intervention group :Pucotenlimab, nab-paclitaxel and carboplatin
Control group:Pucotenlimab monotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis and clinical manifestations are consistent with acral melanoma; 2. Age >=18 years and =1500/µL, platelets count >= 80000/µL, and hemoglobin >=9.0 g/dl; 8. International normalized ratio = 50ml/min; 10. ALT and AST =55%; 12. Women of reproductive age must have negative HCG test results in serum or urine within 7 days before enrollment, and are willing to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug, or those have been surgically sterilized or menopausal. For men, they must agree to use appropriate methods of contraception during the trial period and within 3 months after the last administration of the trial drug, or those have been surgically sterilized; 13. The wound heals well without obvious bleeding, exudation, or purulent secretion; 14. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Having other malignant tumors at the same time; 2. Having previous anti-tumor treatments such as chemotherapy, anti-angiogenic drugs, and radiation therapy (allowing for previous interferon therapy and immune checkpoint inhibitor therapy, but discontinuation of medication more than 6 months prior to enrollment in this study); 3. Having active infection, such as HIV infection, hepatitis B virus DNA quantitation >= 1 × 10^3 copies/ml, hepatitis C virus RNA quantitation >= ULN, or active tuberculosis, etc; 4. Lactating or pregnant women; 5. Severe cardiovascular and cerebrovascular diseases including grade >= 2 myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >= 450 ms for men and >= 470 ms for women); according to NYHA standard, grade III ~ IV cardiac dysfunction, or left ventricular ejection fraction (LVEF) < 55%; 6. Those who are allergic to the trial drug; 7. History of mental illness: schizophrenia, anxiety disorder, depression, bipolar disorder, and other mental diseases receiving treatment or intervention; 8. Suffering from autoimmune diseases such as autoimmune hepatitis, systemic lupus erythematosus, etc; 9. Arterial/venous thrombosis events occurred within 6 months, such as cerebrovascular thrombosis events, deep venous thrombosis and pulmonary embolism; 10. Other factors that researchers consider inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median recurrence-free survival;Median distant metastasis-free survival;Median overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactYu Jiang
West China Hospital, Sichuan University
Outcome results
None listed