Phase II Study in the Treatment of Patients With Advanced Mucinous Melanoma

Inclusion Criteria

• •1. Men and women, aged 18 to 80 years.
• •2. Patients with pathohistologically confirmed, unresectable or metastatic mucosal melanoma.
• •3. No prior treatment with any systemic antineoplastic agents (prior adjuvant or neoadjuvant therapy is allowed, but should be completed at least 3 weeks prior to randomization and all related adverse events have returned to normal or CTC-AE Grade 1).
• •4. Have a score of 0 or 1 on the ECOG scale.
• •5. Tumor tissue samples must be available for PD-L1 expression testing.
• •6. At least one measurable lesion according to RECIST 1.1, and the lesion has not been irradiated.
• •7. Organ function must meet the following requirements (within 7 days prior to randomization):
• •Peripheral blood: absolute neutrophil count (ANC) ≥1.5 × 109/L, platelets (PLT) ≥100 × 109/L, hemoglobin (HB) ≥9 g/dL (no blood transfusion or blood components within 14 days before testing); Liver: Serum bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN),, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN (≤5 x ULN in case of liver metastases); Serum creatinine ≤1.5 x ULN; International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 x ULN (only for patients not receiving anticoagulant therapy; patients receiving anticoagulant therapy should keep the anticoagulant within the therapeutic requirements); Normal cardiac function, i.e., normal or abnormal electrocardiogram without clinical significance, and left ventricular ejection fraction (LVEF) greater than 50% on cardiac ultrasound.
• •8. Women of childbearing age must have a negative pregnancy test within 7 days prior to treatment; men of reproductive potential or women of childbearing potential must use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine contraceptive devices, abstinence or barrier contraception in combination with spermicides) throughout the trial and continue contraception for 3 months after the end of treatment.
• •9. Subjects are willing to participate in this study and sign informed consent form, have good compliance and cooperate with the follow-up.
• •12. History of active pulmonary tuberculosis.
• •13. Have any uncontrollable clinical problems, including but not limited to:
• •* Active autoimmune disease requiring systemic steroid/immunosuppressive therapy, such as hypophysitis, colitis, hepatitis, nephritis, etc.;
• •* Have the following occurrence within 6 months prior to randomization: 1) deep vein thrombosis or pulmonary embolism; 2) percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; 3) cerebrovascular accident, transient ischemic attack.
• •* Other serious, uncontrollable concomitant illness that may affect protocol compliance or interfere with interpretation of results, including active opportunistic infection or progressive (severe) infection, uncontrolled diabetes, cardiovascular disease (New York Heart Association class III or IV heart failure, second degree or higher heart block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm).
• •14. Any condition that affects the subject's swallowing of the drug, and any condition that affects the absorption or pharmacokinetics of the investigational product.
• •15. Have received stem cell transplant or organ transplant.
• •16. Women of childbearing age, pregnant or lactating women with positive serum or urine pregnancy test 7 days before starting treatment.
• •17. Have a history of psychotropic drug abuse and unable to withdraw or have a history of mental disorders.
• •18. Other severe, acute, or chronic medical conditions or laboratory abnormalities that, in the judgment of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.
• •19. Patients who are judged by the investigator to have poor compliance, or other conditions that make them unsuitable for this trial.