Melanoma
Conditions
Interventions
Case series:null
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The screening criteria for melanoma database of Zhongshan Hospital Affiliated to Fudan University were as follows: 1. completely resected melanoma; 2. all gene mutation forms; 3. patients with stage III and above melanoma evaluated according to CSCO guidelines for diagnosis and treatment of melanoma (China's PD-1 inhibitor was approved for marketing in 2018, so the database information of this project is mainly in 2018 and beyond); 4. accept PD-1 Inhibitor therapy. The information of 118 eligible patients has been screened out and processed as training samples. The existing follow-up data were used, including overall survival, distant metastasis free survival, physical status assessment (Eastern cancer cooperation group standard), safety, relapse free and relapse free survival. Specifically: (1) Melanoma confirmed by histology / cytology; (2) Aged >=18 years; (3) ECOG physical status score was 0 or 1; (4) According to the "Chinese society of clinical oncology guidelines for the diagnosis and treatment of melanoma 2019" stage III-IV patients; (5) RECIST v1.1 standard, at least one measurable lesion or measurable lesion with definite progression after local treatment (based on RECIST v1.1 standard); (6) The expected survival time was more than 12 weeks; (7) Female patients of childbearing age or male patients whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the last medication; (8) Can sign written informed consent for immunotherapy, and be able to follow up and relevant procedures.
Exclusion criteria
Exclusion criteria: 1. Any life-threatening bleeding events occurred in the past 3 months, including the need for blood transfusion, surgery or local treatment, and continuous drug treatment; 2. The history of arteriovenous thromboembolism within 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. Implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except for patients with stable thrombosis after conventional anticoagulant therapy. Prophylactic use of low-molecular-weight heparin (e.g. enoxaparin 40mg / day) is allowed; 3. Toxicity (excluding alopecia, nonclinical significance, and asymptomatic laboratory abnormalities) not recovered to National Cancer Institute general adverse event nomenclature 5.0 (NCI CTCAE 5.0) grade 0 or 1 caused by previous treatment prior to the first dose of study treatment; 4. Symptomatic congestive heart failure (NYHA grade II-IV). Symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or corrected QTc at screening > 500ms (calculated by fridericia method); 5. Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy. Previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, lung function damage and other lung diseases. Active pulmonary tuberculosis (TB), who is receiving anti tuberculosis treatment or has received anti tuberculosis treatment within 1 year before the first administration; 6. Severe infection in active stage or poorly controlled. Severe infection, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications, occurred within 4 weeks before the first administration; 7. Known history of primary immunodeficiency. Only patients with positive autoantibodies need to confirm whether there are autoimmune diseases according to the judgment of the researchers; 8. Live attenuated vaccine should be received within 4 weeks before the first administration or during the study period; 9. Uncontrolled metabolic disorders or other non malignant tumor organ diseases or systemic diseases or cancer secondary reactions, which may lead to high medical risk and / or uncertainty of survival evaluation, which are not suitable for the group according to the researcher's judgment, or there are other situations that the researcher judges are not suitable for the group; 10. Severe allergic reactions to any PD-1 inhibitor are known; 11. Pregnant or lactating women; 12. Other acute or chronic diseases, mental disorders, or laboratory test value abnormalities that may result in increased risk associated with study participation or drug administration, or interference with the interpretation of study results, and the patient is classified as ineligible to participate in the study according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactJiaqi Liu
Zhongshan Hospital, Fudan University
Outcome results
None listed