melanoma
Conditions
Interventions
Treatment Cohort:chemoradiotherapy with immunotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical research; Fully understand this study and voluntarily sign the informed consent form; Willing to follow and capable of completing all experimental procedures; 2. Male or female aged >= 18 years old; 3. Mucosal melanoma confirmed by pathology; 4. The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 1;; 5. Primary tumor R0/R1 resection; 6. If there are positive lymph nodes diagnosed by clinical or imaging examinations lymph node dissection is required; 7. There is no distant metastasis assessed by imaging; 8. Have not received systematic anti-tumor treatment or radiotherapy for mucosal melanoma in the past; 9. Adequate organ function defined as follows: 9.1) Hematological system (without receiving blood transfusion granulocyte colony-stimulating factor or other medical support within 14 days prior to starting the study drug treatment): a) Neutrophil count (ANC) >= 1.5 × 10^9/L; b) Platelet count (PLT) >= 100 × 10^9/L; c) Hemoglobin (Hb) >= 90 g/L; 9.2) Liver function: a) Total bilirubin (TBIL) = 50 ml/min and = 2+ a 24-hour urine protein quantification test is required. If the 24-hour urine protein quantification is= 12 weeks; 11. Female subjects with fertility who have a negative blood pregnancy result within 7 days before starting the study treatment and are willing to maintain abstinence or take medically recognized and effective contraceptive measures (such as intrauterine devices and condoms) from the date of signing the informed consent form until 6 months after the last use of the medication; 12. Male participants are willing to abstain from sexual activity or adopt medically recognized and effective contraceptive measures from the date of signing the informed consent form until 6 months after the last use of medication and not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic diseases severe drug allergies or known allergies to any component of the study drug; 2. Mucosal melanoma originating from the choroid skin or at the junction of skin and mucosa and primary unknown melanoma; 3. Visible residue with naked eye or endoscope; 4. Previously received radiation therapy in the same area; Previously received treatment with temozolomide and cisplatin; Previously received immunotherapy including antibody drugs such as aPD-1 aPD-L1 aCTLA4 or cell therapy such as CAR-T and TILs; 5. Completed surgery more than 3 months ago; 6. Evidence of significant coagulation disorders or other obvious bleeding risks: 6.1) History of intracranial hemorrhage or spinal cord hemorrhage; 6.2) Patients with tumor lesions invading large blood vessels and having a significant risk of bleeding; 6.3) Within the 6 months prior to starting the study treatment there has been a thrombotic or embolic event (excluding asymptomatic and untreated intermuscular vein thrombosis) or significant vascular disease (such as aortic aneurysm requiring surgical repair); 6.4) Clinical significant hemoptysis or tumor bleeding for any reason occurring within 6 months prior to the start of treatment; 6.5) Within 2 weeks before starting the study treatment use anticoagulant therapy for therapeutic purposes (excluding low molecular weight heparin); 6.6) Within 10 days before starting the study treatment use antiplatelet drugs such as aspirin (>325 mg/day) clopidogrel (>75 mg/day) dipyridamole clopidogrel or cilostazol or those who require long-term antiplatelet therapy; 7. Received the following treatments or medications before starting the study drug treatment: 7.1) underwent invasive dental procedures (such as dental implants) within 4 weeks before starting the study drug treatment or required elective surgery during the trial period; 7.2) Have received systemic corticosteroid (prednisone>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive therapy within 14 days prior to initiating drug treatment; Excluding local use of glucocorticoids or short-term use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies); 7.3) Have received attenuated live vaccine within 4 weeks before starting the study drug treatment; 7.4) Have received intravenous broad-spectrum antibiotic treatment within 14 days before starting the study treatment; 8. Subjects with active or ever suffered from autoimmune diseases that may recur (such as systemic lupus erythematosus rheumatoid arthritis vasculitis etc.) excluding clinically stable autoimmune thyroid disease type I diabetes subjects; 9. Within 5 years before the start of the study drug treatment he has suffered from other active malignant tumors except for those that can be treated locally and have been cured (such as skin basal cell or squamous cell carcinoma superficial or non-invasive bladder cancer cervical carcinoma in situ breast intraductal carcinoma in situ thyroid papillary carcinoma); 10. Within 6 months before starting the study of drug treatment the following situations occur: 10.1) acute coronary syndrome coronary artery bypass grafting congestive heart failure aortic dissection stroke or other grade 3 or above cardiovascular and cerebrovascular events; 10.2) The mean QT interval (QTcF) corrected by the Fridericia method is>450 ms for males and>470 ms for females; 10.3) There are any factors that increase the risk of QTc prolongat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year relapse free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;1 year distant metastasis free survival rate;saftey;1 year local recurrence free survival rate; | — |
Countries
China
Contacts
Public ContactYu Xu/ Zhen Zhang
Fudan University Shanghai Cancer Center
Outcome results
None listed