Melanoma
Conditions
Interventions
Experimental group:Intravenous infusion of sintilimab
Experimental group:Cryoablation of liver metastases
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed metastatic malignant melanoma patients after failure of standard therapy; 2. Presence of liver metastases, and at least 1 lesion suitable for cryoablation after evaluation; 3. Largest diameter of intrahepatic metastases =1.5*10^9/L ; white blood cells>=3.0*10^9/L; platelets>=75*10^9/L; hemoglobin>=80g/L; serum ALT, AST =30g/L; total bilirubin<=1.5*ULN.
Exclusion criteria
Exclusion criteria: 1. The previous liver metastases have received local therapy; 2. Child-Pugh score >= 7; liver function decompensation, such as massive ascites, gastric esophageal varices, and upper gastrointestinal bleeding within 1 year, hepatic encephalopathy, bilirubin encephalopathy; 3. Patients with known central nervous system metastasis and clinically unstable, or acute meningitis (except those who have received treatment for brain metastases and are clinically stable with central nervous system metastasis). Clinical stability needs to meet: (1) No new brain lesions or no expansion of the original lesions (confirmed by MRI); (2) No hormone therapy for at least 2 weeks; (3) No new neurological symptoms and the original neurological symptoms have returned to normal; 4. Previous use of immune checkpoint inhibitors and immune-related adverse reactions of grade 3 or above; 5. pregnant or breastfeeding women; 6. History of HIV infection; 7. History of other malignant tumors within 5 years (excluding early basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma); 8. Any of the following conditions in the 12 months prior to the start of the study: myocardial infarction, severe/unstable angina, congestive heart failure, cerebrovascular accident, pulmonary embolism; 9. Severe impairment of liver and kidney function, or uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poorly controlled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >90mmHg ), or clinically significant (e.g. active) cardiovascular and cerebrovascular diseases, such as cerebrovascular accident within 6 months, myocardial infarction, unstable angina, congestive heart failure with NYHA class II or above, severe Arrhythmias that cannot be controlled with medication, electrocardiogram results that show clinically significant abnormalities in 3 consecutive times (at least 5 minutes between each time), or psychiatric disorders and drug abusers, which the investigator believes may increase the risk of the subject or interfere with the test any circumstances of the result; 10. History of organ transplantation in the past; 11. The patient has other serious acute or chronic physical or psychiatric diseases or abnormal laboratory tests, which may increase the risk of the study, or interfere with the interpretation of the results and are not suitable for enrollment; 12. Uncontrolled concomitant diseases or infectious diseases, such as acute active infections requiring systemic antibiotics, antiviral or antifungal treatment within 2 weeks before enrollment (HBV patients with DNA copy number greater than 500copy/ml) ); 13. Serious adverse reactions to contrast media have occurred in the past; 14. Any patient with active autoimmune disease or with a history of autoimmune disease determined by the investigator to be inappropriate for this study, including but not limited to the following diseases: systemic lupus erythematosus, immune-related neuropathy, multiple sclerosis, Guillain-Barre syndrome, myasthenia gravis, connective tissue disorders, inflammatory bowel disease including Crohn's disease, ulcerative colitis; 15. The investigator assesses that the subject is unable or unwilling to comply with the requirements of the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month progression free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression free survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactWeijun Fan
Sun Yat-Sen University Cancer Center
Outcome results
None listed