melanoma
Conditions
Interventions
Cryoablation plus anti-PD1 antibody:NA
Anti-PD1 antibody:NA
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed malignant melanoma; 2. Presence of multiple hepatic metastases; 3. Received either anti-PD-1 antibody combined with cryoablation or anti-PD-1 antibody; 4. ECOG PS score of 0 or 1; 5. No history of autoimmune diseases; 6. Expected life span > 3 months.
Exclusion criteria
Exclusion criteria: 1. Received PD-1 antibody therapy prior to the detection of hepatic metastases; 2. ECOG PS score >= 2; 3. Child-Pugh score >= 7; or decompensated liver dysfunction, including:Massive ascites, Gastroesophageal varices with upper gastrointestinal bleeding within 1 year, Hepatic encephalopathy, Bilirubin encephalopathy; 4. Known unstable central nervous system (CNS) metastases or acute meningitis (except for patients with treated and clinically stable CNS metastases); 5. Previous grade 3 or higher immune-related adverse events (irAEs) from immune checkpoint inhibitors; 6. Pregnant or lactating women; 7. History of HIV infection; 8. History of other malignancies within 5 years (except for early-stage basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Response Rate; | — |
Countries
China
Contacts
Public ContactWeijun Fan
Sun Yat-sen University Cancer Center
Outcome results
None listed