Von Hippel–Lindau disease
Conditions
Interventions
Intervention group:Neoadjuvant therapy of Toripalimab plus Axitinib follow by nephrone-sparing surgery
Sponsors
Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. ECOG 0-1; 3. Clinical diagnosis of Von Hipple-Lindau disease; 4. Maximal diameter of one (or more) tumor >= 3cm, and stage T1-2N0M0; 5. planned for nephrone-sparing surgery; 6. At least one high-risk tumor for nephrone-sparing surgery: R.E.N.A.L. score >= 7; or complete endophytic; or hilar/central mass; tumor in solitary kidney; 7. Normal organ function; 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior treatment of targeted therapy, or immunotherapy, or any other anti-cancer systemic therapy; 2. Immediate intervention required for any VHL disease associated lesion (kidney tumor, or hemangioblastoma, or pancreatic neuroendocrine neoplasm etc.); 3. Any autoimmune disease requiring immunosuppressant drugs or glucocorticoid; 4. Poorly controlled hypertension, diabetes, cardiovascular or cerebrovascular diseases; 5. Pregnancy or prepared for pregnancy; 6. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (kidney tumors);Safety (Adverse events);Complication rate; | — |
Countries
China
Contacts
Public ContactKong Wen
Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed