recurrent respiratory papillomatosis (RRP)
Conditions
Interventions
Experimental group:Pucotenlimab
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed squamous papilloma, with or without lower respiratory tract involvement (trachea, bronchus, lung), and HPV-6/11 positive by PCR; 2.Disease severity meeting >=1 of the following: (1).>=2 surgical procedures in past 12 months; (2).Laryngeal RRP: Derkay score >=10; (3).Pulmonary RRP: Measurable disease per RECIST 1.1; 3.ECOG performance status 0-1; 4.Adequate organ function: Hematology:(1). ANC >=1.5×10^9/L, platelets >=80×10^9/L, hemoglobin >=90 g/L (no transfusion within 2 weeks); (2).Liver: ALT/AST =60 mL/min; (4).Cardiac: LVEF >=50%; 5.Women of childbearing potential: negative pregnancy test; all subjects: agreement to contraception; 6.Signed informed consent; willingness to comply with protocol-mandated treatment adjustments and follow-up; 7. Age: >=18 years old,<70 years old.
Exclusion criteria
Exclusion criteria: 1.HPV-16/18 positive or co-infection; 2.HIV positive, active hepatitis B/C, or known immunodeficiency; 3.Active autoimmune disease (e.g., rheumatoid arthritis, SLE, IBD); 4.Prior systemic immunosuppression within 6 months (prednisone >10 mg/day) or previous immune checkpoint inhibitor therapy; 5.Uncontrolled comorbidities: diabetes (HbA1c >8%), hypertension (>140/90 mmHg), arrhythmia requiring therapy (QTcF >=450 ms in males), NYHA Class II-IV heart failure, drug-dependent thyroid dysfunction, active TB, or interstitial lung disease; 6.Solid organ or bone marrow transplant; 7.Pregnant or lactating; 8.Severe hypersensitivity to PD-1 inhibitors or excipients; 9.Other malignancy within 5 years (except cured basal cell carcinoma or cervical CIS); 10.Substance abuse or psychiatric disorder precluding compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual surgical burden;Disease Control Rate (DCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Voice function and life quality;Changes in anatomy scores;Change of HPV viral load;No prolonged operation interval; | — |
Countries
China
Contacts
Public ContactWei Chunsheng
Eye & ENT hospital of Fudan University
Outcome results
None listed