OncoMatch/Clinical Trials/NCT06791070
A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum
Is NCT06791070 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Disitamab Vedotin combined with Toripalimab for paget disease, extramammary.
Treatment: Disitamab Vedotin combined with Toripalimab — The goal of this clinical trial is to learn if Disitamab Vedotin combined with Toripalimab works to treat advanced HER2-positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. The main questions it aims to answer are: Does this combination reduce tumor volume and delay disease progression? What medical problems do participants have when receving this combination? Participants will: Intravenous using this combination every 3 weeks until disease progression or intolerable adverse reactions occur. Visit the clinic once every 3 weeks for checkups and tests.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC ≥ 1+)
pathologically confirmed as HER2 positive, i.e., immunohistochemical test HER2 ≥ 1+
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, Platelet (PLT) ≥70×10^9/L, Hemoglobin (HGB) ≥80g/L
Kidney function
Serum Creatinine (Cr) ≤1.5×ULN, or Creatinine Clearance ≥50 mL/min
Liver function
Total Bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤3×ULN; Serum Albumin ≥28 g/L; ALP ≤5×ULN
Adequate organ function: Blood routine: Absolute Neutrophil Count (ANC) ≥1.5×10^9/L, Platelet (PLT) ≥70×10^9/L, Hemoglobin (HGB) ≥80g/L; Liver function: Total Bilirubin (TBIL) ≤1.5×ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3×ULN; Serum Albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; ... Renal function: Serum Creatinine (Cr) ≤1.5×ULN, or Creatinine Clearance ≥50 mL/min ... Coagulation function: INR ≤1.5 / PT ≤1.5×ULN, aPTT ≤1.5×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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