OncoMatch/Clinical Trials/NCT07717242
Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer
Is NCT07717242 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments for bladder urothelial carcinoma.
Treatment: Disitamab vedotin · Toripalimab · Sitagliptin · Zeprumetostat · Tafolecimab · Ursodeoxycholic Acid — This is a multicenter, prospective, open-label, Phase II, four-arm parallel study evaluating the efficacy and safety of different sensitization strategies combined with disitamab vedotin and toripalimab in patients with HER2-positive muscle-invasive urothelial carcinoma of the bladder (MIBC). Eligible patients with cT2-4aN0M0 HER2-positive urothelial carcinoma of the bladder will receive neoadjuvant disitamab vedotin plus toripalimab in combination with one of four sensitizing agents: sitagliptin, tazemetostat, tafolecimab, or ursodeoxycholic acid. After six cycles of neoadjuvant treatment, patients will undergo comprehensive response assessment, including imaging, cystoscopy, urine cytology, and complete transurethral resection of bladder tumor (cTURBT). Patients who achieve a clinical complete response (cCR) may enter a bladder-preservation treatment pathway, including additional disitamab vedotin plus toripalimab and subsequent toripalimab maintenance therapy. Patients who do not achieve cCR will be considered for salvage radical cystectomy. The primary objective is to evaluate the cCR rate of each treatment strategy. Secondary objectives include bladder-intact disease-free survival, overall survival, bladder preservation rate, safety, quality of life, treatment costs, and exploratory biomarker analyses.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) expression (≥1+ by IHC)
HER2 expression ≥1+ confirmed by immunohistochemistry using a pretreatment tumor specimen tested at a local laboratory
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1/PD-L1/PD-L2/CTLA-4/LAG-3/HER2/Nectin-4 targeted therapy or other T-cell checkpoint pathway inhibitor
Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, LAG-3, HER2, or Nectin-4, or with other antibodies or drugs specifically targeting T-cell co-stimulatory or checkpoint pathways
Cannot have received: radiotherapy for bladder cancer
Prior radiotherapy for bladder cancer
Cannot have received: antitumor drug therapy
Exception: systemic chemotherapy allowed if treatment-free interval ≥12 months before neoadjuvant study treatment; local intravesical chemotherapy or immunotherapy allowed if completed ≥1 week before neoadjuvant study treatment
Prior antitumor drug therapy, except for the following: 1. For participants who previously received systemic chemotherapy, a treatment-free interval of at least 12 months from the last treatment to the start of neoadjuvant study treatment is required. 2. Local intravesical chemotherapy or immunotherapy must have been completed at least 1 week before the start of neoadjuvant study treatment.
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10^9/L; Platelet count ≥90 × 10^9/L; Hemoglobin ≥90 g/L; INR or aPTT ≤1.5 × ULN
Liver function
Total serum bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert syndrome or indirect bilirubin elevation of extrahepatic origin); AST, ALT, and alkaline phosphatase ≤2.5 × ULN
Adequate organ function, as determined by the following screening laboratory values obtained within 14 days before enrollment: ... see full text
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07717242 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PD-1/PD-L1/PD-L2/CTLA-4/LAG-3/HER2/Nectin-4 targeted therapy or other T-cell checkpoint pathway inhibitor, radiotherapy for bladder cancer, antitumor drug therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages