PTC-guided Neoadjuvant Therapy For Muscle-invasive Bladder Cancer

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07690878
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • PTC guided individualized neoadjuvant therapy — DRUG
    Fresh tumor tissue will be collected before neoadjuvant treatment to generate Patient-derived Tumor-like Cell Clusters (PTC) for ex vivo drug sensitivity testing. Based on the PTC results, each participant will receive an individualized neoadjuvant regimen selected from gemcitabine plus cisplatin, disitamab vedotin (RC48), enfortumab vedotin, toripalimab, or their protocol-defined combinations. Treatment will be administered for up to 4 cycles before radical cystectomy and pelvic lymph node dissection.

Study Details

This study evaluates Patient-derived Tumor-like Cell Clusters (PTC)-guided individualized neoadjuvant therapy in patients with muscle-invasive bladder cancer who are candidates for radical cystectomy.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Experimental Group

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: immediately evaluated after surgery ]

Central Contacts

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