Status:
RECRUITING
Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients
Lead Sponsor:
Sheng Zhang
Conditions:
Urothelial Carcinoma
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This multicenter, prospective phase II clinical trial aims to evaluate the efficacy and safety of medical compression stockings in preventing peripheral neuropathy induced by antibody-drug conjugates ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years Histologically or cytologically confirmed advanced malignancy (including but not limited to urothelial carcinoma) eligible for MMAE-containing ADC therapy (e.g., EV, DV, BV)
- ECOG performance status 0-2
- No baseline peripheral neuropathy ≥ Grade 1 (CTCAE v5.0)
- Stable tumor status without other neurotoxic drugs in the past 2 months
- Adequate organ function (blood counts, liver and kidney function) per protocol
- Expected survival ≥ 3 months
- Ability and willingness to comply with study procedures and provide written informed consent
Exclusion
- Poor compliance or inability to follow protocol
- Pre-existing peripheral neuropathy ≥ Grade 1 from prior platinum/taxane treatment
- Severe diabetes or peripheral vascular disease
- Neurological disorders causing nerve compression (e.g., carpal tunnel syndrome, radiculopathy)
- Severe psychiatric conditions (depression, bipolar disorder, substance abuse)
- Active uncontrolled infections requiring systemic antibiotics/antifungals/antivirals (≥ CTCAE Grade 2)
- Active hepatitis or significant liver dysfunction not meeting inclusion criteria
- Renal failure requiring dialysis
- Immunodeficiency or history of organ transplantation
- Severe nausea, headache, fatigue, or other debilitating symptoms
- Active tuberculosis or uncontrolled pleural/pericardial effusion/ascites
- Hypersensitivity to monoclonal antibodies or study device components
- Participation in other clinical trials within 4 weeks
- Known bleeding or coagulation disorders or receiving thrombolytic therapy
- Any other condition judged by the investigator to preclude safe participation
Key Trial Info
Start Date :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT07164950
Start Date
August 30 2025
End Date
July 1 2026
Last Update
September 15 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China