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New treatment option for Urothelial Carcinoma
Official title Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients
ClinicalTrials.gov ID: NCT07164950
What this study is testing
- What it's testing
- 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 (ADCs) containing monomethyl auristatin E (MMAE) in patients with advanced cancers, including urothelial carcinoma. Eligible participants will have no baseline ≥ grade 1 neuropathy and will be scheduled to receive MMAE-containing ADC therapy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥ 18 years Histologically or cytologically confirmed advanced malignancy (including but not limited to urothelial carcinoma) eligible for...
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.