A Multicenter, Prospective, Phase II Clinical Trial Investigating the Use of Compression Stockings to Prevent Peripheral Neuropathy Induced by Antibody-Drug Conjugates (ADCs) in Patients With Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Incidence of Grade ≥1 Peripheral Neuropathy (CTCAE v5.0)
研究概览
简要总结
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 total of 58 patients will be enrolled and followed for 24 months. In this self-controlled design, the left foot will be fitted with a medical compression stocking while the right foot remains uncovered, starting 15 minutes before infusion and continuing until 15 minutes after infusion (total duration: 120 minutes). Peripheral neuropathy will be assessed before treatment, after cycle 3, within 1 week after treatment completion, and 1 month after completion, using CTCAE v5.0 and patient-reported questionnaires (QLQ-C30 and FACT-GOG-NTx). Toe temperature will be measured to assess local microcirculation changes. The study will also monitor compression-related adverse events. The results will provide evidence for preventive strategies to reduce ADC-induced peripheral neuropathy and improve patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of Grade ≥1 Peripheral Neuropathy (CTCAE v5.0)
时间窗: Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion.
The proportion of patients who develop Grade ≥1 peripheral neuropathy, as assessed by CTCAE version 5.0.
次要结局
- Change in Quality of Life Scores (EORTC QLQ-C30)(Baseline; At the end of Cycle 3 (each cycle = 28 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion.)
- Peripheral Neuropathy Severity (FACT-GOG-NTx Scale)(Baseline; At the end of Cycle 3 (each cycle = 28 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion.)
- Left vs. Right Lower Limb Neuropathy Comparison (FACT-GOG-NTx Scale)(Baseline; At the end of Cycle 3 (each cycle = 28 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion)
- Incidence of Grade ≥2 Peripheral Neuropathy (CTCAE v5.0)(Measured at baseline, after the 3rd treatment cycle, at treatment completion, and 1 month after treatment completion.)
- Toe Temperature Changes (Infrared Thermography)(Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days).)
研究者
Sheng Zhang
Prof.
Fudan University