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临床试验/NCT05922358
NCT05922358尚未招募2 期

Observation of Oxaliplatin Hypersensitivity and Neurotoxicity in GI Tract, and Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors: A Prospective, Open-Label, Multicenter, Phase II Study

Fujian Cancer Hospital0 个研究点目标入组 500 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
500
主要终点
Completion rate of 3 cycles of re-chemotherapy with oxaliplatin

研究概览

简要总结

The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.

详细描述

The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.

Patients with GI receiving oxaliplatin-containing regimens were prospectively observed, and patients with oxaliplatin grade I-III hypersensitivity reactions judged by clinicians based on clinical symptoms and signs entered the oxaliplatin reuse study . For patients with grade I-III oxaliplatin allergy, oxaliplatin skin test with 3 concentration gradients (0.01 mg/ml, 0.1 mg/ml and 5 mg/ml) was performed, and 5% glucose Water served as a negative control. 15-20 minutes to read test results. If the largest diameter of the rash was greater than 3 mm of the negative control, it was judged as a positive result. Afterwards, interventions were performed in different ways according to the grade of oxaliplatin allergic reaction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Patients who plan to receive oxaliplatin treatment;
  • Male or female aged 18-75 year;
  • ECOG PS 0-2;
  • The expected survival time is more than 3 months;
  • Capable and willing to accept survey patients

排除标准

  • 1.Patients who were not suitable for the enrollment of this study judged by the investigator

结局指标

主要结局

Completion rate of 3 cycles of re-chemotherapy with oxaliplatin

时间窗: 2 years

Completion rate of 3 cycles of re-chemotherapy with oxaliplatin

次要结局

  • Concordance rate between oxaliplatin skin test results and clinicians' judgment(2 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

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