Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors
- Conditions
- Gastrointestinal Tumors
- Interventions
- Combination Product: Anti-allergic treatment
- Registration Number
- NCT05922358
- Lead Sponsor
- Fujian Cancer Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
1.Patients who were not suitable for the enrollment of this study judged by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description hypersensitivity group Anti-allergic treatment Corresponding intervention measures are given for different levels of hypersensitivity reactions
- Primary Outcome Measures
Name Time Method Completion rate of 3 cycles of re-chemotherapy with oxaliplatin 2 years Completion rate of 3 cycles of re-chemotherapy with oxaliplatin
- Secondary Outcome Measures
Name Time Method Concordance rate between oxaliplatin skin test results and clinicians' judgment 2 years Concordance rate between oxaliplatin skin test results and clinicians' judgment