Clinical trial · Interventional
Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Tumors | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-allergic treatment | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hypersensitivity group
- description
- Corresponding intervention measures are given for different levels of hypersensitivity reactions
- interventionNames
- Combination Product: Anti-allergic treatment
Primary outcomes (1)
- measure
- Completion rate of 3 cycles of re-chemotherapy with oxaliplatin
- timeFrame
- 2 years
- description
- Completion rate of 3 cycles of re-chemotherapy with oxaliplatin
Secondary outcomes (1)
- measure
- Concordance rate between oxaliplatin skin test results and clinicians' judgment
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who plan to receive oxaliplatin treatment; 2. Male or female aged 18-75 year; 3. ECOG PS 0-2; 4. The expected survival time is more than 3 months; 5. Capable and willing to accept survey patients Exclusion Criteria: 1.Patients who were not suitable for the enrollment of this study judged by the investigator
References
Publications (0)
Data not yet available