drugset
drugset / Trial / NCT05922358

Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors

NCT05922358 ↗

Phase 2 Not yet recruiting 500 enrolled Fujian Cancer Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-09-01
Primary completion
2025-09-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetirizine Other / unclassified 10 mg Oral
Subject Cimetidine Small molecule 40 mg Intravenous
Subject Dexamethasone Small molecule 8 mg Oral
Subject Dexamethasone Small molecule 10 mg Oral
Subject Oxaliplatin Small molecule 0.01 mg/ml Intravenous
Subject Oxaliplatin Small molecule 0.1 mg/ml Intravenous
Subject Oxaliplatin Small molecule 5 mg/ml Intravenous
Subject Promethazine Small molecule 25 mg Intramuscular
Subject Ranitidine Unknown 150 mg Oral

Indications

digestive system neoplasm