Gastrointestinal Tumors Clinical Trial
Official title:
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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06152757 -
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
|
Early Phase 1 | |
| Terminated |
NCT04171141 -
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
|
Phase 1 | |
| Completed |
NCT01552291 -
The Impact of Preoperative Oral Glutamine Intake on the Immunocompetence and Outcomes of Malnourished Patients Undergoing Major Abdominal Surgery Due to Malignancies
|
Phase 4 | |
| Active, not recruiting |
NCT03833700 -
A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)
|
Phase 1 | |
| Recruiting |
NCT06085365 -
Effects of Immunonutrition on the Improvement of Postoperative Adjuvant Chemotherapy Related Adverse Reactions in Patients With Gastrointestinal Tumors
|
Phase 3 | |
| Completed |
NCT01640665 -
Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors
|
Phase 1 | |
| Recruiting |
NCT04629326 -
PD-L1 Targeting Molecular Imaging of Solid Tumors
|
N/A | |
| Recruiting |
NCT05981235 -
Phase 1 Trial of AZD6422 in CLDN18.2+ GI Tumors
|
Phase 1 | |
| Recruiting |
NCT05262335 -
Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis (ALTER-G-001)
|
Phase 2 | |
| Terminated |
NCT01648465 -
Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors
|
Phase 2 | |
| Not yet recruiting |
NCT06263205 -
Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
|
N/A |