Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05922358
Other study ID # SYLT-027
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2026

Study information

Verified date June 2023
Source Fujian Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date September 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Combination Product:
Anti-allergic treatment
For grade I-III hypersensitivity to oxaliplatin, oxa 0.01 mg/ml, 0.1 mg/ml and 5 mg/ml were used in sequence for skin test. 5% GS was used as a negative control. Test results are read within 15 to 20 minutes. Grade IV: Permanently stop using oxaliplatin; Grade I-II: Take orally (cetirizine 10 mg bid, dexamethasone 8 mg bid, ranitidine 150 mg bid*3dose) the day before the next cycle of oxaliplatin. The infusion rate is 50% of the original rate; if a grade II hypersensitivity reaction occurs again, the treatment method is the same as that of a grade III hypersensitivity reaction. Grade III: Oral drugs are the same as above. 0.5h before oxaliplatin: dexamethasone 10mg iv, cimetidine 40mg iv, promethazine 25mg im. The first bag of 10% total amount of oxaliplatin + 5% GS500ml: 5ml/h*1h, 45ml/h*1h, then 225ml/h*2 hours; then dexamethasone 10mg iv; the second bag of 90% total Oxa +5%GS500ml: 100ml/h*0.5h, then 150ml/h*3 hours.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fujian Cancer Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Completion rate of 3 cycles of re-chemotherapy with oxaliplatin Completion rate of 3 cycles of re-chemotherapy with oxaliplatin 2 years
Secondary Concordance rate between oxaliplatin skin test results and clinicians' judgment Concordance rate between oxaliplatin skin test results and clinicians' judgment 2 years
See also
  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