Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors

NCT05922358 | Not Yet Recruiting Phase 2

• 1 other identifier: SYLT-027
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Tumors

Outcome Measures

Primary Outcomes (1)

• Completion rate of 3 cycles of re-chemotherapy with oxaliplatin

  Completion rate of 3 cycles of re-chemotherapy with oxaliplatin

  2 years

Secondary Outcomes (1)

• Concordance rate between oxaliplatin skin test results and clinicians' judgment

  2 years

Study Arms (1)

hypersensitivity group

EXPERIMENTAL

Corresponding intervention measures are given for different levels of hypersensitivity reactions

Combination Product: Anti-allergic treatment

Interventions

Anti-allergic treatment COMBINATION_PRODUCT

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.

hypersensitivity group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who were not suitable for the enrollment of this study judged by the investigator

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 28, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 28, 2023

Record last verified: 2023-06