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Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors

ConditionGastrointestinal Tumors
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: hypersensitivity groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Completion rate of 3 cycles of re-chemotherapy with oxaliplatin

Completion rate of 3 cycles of re-chemotherapy with oxaliplatin

Time frame
2 years

Secondary outcomes

1

Concordance rate between oxaliplatin skin test results and clinicians' judgment

Concordance rate between oxaliplatin skin test results and clinicians' judgment

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: