This is a prospective clinical study enrolling eligible subjects scheduled to receive oxaliplatin-based chemotherapy after signing informed consent forms. Subjects are randomly assigned to two groups. Group 1 (skin test group) receives an intradermal injection of 0.02 mL oxaliplatin solution (0.01-5.00 mg/mL) before cycles 6-10 (oxaliplatin-naive patients) or cycles 2-6 (patients with recurrence after adjuvant oxaliplatin chemotherapy), with a simultaneous self-negative control (0.02 mL 0.9% normal saline). A total of 1650 person-times will be included. Group 2 (negative control group) includes 50 subjects who receive 0.02 mL 0.9% normal saline intradermally before cycle 6 or 2. Assessments include: 1. Skin test results evaluated 15-30 minutes post-injection; a positive result is defined as a wheal ≥5 mm with surrounding erythema 2. Maximum diameter of skin test rash measured 15-30 minutes post-injection 3. Biomarker detection at three time points: pre-initial skin test, 1 hour post-skin test, and 1 hour post-first medication (carboxypeptidase A3, 9α,11β-PGF2, cysteinyl leukotrienes LTC4/LTD4/LTE4, IL-4/5/1β/6/8, TNF-α, MCP-1, mast cell chymase, total tryptase, ΔTryptase, ΔIL-6 peak); pre-skin test assessments include basophil activation rate, total IgE, LDH, lymphocytes, monocytes, and eosinophils 4. Occurrence, onset time, severity (graded per NCI-CTCAE Version 5.0), and classification of oxaliplatin infusion-related hypersensitivity reactions Follow-up continues until cycle 10 (cycle 6 for oxaliplatin re-exposed patients) or the first occurrence of: hypersensitivity reaction, disease progression requiring new anti-tumor therapy, intolerable toxicity, consent withdrawal, loss to follow-up, death, or other protocol-specified termination conditions. The negative control group is exclusively used for exploratory biomarker correlation analysis to assess the impact of skin test procedures, and is excluded from primary (sensitivity, specificity) and secondary (predictive values, likelihood ratios, Kappa coefficient) endpoint analyses. Limitations of this exploratory analysis are explicitly stated. Biomarker correlation analysis uses first skin test baseline data from 50 subjects per group (total 100 randomized cases). Variable block stratified randomization is performed, stratified by oxaliplatin-naive status and presence of comorbidities (diabetes, hypertension, renal insufficiency).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
380
Administer 0.02 mL of oxaliplatin solution at 0.01-5.00 mg/mL intradermally before cycles 6 to 10 for oxaliplatin-naive patients, or before cycles 2 to 6 for patients with recurrent disease after adjuvant oxaliplatin chemotherapy. Meanwhile, conduct self-negative control via intradermal injection of 0.02 mL 0.9% normal saline.
Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2
Fujian Cancer Hospital
Fuzhou, Fujian, China
sensitivity and specificity
The proportion of patients with positive pre-medication skin test results among all patients who developed defined hypersensitivity reactions during the study The proportion of patients with negative pre-medication skin test results among all participants without hypersensitivity reactions during the study
Time frame: One month after study completion
Additional Diagnostic Performance Indices of Oxaliplatin Skin Test
Calculate the following diagnostic indices of the oxaliplatin skin test: positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), negative likelihood ratio (LR-), and diagnostic odds ratio (DOR).
Time frame: One month after study completion
Kappa Coefficient of Agreement
Evaluate the level of agreement between the oxaliplatin skin test results (positive/negative) and the clinical diagnosis of oxaliplatin-induced hypersensitivity reactions using the Cohen's Kappa coefficient.
Time frame: One month after study completion
Incidence and Severity of Skin Test-Related Adverse Events
Record and grade all adverse events occurring within 72 hours after skin test administration according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Time frame: Within 30 days after study completion
Correlation Between Serum Biomarkers and Skin Test Parameters
Analyze the correlation between serum biomarker levels and the following skin test parameters: Performance of the skin test procedure itself Skin test results (positive vs. negative) Diameter of the wheal induced by the skin test
Time frame: At baseline (pre-skin test) and 1 month after study completion
Correlation Between Serum Biomarkers and Hypersensitivity Reaction Incidence
Evaluate the association between baseline and post-treatment serum biomarker levels and the incidence of protocol-defined oxaliplatin-induced hypersensitivity reactions.
Time frame: Throughout the study duration and up to 1 month after study completion
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