A Prospective Study on the Clinical Value of Skin Test for Oxaliplatin Hypersensitivity Reaction and Its Correlation With Biomarkers
22 de maio de 2026 atualizado por: Fujian Cancer Hospital
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:
- Skin test results evaluated 15-30 minutes post-injection; a positive result is defined as a wheal ≥5 mm with surrounding erythema
- Maximum diameter of skin test rash measured 15-30 minutes post-injection
- 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
- 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).
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
380
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Rongbo Lin
- Número de telefone: +8613705919382
- E-mail: rongbo_lin@163.com
Locais de estudo
-
-
Fujian
-
Fuzhou, Fujian, China
- Fujian Cancer Hospital
-
Investigador principal:
- Rongbo Lin
-
Contato:
- Rongbo Lin
- Número de telefone: +8613705919382
- E-mail: rongbo_lin@163.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Aged 18 years or older.
- Patients scheduled to receive oxaliplatin-containing chemotherapy during the study.
- Treatment-naive patients to oxaliplatin are eligible. Patients who may resume oxaliplatin treatment after prior adjuvant oxaliplatin chemotherapy can be enrolled as assessed by investigators.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. Estimated survival time of no less than 3 months.
- No contraindications to oxaliplatin chemotherapy.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization, and agree to use effective contraception throughout the study and for 3 months after the last dose. Male subjects with childbearing potential female partners shall adopt reliable contraceptive measures during the study and within 3 months after final administration. Lactating women are excluded.
- Subjects fully understand the study, voluntarily sign written informed consent, and are willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other study procedures.
Exclusion Criteria:
- Received systemic steroid therapy exceeding 10 mg prednisone equivalent daily or other immunosuppressants within 21 days prior to enrollment; topical steroids applied to skin test area within 7 days before enrollment; anti-IL-6 monoclonal antibodies such as tocilizumab within 3 months prior to enrollment; anti-IgE monoclonal antibodies such as omalizumab within 6 months prior to enrollment.
- Any unresolved toxicity from previous treatment not recovered to Grade 0 or 1 per NCI CTCAE Version 6.0 before enrollment, excluding alopecia and clinically insignificant asymptomatic laboratory abnormalities.
- Known hypersensitivity to oxaliplatin or other platinum agents, ingredients and excipients of combined chemotherapeutic drugs.
- Grade 2 or higher peripheral neuropathy prior to initial medication.
- Active autoimmune diseases requiring systemic treatment with immunomodulators, corticosteroids or immunosuppressants. Replacement therapies including thyroxine, insulin and physiological corticosteroids for adrenal or pituitary insufficiency are permitted.
- Uncontrolled complications, including persistent active infection or fever ≥38℃; psychiatric or social disorders that may impair study compliance, increase adverse event risks or compromise the capacity to provide informed consent.
- Treatment with any investigational drug or participation in other clinical trials within 28 days before randomization. Enrollment is allowed if the investigational drug is deemed not to affect skin test results and relevant indicators by investigators.
- Clinically significant underlying diseases judged by investigators to interfere with drug administration or protocol compliance.
- Pregnant or breastfeeding females.
- Other subjects deemed ineligible by investigators.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: skin test
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.
|
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.
|
|
Comparador Falso: Negative control
Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2.
|
Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
sensitivity and specificity
Prazo: One month after study completion
|
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
|
One month after study completion
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Additional Diagnostic Performance Indices of Oxaliplatin Skin Test
Prazo: One month after study completion
|
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).
|
One month after study completion
|
|
Kappa Coefficient of Agreement
Prazo: One month after study completion
|
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.
|
One month after study completion
|
|
Incidence and Severity of Skin Test-Related Adverse Events
Prazo: Within 30 days after study completion
|
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.
|
Within 30 days after study completion
|
|
Correlation Between Serum Biomarkers and Skin Test Parameters
Prazo: At baseline (pre-skin test) and 1 month after study completion
|
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 |
At baseline (pre-skin test) and 1 month after study completion
|
|
Correlation Between Serum Biomarkers and Hypersensitivity Reaction Incidence
Prazo: Throughout the study duration and up to 1 month after study completion
|
Evaluate the association between baseline and post-treatment serum biomarker levels and the incidence of protocol-defined oxaliplatin-induced hypersensitivity reactions.
|
Throughout the study duration and up to 1 month after study completion
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2028
Conclusão do estudo (Estimado)
1 de junho de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
22 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2026
Primeira postagem (Real)
29 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SYLT-034
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of study participants, as the study involves sensitive medical information and biological sample data.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .