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A Prospective Study on the Clinical Value of Skin Test for Oxaliplatin Hypersensitivity Reaction and Its Correlation With Biomarkers

2026년 5월 22일 업데이트: 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:

  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).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

380

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Fujian
      • Fuzhou, Fujian, 중국
        • Fujian Cancer Hospital
        • 수석 연구원:
          • Rongbo Lin
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Oxaliplatin
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.
가짜 비교기: Negative control
Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2.
의약품: Saline (0.9% NaCl)
Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
sensitivity and specificity
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Additional Diagnostic Performance Indices of Oxaliplatin Skin Test
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fujian Cancer Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2029년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 5월 22일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 22일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SYLT-034

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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