Hypersensitivity ReactionNCT07613905
A Prospective Study on the Clinical Value of Skin Test for Oxaliplatin Hypersensitivity Reaction and Its Correlation With Biomarkers
A study testing Oxaliplatin and Saline (0.9% NaCl) in people with Hypersensitivity Reaction, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity Reaction
- What is being tested?
- Oxaliplatin and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Cancer Hospital
Fuzhou, Fujian
Rongbo Lin, +8613705919382, rongbo_lin@163.com
Rongbo Lin
About this study
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.
Read more
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).
- Conditions
- Hypersensitivity Reaction
- Being tested
- Oxaliplatin, Saline (0.9% NaCl)
- Keywords
- Oxaliplatin, skin test
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
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.
Saline (0.9% NaCl)Drug
Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2
| Study group | Role | What they receive |
|---|---|---|
| skin test | Experimental | 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. Receives: Drug: Oxaliplatin |
| Negative control | Sham comparator | Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2. Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month after study completion
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Throughout the study duration and up to 1 month after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity ReactionStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary endpoint and all key secondary endpoints of this study are analyzed solely based on the single experimental arm. The control group is established only for exploratory biomarker correlation analysis to evaluate the impact of skin test procedures on detection indicators. Therefore, despite the adoption of random grouping, this study is essentially a single-arm trial in terms of core design objectives and main analysis set. Since an error will be triggered if single-arm design is selected while the number of arms is set to 2, parallel design is chosen for the Interventional Study Model instead.
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613905
- Sponsor's protocol ID
- SYLT-034
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Clinical Value of Skin Test for Oxaliplatin Hypersensitivity Reaction and Its Correlation With Biomarkers
- ClinicalTrials.gov ID
- NCT07613905
- Acronym / sponsor ID
- SYLT-034
- Conditions
- Hypersensitivity Reaction
- Keywords
- Oxaliplatin, skin test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary endpoint and all key secondary endpoints of this study are analyzed solely based on the single experimental arm. The control group is established only for exploratory biomarker correlation analysis to evaluate the impact of skin test procedures on detection indicators. Therefore, despite the adoption of random grouping, this study is essentially a single-arm trial in terms of core design objectives and main analysis set. Since an error will be triggered if single-arm design is selected while the number of arms is set to 2, parallel design is chosen for the Interventional Study Model instead.
| Arm | Type | Receives |
|---|---|---|
| skin test | Experimental | Drug: OxaliplatinAdminister 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. |
| Negative control | Sham comparator | Drug: Saline (0.9% NaCl)Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAdminister 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. | Drug | skin test |
| Saline (0.9% NaCl)Inject 0.02 mL of 0.9% normal saline intradermally prior to administration of Cycle 6 or Cycle 2 | Drug | Negative control |
Primary outcome
sensitivity and specificity
Time frame: 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
5 secondary outcomes
Additional Diagnostic Performance Indices of Oxaliplatin Skin Test
Time frame: One month after study completion
Kappa Coefficient of Agreement
Time frame: One month after study completion
Incidence and Severity of Skin Test-Related Adverse Events
Time frame: Within 30 days after study completion
Correlation Between Serum Biomarkers and Skin Test Parameters
Time frame: At baseline (pre-skin test) and 1 month after study completion
Correlation Between Serum Biomarkers and Hypersensitivity Reaction Incidence
Time frame: Throughout the study duration and up to 1 month after study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Hypersensitivity Reaction
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxaliplatin and Saline (0.9% NaCl) in people with Hypersensitivity Reaction, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rongbo Lin (+8613705919382, rongbo_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity (time frame: One month after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.