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Simple skin test may prevent chemotherapy allergies

NCT ID NCT07613905

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a skin test can predict allergic reactions to the chemotherapy drug oxaliplatin. About 380 cancer patients will receive a tiny amount of oxaliplatin under the skin before their regular treatment. Researchers will check if the skin test results match who actually has an allergic reaction, and also look at blood markers. The goal is to find a way to prevent dangerous allergic reactions during chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oxaliplatin
What this could lead to
If successful, this could provide a simple skin test to predict and prevent severe allergic reactions to oxaliplatin, making chemotherapy safer.
What could go wrong
This is an early exploratory study, not a treatment trial. The skin test may not reliably predict reactions, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

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