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New chemo combo shows promise for head and neck cancer before surgery

NCT ID NCT05294900

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested two chemotherapy drugs, paclitaxel and carboplatin, given before surgery to 79 people with locally advanced head and neck cancer. The goal was to see how well the drugs shrink tumors before surgery. The main measure was a major pathologic response, meaning 10% or fewer cancer cells left in the tumor after treatment. The study aims to find a less toxic alternative to standard chemotherapy.

What this could mean

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

Active substance
paclitaxel and carboplatin (chemotherapy drugs)
What this could lead to
If successful, this could offer a less toxic chemotherapy option before surgery for head and neck cancer, potentially improving survival and reducing side effects.
What could go wrong
This is a small, early-phase trial (79 participants) with no comparison group. Results may not apply to all patients, and the treatment may still cause significant side effects.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

May 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

20 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 1. A patient whose potentially surgical, teletransfer-free HNSCC of oral, hypodermic, occipital, and larynx has been tissue-confirmed Oral cancer of III-IV, laryngeal cancer, hypodermic cancer, HPV-negative head cancer II-III HPV positive head cancer 2. A disease that can be measured, defined as a lesion that can be accurately measured pursuant to RECIST 1.1 3. Where the candidate subject to the test prepares the consent of the person subject to the test after obtaining approval required by region before the commencement of any plan-related procedures, including screening evaluation 4. Adult men and women over 20 years old at the time of participation in clinical trials 5. Eastern Cancer Cooperation Research Group (Eastern Cooperative Oncology Group, ECOG) Activity Status 0 or 1 6. A patient with a life expectancy of at least 12 weeks 7. Proper and normal organ and bone marrow functions as defined below: * hemoglobin test 9.0 g/dL * Absolute neutropenic number (ANC) set 109/L (1500 per mm3) * Platelet count 75,000 per mm3 * 1.5 times the total ULN of serum biliubine test institution * 2.5 times the ULN of the AST (SGOT)/ALT (SGPT) test institute. * Creatinine cleaning rate measured by 24-hour urine collection samples \> 40 mL/min or calculated by Cockcroft Gault formula (Cockcroft and Gault 1976) \>40 mL/min: 8. Women who have evidence after menopause or pre-menopausal women whose urine or serum pregnancy test results are negative. Women who have amenorrhea for 12 months without other medical reasons are considered after menopause. The following age requirements apply: * Even under the age of 50, she is in amenorrhea for at least 12 months after discontinuing exogenous hormone treatment, and if the LH and FSH levels are the menopause levels of the test institute, or if she underwent a surgical infertility operation (bilateral ovarian resection or complete hysterectomy), she is considered a menopause woman. * Women who have been in amenorrhea for at least 12 months after stopping all external hormone treatment, or whose last menstrual period is at least a year before and after radiation-induced menopause, or more than a year after chemotherapy induced menopause or who have undergone surgical infertility (bilateral ovarian resection, bilateral tubulectomy, or full hysterectomy) are considered women with menopause. Exclusion 1. Direct involvement in the planning and/or implementation of this clinical trial 2. Patients with nasopharyngeal cancer 3. A patient who has experienced previous treatment for head and neck cancer (including a history of radiation treatment) 4. Patients who have participated in other clinical trials using clinical drugs within the past month 5. A patient registered simultaneously in a clinical trial other than an observation (non-mediate) clinical trial or an intermediary clinical trial tracer 6. Patients who need to use additional chemotherapy, clinical medicine, biological medicine, or hormone therapy for chemotherapy: Provided, That the simultaneous use of hormone therapy (e.g. hormone replacement therapy) for conditions unrelated to cancer is allowed. 7. The toxicity of at least NCI CTCAE Level 2 of the previous anti-cancer treatment, which has not yet been resolved: Provided, That laboratory values defined as hair loss, vitiligo, and selection criteria shall be excluded. 8. Neuropathy of grade 2 or higher is determined after consultation with a clinical trial doctor on a case-by-case basis. 9. Patients with irreversible toxicity that is not expected to worsen due to the administration of clinical trials can participate in the test only after consultation with a clinical trial doctor. 10. Patients who undergo a major operation (according to the tester's definition) within 28 days before the initial administration of clinical medication. Note: Local surgery on independent lesions for the purpose of conventional treatment is acceptable. 11. Intractable diseases, but not limited to the following: ongoing or active infections; symptom congestive heart failure; uncontrolled high blood pressure; unstable angina; heart veins; epileptic lung disease; Major chronic gastrointestinal conditions with diarrhea; All mental/social conditions that may restrict compliance with clinical trial requirements or significantly increase the risk of adverse reactions or hinder the subject's ability to write consent 12. A patient who has a history of another primary malignant tumor: Provided, That the following shall not apply: * A past malignant tumor that was treated for the purpose of complete cure and has no history of a known active disease within five years before the initial administration of clinical medication and has a low risk of recurrence * non-black skin cancer treated properly or malignant black spots without evidence of disease * Carcinoma that has been properly treated and has no evidence of disease 13. History of active primary immune deficiency 14. Women who are currently pregnant or breastfeeding or fertile men and women who are not willing to use effective contraception from the time of screening to 180 days after the end of clinical treatment 15. Patients who are known to be allergic or irritable to clinical trials drugs or their siblings 16. Patients who are not suitable to participate in clinical trials and are not expected to comply with clinical trial procedures, restrictions, and requirements according to the judgment of the tester

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Contacts and locations

Locations

  • Yonsei University Health System, Severance Hospital

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.