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Promising cocktail aims to save voice boxes in head and neck cancer

NCT ID NCT07310771

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a combination of two targeted drugs (sintilimab and nimotuzumab) plus chemotherapy for people with advanced head and neck cancer that hasn't spread. The goal is to see if this approach can shrink tumors enough to avoid removing the larynx (voice box). The study will enroll 23 participants and track how well the cancer responds and how long it stays away.

What this could mean

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

Active substance
sintilimab (an immunotherapy drug), nimotuzumab (a targeted antibody), and chemotherapy (paclitaxel and cisplatin)
What this could lead to
If successful, this combination could offer a more effective treatment option for locally advanced head and neck cancer, potentially helping more patients avoid larynx removal.
What could go wrong
This is a small, early-phase (phase 2) study with only 23 participants, so results may not apply to everyone. Combining multiple drugs also raises the risk of serious 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

About 23 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 to 75 years

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: 1. Provision of written informed consent, with full understanding of and agreement to comply with study requirements and the visit schedule. 2. Age 18-75 years (inclusive) at the time of informed consent; either sex. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of the head and neck as assessed by the investigator. 5. Documented EGFR-positive tumor. 6. No prior systemic therapy for head and neck squamous cell carcinoma. 7. At least one measurable lesion per RECIST v1.1. 8. Estimated life expectancy ≥ 12 weeks. 9. Adequate bone-marrow and organ function. Exclusion Criteria: 1. Known hypersensitivity to any component of PD(L)-1 inhibitors, paclitaxel, or cisplatin. 2. Prior or concurrent malignancy (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma disease-free for \>5 years). 3. Uncontrolled cardiac symptoms or clinically significant cardiac disease. 4. Previous therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or receipt of therapeutic cancer vaccines or live vaccines within 4 weeks before first study-dose administration. 5. Failure to recover to ≤ Grade 1 (per CTCAE) from prior anti-tumour therapy-except alopecia or residual neurotoxicity related to prior platinum-before first study dose. 6. Severe infection (\> CTCAE Grade 2) within 4 weeks before first study dose. 7. Active autoimmune disease or documented autoimmune-disease history requiring systemic therapy. 8. History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency syndromes, or prior solid-organ or allogeneic bone-marrow transplantation. 9. History of interstitial lung disease or non-infectious pneumonitis. 10. Evidence of active tuberculosis infection on history or CT imaging. 11. Active hepatitis B (HBV DNA ≥ 500 IU/mL or ≥ 2,500 copies/mL). 12. History of substance abuse, alcohol abuse, or drug addiction. 13. Pregnant or lactating women. 14. Any condition that, in the investigator's opinion, could necessitate premature withdrawal from the study.

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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 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 ↗

  2. 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.