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Immunotherapy cocktail aims to shrink head and neck tumors before surgery

NCT ID NCT07371897

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether adding chemotherapy to the immunotherapy drug toripalimab before surgery helps keep head and neck cancer from coming back. About 154 adults with advanced but operable cancer will get either toripalimab alone or with chemo for two cycles, then have surgery and radiation. The goal is to see which approach leads to longer cancer-free survival.

What this could mean

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

Active substance
Toripalimab (immunotherapy) with or without docetaxel and cisplatin (chemotherapy)
What this could lead to
If successful, this could offer a more effective pre-surgery treatment to lower the chance of head and neck cancer returning.
What could go wrong
This is an early-stage Phase 3 trial with only 154 participants. The added chemo may increase side effects without improving outcomes, 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 154 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

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

18 to 70 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: * Pathologically confirmed, newly diagnosed, non-metastatic, operable locally advanced head-and-neck squamous cell carcinoma (oral cavity, larynx, hypopharynx, or oropharynx) Stage III-IVA (p16-positive oropharynx T4N0-N2; p16-negative oropharynx III-IVA; larynx/hypopharynx/oral cavity III-IVA) PD-L1 CPS ≥ 1 Age 18-70 years ECOG performance status 0-1 Adequate organ function (ANC ≥ 2.0×10⁹/L, platelets ≥ 100×10⁹/L, TBIL \< 1.5×ULN, ALT/AST \< 1.5×ULN, creatinine \< 1.5×ULN) No prior head-and-neck cancer surgery or radiotherapy No other malignancy within 5 years Signed informed consent Exclusion Criteria: * Previous systemic anti-cancer therapy for head-and-neck cancer Known hypersensitivity to study drugs Active or untreated hepatitis B/C, HIV positivity Severe cardiac, pulmonary, liver, or renal insufficiency precluding surgery Pregnancy or lactation Psychiatric or social conditions preventing compliance Organ transplant on chronic immunosuppression

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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.

Head and neck squamous cell carcinoma HNSCC

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.

More trials for these conditions

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