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Can an immunotherapy combo shrink head and neck tumors before surgery?

NCT ID NCT07751276

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial is testing whether adding the immunotherapy drug finotonlimab to chemotherapy before and after surgery can improve outcomes for people with stage II head and neck squamous cell carcinoma. Participants will receive either standard treatment (surgery plus chemoradiotherapy) or finotonlimab combined with chemotherapy before surgery, followed by finotonlimab maintenance after surgery. The study will measure how long participants live without the cancer returning or spreading, as well as overall survival.

What this could mean

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

Active substance
finotonlimab combined with chemotherapy (albumin-bound paclitaxel and carboplatin or cisplatin)
What this could lead to
If successful, this approach could improve event-free survival and overall survival for people with stage II head and neck cancer, potentially leading to a new standard perioperative treatment.
What could go wrong
This is a phase 2 trial with a moderate sample size, so results may not be definitive. Adding immunotherapy to chemotherapy can increase immune-related side effects, and the benefit over standard surgery plus chemoradiotherapy is not yet proven.

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 142 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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 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. Age 18-75 years 2. Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) 3. Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable 4. ECOG sccore 0-1 5. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for the current head and neck tumor 6. Willing to undergo surgical treatment 7. No significant contraindications to immunotherapy, radiotherapy, or chemotherapy 8. Major organ function meets the following criteria: a) Hematologic: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L (no blood transfusion or blood products, no G-CSF or other hematopoietic growth factors within 14 days); b) Biochemistry: serum albumin ≥ 3.0 g/dL (30 g/L), TBIL ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) Adequate coagulation: defined as INR or PT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, PT within the intended therapeutic range of the anticoagulant is acceptable 9. Both male and female subjects are eligible; women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody 10. The subject voluntarily enrolls in this study, signs the informed consent form, demonstrates good compliance, and cooperates with follow-up Exclusion Criteria: 1. Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways 2. Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia) 3. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection) 4. Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies 5. Within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA class ≥ 2 cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure 6. Receipt of a live vaccine within 4 weeks prior to the first dose of study drug; inactivated influenza vaccine administered by injection is permitted, while intranasal live attenuated influenza vaccine is not permitted 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation 8. Known history of psychotropic substance abuse or drug addiction 9. Pregnant or lactating women 10. Diagnosis of any other malignancy within 5 years prior to study entry, except for curatively treated localized cancers including basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma 11. Any other severe physical or psychiatric illness or laboratory abnormality that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for study participation in the opinion of the investigator

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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.

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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.