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New triple therapy aims to wipe out head and neck tumors before surgery

NCT ID NCT07393477

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a combination of three drugs (becotatug vedotin, pucotenlimab, and cisplatin) given before surgery can shrink or eliminate tumors in people with advanced head and neck cancer. About 30 adults aged 18-70 with stage III/IVA disease who have not had prior treatment will receive the therapy for 6-12 weeks. Researchers will check how many patients have no cancer cells left after treatment and how long they stay cancer-free.

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 30 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

May 2029

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: 1. Aged 18-70 years (inclusive). 2. Histopathologically confirmed Stage III/IVA head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx (per 8th edition AJCC Cancer Staging Manual). 3. Measurable primary lesions per RECIST v1.1. 4. Treatment-naive (no prior anti-tumor therapy for current disease). 5. ECOG performance status 0-1. 6. Eligible for elective standard surgery plus adjuvant chemoradiotherapy/radiotherapy (investigator-assessed). 7. No active autoimmune diseases. 8. No concurrent malignant tumors. 9. Estimated life expectancy \>= 6 months. 10. Available tumor tissue for PD-L1 IHC testing (22C3 DAKO assay). 11. Adequate hematological function (screening): ANC \>= 1.5×10⁹/L, platelets \>= 100×10⁹/L, Hb \>= 100 g/L, WBC \>= 3.5×10⁹/L; no blood transfusion or bleeding tendency within 7 days. 12. Normal liver function: ALT, AST, ALP, serum bilirubin \<= 1.5×ULN. 13. Normal renal function: Serum Cr \<= 1.5×ULN or creatinine clearance \> 60 mL/min. 14. HPV status confirmed by p16 IHC and in situ hybridization (ISH). 15. Voluntary participation with signed informed consent; legal guardian-signed consent for incompetent subjects, and witness-supervised consent for illiterate subjects. Exclusion Criteria: 1. Cachexia or multiple organ failure. 2. Active autoimmune disease of any type. 3. Concomitant second primary malignancy (e.g., esophageal cancer). 4. Severe active infection requiring systemic therapy. 5. Uncontrolled serious medical conditions interfering with study treatment (e.g., severe heart/cerebrovascular disease, uncontrolled diabetes/hypertension, active peptic ulcer). 6. Dementia, altered mental status, or other conditions impairing informed consent or questionnaire completion. 7. Peripheral neuropathy \>= Grade 2 per CTCAE v5.0. 8. Hearing impairment \>= Grade 2 per CTCAE v5.0. 9. History of malignancy within 5 years prior to screening. 10. Known HIV-positive status or diagnosed AIDS. 11. Nasopharyngeal carcinoma or HNSCC at sites other than oral cavity, oropharynx, larynx, hypopharynx (e.g., paranasal sinuses, unknown primary). 12. Receipt of investigational drugs or participation in other interventional trials within 30 days prior to screening. 13. Systemic glucocorticoids (\>10 mg prednisone equivalent/day) or other immunosuppressants within 14 days prior to randomization (inhaled/topical steroids and adrenal hormone replacement are permitted without active autoimmune disease). 14. Pregnant/lactating women; subjects of childbearing potential refusing contraception. 15. Active infection requiring treatment or systemic anti-infective use within 1 week prior to first dose. 16. Live vaccine administration within 30 days prior to first dose. 17. Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill status). 18. Other conditions deemed unsuitable for enrollment by 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 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

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

More trials for these conditions

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