New drug cocktail shows promise for tough head and neck cancers

NCT ID NCT07618624

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving a combination of three drugs (finotonlimab, cetuximab, and docetaxel) before surgery can shrink tumors in people whose head and neck cancer has come back after prior immunotherapy and chemotherapy. The goal is to see if this approach leads to fewer cancer cells remaining after surgery. The trial involves 42 adults with a specific type of head and neck cancer that can still be surgically removed.

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 42 people

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

Started

Apr 2026

Expected to finish

Dec 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 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. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 2. Age 18-75 years at time of consent 3. Histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma with PD-L1 CPS at least 1 4. Disease progression after prior treatment including both PD-1(L1) inhibitor and platinum-based therapy (combined or sequential) 5. No EGFR-targeted therapy within 6 months prior to enrollment 6. Willing to provide archived tumor tissue or undergo fresh tumor biopsy for PD-L1 testing 7. At least one measurable extracranial lesion per RECIST v1.1; previously treated lesions must demonstrate clear progression 3 or more months after last local treatment 8. Resectable disease with no distant metastasis, as assessed by a multidisciplinary team 9. Adequate organ function within 7 days prior to enrollment: ANC at least 2.0 x 10\^9/L, platelet count at least 100 x 10\^9/L; total bilirubin less than 1.5 x ULN, ALT/AST less than 2.5 x ULN; serum creatinine less than 1.5 x ULN 10. Signed informed consent prior to any study-specific procedures 11. Life expectancy greater than 3 months 12. Effective contraception during study and for 6 months after last dose EXCLUSION CRITERIA: 1. History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ) 2. Comorbidities requiring long-term immunosuppressive therapy or corticosteroids at immunosuppressive doses 3. Immunodeficiency or history of organ transplantation (including interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism) 4. HIV/AIDS; untreated active hepatitis B (HBV-DNA at least 500 IU/mL); hepatitis C (HCV-RNA above detection limit); or HBV/HCV co-infection 5. High-dose systemic corticosteroids within 4 weeks prior to enrollment 6. Pregnant or lactating women; fertile patients not using effective contraception 7. Laboratory values not meeting inclusion criteria within 7 days 8. Significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function 9. Severe uncontrolled comorbidities or active infections 10. Concurrent participation in other clinical trials 11. Refusal or inability to sign informed consent 12. Other contraindications to study treatment as determined by the investigator 13. Psychiatric disorders or mental illness resulting in lack of legal capacity

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms 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

    9 sites. The list below names each one and where it is.

  2. 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 ↗

  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

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, China

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, China

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, China

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

  • The First People's Hospital of Foshan

    Foshan, Guangdong, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

More trials for these conditions

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