New drug cocktail shows promise for tough head and neck cancers
NCT ID NCT07618624
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
9 sites. The list below names each one and where it is.
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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.
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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
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Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
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Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
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Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
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Guangzhou First People's Hospital
Guangzhou, Guangdong, China
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Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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The First People's Hospital of Foshan
Foshan, Guangdong, China
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The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A prospective imaging study of target definition and radiation planning workflows on the integrated TrueBeam-HyperSight system for patients receiving radiation therapy
- Can a new drug combo slow advanced head and neck cancer?
- Can a Self-Care program ease Post-Cancer swelling in the head and neck?
- Blood biomarkers may foreshadow Radiation-Induced dry mouth
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can a smart breathing device make life with a tracheostomy more comfortable?