New cocktail aims to shrink head and neck tumors before surgery
NCT ID NCT07601737
First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 3 times
Summary
This phase II trial tests whether adding the targeted drug nimotuzumab to immunotherapy and chemotherapy before surgery can improve outcomes for people with locally advanced head and neck cancer. About 182 participants will receive the combination or standard treatment. The main goal is to see if it increases the chance of being cancer-free after two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nimotuzumab combined with tislelizumab (or pembrolizumab), albumin-bound paclitaxel (or docetaxel), and cisplatin (or carboplatin)
- What this could lead to
- If successful, this could lead to a more effective neoadjuvant treatment for locally advanced head and neck cancer, potentially improving survival and reducing recurrence.
- What could go wrong
- This is an early phase II trial with a modest number of participants. The combination may cause significant side effects, and results may not generalize to all patients or stages of disease.
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
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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 182 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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Apr 2030
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. Age 18 to 75 years inclusive. 2. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition. 3. Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 5. For oropharyngeal carcinoma: mandatory p16 immunohistochemistry (testing within standard of care is acceptable; repeat testing not required). p16 testing is not required for other tumor locations. 6. Availability of tumor tissue (archived or newly obtained) for PD-L1 testing (prior testing is acceptable; repeat testing not required). 7. At least one measurable lesion per RECIST 1.1. 8. Life expectancy ≥ 6 months. 9. Adequate hematologic function: White blood cell count ≥ 4.0 × 10⁹/L Absolute neutrophil count ≥ 1.5 × 10⁹/L Platelet count ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L 10. Adequate renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR Creatinine clearance (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula: Female: CrCl (mL/min) = (140 - age) × body weight (kg) × 0.85 / (72 × serum creatinine (mg/dL)) Male: CrCl (mL/min) = (140 - age) × body weight (kg) × 1.00 / (72 × serum creatinine (mg/dL)) 11. Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN 12. Female subjects: negative pregnancy test within 2 weeks before first study drug, non-lactating. Females: highly effective contraception required during study and for 6 months after last study drug. Males: highly effective contraception required during study and for 6 months after last study drug. 13. Written informed consent obtained prior to any study-specific procedures, and willingness to comply with all study visits and protocol requirements. Exclusion Criteria: 1. Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment. 2. Participation in another interventional clinical trial within 30 days prior to screening. 3. In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol. 4. Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection. 5. History of other malignancy within the past 5 years (except cured basal cell carcinoma of the skin). 6. History of primary immunodeficiency disease. 7. Presence of uncontrolled comorbidities, including heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders, etc. 8. Known HIV infection, active viral hepatitis, or active tuberculosis. 9. Underwent major surgery within 90 days prior to the first study drug, or planning major surgery unrelated to this cancer treatment. 10. Hypersensitivity to any study drug or their components. 11. Pregnant (confirmed by serum or urine HCG test) or lactating woman; or subject of childbearing potential unwilling or unable to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment (applicable to both males and females). 12. Investigator considers the subject not suitable for study participation. 13. Unwilling to participate or unable to provide written informed consent. 14. Receipt of a live vaccine within 30 days before the first study drug administration.
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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
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Shanghai First People's Hospital
RECRUITINGShanghai, China
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- Radiation plus targeted antibody tested in older head and neck cancer patients