Can immunotherapy before surgery shrink head and neck tumors?
NCT ID NCT04947241
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether adding the immunotherapy drug toripalimab to standard chemotherapy (gemcitabine and cisplatin) before surgery can help patients with locally advanced head and neck squamous cell carcinoma. The trial enrolls about 20 adults whose tumors can be removed by surgery. Participants receive two cycles of the combination treatment before their operation, and researchers track how much cancer remains in the removed tissue, how well the tumor responds, and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab, an immunotherapy drug, combined with gemcitabine and cisplatin chemotherapy
- What this could lead to
- If it works, this could point toward a pre-surgery treatment plan that shrinks head and neck tumors enough to make surgery more effective and lower the chance of the cancer returning.
- What could go wrong
- This is a very small, early-stage trial with only 20 participants and no control group, so any benefit seen may not hold up in larger studies. Adding immunotherapy to chemotherapy can also cause immune-related side effects that need monitoring.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Jan 2027
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 70 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. Untreated locally advanced head and neck squamous cell carcinoma confirmed by histology or cytology; 2. Patients who are recommended to perform surgery; 3. Patients between 18 and 70 years old; 4. ECOG: 0~2 points; 5. Estimated survival time ≥ 6 months; 6. At least one measurable lesion should be detected according to the RECIST 1.1; 7. The major organs meet the following standards (no blood components and cell growth factors are injected within 14 days): 1. Hemoglobin HB≥90 g/L; neutrophil ANC≥1.5×109/L; platelet count PLT≥100×109/L; 2. Serum albumin ≥28g/L; 3. Total bilirubin TBIL≤1.5×upper limit of normal, alanine aminotransferase ALT, aspartate aminotransferase AST≤2.5×upper limit of normal; if there is liver metastasis, ALT and AST≤5×upper limit of normal; 4. Serum creatinine ≤1.5×upper limit of normal, and creatinine clearance ≥50 mL/min; 5. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × upper limit of normal (for the use of stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin, and INR in the anticoagulant expected treatment can be filtered within the scope); 6. TSH≤ upper limit of normal; if abnormal, the T3 and T4 levels should be examined, and the T3 and T4 levels are normal. 8. Women of childbearing age should take contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the medication period and within 3 months after the medication; the serum or urine pregnancy test is negative within 7 days before the study is enrolled, And must be a non-lactating patient, and the male should agree to take contraceptive measures during the study period and within 3 months after the end of the study period; 9. The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up. Exclusion Criteria: 1. Pregnant or lactating women; 2. Allergic to anti-PD-1 monoclonal antibody, gemcitabine, or cisplatin; 3. History of other malignant tumors in the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma; 4. Uncontrollable clinical symptoms or diseases of the heart, such as: (1) Heart failure, NYHA Ⅱ, III or IV (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Supraventricular in clinical significance or Patients with ventricular arrhythmia requiring clinical intervention; 5. Have received any of the following treatments: 1. Have received any research relevant drugs before enrolling in this research; 2. Enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or intervention in a new clinical study follow-up; 3. Patients who need to be given corticosteroids (more than 10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before giving medication for the first time, except for local inflammation and prevention of allergies, nausea and vomiting The case of corticosteroids. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal corticosteroids with a dose greater than 10 mg per day of prednisone curative dose are allowed to replace; 4. Have been vaccinated with anti-tumor vaccine or have been vaccinated with live vaccine within 4 weeks before the first administration of study drug; 5. Received major surgery or severe trauma within 4 weeks before using the study drug for the first time; 6. The left ventricular ejection fraction of the heart is greater than or equal to 60%; 6. Severe infection (CTC AE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest active lung inflammation , There are symptoms and signs of infection 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics); 7. Have active autoimmune diseases, history of autoimmune diseases; 8. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation; 9. Patients with active tuberculosis infection found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection but without formal treatment 1 year before being checked; 10. The subject has active hepatitis (HBV DNA ≥ 2000IU/ml or 10,000 copies/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analysis method); 11. History of psychotropic drug abuse, alcohol and drug abuse; 12. Symptomatic brain metastases (confirmed or suspected); 13. The patients who are reckoned as not suitable for inclusion.
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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.
Contacts and locations
Locations
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Fifth Affilliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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