Can a Four-Part combo before surgery wipe out head and neck tumors?
NCT ID NCT05343325
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether giving low-dose radiotherapy, the immunotherapy drug tislelizumab, and two chemotherapy drugs before surgery helps people with locally advanced head and neck squamous cell carcinoma. The trial enrolls adults with untreated, operable stage III to IVB disease. Participants receive two cycles of the combination, then undergo surgery three to four weeks later. The main goal is to see how often no viable tumor cells remain in the removed tissue, a measure called pathological complete response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab combined with low-dose radiotherapy, albumin-bound paclitaxel, and cisplatin
- What this could lead to
- If the combination works, it could raise the chance that surgery removes all visible cancer and lower the risk of the cancer returning.
- What could go wrong
- This is a small, single-arm phase 2 trial with 25 participants, so results may not hold in larger studies. Adding immunotherapy and radiation before surgery can cause immune-related side effects and may delay or complicate the operation.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Mar 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, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system; 2. Eligible for radical surgery, as judged by surgeons. 3. Aged ≥ 18 years and ≤ 70 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Life expectancy of more than 6 months. 6. At least one measurable lesion according to RECIST 1.1. 7. Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test): 1. Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 109/L; and platelet count ≥ 100 × 109/L; 2. Serum albumin ≥ 28 g/L; 3. Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; 4. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min; 5. Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ). 43/5000 6. Thyroid Stimulating Hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels should be examined, and patients with normal T3 and T4 levels can be screened. 8. Women of childbearing age should agree to the use of contraception (e.g., intrauterine devices, birth control pills, or condoms) during drug administration and for 3 months thereafter. 9. Subjects voluntarily join the study and sign an informed consent form, with good compliance. Exclusion Criteria (Patients will be excluded if any of the following criteria is met): 1. Pregnant or lactating women. 2. A history of allergies to PD-1 inhibitors or any of albumin-bound paclitaxel or cisplatin. 3. A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma. 4. Uncontrolled cardiac clinical symptoms or diseases, such as :(1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) patients with clinically significant ventricular or ventricular arrhythmias requiring intervention. 5. Have received any of the following treatments: 1. Any research drug received prior to the first dose of the current research drug. 2. Joined another clinical study at the same time, unless it is an observational (noninterventional) clinical study or an intervention during a follow-up. 3. Needed systemic treatment with corticosteroids (more than 10 mg of prednisone or equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergies or nausea and vomiting. In the absence of active autoimmune diseases, inhalation or partial use of steroids and adrenal corticosteroid replacements at doses greater than 10 mg per day of fentanyl equivalent is permitted. 4. Live vaccines were administered within 4 weeks prior to the first administration of research drugs. 5. Major surgery or severe trauma within four weeks of initial use of the study drug. 6. Serious infections (greater than grade 2 according to the Common Terminology Criteria for Adverse Events), such as severe pneumonia, bacteremia, and infection comorbidities, which required hospitalization, occurred within 4 weeks prior to the first dose of the study drug; baseline chest imaging examinations indicate the presence of active lung inflammation or symptoms and signs of infection within 2 weeks prior to the first dose of the study drug or indicate the need for oral or intravenous antibiotic treatment (excluding the use of preventive antibiotics). 7. A history of active autoimmune diseases and syndromes (including, but not limited to, interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo or cured childhood asthma/allergies that do not require any intervention in adulthood are not excluded. 8. A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation. 9. Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment. 10. Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection). 11. Known history of psychotropic drug abuse, alcoholism and drug use. 12. Not suitable for inclusion, as judged by the researcher.
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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 Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000, China
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Zhigang Liu
Dongguan, 523059, China
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Other studies related to the condition(s) this trial covers.
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