Triple therapy shrinks head and neck tumors before surgery in early trial
NCT ID NCT06494189
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of low-dose radiation, an immunotherapy drug (tislelizumab), and a targeted therapy (afatinib) given before surgery to people with head and neck cancer. The main goal was to find a safe dose and see how well the treatment shrinks tumors. Nine patients took part, and the study is now complete.
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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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9 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Apr 2025
- 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 years and older
- 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 years or above. 2. Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following condition: * were newly diagnosed and without distant metastasis;were deemed surgically * resectable evaluated by a head and neck surgeon; * were willing to undergo surgery. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Adequate organ and bone marrow function: * absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L; * ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN; albumin≥ 2.8 g/dL; * creatinine clearance ≥ 60 ml/min; * INR≤ 1.5, APTT≤ 1.5×ULN. 5. Written informed consent. Exclusion Criteria: 1. History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.) 2. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease. 3. Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components. 4. Any of prior therapy with: * anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs; * antitumor vaccine; * any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period; * major surgery or serious trauma within 4 weeks before the first dose; * toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 Grade 1 or the level specified by the inclusion/exclusion criteria. 5. With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc. 6. With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment. 7. With hyperthyroidism, or organic thyroid disease. 8. With active infection, or unexplained fever during the screening period or 48 hours before the first dose. 9. With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome. 10. History of a clear neurological or psychiatric disorder. 11. History of drug abuse or alcohol abuse. 12. Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures. 13. Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial. 14. Any other factors that are not suitable for inclusion in this study judged by investigators.
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Genom att skicka in godkänner du våra Användarvillkor
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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West China Hospital, Sichuan University
Chengdu, Sichuan, 610000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can immunotherapy before surgery stop early oral cancer from returning?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Can a glowing dye show surgeons where head and neck tumors end?
- Re-irradiation plus cetuximab targets head and neck tumors that return