Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.
Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram...
https://pubmed.ncbi.nlm.nih.gov/30207593Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07040956
A Prospective Randomized Controlled Trial Comparing Low-Dose Radiotherapy Combined With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone as Neoadjuvant Therapy in Patients With Operable Head and Neck Squamous Cell Carcinoma.
Led by West China Hospital · Updated on 2026-05-04
98
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating treatments for head and neck squamous cell carcinoma (HNSCC), a common and serious cancer affecting patients' appearance and functions. The study compares the effects of adding low-dose radiotherapy to a combination of targeted therapy and immunotherapy before surgery, aiming to improve surgery outcomes and organ preservation. This Phase 2 trial follows promising earlier research showing potential benefits of combining these therapies. Participants are randomly assigned to one of two groups: one group receives low-dose radiotherapy along with targeted therapy (afatinib) and immunotherapy (tislelizumab), while the other group receives only targeted therapy and immunotherapy. Treatments include tislelizumab given intravenously on days 1 and 22, afatinib taken continuously for 42 days, and low-dose radiotherapy at 4 Gy in two fractions for the experimental group. Surgery is performed after the neoadjuvant therapies. During the study, participants undergo evaluations including intraoperative assessments of major pathologic response, pathologic complete response, and objective response rate over approximately two months of neoadjuvant therapy. The research team monitors safety, treatment effects, and surgical outcomes. Participation lasts from treatment initiation through surgery and follow-up assessments, aiming to provide new options for managing operable HNSCC.
CONDITIONS
Brief Title
A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neoadjuvant Therapy in Operable HNSCC Patients.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or above.
- Patients with pathologically confirmed head and neck squamous cell carcinoma (except nasopharyngeal carcinoma) newly diagnosed without distant metastasis.
- Tumor must be surgically resectable as evaluated by a head and neck surgeon.
- Willingness to undergo surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ and bone marrow function including specific blood counts and liver and kidney function parameters.
- Written informed consent provided.
You will not qualify if you...
- History of other malignancies unless cured and without recurrence within 5 years (exceptions apply).
- Active or severe autoimmune disease requiring systemic treatment.
- History of severe allergic reactions to drugs or allergies to study drug components.
- Previous treatment with anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibodies, anti-EGFR antibodies, EGFR-TKIs, or certain vaccines within 4 weeks before study.
- Major surgery or serious trauma within 4 weeks before first dose.
- Unresolved toxicity from prior antitumor therapy above specified severity.
- Serious medical conditions including certain heart diseases, poorly controlled diabetes or hypertension, or low ejection fraction.
- Active or uncontrolled lung diseases including pneumonitis or tuberculosis.
- Hyperthyroidism or organic thyroid disease.
- Active infection or unexplained fever near study start.
- Active hepatitis B or C, positive HIV, or acquired immunodeficiency syndrome.
- History of neurological or psychiatric disorders.
- History of drug or alcohol abuse.
- Women who are pregnant, breastfeeding, planning pregnancy, or unwilling to use contraception during and shortly after the study.
- Use of investigational drugs within 4 weeks prior or simultaneous enrollment in another clinical trial.
- Any other factors judged unsuitable by investigators.
AI-Screening
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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 6 weeks
Participants receive neoadjuvant therapy with either low-dose radiotherapy combined with targeted therapy and immunotherapy or targeted therapy and immunotherapy alone before surgery.
Tislelizumab administered on days 1 and 22; afatinib taken continuously from days 1 to 42; low-dose radiotherapy given as 4Gy in 2 fractions (for experimental group)
Surgery
Duration - 1 day
Participants undergo surgery to remove the tumor after completing neoadjuvant therapy.
1 surgical visit
Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology
Chengdu, Sichuan, China, 610000
Actively Recruiting
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Research Team
X
Xingchen Peng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Promising new advances in head and neck radiotherapy.
P M Harari
https://pubmed.ncbi.nlm.nih.gov/15987991Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial.
Robert Haddad, Anne O'Neill, Guilherme Rabinowits...
https://pubmed.ncbi.nlm.nih.gov/23414589Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer.
Ezra E W Cohen, Theodore G Karrison, Masha Kocherginsky...
https://pubmed.ncbi.nlm.nih.gov/25049329Induction Chemotherapy Followed by Cetuximab Radiotherapy Is Not Superior to Concurrent Chemoradiotherapy for Head and Neck Carcinomas: Results of the GORTEC 2007-02 Phase III Randomized Trial.
Lionnel Geoffrois, Laurent Martin, Dominique De Raucourt...
https://pubmed.ncbi.nlm.nih.gov/30016178Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial.
Jean-Pascal H Machiels, Robert I Haddad, Jérôme Fayette...
https://pubmed.ncbi.nlm.nih.gov/25892145