Combining low-dose radiotherapy with immunotherapy and targeted therapy for head and neck cancer treatment

A Prospective, Single-arm Clinical Study of Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

This study is testing a new treatment combining low-dose radiation with immunotherapy and targeted therapy to see if it helps patients with head and neck cancer before surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: tislelizumab, afatinib, teslizumab, chemotherapy, Immunotherapy, radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06494189 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of a combination treatment involving low-dose radiotherapy, tislelizumab (an immunotherapy), and afatinib (a targeted therapy) for patients with surgically resectable head and neck squamous cell carcinoma (HNSCC). The aim is to explore new neoadjuvant treatment options that could potentially improve clinical outcomes for patients diagnosed with this aggressive cancer. By reducing tumor volume and enhancing the effectiveness of surgery, the study seeks to address the urgent need for better treatment strategies in HNSCC. Participants will be closely monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, surgically resectable head and neck squamous cell carcinoma without distant metastasis.

Not a fit: Patients with a history of other malignancies or those with nasopharyngeal carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and better surgical outcomes for patients with head and neck cancer.

How similar studies have performed: While some trials have shown feasibility for neoadjuvant immunotherapy in HNSCC, this specific combination approach is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Xingchen Peng, Professor — West China Hospital
• Study coordinator: Xingchen Peng, Professor

Conditions Head and Neck Cancer