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

Neoadjuvant Low-Dose Radiotherapy Combined With Targeted-Immunotherapy Versus Targeted-Immunotherapy Alone in Operable Head and Neck Squamous Cell Carcinoma: A Prospective Randomized Controlled Trial

This study is testing if giving low-dose radiation along with targeted immunotherapy before surgery can help people with head and neck cancer have better outcomes and lower chances of the cancer coming back.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: immunotherapy, Tislelizumab, Afatinib, chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06804850 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of combining neoadjuvant low-dose radiotherapy with targeted immunotherapy compared to using targeted immunotherapy alone in patients with resectable head and neck squamous cell carcinoma (HNSCC). The study aims to improve surgical outcomes and reduce recurrence rates by enhancing the anti-tumor immune response through this combination approach. Patients will receive treatments prior to surgery, with the goal of increasing the likelihood of successful tumor removal and preserving organ function. The trial is designed for patients who are newly diagnosed and have not yet experienced distant metastasis.

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.

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 significantly improve surgical outcomes and survival rates for patients with head and neck cancer.

How similar studies have performed: Previous studies have shown promising results with the combination of low-dose radiotherapy and immunotherapy, indicating potential for success in this approach.

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:

（1）anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs； （2）antitumor vaccine; （3）any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period; （4）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

• Study coordinator: Xingchen Peng, Professor

Conditions: Head and Neck Cancer