Neoadjuvant therapy for advanced hypopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination of immunotherapy, cetuximab, and platinum as neoadjuvant therapy for patients with resectable locally advanced hypopharyngeal carcinoma. Participants will undergo three cycles of treatment followed by radical surgery and subsequent radiotherapy or chemoradiotherapy. The study aims to assess the pathologic complete response rate, major pathologic response rate, overall response rate, and safety, as well as the quality of life of participants. This approach seeks to improve survival outcomes for patients with this aggressive cancer type.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically confirmed as hypopharyngeal squamous cell carcinoma;
* Age between 18-75 years;
* Patients with resectable locally advanced hypopharyngeal cancer with T3-4aN0-3bM0 (AJCC 8th) require total laryngectomy;
* Have at least one evaluable target lesion according to RECIST 1.1 criteria.
* No previous treatment for hypopharyngeal carcinoma;
* Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
* Estimated survival ≥ 6 months;
* Normal organ function;
* HBV DNA \< 500 IU/mL (or 2500 copies/mL) and HCV RNA negative;
* Signed informed consent;
* Patients who are compliant, willing, and able to follow visiting schedules, treatment plans, laboratory tests, and other research procedures.
* Male and no pregnant female; able to use the contraceptive method during treatment.

Exclusion Criteria:

* Have a history of other cancers in the past five years, except for the following cancers that are cured in the past five years: basal cell carcinoma and squamous cell carcinoma of the skin, early prostate cancer, papillary thyroid cancer, breast ductal carcinoma in situ and cervix carcinoma in situ;
* The target lesion has been treated with radiation therapy or surgery, except for biopsy to confirm the diagnosis of hypopharyngeal carcinoma;
* Previous chemotherapy, immunotherapy, or bio-targeted therapy for the primary tumor;
* Patients who have participated in other clinical trials within four weeks before the trial;
* Any of the following diseases within six months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
* Those with hypertension who cannot be reduced to normal range by antihypertensive drugs (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg).
* Patients with grade I or above coronary heart disease, arrhythmia (including QTc interval prolongation \> 450 ms for men and \> 470 ms for women), and cardiac insufficiency.
* Patients with positive urine protein (urine protein test 2 + or above, or 24-hour urine protein quantification \>1.0g).
* Patients with severe allergic history or allergic constitution; an active autoimmune disease that may worsen when receiving immunostimulants. Patients with type I diabetes, vitiligo, psoriasis, or diseases of hypothyroidism or hyperthyroidism that do not require immunosuppressive therapy are eligible to participate in the study.
* Subjects requiring systemic therapy with corticosteroids (\> 10 mg prednisone or equivalent) or other immunosuppressants within two weeks before the first use of the study drug.
* Previously diagnosed immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) - related disease. hepatitis B virus (HBV) surface antigen positive and HBV-DNA ≥ 500 IU/mL (or 2500 copies/mL), or HCV RNA positive. History of active or previous tuberculosis (TB).
* Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders.
* Vaccination within four weeks before enrollment, except for inactivated vaccine.
* Pregnant or lactating women, those who are in the reproductive period and do not use effective contraception;
* Those whom the investigator deems unsuitable to participate in this trial, such as severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or psychiatric illness (including recent or active suicidal ideation or behavior) or abnormal laboratory tests.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Lei Tao — Eye & ENT Hospital of Fudan University
• Study coordinator: Lei Tao, PhD
• Email: doctortaolei@163.com
• Phone: 13916944810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.