Neoadjuvant therapy for advanced hypopharyngeal cancer

Neoadjuvant Therapy With Toripalimab Combined With Cetuximab and Platinum for Resectable Locally Advanced Hypopharyngeal Cancer

This study is testing a new combination of immunotherapy and chemotherapy to see if it can help people with advanced hypopharyngeal cancer before they have surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone, cetuximab, toripalimab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06151743 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed resectable locally advanced hypopharyngeal squamous cell carcinoma.

Not a fit: Patients with a history of other cancers in the past five years or those who have received prior treatment for hypopharyngeal carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with locally advanced hypopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and targeted therapies in head and neck cancers, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions: Locally Advanced Hypopharyngeal Carcinoma