Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. More than 50% of patients are diagnosed with locally advanced disease, necessitating intensive treatments that significantly impact their quality of life. Despite these efforts, the prognosis for laryngeal and hypopharyngeal cancers remains grim, with a 5-year survival rate of 30% to 50%.

Past approaches focused on preserving laryngeal function and patient well-being, including minimally invasive surgery, advanced radiotherapy, and induction chemotherapy. Our prior research highlighted the effectiveness of combining toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgery. Positive short-term outcomes and manageable side effects were observed, with encouraging larynx preservation rates after one year.

Against this backdrop, the current study aims to explore neoadjuvant immunotherapy combined with chemotherapy for patients with locally advanced laryngeal and hypopharyngeal cancer. It seeks to compare the therapeutic efficacy and quality of life impacts of concurrent radiochemotherapy and organ-preserving surgery. The ultimate goal is to identify optimal strategies for future interventions.

Eligibility criteria

Qualifiers

Signing of the informed consent form and willingness to comply with the study protocol.

Age ≥18 and ≤75 years.

Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma.

Locally advanced laryngeal/hypopharyngeal cancer patients eligible for surgical resection (AJCC 8th edition stage: T2N+M0, T3-T4aN0-3M0).

Disqualifiers

History of allergic reactions to any components of toripalimab, paclitaxel, or cisplatin.

Pre-existing tracheostomy due to laryngeal dysfunction before treatment.

History of or concurrent presence of other malignancies (except for those cured and with no cancer-related survival exceeding 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer). Patients with concurrent hypopharyngeal and esophageal cancers, where the lesions are not anatomically adjacent, will be diagnosed as having dual primary tumors and will not be eligible for inclusion.

NYHA Class II or higher heart failure.

Trial design

Treatments tested in this trial

  • Surgery
  • Radiation
  • Toripalimab

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fudan University

Lead sponsor

Fudan University Eye Ear Nose and Throat Hospital

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Collaborator

Ruijin Hospital

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator