Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEye & ENT Hospital of Fudan University

About this trial

This is a multi-center, randomized controlled, prospective clinical study.

Eligibility criteria

Qualifiers

Willingness to provide written informed consent;

Age ≥18 and ≤75 years;

Treatment-naïve for malignant disease;

Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;

Disqualifiers

Pregnancy or breastfeeding status;

Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;

Poorly controlled cardiovascular conditions or other diseases;

Active or documented history of autoimmune diseases requiring systemic treatment;

Trial design

Treatments tested in this trial

  • Finolizumab
  • Albumin-Bound Paclitaxel /nab-Paclitaxel
  • Cisplatin
  • Definitive radiotherapy
  • Surgery with postoperative radiotherapy or chemoradiotherapy.

Treatment groups

116 Participants
are divided into 2 treatment groups