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

Locations

7
Harbin Medical University Cancer Hospital HarbinHeilongjiang, China
Shandong Provincial ENT Hospital JinanShandong, China
Beijing Tongren Hospital, Capital Medical University Beijing China
Cancer Hospital Chinese Academy of Medical Sciences Beijing China

Sponsors and collaborators

Eye & ENT Hospital of Fudan University

Lead sponsor