NCT06957938

Comparing Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma

A Prospective, Multi-centered, Randomized Phase III Study to Compare Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor Versus Neoadjuvant Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant chemotherapy combined with immunotherapy has achieved promising pathological remission rates in locally advanced head and neck squamous cell carcinoma and has offered new hope for patients with locally advanced laryngeal and hypopharyngeal cancer. In our center's previous phase II study on locally advanced laryngeal and hypopharyngeal cancer, neoadjuvant chemotherapy combined with immunotherapy showed good 1 - year laryngeal preservation rate and 1 - year PFS rate. However, in locally advanced laryngeal and hypopharyngeal cancer, whether neoadjuvant chemotherapy combined with PD-1 inhibitor, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival, event - free survival and overall survival remains unclear. Thus, this study aims to explore in locally advanced laryngeal and hypopharyngeal cancer whether neoadjuvant immuno - chemotherapy, compared with neoadjuvant chemotherapy, can improve laryngeal preservation survival and bring benefits in quality of life.

Conditions

• Laryngeal Carcinoma
• Hypopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy (NACT)	Neoadjuvant Chemotherapy with paclitaxel (or albumin - bound paclitaxel) and cisplatin
DRUG	Neoadjuvant and maintenance Tislelizumab	Neoadjuvant and maintenance Tislelizumab
RADIATION	Concurrent chemo-radiotherapy (CCRT)	Concurrent chemo-radiotherapy (CCRT), with cisplatin-based chemotherapy
PROCEDURE	Surgery and adjuvant (chemo-)radiotherapy	Definitive surgery, with adjuvant (chemo-)radiotherapy, depending on pathologic findings.

Timeline

• Start date: 2025-04-28
• Primary completion: 2029-05-01
• Completion: 2031-05-01
• First posted: 2025-05-06
• Last updated: 2025-05-08

Locations

1 site across 1 country: China