drugset / Trial / NCT06151743

Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal Carcinoma

NCT06151743 ↗

Phase 2 Recruiting 32 enrolled Eye & ENT Hospital of Fudan University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal cancer. Participants will receive three cycles of TPC neoadjuvant therapy (toripalimab+ cetuximab + platinum), radical surgery (laryngeal preservation surgery if possible), and sequential (chemo)radiotherapy treatment after surgery. This trial aims to answer the following questions: 1. pCR rate 2. MPR rate, ORR, LPR/DFS/OS rare at 1 and 2 years 3. Safety and quality of life

Timeline

Start
2024-01-18
Primary completion
2024-12-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 240 mg/m2 Intravenous