NCT06647563

Neoadjuvant Toripalimab + Chemotherapy ± Cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma (Neo-ICT)

A Randomized Controlled Study of Toripalimab Combined With Chemotherapy or With Chemotherapy/Cetuximab as Neoadjuvant Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Neo-ICT)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, active-controlled, open-label clinical trial for participants with newly diagnosed Stage III-IVb, resectable, locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). The study consists of two experimental arms and one control arm. Participants in Experimental Arm A will receive two cycles of Toripalimab, albumin-bound paclitaxel, carboplatin, and cetuximab prior to surgery. Participants in Experimental Arm B will receive two cycles of Toripalimab, albumin-bound paclitaxel, and carboplatin before surgical intervention. Following the surgical procedure, individuals in both Experimental Arm A and B will continue to receive 15 cycles of Toripalimab. The Control Arm will undergo the current standard treatment without preoperative drug intervention. Postoperatively, participants will be administered postoperative radiotherapy or chemoradiotherapy based on their recurrence risk. The primary study hypotheses are that the treatments in the Experimental Arms will improve the 2-year event-free survival (EFS) rates compared to the standard control treatment.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	Toripalimab	Specified dose on specified days
BIOLOGICAL	Cetuximab	Specified dose on specified days
DRUG	Albumin-Bound Paclitaxel	Specified dose on specified days
DRUG	Carboplatin	Specified dose on specified days
DRUG	Cisplatin	Specified dose on specified days
RADIATION	Radiotherapy 60 Gray/day	Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
RADIATION	Radiotherapy 66 Gray/day	High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
RADIATION	Radiotherapy 70 Gray/day	Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.

Timeline

• Start date: 2024-11-01
• Primary completion: 2029-09-30
• Completion: 2030-09-30
• First posted: 2024-10-18
• Last updated: 2024-10-18