NCT06647563View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2030

Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
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.

All Listed Sponsors
lead

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER