Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07601737
PHASE2

Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.

Official title: A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2026-04-20

Completion Date

2030-04-30

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

Nimotuzumab Injection

Nimotuzumab 400mg,d3,Q3W,for two cycles。

DRUG

Tislelizumab

tislelizumab (or pembrolizumab) 200mg,d1,Q3W,for two cycles。

DRUG

Albumin-Bound Paclitaxel /nab-Paclitaxel

Albumin-bound paclitaxel 180 mg/m² (or docetaxel 75 mg/m²), administered on day 3, every 3 weeks (Q3W);for two cycles。

DRUG

Cisplatin (Or Carboplatin)

Cisplatin 75 mg/m² (carboplatin AUC=5 may be substituted if cisplatin is not tolerated), administered on day 3, every 3 weeks (Q3W).for two cycles。

PROCEDURE

Radical surgery of tumor

Standard radical surgery of tumor

RADIATION

Concurrent chemoradiotherapy

Concurrent chemoradiotherapy: Radiotherapy: intensity modulated conformal radiotherapy (IMRT) was used with a total dose of 60-66gy (2gy/f, 30-33f). Chemotherapy: Cisplatin 40 mg/m2, QW, 6-7 times in total; Targeting: nimotuzumab 200mg, QW, 6-7 times in total.

Locations (1)

Shanghai First People's Hospital

Shanghai, China