NCT06771596

Nimotuzumab High-risk, Locally Advanced Squamous Cell Carcinoma of the Cervix

A Prospective, Single-arm Study on Nimotuzumab Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced High-risk Squamous Cell Carcinoma of the Cervix

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The efficacy and safety of nimotuzumab in the treatment of high-risk, locally advanced squamous cell carcinoma of the cervix.

Detailed description

The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy in the treatment of high-risk locally advanced cervical squamous cell carcinoma. This study adopts a single-arm design, and the primary efficacy endpoint is the 2-year progression-free survival (PFS) rate.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
DRUG	Nimotuzumab Injection	Nimotuzumab is a highly humanized monoclonal antibody of IgG1 type, with a humanization rate of 95%. It is highly specific, has a long half - life, and shows high selectivity and a high degree of humanization. It can specifically block the epidermal growth factor receptor (EGFR) signaling pathway and mediate immune effects such as antibody - dependent cell - mediated cytotoxicity (ADCC) and complement - dependent cytotoxicity (CDC). It also promotes the endocytosis and degradation of EGFR, thereby inhibiting the proliferation of tumor cells and promoting the apoptosis of tumor cells, reversing the malignant biological behavior of tumor cells at the molecular level.

Timeline

• Start date: 2021-05-12
• Primary completion: 2025-07-01
• Completion: 2025-09-01
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China