NCT04678791

Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma

To Investigate the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Local Advanced Cervical Squamous Cell Carcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.

Detailed description

This study adopts a multi-center, randomized controlled, open-label clinical trial design.

Conditions

• Cervical Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab	Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
DRUG	Cisplatin	Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
RADIATION	External-beam radiation	Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
RADIATION	Brachytherapy	Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 \~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2020-12-22
• Last updated: 2020-12-22

Locations

1 site across 1 country: China