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NOT YET RECRUITING
NCT06333821
PHASE3

A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma

Sponsor: Biotech Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma. The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival.

Official title: A Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

460

Start Date

2024-04-01

Completion Date

2030-04-01

Last Updated

2024-03-27

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Nimotuzumab

Nimotuzumab 400mg

DRUG

Cisplatin

Cisplatin 40mg/m\^2

RADIATION

External Beam Radiotherapy (EBRT)

External Beam Radiotherapy (EBRT)

RADIATION

Brachytherapy

Brachytherapy

DRUG

placebo for Nimotuzumab

placebo for Nimotuzumab 400mg