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

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.

Conditions

• Cervical Cancer

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

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.

  lead OTHER

Principal Investigators

• Junjie Wang · Peking University Third Hospital

• Lichun Wei · TThe First Affiliated Hospital，the Air Force Medical University

• Lijuan Zou · The Second Affiliated Hospital of Dalian Medical University

• Zi Liu · First Affiliated Hospital Xi'an Jiaotong University

• Jiayi Chen · Ruijin Hospital

• Huijun Cheng · Henan Cancer Hospital

• Rutie Yin · West China Second University Hospital

• Xiangkun Yuan · Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine.HeBei

• Hui Qiu · Zhongnan Hospital

• Hong Zhu · Xiangya Hospital of Central South University

• Tiejun Wang · Second Hospital of Jilin University

• Xiaomei Fan · The Fourth Hospital of Hebei Medical University Hebei Tumor Hospital

• Keqiang Zhang · Hunan Cancer Hospital

• Dihong Tang · Hunan Cancer Hospital

• Qiongyu Lan · Second Affiliated Hospital of Nanchang University

• Xiaoying Xue · The Second Hospital of Hebei Medical University

• Song Gao · Shengjing Hospital

• Guang Li · First Hospital of China Medical University

• Qiuhong Tian · The First Affiliated Hospital of Nanchang University

• Guoqing Wang · Shaanxi Provincial Cancer Hospital

• Dong Qian · The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

• Manbo Cai · The First Affiliated Hospital of University of South China

• Yuhua Gao · Liaoning Cancer Hospital & Institute

• Dehua Wu · Nanfang Hospital, Southern Medical University

• Xiaoge Sun · The Affiliated Hospital of Inner Mongolia Medical University

• Yunyan Zhang · Cancer Hospital Affiliated to Harbin Medical University

• Kun Gao · Guangxi Medical University Cancer Center

• Qin Lin · The First Affiliated Hospital of Xiamen University

• Qin Xu · Fujian Cancer Hospital

• Hao Yang · Peking University Cancer Hospital Inner Mongolia Hospital

• Rong Huang · First People's Hospital of Foshan

• Xianming Li · Shenzhen People's Hospital

• Juntao Ran · LanZhou University

• Xiaojie Ma · Affiliated Hospital of North Sichuan Medical College

• Xingrao Wu · Yunnan Cancer Hospital

• Yipeng Song · Yantai Yuhuangding Hospital

• Jun Wang · Tianjin Cancer Hospital Airport Hospital

• Dapeng Li · Shandong Cancer Hospital ＆ Institute

• Siyuan Zeng · Jiangxi Maternal and Child Health Hospital

• Hongyun Shi · Affiliated Hospital of Hebei University

• Weihu Wang · Peking University Cancer Hospital & Institute

• Jidong Zhang · Shanxi Province Cancer Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2030-04-01

Completion

2030-04-01