- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06333821
A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma
A Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Ping Jiang
- Phone Number: 13439796018
- Email: drjiangping@qq.com
Study Contact Backup
- Name: Junjie Wang
- Phone Number: 13701076310
- Email: junjiewang_edu@sina.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1.Aged 18-80 years old;
- 2.Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
- 3.At least one measurable lesion according to RECIST 1.1;
- 4.Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria: Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 1.5 × 10^9/L and white blood cell count ≥ 3.0 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN ; Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;
- 5.ECOG score 0-1 points;
- 6.Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation); Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;
- 7.Compliance is good and informed consent is voluntarily signed.
Exclusion Criteria:
- 1.Cervical adenocarcinoma and rare pathological types of malignant tumors;
- 2.Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
- 3.Ureteral obstruction, inability to place ureteral stent or pyelostomy;
- 4.Pregnant or lactating women;
- 5.Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
- 6.Had undergone major surgery (except biopsy) within 4 weeks prior to randomization;
- 7.Had received a live vaccine within 4 weeks prior to the initial study drug treatment or planned to vaccinate during the study;
- 8.Human immunodeficiency virus (HIV) infection;Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);
- 9.Had the following serious medical conditions: a) Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg), or had experienced a hypertensive crisis; b) Myocardial infarction and unstable angina occurred within 6 months before randomization; c) Decompensated heart failure within three months before enrollment (NYHA class III and IV); d) The presence of severe arrhythmias requiring long-term medical intervention, except in patients with asymptomatic atrial fibrillation with stable ventricular rate; e) Left ventricular ejection fraction (LVEF)<50%; f) The presence of uncontrolled hyperglycemia; g) The presence of uncontrollable infections;
- 10.The presence of active or suspected autoimmune diseases, except for type 1 diabetes、hypothyroidism or skin conditions that do not require systemic treatment (vitiligo、psoriasis or alopecia);
- 11.Conditions requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days before randomization;
- 12.Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
- 13.Patients with Crohn's disease and ulcerative colitis;
- 14.Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
- 15.Patients with known hypersensitivity to Nimotuzumab or its components;
- 16.Patients with contraindications to cisplatin、carboplatin and paclitaxel;
- 17.Patients with neurological or psychiatric disorders affecting cognitive ability;
- 18.Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;
- 19.Any condition that, in the opinion of the Investigator, may be inappropriate for patients in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nimotuzumab+chemoradiotherapy
Participants receive Nimotuzumab 400 mg intravenously (IV) on Day 1 of each week cycle (QW) for 7-8 cycles followed by Nimotuzumab 400 mg IV on Day 1 of each 2-week cycle (Q2W) for an additional 12 cycles.
During the QW dosing period of Nimotuzumab, participants receive concurrent chemoradiotherapy.
The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once or divides into 3 times per week (QW) for 4 or 5 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80-85 Gray Units (Gy) for volume-directed given with the total duration of radiation treatment not to exceed 8 weeks .
|
Brachytherapy
Nimotuzumab 400mg
Cisplatin 40mg/m^2
External Beam Radiotherapy (EBRT)
|
Experimental: placebo for Nimotuzumab+chemoradiotherapy
Participants receive placebo for Nimotuzumab 400 mg intravenously (IV) on Day 1 of each week cycle (QW) for 7-8 cycles followed by placebo 400 mg IV on Day 1 of each 2-week cycle (Q2W) for an additional 12 cycles.
During the QW dosing period of placebo, participants receive concurrent chemoradiotherapy.
The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once or divides into 3 times per week (QW) for 4 or 5 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80-85 Gray Units (Gy) for volume-directed given with the total duration of radiation treatment not to exceed 8 weeks .
|
Brachytherapy
Cisplatin 40mg/m^2
External Beam Radiotherapy (EBRT)
placebo for Nimotuzumab 400mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 5 years
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
|
Up to approximately 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator
Time Frame: Up to approximately 5 years
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
|
Up to approximately 5 years
|
3-,5-Year Overall Survival (OS)
Time Frame: Up to approximately 3 and 5 years
|
OS is the time from randomization to death due to any cause.
|
Up to approximately 3 and 5 years
|
3-,5-Year Disease Free Survival(DFS)
Time Frame: Up to approximately 3 and 5 years
|
DFS is defined as the time from randomization to disease recurrence or death due to any cause.
|
Up to approximately 3 and 5 years
|
3-,5-Year Locoregional Recurrence-Free Survival(LRRFS)
Time Frame: Up to approximately 3 and 5 years
|
Locoregional recurrence-free survival (LRRFS) was defined as the absence of either consistent or relapsed disease at the primary tumor site or the regional lymph nodes
|
Up to approximately 3 and 5 years
|
3-,5-Year Distant Metastasis-free Survival (DMFS)
Time Frame: Up to approximately 3 and 5 years
|
Distant metastasis-free survival (DMFS) was calculated from the date of patient recruitment to the date of distant metastasis.
|
Up to approximately 3 and 5 years
|
Tumor Regression Rate(TRR)
Time Frame: From date of randomization until the date of brachytherapy,assessed up to 5 weeks
|
The maximum diameter represents the size of the tumor by MRI.
Tumor size for each patient were obtained: pre-RT tumor size (V1), pre- brachytherapy tumor size (V2).
TRR=(V1-V2)/V1 × 100%.
|
From date of randomization until the date of brachytherapy,assessed up to 5 weeks
|
Complete Response Rate
Time Frame: From date of randomization until the date of brachytherapy,assessed up to 5 weeks
|
The proportion of subjects with the best complete response in this group assessed by MRI.
|
From date of randomization until the date of brachytherapy,assessed up to 5 weeks
|
Complete Response Rate
Time Frame: 3 months later after treatment
|
The proportion of subjects with the best complete response in this group assessed by MRI.
|
3 months later after treatment
|
Objective Response Rate
Time Frame: 3 months later after treatment
|
The proportion of subjects with the best complete response or partial response in this group assessed by MRI.
|
3 months later after treatment
|
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
Time Frame: Baseline and up to approximately 5 years
|
The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants.
The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties.
The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life.
Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status.
The change from baseline in EORTC QLQ-C30 score will be presented.
|
Baseline and up to approximately 5 years
|
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
Time Frame: Baseline and up to approximately 5 years
|
The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments.
The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning.
The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment.
The change from baseline in EORTC QLQ-CX24 score will be presented.
|
Baseline and up to approximately 5 years
|
Incidence of Treatment-Emergent Adverse Events
Time Frame: Within 30 days from the start of treatment to the end of the last treatment
|
Safety was assessed as adverse events during treatment, the incidence of various adverse events such as adverse events related to the study drug during treatment, laboratory tests, etc
|
Within 30 days from the start of treatment to the end of the last treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Junjie Wang, Peking University Third Hospital
- Study Chair: Lichun Wei, TThe First Affiliated Hospital,the Air Force Medical University
- Study Chair: Lijuan Zou, The Second Affiliated Hospital of Dalian Medical University
- Study Chair: Zi Liu, First Affiliated Hospital Xi'an Jiaotong University
- Study Chair: Jiayi Chen, Ruijin Hospital
- Study Chair: Huijun Cheng, Henan Cancer Hospital
- Study Chair: Rutie Yin, West China Second University Hospital
- Study Chair: Xiangkun Yuan, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine.HeBei
- Study Chair: Hui Qiu, Wuhan University Zhongnan Hospital
- Study Chair: Hong Zhu, Xiangya Hospital of Central South University
- Study Chair: Tiejun Wang, The Second Norman Bethune Hospital of Jilin University
- Study Chair: Xiaomei Fan, The Fourth Hospital of Hebei Medical University Hebei Tumor Hospital
- Study Chair: Keqiang Zhang, Hunan Cancer Hospital
- Study Chair: Dihong Tang, Hunan Cancer Hospital
- Study Chair: Qiongyu Lan, Second Affiliated Hospital of Nanchang University
- Study Chair: Xiaoying Xue, The Second Hospital of Hebei Medical University
- Study Chair: Song Gao, Shengjing Hospital
- Study Chair: Guang Li, First Hospital of China Medical University
- Study Chair: Qiuhong Tian, The First Affiliated Hospital of Nanchang University
- Study Chair: Guoqing Wang, Shanxi Provincial Cancer Hospital
- Study Chair: Dong Qian, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
- Study Chair: Manbo Cai, The First Affiliated Hospital of University of South China
- Study Chair: Yuhua Gao, Liaoning cancer Hospital & Institute
- Study Chair: Dehua Wu, Nanfang Hospital, Southern Medical University
- Study Chair: Xiaoge Sun, The Affiliated Hospital of Inner Mongolia Medical University
- Study Chair: Yunyan Zhang, Cancer Hospital Affiliated to Harbin Medical University
- Study Chair: Kun Gao, Guangxi Medical University Cancer Center
- Study Chair: Qin Lin, The First Affiliated hospital of Xiamen University
- Study Chair: Qin Xu, Fujian Cancer Hospital
- Study Chair: Hao Yang, Peking University Cancer Hospital Inner Mongolia Hospital
- Study Chair: Rong Huang, First People's Hospital of Foshan
- Study Chair: Xianming Li, Shenzhen People's Hospital
- Study Chair: Juntao Ran, LanZhou University
- Study Chair: Xiaojie Ma, Affiliated Hospital of North Sichuan Medical College
- Study Chair: Xingrao Wu, Yunnan Cancer Hospital
- Study Chair: Yipeng Song, Yantai Yuhuangding Hospital
- Study Chair: Jun Wang, Tianjin Cancer Hospital Airport Hospital
- Study Chair: Dapeng Li, Shandong Cancer Hospital & Institute
- Study Chair: Siyuan Zeng, Jiangxi Maternal and Child Health Hospital
- Study Chair: Hongyun Shi, Affiliated Hospital of Hebei University
- Study Chair: Weihu Wang, Peking University Cancer Hospital & Institute
- Study Chair: Jidong Zhang, Shanxi Province Cancer Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Carcinoma
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Nimotuzumab
Other Study ID Numbers
- BPL-Nim-CC-3003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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