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

NCT06333821 | Not Yet Recruiting Phase 3

• 1 other identifier: BPL-Nim-CC-3003
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR)

  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 Outcomes (12)

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator

  Up to approximately 5 years

• 3-,5-Year Overall Survival (OS)

  Up to approximately 3 and 5 years

• 3-,5-Year Disease Free Survival(DFS)

  Up to approximately 3 and 5 years

• 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS)

  Up to approximately 3 and 5 years

• 3-,5-Year Distant Metastasis-free Survival (DMFS)

  Up to approximately 3 and 5 years

Study Arms (2)

Nimotuzumab+chemoradiotherapy

EXPERIMENTAL

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 .

Biological: Nimotuzumab; Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Radiation: Brachytherapy

placebo for Nimotuzumab+chemoradiotherapy

EXPERIMENTAL

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 .

Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Radiation: Brachytherapy; Drug: placebo for Nimotuzumab

Interventions

Nimotuzumab BIOLOGICAL

Nimotuzumab 400mg

Nimotuzumab+chemoradiotherapy

Cisplatin DRUG

Cisplatin 40mg/m\^2

Nimotuzumab+chemoradiotherapy; placebo for Nimotuzumab+chemoradiotherapy

External Beam Radiotherapy (EBRT) RADIATION

External Beam Radiotherapy (EBRT)

Nimotuzumab+chemoradiotherapy; placebo for Nimotuzumab+chemoradiotherapy

Brachytherapy RADIATION

Brachytherapy

Nimotuzumab+chemoradiotherapy; placebo for Nimotuzumab+chemoradiotherapy

placebo for Nimotuzumab DRUG

placebo for Nimotuzumab 400mg

Also known as: placebo

placebo for Nimotuzumab+chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years old;
• Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
• At least one measurable lesion according to RECIST 1.1;
• 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;
• ECOG score 0-1 points;
• 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;
• Compliance is good and informed consent is voluntarily signed.

You may not qualify if:

• Cervical adenocarcinoma and rare pathological types of malignant tumors;
• Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
• Ureteral obstruction, inability to place ureteral stent or pyelostomy;
• Pregnant or lactating women;
• Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
• Had undergone major surgery (except biopsy) within 4 weeks prior to randomization;
• Had received a live vaccine within 4 weeks prior to the initial study drug treatment or planned to vaccinate during the study;
• 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);
• 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；
• 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)；
• Conditions requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days before randomization；
• Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
• Patients with Crohn's disease and ulcerative colitis;
• Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
• Patients with known hypersensitivity to Nimotuzumab or its components;

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Related Publications (1)

• Wei S, Li X, Liu Z, Wei L, Zou L, Zhang Y, Sun X, Gao Y, Zhuo Y, Zhang M, Qu A, Zhang H, Guo H, Jiang P, Wang J. Nimotuzumab plus concurrent chemoradiotherapy sequential maintenance treatment for locally advanced cervical squamous cell carcinoma (NOTABLE-306): a multicenter, prospective, randomized, double-blind, placebo-controlled trial. J Gynecol Oncol. 2025 Dec 11. doi: 10.3802/jgo.2026.37.e46. Online ahead of print.

  PMID: 41514314 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

nimotuzumab; Cisplatin; Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Therapeutics

Study Officials

• 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

  Zhongnan Hospital

  STUDY CHAIR

• Hong Zhu

  Xiangya Hospital of Central South University

  STUDY CHAIR

• Tiejun Wang

  Second 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 CHAIR

Central Study Contacts

Junjie Wang

CONTACT

13701076310; junjiewang_edu@sina.cn

Ping Jiang

CONTACT

13439796018; drjiangping@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is double-blind and will blind both the investigator and the subjects. All participants in the study (including data managers and biostatisticians) will be unaware of treatment assignment (except blind statisticians).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share