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Cervical CancerPhase 3NCT06333821

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

A Phase 3 study testing Nimotuzumab, Cisplatin and External Beam Radiotherapy (EBRT) in people with Cervical Cancer, run by Biotech Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Nimotuzumab, Cisplatin and External Beam Radiotherapy (EBRT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 1 Apr 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Junjie Wang contact

13701076310

junjiewang_edu@sina.cn

Ping Jiang contact

13439796018

drjiangping@qq.com

About this study

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

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.

Read the detailed description

This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical study.The trail will enroll 460 subjects (FIGO 2018, stageIB3-IVA)who meet enrollment criteria but do not meet exclusion criteria. According to clinical stage (FIGO 2018 stage, stage IB3-IIB or III-IVA) 、tumor diameter (>4cm or ≤4cm)、 age (≥18 years and < 65 years old or ≥65 years old and ≤80 years old) for stratified randomization. They are divided into experimental group and control group according to 1:1. Patients in the experimental group will receive nimotuzumab 400mg on the basis of concurrent chemoradiotherapy, once a week for 7-8 weeks, and then maintenance treatment once every 2 weeks for 24 weeks. Using placebo(Nimotuzumab injection mimics) in the control group 80 ml on the basis of concurrent chemoradiotherapy, once a week for 7 to 8 weeks, after the maintenance treatment, once every 2 weeks for 24 weeks. Patients with incomplete tumor response assessed by imaging and pathological examination 3 months after radiotherapy can be given 2-4 cycles of adjuvant chemotherapy with cisplatin/carboplatin combined with paclitaxel regimen. Regular imaging examination and survival follow-up were performed after treatment. The primary efficacy end point was progression-free survival.

Conditions
Cervical Cancer
Being tested
Nimotuzumab, Cisplatin, External Beam Radiotherapy (EBRT), Brachytherapy, placebo for Nimotuzumab
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NimotuzumabBiological

    Nimotuzumab 400mg

  • CisplatinDrug

    Cisplatin 40mg/m^2

  • External Beam Radiotherapy (EBRT)Radiation

    External Beam Radiotherapy (EBRT)

  • BrachytherapyRadiation

    Brachytherapy

  • placebo for NimotuzumabDrug

    Also called placebo

    placebo for Nimotuzumab 400mg

Study groups in NCT06333821
Study groupRoleWhat they receive
Nimotuzumab+chemoradiotherapyExperimentalParticipants 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 .
Receives: Biological: Nimotuzumab; Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Radiation: Brachytherapy
placebo for Nimotuzumab+chemoradiotherapyExperimentalParticipants 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 .
Receives: Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Radiation: Brachytherapy; Drug: placebo for Nimotuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 5 years

Secondary outcomes (12)

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

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years

  2. 3-,5-Year Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    Measured: Up to approximately 3 and 5 years

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

    DFS is defined as the time from randomization to disease recurrence or death due to any cause.

    Measured: Up to approximately 3 and 5 years

  4. 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS)

    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

    Measured: Up to approximately 3 and 5 years

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

    Distant metastasis-free survival (DMFS) was calculated from the date of patient recruitment to the date of distant metastasis.

    Measured: Up to approximately 3 and 5 years

  6. Tumor Regression Rate(TRR)

    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%.

    Measured: From date of randomization until the date of brachytherapy,assessed up to 5 weeks

  7. Complete Response Rate

    The proportion of subjects with the best complete response in this group assessed by MRI.

    Measured: From date of randomization until the date of brachytherapy,assessed up to 5 weeks

  8. Complete Response Rate

    The proportion of subjects with the best complete response in this group assessed by MRI.

    Measured: 3 months later after treatment

  9. Objective Response Rate

    The proportion of subjects with the best complete response or partial response in this group assessed by MRI.

    Measured: 3 months later after treatment

  10. 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

    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.

    Measured: Baseline and up to approximately 5 years

  11. 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

    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.

    Measured: Baseline and up to approximately 5 years

  12. Incidence of Treatment-Emergent Adverse Events

    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

    Measured: Within 30 days from the start of treatment to the end of the last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion1 Apr 2030 (estimated)
  4. Study completion1 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333821
Sponsor's protocol ID
BPL-Nim-CC-3003
Status last verified
Mar 2024
First submitted
9 Feb 2023
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 May;37(3):e46. doi: 10.3802/jgo.2026.37.e46. Epub 2025 Dec 11.

    PubMed 41514314

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nimotuzumab, Cisplatin and External Beam Radiotherapy (EBRT) in people with Cervical Cancer, run by Biotech Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junjie Wang (13701076310, junjiewang_edu@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06333821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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