Nimotuzumab in Combined With Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cervical Carcinoma

January 16, 2025 updated by: Biotech Pharmaceutical Co., Ltd.

An Multicenter, Randomized，Double-blind, Controlled Clinical Study of Nimotuzumab in Combined With First-line Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cervical Squamous Cell Carcinoma

This is an multicenter, randomized，double-blind, controlled clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with TP regimen (Paclitaxel + Cisplatin) for treatment of IVB stage, recurrent or persistent cervical squamous cell carcinoma .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This clinical study is designed as an multicenter, randomized，double-blind, controlled clinical study to evaluate the clinical efficacy and safety of Nimotuzumab combined with TP regimen (Paclitaxel + Cisplatin) for treatment of IVB stage, recurrent or persistent cervical squamous cell carcinoma . The main endpoint is overall survival time, The secondary endpoint is no disease progression time,objective response rate and the quality of life.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Cancer Institute and Hospital , Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntary and sign a consent form;
  2. Age 18-75 years old ;
  3. Histological diagnosis as cervical squamous cell carcinoma ;
  4. Histologically and/or cytologically confirmed stage IVB or first recurrent or persistent cervical cancer (Mainly refers to the primary radiotherapy or concurrent chemoradiotherapy at least 3 months after the tumor remains or progress) and patients cannot receive surgery or radiation ;
  5. Received taxoplatin + platinum combined chemotherapy stopped taking the drug for at least half a year, or received radiotherapy or concurrent chemoradiotherapy (cisplatin or cisplatin combined with 5-FU) for at least 3 months ;
  6. According to the RECIST 1.1 criteria,there is at least one measurable lesion . The maximum diameter must meet the requirements : CT scan ≥10mm (CT scan thickness is less than 5mm); Clinical routine examination instrument 10mm (tumor lesions that cannot be accurately measured by diameter instruments should be recorded as unmeasurable), chest X-ray ≥20mm; Malignant lymph nodes: pathologically enlarged and measurable, single lymph node CT scan diameter ≥15mm (CT scan Layer thickness not more than 5mm) ;
  7. Patients need to recover from toxic side effects (except decreased hemoglobin) of previous treatments (surgery, chemoradiotherapy, radiation therapy) to grade 1 or below （CTCAE 4.03）;
  8. ECOG performance status 0-1 ;
  9. Life expectancy of more than 3 months ;
  10. Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L,Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L ;
  11. TBIL≤1.5 ULN; ALK,AST and ALT≤2.5 ULN or ≤5 ULN(Liver metastasis) ; serum creatinine ≤ 1.5 ULN -

Exclusion Criteria:

  1. Simple mediastinal or/and supraclavicular lymph node metastases ;
  2. Bone metastases alone or multiple metastases with bone metastases requiring radiotherapy for pain relief ;
  3. Patients with recurrence and metastasis after the end of the last administration of neoadjuvant chemotherapy or postoperative adjuvant chemotherapy < 6 months ;
  4. Received anti-EGFR monoclonal antibody or small molecule TKI within 6 months prior to enrollment ;
  5. Major surgery within 4 weeks or planned surgery or radiation therap ;
  6. Participants in other interventional clinical trials within 1 month prior to informed consent ;
  7. Neurological or psychiatric abnormalities that affect cognitive ability, including brain metastases ;
  8. With clear peripheral neuropathy and related symptoms in the past;
  9. Active clinical infection (>grade 2 NCI-CTCAE 4.03), active tuberculosis, and known or self-reported HIV infection or active hepatitis B or C ;
  10. Severe respiratory system, blood system disease, intractable dysentery or intestinal cramps, intestinal obstruction, or poorly controlled diabetes ;
  11. Uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg), congestive heart failure above NYHA Ⅲ, unstable angina or poorly controlled arrhythmia , circulatory diseases such as myocardial infarction before enrollment within 6 months ;
  12. Have allergic reactions to study drugs and similar drugs ;
  13. Pregnant or breast-feeding or refused to take contraceptive method;
  14. Other malignant tumor;
  15. Any other serious complications or dysfunction of the organ system, as judged by the investigator, will affect the safety of the patient or interfere with the evaluation of the test drug ; -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nimotuzumab+TP(paclitaxel+cisplatin)
experimental group
Drug: Nimotuzumab
Nimotuzumab in combined with chemotherapy period, 400mg, day1, administered intravenously before chemotherapy ,weekly, for 18 weeks; Maintenance period, 400mg, every two weeks until disease progression or intolerable toxicity , maximum duration is 60 weeks .
Other Names:
  • h-R3
Drug: Paclitaxel
175mg/m^2,for 3 hour,day1,21 days for a cycle ,until disease progression or toxicity，maximum duration is 6 cycles.
Other Names:
  • Paclitaxel Injection
Drug: Cisplatin
50mg/m^2,day1orday2，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
Other Names:
  • Cisplatin for Injection
Placebo Comparator: Placebo + TP(paclitaxel+cisplatin)
control group
Drug: Paclitaxel
175mg/m^2,for 3 hour,day1,21 days for a cycle ,until disease progression or toxicity，maximum duration is 6 cycles.
Other Names:
  • Paclitaxel Injection
Drug: Cisplatin
50mg/m^2,day1orday2，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
Other Names:
  • Cisplatin for Injection
Drug: Placebo
Placebo in combined with chemotherapy period, 400mg, day1, administered intravenously before chemotherapy ,weekly, for 18 weeks; Maintenance period, 400mg, every two weeks until disease progression or intolerable toxicity , maximum duration is 60 weeks .
Other Names:
  • Nimotuzumab Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 46 months
OS was defined as the time from randomization to death due to any cause.
Up to approximately 46 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to approximately 46 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD.
Up to approximately 46 months
Objective Response Rate
Time Frame: Up to approximately 46 months
This wil be evaluated by RECISIT 1.1 criteria.It is dependent on imaging evaluation which will be done every 6 weeks. ORR is the percent of the patient who is evaluated as complete response(CR) or partial response (PR),that is (CR+PR)%.
Up to approximately 46 months
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 46months
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 46months
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 46months
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 46months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotech Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: lingying wu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BPL-Nim-CC-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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