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

Last updated: January 16, 2025
Sponsor: Biotech Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Carcinoma

Lung Cancer

Squamous Cell Carcinoma

Treatment

Nimotuzumab

Paclitaxel

Placebo

Clinical Study ID

NCT06781073
BPL-Nim-CC-2
  • Ages 18-75
  • Female

Study Summary

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 .

Eligibility Criteria

Inclusion

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 orpersistent cervical cancer (Mainly refers to the primary radiotherapy or concurrentchemoradiotherapy at least 3 months after the tumor remains or progress) andpatients cannot receive surgery or radiation ;

  5. Received taxoplatin + platinum combined chemotherapy stopped taking the drug for atleast 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 . Themaximum diameter must meet the requirements : CT scan ≥10mm (CT scan thickness isless than 5mm); Clinical routine examination instrument 10mm (tumor lesions thatcannot be accurately measured by diameter instruments should be recorded asunmeasurable), chest X-ray ≥20mm; Malignant lymph nodes: pathologically enlarged andmeasurable, single lymph node CT scan diameter ≥15mm (CT scan Layer thickness notmore than 5mm) ;

  7. Patients need to recover from toxic side effects (except decreased hemoglobin) ofprevious treatments (surgery, chemoradiotherapy, radiation therapy) to grade 1 orbelow (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 neutrophilcount≥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

Exclusion Criteria:

  1. Simple mediastinal or/and supraclavicular lymph node metastases ;

  2. Bone metastases alone or multiple metastases with bone metastases requiringradiotherapy for pain relief ;

  3. Patients with recurrence and metastasis after the end of the last administration ofneoadjuvant chemotherapy or postoperative adjuvant chemotherapy < 6 months ;

  4. Received anti-EGFR monoclonal antibody or small molecule TKI within 6 months priorto enrollment ;

  5. Major surgery within 4 weeks or planned surgery or radiation therap ;

  6. Participants in other interventional clinical trials within 1 month prior toinformed consent ;

  7. Neurological or psychiatric abnormalities that affect cognitive ability, includingbrain 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 knownor self-reported HIV infection or active hepatitis B or C ;

  10. Severe respiratory system, blood system disease, intractable dysentery or intestinalcramps, intestinal obstruction, or poorly controlled diabetes ;

  11. Uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg), congestive heart failureabove NYHA Ⅲ, unstable angina or poorly controlled arrhythmia , circulatory diseasessuch 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 theinvestigator, will affect the safety of the patient or interfere with the evaluationof the test drug ; -

Study Design

Total Participants: 118
Treatment Group(s): 4
Primary Treatment: Nimotuzumab
Phase: 3
Study Start date:
July 06, 2017
Estimated Completion Date:
December 06, 2024

Study 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.

Connect with a study center

  • Cancer Institute and Hospital , Chinese Academy of Medical Sciences

    Beijing,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.