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

NCT06781073 | Completed Phase 3 DMC

• 1 other identifier: BPL-Nim-CC-2
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Cervical Squamous Cell Carcinoma; Persistent

Keywords

Nimotuzumab; paclitaxel; cisplatin

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the time from randomization to death due to any cause.

  Up to approximately 46 months

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  Up to approximately 46 months

• Objective Response Rate

  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

  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

  Baseline and up to approximately 46months

Study Arms (2)

Nimotuzumab+TP(paclitaxel+cisplatin)

EXPERIMENTAL

experimental group

Drug: Nimotuzumab; Drug: Paclitaxel; Drug: Cisplatin

Placebo + TP(paclitaxel+cisplatin)

PLACEBO COMPARATOR

control group

Drug: Paclitaxel; Drug: Cisplatin; Drug: Placebo

Interventions

Nimotuzumab DRUG

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 .

Also known as: h-R3

Nimotuzumab+TP(paclitaxel+cisplatin)

Paclitaxel DRUG

175mg/m\^2,for 3 hour,day1,21 days for a cycle ,until disease progression or toxicity，maximum duration is 6 cycles.

Also known as: Paclitaxel Injection

Nimotuzumab+TP(paclitaxel+cisplatin); Placebo + TP(paclitaxel+cisplatin)

Cisplatin DRUG

50mg/m\^2,day1orday2，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.

Also known as: Cisplatin for Injection

Nimotuzumab+TP(paclitaxel+cisplatin); Placebo + TP(paclitaxel+cisplatin)

Placebo DRUG

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 .

Also known as: Nimotuzumab Placebo

Placebo + TP(paclitaxel+cisplatin)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary and sign a consent form;
• Age 18-75 years old ;
• Histological diagnosis as cervical squamous cell carcinoma ;
• 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 ;
• 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 ;
• 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) ;
• 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）;
• ECOG performance status 0-1 ;
• Life expectancy of more than 3 months ;
• Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L,Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L ;
• TBIL≤1.5 ULN; ALK,AST and ALT≤2.5 ULN or ≤5 ULN(Liver metastasis) ; serum creatinine ≤ 1.5 ULN -

You may not qualify if:

• Simple mediastinal or/and supraclavicular lymph node metastases ;
• Bone metastases alone or multiple metastases with bone metastases requiring radiotherapy for pain relief ;
• Patients with recurrence and metastasis after the end of the last administration of neoadjuvant chemotherapy or postoperative adjuvant chemotherapy \< 6 months ;
• Received anti-EGFR monoclonal antibody or small molecule TKI within 6 months prior to enrollment ;
• Major surgery within 4 weeks or planned surgery or radiation therap ;
• Participants in other interventional clinical trials within 1 month prior to informed consent ;
• Neurological or psychiatric abnormalities that affect cognitive ability, including brain metastases ;
• With clear peripheral neuropathy and related symptoms in the past;
• Active clinical infection (\>grade 2 NCI-CTCAE 4.03), active tuberculosis, and known or self-reported HIV infection or active hepatitis B or C ;
• Severe respiratory system, blood system disease, intractable dysentery or intestinal cramps, intestinal obstruction, or poorly controlled diabetes ;
• 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 ;
• Have allergic reactions to study drugs and similar drugs ;
• Pregnant or breast-feeding or refused to take contraceptive method;
• Other malignant tumor;
• 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 ; -

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital , Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Interventions

nimotuzumab; Paclitaxel; Cisplatin; Injections

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• lingying wu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: January 17, 2025
• Study Start: July 6, 2017
• Primary Completion: November 25, 2024
• Study Completion: December 6, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)