NCT06781073已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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 ; -
研究组 & 干预措施
Nimotuzumab+TP(paclitaxel+cisplatin)
Experimental
experimental group
干预措施: Nimotuzumab (Drug)
Nimotuzumab+TP(paclitaxel+cisplatin)
Experimental
experimental group
干预措施: Paclitaxel (Drug)
Nimotuzumab+TP(paclitaxel+cisplatin)
Experimental
experimental group
干预措施: Cisplatin (Drug)
Placebo + TP(paclitaxel+cisplatin)
Placebo Comparator
control group
干预措施: Paclitaxel (Drug)
Placebo + TP(paclitaxel+cisplatin)
Placebo Comparator
control group
干预措施: Cisplatin (Drug)
Placebo + TP(paclitaxel+cisplatin)
Placebo Comparator
control group
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 46 months
OS was defined as the time from randomization to death due to any cause.
次要结局
- 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)
研究者
研究点 (1)
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