NCT03744208Unknown2 期
A Study of Evaluating Recombinant Human Anti-EGFR Monoclonal Antibody (SCT200) and Standard Chemotherapy for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Shi Yuankai0 个研究点目标入组 30 人开始时间: 2018年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of first-line with recombinant anti-EGFR monoclonal antibody（SCT200）and standard chemotherapy in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.
详细描述
This open label, single-arm and multicenter phase II study is designed to evaluate Objective Response Rate (ORR) of first-line with anti-EGFR monoclonal antibody（SCT200）and standard chemotherapy in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this clinical trial and sign an informed consent form;
- •Male or female, age ≥ 18 and ≤ 75 years old;
- •ECOG fitness status score 0 to 1;
- •Recurrent and/or metastatic HNSCC (except nasopharyngeal carcinoma) diagnosed by pathology ；
- •Not suitable for topical treatment. Patients with only recurrent disease (no metastasis) must have received radiotherapy (as post-operative adjuvant therapy or as a treatment for locally advanced HNSCC) as a "localized area treatment" and radiotherapy must be completed at least 6 months prior to screening imaging；
- •Laboratory inspection:
- •Blood routine: neutrophils ≥1.5×l09/L, platelets≥75×109/L, hemoglobin≥80g/L;
- •Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ upper limit of normal value × 3 for liver metastasis, ALT and AST ≤ upper limit of normal value for liver metastases × 5; total bilirubin ( TBIL) ≤ upper limit of normal value × 1.5;
- •Renal function: creatinine (Cr) ≤ normal upper limit × 1.5;
- •Electrolyte: Magnesium ≥ normal lower limit;
- •According to the RECIST standard version 1.1, there is at least one measurable tumor lesion.
排除标准
- •Patients with a history of central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastasis, imaging confirmation must be performed within 28 days prior to enrollment to exclude central nervous system metastasis;
- •Received systemic chemotherapy for advanced or metastatic HNSCC, but do not include induction chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy (the end of this treatment must be more than 6 months from the first trial);
- •There are other medical history of malignant tumors, except that the malignant lesions have been treated with therapeutic measures 5 years or more before enrollment and there are no known active lesions. The investigator judges that the risk of recurrence is low; Non-melanoma skin cancer, and no evidence of worsening disease; adequately treated cervical cancer in situ, and no evidence of worsening disease; prostatic intraepithelial neoplasia, no evidence of prostate cancer recurrence;
- •known to be allergic to antibodies or other components contained in the test drug;
- •have received EGFR antibodies (such as panitumumab, cetuximab or its analogs), or small molecule EGFR inhibitors (such as gefitinib, erlotinib, lapatinib, etc.);
- •In the 4 weeks or 4 weeks before enrollment, they received anti-tumor drugs (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) or received research drug treatment and could not be included in the evaluation by the investigator. Pain-free palliative radiotherapy for bones;
- •At the time of enrollment, patients still had ≥2 peripheral neuropathy or hearing loss;
- •Patients have been enrolled in other study devices or study drug studies at screening time, or have been deactivated for less than or equal to 4 weeks from other study drugs or study devices;
- •Conduct or plan major surgery within 4 weeks prior to enrollment;
- •Received transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to enrollment;
- •Clinically significant cardiovascular disease (defined as: unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] ≥ II), uncontrollable severe arrhythmia);
- •Myocardial infarction occurred within 6 months prior to enrollment;
- •History of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
- •have clinical symptoms, require clinical intervention or serous effusion (such as pleural effusion and ascites) with a stabilization time of less than 4 weeks;
- •medical or psychiatric history or laboratory abnormal medical history that may interfere with the interpretation of the results;
- •Patients who are pregnant or breast-feeding, or who plan to be pregnant during the treatment period and within 6 months after the end of treatment;
- •Patients (including male or female patients) who are unwilling to receive effective contraception during the treatment period and within 6 months after the end of treatment;
- •HCV antibody positive; or HIV positive; or HBV test results: HBsAg positive and / or HBcAb positive and HBV DNA ≥ 104 copy number or ≥ 2000 IU / ml;
- •Patients have active or uncontrollable infections (except for simple urinary tract infections or upper respiratory tract infections) requiring systemic treatment within 2 weeks or 2 weeks prior to enrollment;
- •known patients have alcohol or drug addiction;
- •The investigator believes that patients have other conditions that may affect their adherence to protocol adherence and study indicators, and are not suitable for patients participating in the study.
研究组 & 干预措施
Anti-EGFR monoclonal antibody
Experimental
DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
干预措施: Anti-EGFR monoclonal antibody (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 1 year
ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.
次要结局
- Immunogenicity(1 year)
- Disease control rate (DCR)(1 year)
- Progresssion free survival(PFS)(1 year)
- Overall survival(OS)(1 year)
- EORTC QLQ-C30(1 year)
- EORTC QLQ-H&N35(1 year)
研究者
Shi Yuankai
Vice-president
Chinese Academy of Medical Sciences
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