NCT04367909Unknown2 期
A Phase II, Prospective, Single-center, Randomized, Controlled Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell Carcinoma
Xin-Hua Xu1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年6月21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
- 68
- 试验地点
- 1
- 主要终点
- Compare Progression Free Survival (PFS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy using RECIST 1.1.
研究概览
简要总结
This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of TC Regimenwith or without nimotuzumab in recurrent metastatic oral squamous cell carcinoma. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
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
- 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
- •Volunteer to participate in clinical research; fully understand and know the research and sign informed consent.
- •Age ≥18 years, and ≤75years , either sex.
- •Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or
- •Patients with distant metastasis and/or recurrence of oral squamous cell carcinoma (including gingival cancer, tongue cancer, lip cancer, buccal cancer, oral cancer, etc) diagnosed by histopathology (according to the 8th edition of AJCC).
- •Unable to perform local treatment (including radiotherapy and surgery).
- •Have at least one measurable lesion as defined by RECIST 1.
- •Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present.
- •Normal renal function ：Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ).
- •Normal hematological function：absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency].
- •Has a life expectancy of at ≥3 months.
排除标准
- •Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within three months.
- •Patients who are receiving any other investigational agents within 30 days prior to entering the study.
- •The tumor has metastasized to the brain and / or pia mater.
- •History of other malignancies (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years).
- •Accompanied by other serious diseases, including but not limited to:
- •Uncontrollable congestive heart failure (NYHA grade Ⅲ or Ⅳ), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP > 160mmhg or DBP > 100mmhg) ; Severe active infection; Uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring) ; Mental illness affecting informed consent and / or program compliance.
- •Those who are allergic to the drug or its components used in the program.
- •Pregnancy (confirmed by hCG test in blood or urine) or lactating women, or childbearing age subjects are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
- •Those who are not considered suitable for the study by the researchers.
- •Unwilling to participate in this study or unable to sign informed consent.
研究组 & 干预措施
Nimotuzumab plus TC Regimen chemotherapy
Experimental
Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks
干预措施: Nimotuzumab (Drug)
Nimotuzumab plus TC Regimen chemotherapy
Experimental
Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks
干预措施: Docetaxel (Drug)
Nimotuzumab plus TC Regimen chemotherapy
Experimental
Nimotuzumab (200 mg) plus TC Regimen chemotherapy every 3 weeks
干预措施: Carboplatin (Drug)
TC Regimen chemotherapy
Active Comparator
TC Regimen chemotherapy every 3 weeks
干预措施: Docetaxel (Drug)
TC Regimen chemotherapy
Active Comparator
TC Regimen chemotherapy every 3 weeks
干预措施: Carboplatin (Drug)
结局指标
主要结局
Compare Progression Free Survival (PFS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy using RECIST 1.1.
时间窗: approximately 24 months
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
次要结局
- Compare objective response rate between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.(approximately 24 months)
- Compare Overall Survival (OS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy(approximately 24 months)
- Compare Disease Control Rate (DCR) between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.(approximately 24 months)
- Number of Participants who Experience Treatment Related Adverse Events (AEs).(approximately 24 months)
研究者
Xin-Hua Xu
professor
China Three Gorges University, Yichang, China
研究点 (1)
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