Chemotherapy With Anlotinib in Advanced Cervical Cancer: A Prospective, Single-arm Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer.
TRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. All the enrolled patients received chemotherapy with Anlotinib.
PRIMARY ENDPOINT: Overall survival, defined as the observed length of life from entry into the study to death from any cause or the date of last contact.
详细描述
Patients with advanced (metastatic, persistent, and recurrent) cervical cancer will be recruited from Zhongda Hospital. Only patients who treated with paclitaxel plus nedaplatin will be included in the analysis. All patients receive paclitaxel (135-175mg /m^2) and nedaplatin (100 mg/m^2) infusion on day 1, and then take Anlotinib 12mg/d orally on day 7-21, every 3 weeks. Once patients reached CR or PR, Anlotinib was continued on 12mg/d maintenance therapy until disease progression or unacceptable toxicity was noted.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced (metastatic, persistent, and recurrent) cervical cancer confirmed by imaging and unsuitable for surgery and radiotherapy .
- •Eastern Cooperative Oncology Group (ECOG) Performance Score(PS) 0-1
- •Estimated life expectancy > 3 months
- •Adequate bone marrow function: hemoglobin > 90 g/L, absolute neutrophil count(ANC) > 1.5 × 10^9/L, platelet > 80 × 10^9/L);
- •Adequate hepatic function: total bilirubin < 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5×ULN or <5×ULN for patients with liver metastases;
- •Adequate renal function: serum creatinine < 1.5 × ULN or creatinine clearance rate (CCR) >60 mL/min;
- •Adequate cardiac function: left ventricular ejection fraction (LVEF) > 50%.
排除标准
- •Preexisting thyroid disease, thyroid function cannot be maintained in the normal range after treatment;
- •Have used other anti-VEGF or VEGFR-targeted drugs or received immunotherapy;
- •A history of major surgical treatment within 4 weeks, radiotherapy within 3 weeks, and concurrent chemoradiotherapy within 6 weeks;
- •Receiving hormone or immunosuppressive therapy for various reasons;
- •Inability to swallow oral medication;
- •Any malabsorption;
- •Diseases diagnosed as severe or uncontrollable within 6 months prior to the first day of treatment.
- •Participate in clinical trials of other antitumor drugs within 28 days prior to the start of study treatment;
- •The patient has comorbidities that may endanger the patient's safety or affect the patient's ability to complete the study.
- •According to the researcher's judgment, the patient has an accompanying disease that may jeopardize the patient's safety or affect the patient's ability to complete the study in the investigator's judgment.
结局指标
主要结局
Overall survival
时间窗: Up to 3 years
The time from the first day of treatment until death from any cause
次要结局
- The average score of FACT-Cx TOI [Functional Assessment](Up to 3 years)
- Incidence of Adverse Events [Safety and Tolerability](Up to 3 years)
- Progression-free survival(Up to 3 years)
研究者
Yang Shen
Deputy Director of Zhongda Hospital
Zhongda Hospital