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临床试验/NCT03890055
NCT03890055Unknown4 期

Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride in in Combination With EC/EP

Chifeng Municipal Hospital0 个研究点目标入组 30 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
30
主要终点
PFS

研究概览

简要总结

This study was designed to investigate the efficacy and side effects of combining erlotinib with classical EC/EP chemotherapy regimens.

详细描述

Lung cancer is a common malignant tumor that poses a serious threat to human health. Small cell lung cancer accounts for about 20% of lung cancer. Precision medicine has recently been perfectly interpreted in many tumor types, but the treatment of small cell lung cancer is still bleak. The EC/EP regimen is the most classic chemotherapy regimen for small cell lung cancer with good results but is prone to drug resistance. In 2018, with the development of immunotargeting therapy, small molecule multi-target anti-angi drugs, PARP inhibitors, new chemotherapy drugs, etc., the treatment of small cell lung cancer has ushered in a new dawn. As a kind of highly selective multi-target anti-angiogenic TKI drugs,Anlotinib Hydrochloride is a kind of 1.1 innovative drugs with independent intellectual property rights in China, mainly acting on VEGFR, PDGFR, FGFR and c-Kit. The latest ALTER1202 study confirms that anlotinib is significantly improved for PSC and ORR in SCLC patients who have previously received at least 2-line chemotherapy. OS data is not yet mature, but the benefits of the anlotinib group were observed. The adverse effects of anlotinib were consistent with expectations, no new adverse events were found, and safety was tolerated. Nowadays, the effective combination of traditional chemical therapy with molecular targeting and immunotherapy is the future development direction of lung cancer treatment. Therefore, this topic is designed to combine the efficacy of safety and safety with the treatment of anlotinib with the classic EC/EP chemotherapy regimen. Expected to get longer PFS and OS for patient benefit.

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

入选标准

  • patients 18-75 years of age.
  • A metastatic or recurrent advanced SCLC confirmed by histology or cytology and did not receive any other treatment;
  • a measurable disease
  • an Eastern Cooperative Oncology Group PS of 0-1;
  • an estimated survival duration of >6 months;

排除标准

  • Have used erlotinib or other anti-vascular targeted drugs (eg, Endo, bevacizumab, etc.)
  • Patients who have been treated with chemotherapy or radiotherapy for previous tumors.3.Have appeared or merged with other tumors within 5 years.4.Patients with no measurable lesions; 5.any severe and uncontrolled disease.

研究组 & 干预措施

Clinical trial group

Experimental

(Carboplatin/cisplatin + etoposide)+ (Anlotinib Hydrochloride 12 mg/day ,Each cycle was defined as 2 weeks on-treatment fol- lowed by 1 week off-treatment), after 4-6 cycles of treatment, the treatment was continued with anlotinib until disease progression.

干预措施: Anlotinib Hydrochloride (Drug)

结局指标

主要结局

PFS

时间窗: nine months

progression-free survival

次要结局

  • OS(12 months)
  • ORR(12 months)
  • DCR(12 months)
  • safety assessed by Adverse reactions(12 months)

研究者

发起方
Chifeng Municipal Hospital
申办方类型
Other
责任方
Sponsor

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