Anlotinib Combined with S-1 in the Third-Line Treatment of Stage IV Non-Small Cell Lung Cancer: Study Protocol for Phase II Clinical Trial
| Autor: | Xiaobo Du, Xiyue Yang, Lidan Geng, Miao Xiang, Yixue Wen |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male 0301 basic medicine Oncology medicine.medical_specialty Indoles Lung Neoplasms Adolescent medicine.medical_treatment Placebo Stage IV non-small cell lung cancer Young Adult 03 medical and health sciences 0302 clinical medicine Non-small cell lung cancer Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols Protocol Clinical endpoint Humans Medicine Prospective Studies Lung cancer Aged Randomized Controlled Trials as Topic Tegafur Third-line treatment Chemotherapy business.industry General Medicine Middle Aged Prognosis medicine.disease Survival Rate Clinical trial Drug Combinations Oxonic Acid 030104 developmental biology Research Design Fluorouracil 030220 oncology & carcinogenesis Toxicity Quinolines Female Anlotinib- S-1 business Follow-Up Studies medicine.drug |
| Zdroj: | Asian Pacific Journal of Cancer Prevention : APJCP |
| ISSN: | 2476-762X |
| DOI: | 10.31557/apjcp.2019.20.12.3849 |
| Popis: | Background A proportion of patients with stage IV non-small-cell lung cancer (NSCLC) is predicted to receive third-line treatment. However, currently no standard third-line treatment for NSCLC is available. Anlotinib is an oral, multi-targeted tyrosine kinase (TK) receptor inhibitor, which was approved as a third-line treatment for stage IV NSCLC in China on May 9, 2018. Nevertheless, The objective response rate of patients treated with anlotinib was merely 9.2% and the overall survival was only 3 months compared with the patients treated with placebo. Previous studies have shown that cancer treatment with a combination of chemotherapy with TK receptor inhibitors is effective and safe well tolerated. Therefore, the combination of anlotinib with other chemotherapeutic agents may be an effective treatment strategy for patients with stage IV NSCLC. Oral S-1 is a third-generation fluorouracil derivative; it showed good efficacy and caused relatively low toxicity in patients with NSCLC. Methods The purpose of this trial is to evaluate the efficacy and safety of anlotinib combined with S-1 as the third-line treatment for patients with stage IV NSCLC. This is a prospective, phase II clinical trial. We will enroll29 patients with stage IV NSCLC treated with anlotinib plus S-1. Tumors will be assessed using computed tomography prior to treatment, after two, four, and six cycles of treatment, and during follow-up every 3 months until disease progression or death. The primary endpoint is the objective response rate (ORR). The secondary endpoints are progression-free survival, duration of response, proportion of disease control, and safety. Discussion The expected outcome of this study is that anlotinib combined with S-1 has tolerable toxicity and better ORR than anlotinibmonotherapy. The results may indicate additional treatment options for patients with stage IV NSCLC. . |
| Databáze: | OpenAIRE |
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