A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of Traditional Chinese Medicine Formula LC09 for Treatment of Capecitabine-Induced Hand and Foot Syndrome

RATIONALE: Hand foot syndrome may be treated or reduced by soaking Traditional Chinese Medicine Formula LC09 in patients receiving capecitabine for colorectal and/or breast cancer.
PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for colorectal or breast cancer.

开始日期2015-04-01

申办/合作机构

中日友好医院

100 项与 LC09 相关的临床结果

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100 项与 LC09 相关的转化医学

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100 项与 LC09 相关的专利（医药）

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项与 LC09 相关的文献（医药）

2020-01-01·Integrative Cancer Therapies3区 · 医学

Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, and Parallel-Controlled Trial

3区 · 医学

Article

作者: Jia, Liqun ; Lou, Yanni ; Yu, Ran ; Wu, Xuefeng

Background: LC09 is composed with 5 kinds of traditional Chinese herbal medicines ( Astragalus membranaceus, flowers carthami, lithospermum, geranium wilfordii, and radix angelicae) which are used in China and developed over several thousand years. Aim: To assess the effectiveness and safety of herbal compound LC09 on patients with capecitabine-associated hand-foot syndrome (HFS). Materials and Methods: In this randomized, double-blind, and parallel-controlled study, 156 patients that diagnosed with HFS were randomly assigned to a treatment group (n = 78) or control group (n = 78). Patients were evaluated every week by the National Cancer Institute (NCI) grade and Numerical Rating Scale (NRS) pain scores. The Dermatology Life Quality Index (DLQI) scale and Instrumental Activity of Daily Living (IADL) scale were used to assess the quality of life before the treatment, and at 1 week and after the treatment of 2 cycles. Results: At the baseline, no significant differences were observed between the 2 groups. After treatment, significant differences in NCI grade and NRS pain scores were observed between the 2 groups ( P < .01). In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group ( P < .01). Furthermore, the chemotherapy completion rate between 2 groups was significantly different ( P = .002). In addition, no adverse reactions were observed in either LC09 or control group. Conclusion: LC09 can decrease NCI grade and significantly alleviate pain in HFS patients. Besides, it can also increase chemotherapy completion rate.

2017-12-01·Biomaterials1区 · 工程技术

Tumor cell-targeted delivery of CRISPR/Cas9 by aptamer-functionalized lipopolymer for therapeutic genome editing of VEGFA in osteosarcoma

1区 · 工程技术

Article

作者: Zhu, Hailong ; Wu, Xiaohao ; He, Xiaojuan ; Peng, Songlin ; He, Bing ; Au, D W T ; Lu, Cheng ; Shaikh, Atik Badshah ; Zhang, Zong-Kang ; Chen, Zhihao ; Dang, Lei ; Liang, Chao ; Li, Fangfei ; Liu, Jin ; Wang, Luyao ; Wang, Chao ; Guo, Baosheng ; Zhang, Bao-Ting ; Li, Jie ; Zhang, Ge ; Lu, Aiping

Osteosarcoma (OS) is a highly aggressive pediatric cancer, characterized by frequent lung metastasis and pathologic bone destruction. Vascular endothelial growth factor A (VEGFA), highly expressed in OS, not only contributes to angiogenesis within the tumor microenvironment via paracrine stimulation of vascular endothelial cells, but also acts as an autocrine survival factor for tumor cell themselves, thus making it a promising therapeutic target for OS. CRISPR/Cas9 is a versatile genome editing technology and holds tremendous promise for cancer treatment. However, a major bottleneck to achieve the therapeutic potential of the CRISPR/Cas9 is the lack of in vivo tumor-targeted delivery systems. Here, we screened an OS cell-specific aptamer (LC09) and developed a LC09-functionalized PEG-PEI-Cholesterol (PPC) lipopolymer encapsulating CRISPR/Cas9 plasmids encoding VEGFA gRNA and Cas9. Our results demonstrated that LC09 facilitated selective distribution of CRISPR/Cas9 in both orthotopic OS and lung metastasis, leading to effective VEGFA genome editing in tumor, decreased VEGFA expression and secretion, inhibited orthotopic OS malignancy and lung metastasis, as well as reduced angiogenesis and bone lesion with no detectable toxicity. The delivery system simultaneously restrained autocrine and paracrine VEGFA signaling in tumor cells and could facilitate translating CRISPR-Cas9 into clinical cancer treatment.

Medicine4区 · 医学

Protocol for a prospective, randomized, controlled, double-blind, and monocentric clinical trial

4区 · 医学

ArticleOA

作者: Pei, Yuying ; Wang, Gui ; Lou, Yanni ; Gao, Yu ; Jia, Liqun ; Deng, Chao ; Yu, Ran

AbstractBackground:Molecular targeted anticancer drugs such as multikinase inhibitors have shown obvious therapeutic advantages in a variety of tumors. The occurrence of hand-foot skin reaction (HFSR) is positively correlated with therapeutic effect, but it is also the most common cause of dose limiting toxicity for this treatment. This can lead to interruption or decrement of the treatment, a reduction in quality of life for patients, as well as potentially leading to secondary infections. As a result, the curative effect of targeted anticancer drugs will be negatively impacted. Currently, there is no certain and effective therapy. External use of Chinese herb medicine LC09 in the early treatment of HFSR has shown positive outcomes, but it is necessary to carry out further clinical research to confirm.Objectives:The purpose of this study was to investigate the efficacy and safety of topical soaks of Chinese herbal medicine LC09 for HFSR induced by molecular targeted anticancer drugs.Methods:The trial is a prospective, randomized, controlled, double-blind, monocentric, and interventional study. A total of 66 patients with HFSR will be recruited and randomly assigned to receive either LC09 Granules or placebo. The primary outcomes are the assessment of HFSR grade and pain score. The secondary outcomes are the evaluation of the quality of life, incidence of targeted drug dosage reduction, and incidence of targeted drug withdrawal.Discussion:This prospective, randomized clinical trial will provide valuable data regarding the efficacy and safety of topical soak treatments with LC09 granules for HFSR. Positive results would provide evidence-based complementary therapeutic approach future treatments of HFSR.Trial registration:Chinese Clinical Trial Registry, http://www.chictr.org.cn, ChiCTR1900023679. Registered on 7 June 2019.

100 项与 LC09 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
手足综合症	临床3期	-	中日友好医院	2015-04-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO2019	N/A	手足综合症	156	Chinese Herbal Compound LC09	範鬱積廠鹽範憲餘願築(積積窪憲鬱膚衊窪顧願) = 鑰顧糧遞簾膚齋鏇蓋範獵襯積艱醖觸襯製壓餘 (膚壓繭觸鑰憲窪鏇範膚 ) 更多	-	2019-09-28
ASCO2011	临床2期	手足综合症	102	LC09	(廠選艱遞顧簾築築衊選) = 餘鑰積鏇壓襯範築醖夢鹽繭鏇夢構淵鑰築憲膚 (觸艱壓襯築鬱遞艱醖廠 ) 更多	-	2011-05-20
ASCO2011	临床2期	手足综合症	102	Placebo	(廠選艱遞顧簾築築衊選) = 觸醖醖餘顧構壓衊積醖鹽繭鏇夢構淵鑰築憲膚 (觸艱壓襯築鬱遞艱醖廠 ) 更多	-	2011-05-20
ASCO2010	N/A	-	12	LC09 granules 10g	(遞選選築願觸糧衊鹹夢) = 衊鬱鹽鏇獵糧糧鹽衊繭遞壓糧願築築願艱壓顧 (淵鑰醖淵遞構鏇鑰簾獵 ) 更多	-	2010-05-20