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Brief Title: Adjuvant Therapy With Anlotinib for HCC
Official Title: Adjuvant Therapy With Anlotinib Hydrochloride for Patients With Hepatocellular Carcinoma Who Underwent Curative Resection: a Single Arm Study
Study ID: NCT04947371
Brief Summary: Patients with high risk of disease recurrence after curative resection for hepatocellular carcinoma (HCC) deserve active intervention. However, there's limited treatment choice for these patients. Anlotinib hydrochloride, a multitarget tyrosine kinase inhibitor for both tumor angiogenesis and proliferative signaling in cancer cells, is approved in China for the 3rd line treatment of advanced non-small cell lung cancer. In the current study, we are to evaluate the safety and effects of adjuvant anlotinib therapy for the patients who underwent curative resection for HCC with high risk of tumor recurrence, which is defined by Shanghai Score (Sun, et al. Chin Med J (Engl) 2017).
Detailed Description: Patients with high risk of disease recurrence after curative resection for hepatocellular carcinoma (HCC) deserve active intervention. However, there's limited treatment choice for these patients. Anlotinib hydrochloride, a multitarget tyrosine kinase inhibitor for both tumor angiogenesis and proliferative signaling in cancer cells, is approved in China for the 3rd line treatment of advanced non-small cell lung cancer. In the current study, we are to evaluate the safety and effects of adjuvant anlotinib therapy for the patients who underwent curative resection for HCC with high risk of tumor recurrence, which is defined by Shanghai Score (Sun, et al. Chin Med J (Engl) 2017). The primary outcome of this study is treatment safety, and the secondary outcome is recurrence-free survival and overall survival.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China
Name: Jia Fan, MD&PhD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Hui-Chuan Sun, MD&PhD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR