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Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol.

ABSTRACT: INTRODUCTION:Cancer is a major health problem worldwide and the leading cause of death in many countries. The number of patients with cancer and socioeconomic costs of cancer continues to increase. SH003 is a novel herbal medicine consisting of Astragalus membranaceus, Angelica gigas and Trichosanthes Kirilowii Maximowicz. Preclinical studies have shown that SH003 has therapeutic anticancer effects. The aim of this study is to determine the maximum tolerated dose of SH003 in patients with solid cancers. METHODS AND ANALYSIS:This study is an open-label, dose-escalation trial evaluating the safety and tolerability of SH003. The traditional 3+3?dose-escalation design will be implemented. Patients with solid cancers will be recruited. According to dose level, the patients will receive one to four tablets of SH003, three times a day for 3 weeks. Toxicity will be evaluated using common terminology criteria for adverse events (CTCAE). Dose-limiting toxicities are defined as grade 3 or higher adverse events based on CTCAE. The maximum tolerated dose will be determined by the highest dose at which no more than one of six patients experiences dose-limiting toxicity. ETHICS AND DISSEMINATION:This study has been approved by the institutional review board of the Ajou University Hospital (reference AJIRB-MED-CT1-16-311). The results of this study will be disseminated through a scientific journal and a conference. TRIAL REGISTRATION NUMBER:NCT03081819; Pre-results.

SUBMITTER: Cheon C

PROVIDER: S-EPMC6078237 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol.

Cheon Chunhoo C Kang Sohyeon S Ko Youme Y Kim Mia M Jang Bo-Hyoung BH Shin Yong-Cheol YC Ko Seong-Gyu SG

BMJ open 20180805 8

<h4>Introduction</h4>Cancer is a major health problem worldwide and the leading cause of death in many countries. The number of patients with cancer and socioeconomic costs of cancer continues to increase. SH003 is a novel herbal medicine consisting of <i>Astragalus membranaceus</i>, <i>Angelica gigas</i> and <i>Trichosanthes Kirilowii Maximowicz</i>. Preclinical studies have shown that SH003 has therapeutic anticancer effects. The aim of this study is to determine the maximum tolerated dose of ...[more]

PMID: 30082340

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Dataset Information

Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol.

Publications

Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol.

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