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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.
- herbal medicine
- oncology
- complementary medicine
- clinical trials
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Footnotes
Contributors CC, SK and YK wrote the first manuscript for this trial and contributed to monitoring this trial. MK, B-HJ and Y-CS edited the first manuscript. S-GK conducted all the procedures for this protocol. All authors read and approved the final manuscript.
Funding This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number : HI11C2110). The management, analysis and reporting of study will be conducted independently by the study investigators.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The present study has been approved by the Institutional Review Board of the Ajou University Hospital (reference AJIRB-MED-CT1-16-311).
Provenance and peer review Not commissioned; externally peer reviewed.