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Brief Title: Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma
Official Title: A Pilot Study of Elemene Injectable Emulsion in Treating Patients With Refractory Glioblastoma
Study ID: NCT04674527
Brief Summary: This is a pilot phase I study to evaluate the safety and efficacy on elemene injectable emulsion in treating patients with glioblastoma. Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo.Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs.
Detailed Description: Background * Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo * The study shows that the methodological quality of RCTs of Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs Objectives * To evaluate the safety of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ * To evaluate the efficacy of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ Design This clinical trail is a randomized controlled trial.In control group,patients will receive TMZ-chemotherapy.In experimental group,patients will receive elemene injectable emulsion and TMZ-chemotherapy at the same time.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Name: Jianmin Zhang, MD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: STUDY_CHAIR