An interventional study of Elemene in Advanced Primary Liver Cancer, sponsored by BeiJing Yijiayi Medicine Techonoloy Co., Ltd.. Status unknown at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. · Not applicable, Interventional, and Treatment
Clinical Trial of Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer
Patients with advanced primary liver cancer will be enrolled in the trial , then separated randomly into two group. One group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin , another group treated with Systematic Chemotherapy including Oxaliplatin. The purpose of the study is to evaluate the effect and safety of the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer
BeiJing Yijiayi Medicine Techonoloy Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin
Drug: Elemene
the group treated with Systematic Chemotherapy including Oxaliplatin
Also known as: Oxaliplatin
Objective response rate and/or 1-year survival rate
Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.
Time frame: 1 year
Disease control rate(DCR)
Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Time frame: 1 year
Progression-free survival(PFS)
Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause
Time frame: 1 year
Overall survival(OS)
Overall survival.The time of patient from randomization to death caused by any cause
Time frame: 3 year
Quality of Life Questionnaire (QLQ)
Quality of Life Questionnaire Core 30
Time frame: 3 year
the rate of incidence of adverse events
NCI CTC AE 4.03
Time frame: 3 year
Plan to share: No
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This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Elemene
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.