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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
302 Military Hospital of China
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGObjective 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
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The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Medical University Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGXiehe University of Science and Technology Affiliate Tongji Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGJinan Military General Hospital
Jinan, Shandong, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Qindao University
Qindao, Shandong, China
NOT_YET_RECRUITINGShanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITING