Advanced Primary Liver Cancer
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGElemene
Sponsors
Dalian Holley Kingkong Pharmaceutical Co., Ltd
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One group treated with the Elemene Injection/Elemene Oral Emulusion in Combination with Systematic Chemotherapy including Oxaliplatin , another group treated with Systematic Chemotherapy including Oxaliplatin.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years old，No limit on gender * Patients who are confirmed Locally advanced or metastatic primary liver cancer in accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination, Patients who are unable to accept surgery,radiofrequency ablation、TACE and local therapy ，orLocal treatment progress failed * didn't have any systematic treatment including systematic chemotherapy and molecular targeted therapy * According to RECIST V1.1，1at least has one measurable lesions * ECOG Score ≤1 * Patients who have primary liver cancer with Child - Pugh liver function grade rating A or better B(score\<=7) * Laboratory inspection basically meets the following requirements：Blood test：a. Hb\>=90g/L(without blood transfusion within 14 days), b. ANC\>=1.5×10\^9/L, c. PLT\>=80×10\^9/L. Biochemical test：a. ALB\>=28g/L(without blood transfusion within 14 days), b. ALT and AST \<=5ULN, c. TBIL\<=2ULN, d. Cr\<=1.5ULN.Blood Coagulation function: PT\<=ULN+6seconds * Life expectancy of at least 3 months * Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up
Exclusion criteria
* Patients have a adjuvant therapy using Oxaliplatin within 6 months * Patients have other anti-cancer treatment ， including α-IFN，Arsenious Acid Injection and other Traditional Chinese Medicine Patent Prescription for treating cancer * Patients blood pressure need to be controled(Systolic blood pressure\>150mmHg , Diastolic blood pressure\>90mmHg), Congestive heart failure , Unstable angina pectoris , New angina pectoris , and have no Myocardial infarction within 6months * Patients with severe acute infection and cann't be controled , Chronic suppurative infection , body temperature\>=39℃ ， Pleural effusion（medium and large） combined with infection * Patients with central nervous system metastasis and has symptoms * In the past or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted * Women who is pregnant or during breast feeding and not willing to contraception during the test * Coagulation dysfunction(PT\>16 seconds ， APTT\>43 seconds , TT\>21 seconds , Fib\<2g/L) , With bleeding tendency or the presence of vital organ thrombosis (lung, brain) is receiving thrombolytic or anticoagulant therapy * With a mental illness, or has a history of drugs abuse * Patients accepted any experimental drugs in the past 4 weeks * Other reasons the researchers think not suitable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate and/or 1-year survival rate | 1 year | Objective response rate.The proportion of patients who had a best response rating of complete response and partial response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate(DCR) | 1 year | Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease. |
| Progression-free survival(PFS) | 1 year | Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause |
| Overall survival(OS) | 3 year | Overall survival.The time of patient from randomization to death caused by any cause |
| Quality of Life Questionnaire (QLQ) | 3 year | Quality of Life Questionnaire Core 30 |
| the rate of incidence of adverse events | 3 year | NCI CTC AE 4.03 |
Countries
China
Contacts
Primary ContactShukui Qin
Outcome results
None listed