Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

Study Overview

• Status: Unknown
• Conditions: Advanced Primary Liver Cancer
• Intervention / Treatment: Drug: Elemene Injection/Elemene Oral Emulusion

Detailed Description

Patients with advanced primary liver cancer will be enrolled in the trial , then the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .The purpose of the study is to evaluate the effect and safety of the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment in the treatment of advanced primary liver cancer

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shukui Qin; Phone Number: 025-80864541; Email: qinsk@csco.org.cn

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Medical University Cancer Hospital
      • Contact: Huaimin Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-75 years old，No limit on gender
• Patients who are confirmed Locally advanced or metastatic primary liver cancerin 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
• have systematic treatment before( including systematic chemotherapy and/or molecular targeted therapy) , but the treatment was unsuccessed and the tumor progress
• According to RECIST V1.1，1at least has one measurable lesions
• ECOG Score ≤2
• 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>=60×10^9/L. Biochemical test：a. ALB>=29g/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 other anti-cancer treatment ， including α-IFN，Arsenious Acid Injection and other Traditional Chinese Medicine Patent Prescription for treating cancer
• 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
• Patients with severe acute infection and cann't be controled , Chronic suppurative infection , body temperature>=39℃ ， Pleural effusion（medium and large） combined with infection
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elemene + the best supportive treatment; the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .	Drug: Elemene Injection/Elemene Oral Emulusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCR and/or 6-months survival rate	Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease/	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.	1year
PFS	Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause	1 year
OS	Overrall survival.The time of patient from randomization to death caused by any cause	3 year
QLQ	Quality of Life Questionnaire Core 30	3 year
the rate of incidence of adverse events	NCI CTC AE 4.03	3 year

Collaborators and Investigators

• Sponsor: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
• Collaborators: Dalian Holley Kingkong Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Anticipated): May 27, 2019
• Study Completion (Anticipated): November 27, 2019

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 81YY-ZLLL-16-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No