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

NCT03167775 | Unknown

• 1 other identifier: 81YY-ZLLL-16-19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• ORR

  1year

• PFS

  1 year

• OS

  3 year

• QLQ

  3 year

• the rate of incidence of adverse events

  3 year

Study Arms (1)

Elemene + the best supportive treatment

EXPERIMENTAL

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

Interventions

Elemene Injection/Elemene Oral Emulusion DRUG

Elemene + the best supportive treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiJing Yijiayi Medicine Techonoloy Co., Ltd.: lead
• Dalian Holley Kingkong Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

Henan Medical University Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

elemene

Central Study Contacts

Shukui Qin

CONTACT

025-80864541; qinsk@csco.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 30, 2017
• Study Start: November 28, 2016
• Primary Completion: May 27, 2019
• Study Completion: November 27, 2019
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)