NCT03166553

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2019

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

May 22, 2017

Last Update Submit

May 23, 2017

Conditions

Advanced Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (5)

  • Disease control rate(DCR)

    1 year

  • Progression-free survival(PFS)

    1 year

  • Overall survival(OS)

    3 year

  • Quality of Life Questionnaire (QLQ)

    3 year

  • the rate of incidence of adverse events

    3 year

Study Arms (2)

Elemene +Oxaliplatin

EXPERIMENTAL

the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin

Drug: Elemene

Oxaliplatin

NO INTERVENTION

the group treated with Systematic Chemotherapy including Oxaliplatin

Interventions

ElemeneDRUG
Also known as: Oxaliplatin
Elemene +Oxaliplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

302 Military Hospital of China

Beijing, Beijing Municipality, 100039, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

NOT YET RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

Henan Medical University Cancer Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Xiehe University of Science and Technology Affiliate Tongji Hospital

Wuhan, Hubei, 43000, China

NOT YET RECRUITING

Jinan Military General Hospital

Jinan, Shandong, 250000, China

NOT YET RECRUITING

The Affiliated Hospital of Qindao University

Qindao, Shandong, 266000, China

NOT YET RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

MeSH Terms

Interventions

elemeneOxaliplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Central Study Contacts

Shukui Qin

CONTACT

025-80864541qinsk@csco.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 25, 2017

Study Start

November 28, 2016

Primary Completion

May 28, 2019

Study Completion

November 27, 2019

Last Updated

May 25, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)