Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 16 of 2007 for:    oxaliplatin

Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557503
Recruitment Status : Unknown
Verified July 2015 by Zhu Xu, Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Zhu Xu, Beijing Cancer Hospital

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Progression-free survival (PFS) [ Time Frame: three years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
overall survival (OS) [ Time Frame: three years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE
Official Title  ICMJE An Randomized and Controlled Study of Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE
Brief Summary To investigate the therapy effect and security of oxaliplatin and fluorouracil on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Adult Primary Liver Cancer
Intervention  ICMJE Drug: Oxaliplatin and fluorouracil
Oxaliplatin and fluorouracil by HAIC on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer after TACE
Study Arms  ICMJE
  • Experimental: Oxaliplatin by HAIC after TACE
    To investigate the therapy effect and security of oxaliplatin on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer
    Intervention: Drug: Oxaliplatin and fluorouracil
  • No Intervention: Fluorouracil by HAIC after TACE
    To investigate the therapy effect and security of fluorouracil on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. With written informed consent
  2. Age ranged from 18 to 80 years, both men and women
  3. Confirmed by pathology or clinical diagnosis of liver cancer
  4. Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
  5. Never received TACE treatment
  6. (M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
  7. ECOG PS score of ≤2
  8. expected survival time ≥12 weeks
  9. The test results before 7 days entered the group must meet the following requirements:

Hemoglobin ≥ 90 g / L Absolute neutrophil count (ANC)> 1,500 / mm3 Platelet count ≥ 80x109 / L Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 times the upper limit of normal (UNL) Total bilirubin <3UNL Serum creatinine <1.5 UNL PT or INR, PPT <1.5 UNL (for patients undergoing warfarin or heparin anticoagulant therapy, if there is no evidence that there is an abnormality of the above parameters, you can enter the group, but must be closely monitored to detect at least once a week until the INR stable)

Exclusion Criteria:

  1. Specific circumstances of patients not suitable for TACE therapy / chemotherapy
  2. Hepatic decompensation, or the presence of hepatic encephalopathy
  3. Before entering the study with gastrointestinal bleeding within 30 days
  4. Presence of brain metastasis
  5. Pregnant or lactating women
  6. Active bleeding or sepsis
  7. History of heart disease:

    NYHA two or more of congestive heart failure, symptomatic coronary artery disease Need to use β-blockers or digoxin medication other than arrhythmias

  8. Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension
  9. Not cure severe trauma, acute or incurable ulcer, or three months fracture
  10. The researchers believe their poor compliance
  11. Exist once or primary lesion or histologically different tumors and colorectal cancer, except: head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder cancer (Ta, Tis, T1), and the group 3 years ago, it has been cured of cancer
  12. HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
  13. Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
  14. Need drug therapy epilepsy (such as steroids or antiepileptic drugs
  15. Chemotherapy contraindications exist
  16. Any instability or likely to endanger the patient in this study the safety and compliance of the case
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557503
Other Study ID Numbers  ICMJE 2014KT71
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhu Xu, Beijing Cancer Hospital
Study Sponsor  ICMJE Zhu Xu
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Cancer Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP