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

September 22, 2015 updated by: Zhu Xu

An Randomized and Controlled Study of Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: three years
three years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival (OS)
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhu Xu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014KT71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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