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

Primary Purpose

Advanced Adult Primary Liver Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin and fluorouracil
Sponsored by
Zhu Xu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Adult Primary Liver Cancer focused on measuring TACE; oxaliplatin; fluorouracil; liver cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oxaliplatin by HAIC after TACE

Fluorouracil by HAIC after TACE

Arm Description

To investigate the therapy effect and security of oxaliplatin on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer

To investigate the therapy effect and security of fluorouracil on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

overall survival (OS)

Full Information

First Posted
September 22, 2015
Last Updated
September 22, 2015
Sponsor
Zhu Xu
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1. Study Identification

Unique Protocol Identification Number
NCT02557503
Brief Title
Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE
Official Title
An Randomized and Controlled Study of Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhu Xu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Adult Primary Liver Cancer
Keywords
TACE; oxaliplatin; fluorouracil; liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin by HAIC after TACE
Arm Type
Experimental
Arm Description
To investigate the therapy effect and security of oxaliplatin on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer
Arm Title
Fluorouracil by HAIC after TACE
Arm Type
No Intervention
Arm Description
To investigate the therapy effect and security of fluorouracil on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin and fluorouracil
Intervention Description
Oxaliplatin and fluorouracil by HAIC on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer after TACE
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
three years
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: With written informed consent Age ranged from 18 to 80 years, both men and women Confirmed by pathology or clinical diagnosis of liver cancer Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy Never received TACE treatment (M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm, ECOG PS score of ≤2 expected survival time ≥12 weeks 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: Specific circumstances of patients not suitable for TACE therapy / chemotherapy Hepatic decompensation, or the presence of hepatic encephalopathy Before entering the study with gastrointestinal bleeding within 30 days Presence of brain metastasis Pregnant or lactating women Active bleeding or sepsis 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 Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension Not cure severe trauma, acute or incurable ulcer, or three months fracture The researchers believe their poor compliance 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 HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders Need drug therapy epilepsy (such as steroids or antiepileptic drugs Chemotherapy contraindications exist Any instability or likely to endanger the patient in this study the safety and compliance of the case
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Xu, Master
Phone
0086-10-88195476
Email
zhux387@263.net
First Name & Middle Initial & Last Name & Degree
Zhu Xu, Master

12. IPD Sharing Statement

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

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