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

NCT ID: NCT02557503

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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

Conditions

Advanced Adult Primary Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Oxaliplatin and fluorouracil

Intervention Type: DRUG

Oxaliplatin and fluorouracil by HAIC on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer after TACE

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhu Xu

OTHER

Sponsor Role: lead

Responsible Party

Zhu Xu

Interventional Therapy Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhu Xu, Master

Role: primary

zhux387@263.net

0086-10-88195476

Other Identifiers

2014KT71

Identifier Type: -

Identifier Source: org_study_id