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

Advanced Adult Primary Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557503
• Other study ID #: 2014KT71
• Status: Recruiting
• Phase: Phase 4
• First received: September 22, 2015
• Last updated: September 22, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ß-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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Adult Primary Liver Cancer
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		three years	Yes
Secondary	overall survival (OS)		three years	Yes