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

NCT02557503 | Unknown Phase 4

• 1 other identifier: 2014KT71
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

TACE; oxaliplatin; fluorouracil; liver cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  three years

Secondary Outcomes (1)

• overall survival (OS)

  three years

Study Arms (2)

Oxaliplatin by HAIC after TACE

EXPERIMENTAL

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

Fluorouracil by HAIC after TACE

NO INTERVENTION

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

Interventions

Oxaliplatin and fluorouracil DRUG

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

Oxaliplatin by HAIC after TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhu Xu: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional Therapy Department

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 23, 2015

Record last verified: 2015-07

Locations

CN (1)