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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | three years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | three years |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
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| D008107 |
| Liver Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |