Colon Cancer Liver Metastasis
Conditions
Keywords
TACE; hepatic artery infusion; oxaliplatin; raltitrexed
Brief summary
The purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion
Detailed description
Colorectal cancer is one of the most common malignancies, with 1 million new cases and half a million deaths each year worldwide. The development of metastases is the main cause of death. Liver metastases are diagnosed in 10-25% of patients at the time of resection of their primary colorectal tumor and, eventually, up to 70% of patients with colorectal cancer develop liver metastases.Oxaliplatin and raltitrexed were used for the treatment of colorectal cancer with liver metastases. We aimed to perform a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion.
Interventions
DRUGoxaliplatin and raltitrexed
TACE methods: use of epirubicin 20-40mg emulsifier lipiodol embolization target vessel, with gelatin sponge particles or PVA particles or microspheres embolization supplement. Hepatic arterial chemotherapy: Bi embolization catheter in the hepatic artery or left hepatic artery branch within the right, chemotherapy, for the experimental group (A group): OXA 130mg / m2 artery 0-4 hours pumped Raltitrexed 3mg/m2 4-5 hours pumped into the arteries; the control group (group B)
Sponsors
Zhu Xu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 unresectable colorectal cancer with liver metastases patients(including the primary tumor and liver in patients with brain metastases except outside of metastasis in patients with unresectable) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | three years |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS) | three years |
Countries
China
Outcome results
None listed