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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin by TACE | Experimental | Oxaliplatin for the therapy of Colorectal Cancer With Liver Metastases by TACE.No interventions was raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE. |
|
| Raltitrexed by TACE | No Intervention | Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin and raltitrexed | Drug | 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) |
| 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:
With written informed consent
Age ranged from 18 to 80 years, both men and women
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)
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:
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:
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36212504 | Derived | Feng AW, Guo JH, Gao S, Kou FX, Liu SX, Liu P, Chen H, Wang XD, Xu HF, Cao G, Zhu X. A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases. Front Oncol. 2022 Sep 21;12:913017. doi: 10.3389/fonc.2022.913017. eCollection 2022. |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| C068874 | raltitrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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