Clinical trial · Interventional
Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
NCT02557490CI-TRIAL-00019180unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Liver Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin and raltitrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oxaliplatin by TACE
- description
- 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.
- interventionNames
- Drug: oxaliplatin and raltitrexed
- type
- NO_INTERVENTION
- label
- Raltitrexed by TACE
- description
- Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- three years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFeng 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. PMID 36212504