Clinical trial · Interventional
Hepatic Artery Infusion With Oxaliplatin
Hepatic Arterial Infusion of Oxaliplatin Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator has left institution
Summary
Brief summary (as posted)
Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to obviate the need for initial major surgery (catheter placement) in patients who have unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size to make possible a complete resection of all lesions. Secondary goals are to reduce or eliminate the complexity usually associated with HAI, to accomplish most or all of the treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known toxicology, and established efficacy in colorectal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 Fluorouracil (systemic) | Drug | Fluorouracil | ALIAS |
| Oxaliplatin (via HAI) | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- number of patients who become eligible for total resection of metastatic liver tumor
- measure
- overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.
Secondary outcomes (3)
- measure
- toxicity
- measure
- HAI complexity
- measure
- cost
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed consent 2. Age greater than 17 years 3. Stage IV colorectal cancer 4. Metastasis limited to the liver considered unresectable for cure by standard methods 5. Completely resected primary tumor 6. Life expectancy greater than 3 years excluding cancer 7. Eastern Cooperative Oncology Group (ECOG) status 0, 1, 2 8. Absolute granulocyte count greater than 1500 9. Platelet count greater than 100,000 10. Adequate hepatic function 11. Adequate renal function Exclusion Criteria: 1. Concomitant anticancer therapy other than this protocol 2. Gastroduodenal ulcer 3. Pregnancy or lactation 4. Last treatment for colon cancer less than 4 weeks from this protocol
References
Publications (0)
Data not yet available