Clinical trial · Interventional
Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer
Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
- 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)
RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer. PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ethiodized oil | Drug | — | UNRESOLVED |
| iodine I 131 ethiodized oil | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
- interventionNames
- Radiation: iodine I 131 ethiodized oil
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive an intra-arterial infusion of unlabeled ethiodized oil.
- interventionNames
- Drug: ethiodized oil
Primary outcomes (1)
- measure
- Tumor recurrence at 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of hepatocellular carcinoma (HCC) * Alpha-fetoprotein \< 20 ng/mL * Must have undergone curative treatment for HCC within the past 8-20 weeks, including 1 of the following: * Curative resection * Alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules \< 5 cm in diameter) * No ascites * No other intrahepatic involvement or nodule progression as assessed by ultrasound * No extrahepatic metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * ANC ≥ 1,500/mm³ * Platelet count ≥ 50,000/mm³ * Bilirubin ≤ 51 μmol/L * Creatinine ≤ 120 μmol/L * Not pregnant or nursing * Negative pregnancy test * Child-Pugh score \< 8 (class B) * No decompensated cirrhosis * No encephalopathy * No uncontrolled bleeding * No portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or portal reflux by doppler or CT scan * No unstable medical or surgical disease * No contraindication to vascular arteriography * No history of complications after injection of iodine contrast agents * Not incarcerated PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy * No prior hormonal treatment, including tamoxifen and somatostatin analogs * No prior systemic chemotherapy
References
Publications (0)
Data not yet available