Clinical trial · Interventional
Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis
Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial
NCT04912258CI-TRIAL-00052087unknownPhase 3ClinicalTrials.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)
Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis
Conditions
Conditions (2)
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 Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trans arterial chemoembolization with Irinotecan Drug-eluting Beads | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- DEB-TACE before liver surgery
- interventionNames
- Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads
- type
- NO_INTERVENTION
- label
- Arm B
- description
- direct liver surgery
Primary outcomes (1)
- measure
- liver relapse-free survival
- timeFrame
- 6 months
- description
- from liver surgery to liver relapse
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years; * Histologically proven colorectal liver metastasis； * With liver-dominant disease； * Primarily evaluated as potentially resectable and conversed successfully * Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 (within 1 week prior to randomization) * Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization); * Written informed consent for participation in the trial. Exclusion Criteria: * Primarily evaluated as resectable * Failed to converse * Patients with known hypersensitivity reactions to any of the components of the study treatments. * Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding * Other previous malignancy within 5 years * Known drug abuse/ alcohol abuse * Legal incapacity or limited legal capacity
References
Publications (0)
Data not yet available
No reference posted for this study.