Clinical trial · Interventional
DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC
DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial
NCT06397235CI-TRIAL-00086243recruitingPhase 2ClinicalTrials.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)
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).
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 |
|---|---|---|---|
| Hepatocellular Carcinoma Non-resectable | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE | Drug | — | UNRESOLVED |
| DEB-TACE+HAIC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DEB-TACE+HAIC
- description
- For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The RALOX-based regimen is intra-arterially administered. During follow-up, the treatment will be repeated on demand (about 4-week interval) based on the evaluation of the follow-up laboratory and imaging examination.
- interventionNames
- Drug: DEB-TACE+HAIC
- type
- ACTIVE_COMPARATOR
- label
- DEB-TACE
- description
- Superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * HCC confirmed by histology/cytology or diagnosed clinically. * At least one measurable intrahepatic target lesion. * The largest tumor size \> 7 cm. * Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment. * Child-Pugh score 5-7. * ECOG performance status ≤ 1. * Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds. Exclusion Criteria: * Macrovascular invasion or extrahepatic metastasis. * Diffuse HCC. * Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy. * Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy. * Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment. * History of other malignancies. * Uncontrollable infection. * History of HIV. * Gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3. * History of organ or cells transplantation. * Pregnant or lactating patients.
References
Publications (0)
Data not yet available
No reference posted for this study.