DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC
Recruiting now · Phase 2
Conditions studied: Hepatocellular Carcinoma Non-resectable
In brief
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).
Key facts
- Study ID
- NCT06397235
- Run by
- Second Affiliated Hospital of Guangzhou Medical University
- People needed
- 130
- Starts
- 2024-05-01
- Expected to finish
- 2028-04-30
- Last updated by the study team
- 2025-02-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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