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DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

RecruitingPhase 2Ages 18 Years - 75 YearsAllSecond Affiliated Hospital of Guangzhou Medical U…
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • DEB-TACE+HAIC
  • DEB-TACE
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Where

1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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