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

Summary

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).

Eligibility

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.

Conditions4

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