DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Time Frame
Start Date:2024-05-01
Estimated Completion Date:2028-04-30
Participants
Target number of participants:130
Treatments
Experimental: DEB-TACE+HAIC
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.
Active_comparator: 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.
Leads: Second Affiliated Hospital of Guangzhou Medical University
Collaborators: Guangzhou Development District Hospital, Zhongshan People's Hospital, Guangdong, China, The Affiliated Shunde Hospital of Jinan University