230
Participants
Start Date
February 10, 2022
Primary Completion Date
February 9, 2026
Study Completion Date
February 9, 2026
dTACE-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 proper/left/right hepatic artery. The FOLFOX-based regimen is intra-arterially administered.~During follow-up, the treatment will be repeated on demand (at a 4-6-week interval usually) based on the evaluation of the follow-up laboratory and imaging examination."
HAIC
"HAIC treatment is divided into 3-week cycles. The microcatheter is advanced into the proper/left/right hepatic artery on day 1 in every cycle of treatment. After the patient returned to the ward, the FOLFOX-based regimen is intra-arterially administered though the microcatheter.~The treatment is repeated once every 3 weeks for up to six cycles."
dTACE-HAIC protocol
"CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.~FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h."
HAIC protocol
FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.
RECRUITING
the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou
Hainan General Hospital
OTHER
Maoming People's Hospital
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
First People's Hospital of Foshan
OTHER
Jiangmen Central Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER