NCT05233358

HAIC Combined With Second-line "Target Immunity" for HCC With TACE Standard Treatment Low Response or Failure

HAIC Combined With Second-line "Target Immunity" for Advanced Hepatocellular Carcinoma With Low Response or Failure of TACE Combined With First-line "Target Immunity": A Prospective, Randomized- Control, Multicenter Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: The Central Hospital of Lishui City · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized controlled, multicenter clinical study. The purpose of this study is to explore the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with second-line regorafenib and immune checkpoint inhibitors in the treatment of transarterial chemoembolization (TACE) combined with first-line molecular targeted drugs and immune checkpoint inhibitors with low response or failure in advanced hepatocellular carcinoma.

Detailed description

This is a randomized, open, parallel-controlled, multi-center clinical trial with a type of comparison using a merit test. This study will recruit 176 patients with advanced liver cancer who have received TACE combined with first-line "target immune" therapy and were rated as low response or treatment failure according to mRECIST criteria in multiple research centers across the country. Subjects randomly assigned to the experimental group will receive HAIC in combination with regorafenib and immune checkpoint inhibitors, and subjects randomly assigned to the control group will receive TACE in combination with regorafenib and immune checkpoint inhibitors.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Hepatic Artery Infusion Chemotherapy	HAIC adopts FOLFOX chemotherapy regimen, hepatic arteriography through a radial artery or femoral artery cannulation, routine hepatic artery cannulation, imaging, infusion of chemotherapy drugs into hepatic artery: oxaliplatin 85 mg/m2 on the first day for 0-3 hours, folinic acid 400 mg/m2 for 3-4.5 hours on day 1, fluorouracil 400 mg/m2 for 4.5-6.5 hours on day 1, and fluorouracil 2500 mg/m2 for 46 hours on days 1-3.
PROCEDURE	Transarterial Chemoembolization	Treatment regimens have chosen "lipiodol-based" hepatic arterial chemoembolization, with lipiodol dosage varying from 5-20ml depending on tumor size. The chemotherapy drug is gemcitabine 1.0 combined with 100mg oxaliplatin, combined with 1/3 to 1 dose of solid embolic agent (the dosage is determined by the investigator based on the tumor size). After uniform emulsification, the drug is injected into the supplying blood vessels and stops when the intravascular blood flow is slow. Later, angiography is performed again, and the tumor staining disappears and the supplying artery is occlusions. CT or MRI scans are performed 4 to 6 weeks postoperatively to assess the presence of active lesions. Repeat TACE if active lesions are still present. The frequency of TACE treatment is determined by the investigator and is given according to the patient's condition, generally 2-4 times. The interval between TACE treatments is 30-45 days, with a maximum of six cycles.
DRUG	Regorafenib	Regorafenib is administered for 28 days per treatment cycle, with oral regorafenib on days 1-21, 80-160 mg once daily. The dose is adjusted according to adverse reactions, with a minimum of 80 mg.
DRUG	Immune Checkpoint Inhibitors	Optional immune checkpoint inhibitors include Camrelizumab, Sintilimab, Nivolumab, Pembrolizumab, and Toripalimab. Treatment is based on the immune checkpoint inhibitor before the patients are randomized into the group, and it is not recommended to replace the immune checkpoint inhibitor. The dosage is 200 mg, intravenous infusion, D1, once every 21 days (Q3W). Dosing interruption or dose reduction may be necessary based on individual safety and tolerability considerations; dosing with immune checkpoint inhibitors should not be suspended for more than 4 weeks.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-02-01
• Completion: 2025-02-01
• First posted: 2022-02-10
• Last updated: 2022-02-10