NCT05582278

HAIC+Lenvatinib+Tislelizumab vs D-TACE+Lenvatinib+Tislelizumab for Unresectable HCC

HAIC Combined With Lenvatinib and Tislelizumab Versus D-TACE Combined With Lenvatinib and Tislelizumab in Advanced Unresectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wen Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Drug-eluting Bead-Transarterial chemoembolization (D-TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of D-TACE for patients in Advanced Unresectable HCC. The investigators previous study also revealed similar results in Advanced Unresectable HCC patients treated with D-TACE. Recently, the investigators previous study demonstrated that, compared with D-TACE, hepatic arterial infusion chemotherapy (HAIC) may improve tumor response in Advanced Unresectable HCC. Thus, the investigators carried out this prospective nonrandomized control to demonstrate the superiority of HAIC-based combination therapy over D-TACE-based combination therapy.

Detailed description

HCC is one of the most common malignant tumors with the worst prognosis. At present, except for liver transplantation, surgical resection is the most effective therapy for patients with HCC. However, many patients are found to have advanced cancer as soon as they were diagnosed and lose the opportunity of radical resection and treatments are limited.More and more clinical research failures have hit the investigators' hard, until a clinical study named IMbrave150, published in the New England Journal of Medicine in 2020. It has opened up a new era of combination therapy, breaking the pattern of only a single mode of advanced liver cancer for more than ten years, making the investigators realize that for the treatment of patients with advanced liver cancer, the single treatment effect is often very limited, and combination therapy is the future.The investigators recent research showed that HAIC Combined With Lenvatinib and Tislelizumab brings good results to patients with advanced HCC.To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC-based combination therapy and D-TACE-based combination therapy for those patients in Advanced Unresectable HCC.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	D-TACE	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.
DRUG	HAIC	FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 100 mg/m2 infusion for 2 hours; calcium levofolinate, 200 mg/m2 infusion for 1 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.
DRUG	Lenvatinib	12 mg/d for bodyweight ⩾ 60 kg or 8 mg/d for bodyweight \<60 kg
DRUG	tislelizumab	tislelizumab 200 mg, every 3 weeks.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2022-10-17
• Last updated: 2022-10-17

Locations

1 site across 1 country: China