NCT05131698

Clinical Study of the Efficacy and Safety of Transhepatic Arterial Chemoembolization Combined With Tislelizumab and Lenvatinib in Patients With Advanced Unresectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Cancer Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

ICIs combined with AATDs have gradually become the mainstream treatment modality for advanced hepatocellular carcinoma, and more related clinical trials are underway. This is undoubtedly a breakthrough and the main direction for improving the overall 5-year survival rate of the liver cancer population in the next decade, and a touchstone for exploring the development and value of liver surgery in the era of comprehensive treatment for advanced hepatocellular carcinoma. Overall, there are relatively few reports on various types of translational therapy for advanced HCC, probably for the following two reasons: (1) advanced hepatocellular carcinoma is complex, rapidly progressing, difficult to treat, and has low translational efficiency; (2) the existing translational therapy strategies are highly selective in terms of applicable population, complex treatment process, and institutional dependence, and cannot achieve efficient and successful translation. At present, there are few studies reported on the application of TACE+ICIs+AATDs to carry out translational therapy. In the absence of relevant guidelines for reference, advanced hepatocellular carcinoma may be the best entrance to carry out translational therapy with ICIs combined with AATDs, and after satisfactory results are achieved in the treatment of this group of patients, a point-to-point effect can be generated, facilitating the transformation of TACE+ICIs+AATDs The target population of TACE+ICIs+AATDs translational therapy can be further expanded. To promote the development of hepatocellular carcinoma treatment and improve the long-term survival rate of the overall hepatocellular carcinoma population. In this study, we enrolled patients with advanced HCC and used TACE+ICIs+AATDs for conversion therapy to improve the conversion rate, so that unresectable HCC patients could be converted to a chronic disease state and achieve long-term survival on the one hand, and provide potential for sequential surgical treatment on the other. The drug of choice is lenvatinib. This study provides a basis for the clinical application of translational therapy for advanced hepatocellular carcinoma.

Conditions

• Tislelizumab
• Lenvatinib
• TACE
• Advanced Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tislelizumab and Lenvatinib	TACE therapy: For transarterial infusion chemotherapy before or after TACE embolization, each drug will generally be diluted with 0.9% sodium chloride solution or 5% dextrose solution 150-250 mL and injected slowly into the target artery for ≥20 min. Subsequent TACE therapy will be administered on an as-needed basis as assessed by the clinician, with each treatment interval exceeding 6 weeks and no more than 6 treatments in total. Lenvatinib: The starting dose of lenvatinib will depend on the patient's baseline weight: if baseline weight ≥ 60 kg, patients will receive 12 mg of lenvatinib administered once daily; if baseline weight \< 60 kg, patients will receive 8 mg of lenvatinib once daily. TACE therapy will be given 3 days apart. Tirelizumab: Tirelizumab 200 mg , intravenous infusion on the same day as the first dose of lenvatinib, once every three weeks. Translated with www.DeepL.com/Translator (free version)

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-12-01
• Completion: 2024-07-05
• First posted: 2021-11-23
• Last updated: 2023-01-26

Locations

1 site across 1 country: China