NCT05842317

Lenvatinib Plus Tislelizumab With or Without TACE in First-line Treatment of Unresectable HCC

A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib Plus Tislelizumab	Lenvatinib is 12mg/d for body weight \>= 60kg, 8mg/d for body weight \<60kg, once daily orally, once a day, after meals (take at the same time every day as much as possible); Tislelizumab is administered intravenously at a dose of 200mg/q3w.
DEVICE	Transarterial Chemoembolization(TACE)	A catheter is inserted through a small incision in the groin and guided to the hepatic artery, which supplies blood to the liver;A contrast dye is injected through the catheter to help visualize the blood vessels in the liver; A mixture of chemotherapy drugs and an embolic agent (such as small beads or gel foam) is injected through the catheter and into the artery that feeds the tumor;The embolic agent helps to block the blood flow to the tumor, which starves it of oxygen and nutrients; The chemotherapy drugs are then trapped in the tumor.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-04-15
• Completion: 2024-11-15
• First posted: 2023-05-06
• Last updated: 2024-02-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study
• FDA-regulated device study