NCT05533892

Nocardia Rubra Cell Wall Skeleton (N-CWS) Plus HAIC, Lenvatinib and Tislelizumab in Treating Patients With Advanced HCC

Nocardia Rubra Cell Wall Skeleton Plus Hepatic Arterial Infusion Chemotherapy, Lenvatinib and Tislelizumab for Advanced Hepatocellular Carcinoma: a Single-center, Single-arm, Non-randomized Clinical Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wan-Guang Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Nocardia rubra cell wall skeleton plus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin, lenvatinib and tislelizumab in patients with advanced hepatocellular carcinoma (HCC).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Nocardia rubra cell wall skeleton	Nocardia rubra cell wall skeleton (N-CWS) 400μg hypodermic injected every 1 week (Q1W) for 4 weeks, following by N-CWS 400μg hypodermic injected every 4 weeks (Q4W)
PROCEDURE	Hepatic arterial infusion chemotherapy	administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
DRUG	Lenvatinib	12 mg (or 8 mg) once daily (QD) oral dosing
DRUG	Tislelizumab	200mg intravenously every 3 weeks

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-08-31
• Completion: 2025-02-28
• First posted: 2022-09-09
• Last updated: 2023-12-19

Locations

1 site across 1 country: China