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

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

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

Sponsors & Collaborators

• Chinese Cooperative Group of Liver Cancer

  collaborator OTHER

• Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province

  collaborator OTHER

• M&R Pharm

  collaborator UNKNOWN

• Geneplus-Beijing Co. Ltd.

  collaborator INDUSTRY

• Yuce Biotechnology Co., Ltd.

  collaborator UNKNOWN

• Geneis

  collaborator UNKNOWN

• Simcere Pharmaceutical Co., Ltd

  collaborator OTHER

• BeiGene

  collaborator INDUSTRY

• Haplox Biotechnology Co., Ltd.

  collaborator INDUSTRY

• Wan-Guang Zhang

  lead OTHER

Principal Investigators

• Wan-guang Zhang, M.D. · Tongji Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2024-08-31

Completion

2025-02-28

Countries

• China

Study Locations