Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Lenvatinib

Tislelizumab

Leucovorin

Fluorouracil

Oxaliplatin

Cell Wall Skeleton

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Adjuvants, Immunologic

Immunologic Factors

N-CWS 400μg hypodermic injected every week (Q1W) for 4 weeks, following by N-CWS 400μg hypodermic injected Q4W. Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Tislelizumab 200mg intravenously every 3 weeks.

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)

Nocardia rubra cell wall skeleton

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

Hepatic arterial infusion chemotherapy

12 mg (or 8 mg) once daily (QD) oral dosing

Wan-guang Zhang, M.D.

Ze-yang Ding, M.D.

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).

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

ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.

OS is the length of time from the date of randomization until death from any cause

Safety will be evaluated according to the NCI CTCAE Version 5.0. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause

Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

Spots Global Cancer Trial Database for Nocardia Rubra Cell Wall Skeleton (N-CWS) Plus HAIC, Lenvatinib and Tislelizumab in Treating Patients With Advanced HCC

Trial Identification

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Interventions

Study Description

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