Trial intelligence / Profile preview

Allogeneic NK Cells in Advanced HCC

NCT04162158Phase 2

Key facts

Status
Unknown
Start
Mar 2019
Primary completion
Oct 2022
Countries
1
Sponsor
The Fifth Medical Center of the PLA General Hospital
Modality
Lymphokine-Activated Killer Cells, CAR-NK Cells
Drugs
AlloNK
Conditions
hepatocellular carcinoma (HCC)
01

Overview

Phase 2, open-label trial of AlloNK in hepatocellular carcinoma (HCC) (2 arms), sponsored by The Fifth Medical Center of the PLA General Hospital. Primary endpoints: Incidence of Adverse Events at 2 years and Overall Survival at 2 years. Status: unknown.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • Experimental Arm

    Allogeneic NK cells + Targeted Drug

  • Control Arm

    Targeted Drug alone

03

Who it enrols

Patients with advanced HCC (BCLC C), Child-Pugh A/B (5-9), ECOG PS 0-1, and adequate organ function. Must have a suitable donor.

04

Endpoints

Primary

  • Incidence of Adverse Events

  • Overall Survival

Secondary

  • Disease Control Rate

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