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Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC

NCT04011033 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-08

Study results available
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Summary

Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients receive a diagnosis when their tumors are too advanced for curative approaches and have a dismal prognosis. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but their function is defective in liver cancer. After expansion and restored function in vitro, iNKT cells can home to liver, then they play key antitumor function. We have finished a phase I study of adoptive transfer of autologous iNKT cells for treating patients with unresectable HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study was to verify the effectiveness of iNKT cell infusion in patients with unresectable HCC who had previously failed transcatheter arterial embolization (TAE) / transcatheter arterial chemoembolization (TACE).

Conditions

Interventions

BIOLOGICAL

iNKT cells

5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy.

DRUG

Human recombinated Interleukin-2

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.

PROCEDURE

TAE/TACE

TAE/TACE will be conducted to all patients at 0th week and 4th week.

Sponsors & Collaborators

  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER

  • Beijing Ditan Hospital

    collaborator OTHER

  • Beijing YouAn Hospital

    lead OTHER

Principal Investigators

  • Jun Lu, Director · Beijing YouAn Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-03-01
Completion
2023-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011033 on ClinicalTrials.gov