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Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Patients With HCC at High Risk of Recurrence After Radical Resection

NCT05213637 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2022-02-07

No results posted yet for this study

Summary

This is a multi-center, randomized, open-label pivotal phase II study to evaluate the efficacy and safety of EAL as adjuvant therapy in preventing recurrence in patients with primary HCC at high recurrence risk after radical resection.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

BIOLOGICAL

Expanded Activated Lymphocytes (EAL)

12\~20 doses of EAL (1×10\^9\~2×10\^10 cells per dose) will be infused into patients.

PROCEDURE

transarterial chemoembolization (TACE)

After angiography, fluorouracil will be injected into the proper hepatic artery or the segment of liver where the original lesion is located, and then microcatheter will be introduced into the segment of liver artery where the incision margin is located, and iodized oil injection and epirubicin will be mixed and embolized.

Sponsors & Collaborators

  • Immunotech Applied Science Ltd.

    collaborator INDUSTRY

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Shichun Lu, MD, PhD · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2022-06-30
Completion
2023-04-30

Countries

  • China

Study Locations

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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 NCT05213637 on ClinicalTrials.gov