Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Patients With HCC at High Risk of Recurrence After Radical Resection
A Multicenter, Randomized, Open-label Phase II Study of Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Preventing Recurrence in Patients With Primary Hepatocellular Carcinoma (HCC) at High Recurrence Risk After Radical Resection
1 other identifier
interventional
430
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2018
CompletedFirst Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedFebruary 7, 2022
February 1, 2022
4.2 years
January 27, 2022
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-free survival (RFS)
The time from randomization to first documented of disease recurrence determined by IRC or death from any cause (whichever occurs first).
6 years
Secondary Outcomes (3)
Overall survival (OS)
6 years
Cancer-specific survival (CSS)
6 years
Adverse events (AE)
6 years
Study Arms (2)
EAL Treatment Group
EXPERIMENTALThe patients with primary HCC will receive 12\~20 doses of EAL infusion (1×10\^9\~2×10\^10 cells per dose) in combination of a single transarterial chemoembolization (TACE) after radical resection.
Control Group
ACTIVE COMPARATORThe patients with primary HCC will receive a single TACE after radical resection.
Interventions
12\~20 doses of EAL (1×10\^9\~2×10\^10 cells per dose) will be infused into patients.
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.
Eligibility Criteria
You may qualify if:
- Patients with Stage Ia\~IIIa primary HCC with high recurrence risk (defined as single tumor ≥5cm in diameter, or single tumor \<5cm in diameter with MVI, PVTT, hepatic vein invasion, satellite lesions or AFP ≥400ng/mL, or multiple tumors).
- Patients who have undergone a radical resection.
- ECOG PS Score 0\~2.
- Child-Pugh Score ≤ 7.
- Patients with adequate hematologic and end-organ function.
- HBV-HCC and HCV-HCC patients with active viral infection may receive antiviral treatment simultaneously.
- Patients who have a life expectancy of at least 6 months.
You may not qualify if:
- Patients with a history of immune deficiency or autoimmune diseases (such as rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes mellitus, etc.).
- Patients with a history of other malignant tumors in the past 5 years.
- Patients who received chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, and hormone therapy within 1 month prior to screening.
- Patients who have received microwave ablation, cryotherapy, high-power ultrasound focused ablation and other local ablation methods for liver tumors.
- Patients with postoperative organ dysfunction or heart and lung diseases.
- Patients allergic to albumin or with serious allergy history or mental disease.
- Pregnant or lactating women.
- Anticipated other clinical trials within 4 weeks before this trial.
- Patients with HIV or Treponema pallidum infection, septicemia and other uncontrolled infection.
- Patients after organ or bone marrow transplant.
- Patients with drug or alcohol abuse/addiction.
- Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Immunotech Applied Science Ltd.collaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shichun Lu, MD, PhD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
January 27, 2022
First Posted
January 28, 2022
Study Start
April 25, 2018
Primary Completion
June 30, 2022
Study Completion
April 30, 2023
Last Updated
February 7, 2022
Record last verified: 2022-02