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

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Expanded Activated Lymphocytes (EAL)

transarterial chemoembolization (TACE)

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) focused on measuring HCC, cell therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EAL Treatment Group

Control Group

Arm Description

The 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.

The patients with primary HCC will receive a single TACE after radical resection.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Overall survival (OS)

The time from randomization to death from any cause.

Cancer-specific survival (CSS)

The time from randomization to death from HCC.

Adverse events (AE)

Percentage of participants with adverse events.

Full Information

NCT ID

NCT05213637

First Posted

January 27, 2022

Last Updated

February 4, 2022

Sponsor

Chinese PLA General Hospital

Collaborators

Immunotech Applied Science Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05213637

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2018 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

Collaborators

Immunotech Applied Science Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

HCC, accounting for 80% of all liver cancers, is the third most common cause of cancer-related death worldwide. Radical resection is considered as a curative strategy for patients with primary HCC. However, over 50% of patients experience recurrence after resection, resulting in a very low 5-year survival rate. EAL are ex vivo expanded and activated lymphocytes comprising mainly CD8+ T cells derived from patients' peripheral blood. This is a multi-center, randomized, open-label pivotal phase II study to evaluate the efficacy and safety of EAL in preventing recurrence in patients with primary HCC at high recurrence risk after radical resection. Patients will be randomized in a 1:1 ratio to receive either 20 doses of EAL (1×10^9~2×10^10 per dose) infusion in combination of a single TACE or a single TACE only. Primary endpoint is the independent review committee-determined recurrence-free survival (from randomization to first recurrence or death from any cause). Secondary endpoints include overall survival, cancer-specific survival, adverse events and others.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma (HCC)

Keywords

HCC, cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EAL Treatment Group

Arm Type

Experimental

Arm Description

The 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.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

The patients with primary HCC will receive a single TACE after radical resection.

Intervention Type

Biological

Intervention Name(s)

Expanded Activated Lymphocytes (EAL)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

transarterial chemoembolization (TACE)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recurrence-free survival (RFS)

Description

The time from randomization to first documented of disease recurrence determined by IRC or death from any cause (whichever occurs first).

Time Frame

6 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

The time from randomization to death from any cause.

Time Frame

6 years

Title

Cancer-specific survival (CSS)

Description

The time from randomization to death from HCC.

Time Frame

6 years

Title

Adverse events (AE)

Description

Percentage of participants with adverse events.

Time Frame

6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shichun Lu, MD, PhD

Phone

86-10-66938209

Lsc620213@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shichun Lu, MD, PhD

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shichun Lu, MD, PhD

Phone

86-10-66938209

Lsc620213@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

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

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