Hepatocellular Carcinoma (HCC)Phase 2NCT05213637
Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Patients With HCC at High Risk of Recurrence After Radical Resection
A Phase 2 study testing Expanded Activated Lymphocytes (EAL) and transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC), run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Expanded Activated Lymphocytes (EAL) and transarterial chemoembolization (TACE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2018to 30 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Shichun Lu, MD, PhD, 86-10-66938209, Lsc620213@aliyun.com
About this study
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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Expanded Activated Lymphocytes (EAL), transarterial chemoembolization (TACE)
- Keywords
- HCC, cell therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Activated Lymphocytes (EAL)Biological
12~20 doses of EAL (1×10^9~2×10^10 cells per dose) will be infused into patients.
transarterial chemoembolization (TACE)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EAL Treatment Group | Experimental | 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. Receives: Biological: Expanded Activated Lymphocytes (EAL); Procedure: transarterial chemoembolization (TACE) |
| Control Group | Active comparator | The patients with primary HCC will receive a single TACE after radical resection. Receives: Procedure: transarterial chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 years
Secondary outcomes (3)
Overall survival (OS)
The time from randomization to death from any cause.
Measured: 6 years
Cancer-specific survival (CSS)
The time from randomization to death from HCC.
Measured: 6 years
Adverse events (AE)
Percentage of participants with adverse events.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start25 Apr 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Immunotech Applied Science Ltd.
- Responsible party
- Principal investigator, Prof. Shichun Lu, Chinese PLA General Hospital
- Investigators
- Shichun Lu, MD, PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213637
- Sponsor's protocol ID
- EAL-HCC-001
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05213637
- Acronym / sponsor ID
- EAL-HCC-001
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC, cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Immunotech Applied Science Ltd.
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EAL Treatment Group | Experimental | Biological: Expanded Activated Lymphocytes (EAL), Procedure: transarterial chemoembolization (TACE)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. |
| Control Group | Active comparator | Procedure: transarterial chemoembolization (TACE)The patients with primary HCC will receive a single TACE after radical resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded Activated Lymphocytes (EAL)12~20 doses of EAL (1×10^9~2×10^10 cells per dose) will be infused into patients. | Biological | EAL Treatment Group |
| 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. | Procedure or surgery | Control Group, EAL Treatment Group |
Primary outcome
Recurrence-free survival (RFS)
Time frame: 6 years
The time from randomization to first documented of disease recurrence determined by IRC or death from any cause (whichever occurs first).
3 secondary outcomes
Overall survival (OS)
Time frame: 6 years
Cancer-specific survival (CSS)
Time frame: 6 years
Adverse events (AE)
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shichun Lu, MD, PhD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Expanded Activated Lymphocytes (EAL) and transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC), run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shichun Lu, MD, PhD (86-10-66938209, Lsc620213@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.