Status:
UNKNOWN
Expanded Activated Lymphocytes (EAL) as Adjuvant Therapy in Patients With HCC at High Risk of Recurrence After Radical Resection
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
Immunotech Applied Science Ltd.
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 recur...
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. Ho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT05213637
Start Date
April 25 2018
End Date
April 30 2023
Last Update
February 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853