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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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~
- •Child-Pugh Score ≤
- •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.
排除标准
- •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.
结局指标
主要结局
Recurrence-free survival (RFS)
时间窗: 6 years
The time from randomization to first documented of disease recurrence determined by IRC or death from any cause (whichever occurs first).
次要结局
- Cancer-specific survival (CSS)(6 years)
- Adverse events (AE)(6 years)
- Overall survival (OS)(6 years)
研究者
Prof. Shichun Lu
Director
Chinese PLA General Hospital