Phase I Clinical Trial of Alfa-Fetoprotein,Glypican-3 Based Personalized Cancer Vaccine in Egyptian Patients With Hepatocellular Carcinoma: Pilot Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of the safety of the personalized cancer vaccine
研究概览
简要总结
Evaluate safety and immunogenicity of peptide cancer vaccine in patients with hepatocellular carcinoma (HCC) who developed recurrence after surgical resection and refractory to the available institutional standard of care lines of treatment .
详细描述
Ten patients with hepatocellular carcinoma (HCC) who developed recurrence after surgical resection are refractory to the available institutional standard of care lines of treatment will be recruited to received the peptide cancer vaccine.
Tumour antigen peptides will be identified and separated from each patient and then reinjected with an adjuvant (autologous activated monocytes with autologous tumour derived heat shock protein 70) by subcutaneous route monthly for 6 months preceded by 300 mg cyclophosphamide one week before start of the vaccine.
A follow up for all cases will be performed clinically, laboratorial, and immunologically for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who developed recurrence of HCC after surgical resection .
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group performance status (ECOG) of 0-2 .
- •Patient with radiologically or pathologically confirmed hepatocellular carcinoma.
- •Patients who had been treated with surgical approach as per our (Ain Shams University) institute protocols and developed recurrence after surgery. They were either intolerant to the institute protocol of treatment or showed unresponsiveness of their disease after treatment.
- •Child-Pugh class A or B .
- •LAB values:
- •Hemoglobin (≥ 8 g/dl), platelets (≥ 50,000/µl), leukocytes (≥ 2,500/µl), neutrophils (≥ 1,000/µl), lymphocytes (≥ 500/µl) Liver function: serum bilirubin (< 3 x ULN), Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (< 5 x ULN) Renal function: serum creatinine (< 1.5 x ULN)
- •Patient has not received any antineoplastic chemotherapy, immunotherapy, or radiotherapy for the four weeks prior to the start of study treatment.
- •Pregnancy test should be negative at the first dose of study treatment in fertile females. (Female patients who are not post-menopausal or surgically sterile should use a highly effective method of birth control from the date of signing the consent to the last follow up visit. Pregnancy test should be negative at the first dose of study treatment.)
- •Written informed consent .
排除标准
- •Patients receiving continuous systemic steroid treatment within the last 4 weeks prior to start of study treatment (The use of inhaled and nasally applied steroids, as well as topical steroids outside the vaccination area are permitted)
- •Patients receiving systemic immunotherapy or immunosuppressant medication other than steroids within the last 4 weeks prior to start of study treatment.
- •Patients with a history or evidence of systemic autoimmune disease.
- •Active second malignancy or a prior malignancy within the past 12 months.
- •Acute active infections requiring oral or intravenous antibiotics, antiviral or antifungal therapy within 1 week before the start of study treatment [Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infections are permitted; direct-acting antivirals may be administered when medically indicated].
- •Any other acute medical condition that may compromise patient's safety or the activity of the studied vaccine treatment.
- •Any other concurrent severe or uncontrolled chronic disease such as uncontrolled non-malignant liver, renal or lung disease, or decompensated cardiac failure or coronary insufficiency.
- •Administration of a live, attenuated vaccine within 4 weeks before randomization
- •Known previous major hypersensitivity reactions.
- •History of human immunodeficiency virus (HIV)
- •Evidence of current alcohol or drug abuse
- •Women who are pregnant or who are breast feeding
- •Medical or mental impairments that may limit participation in the study as judged by the investigators disease specialist.
- •History of organ allograft.
- •History of splenectomy.
- •Psychiatric illness or known social situation that would preclude study compliance.
- •Encephalopathy.
结局指标
主要结局
Assessment of the safety of the personalized cancer vaccine
时间窗: 4 weeks
Percentage of patients who developed adverse events (AEs)
Assessment of immunological response
时间窗: 12 weeks
Percentage of change in CD20 +B-cells, CD16+CD56+NK cells,CD4 + cells,CD8+ cells,CD25+regulatory cells
次要结局
- Progression free survival and overall survival time(144 week)
研究者
zeinab ahmed yousif hasan ashour
Professor of Internal Medicine, Allergy and clinical immunology unit
Ain Shams University