Phase IIA Clinical Study Of An Individualized Anti-Cancer Vaccine (CRCL-ALLOVAX) in Subjects With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To evaluate survival compared to historical controls
研究概览
简要总结
This is an open-label, single site, Phase IIA clinical trial to investigate the safety and efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients.
详细描述
Hepatocellular carcinoma (HCC) or primary liver cancer is the third leading cause of cancer death worldwide. It accounts for 90% of all liver cancers. More than 80% of patients present with advanced or unresectable disease.
For patients with vascular invasion and/or metastases, the only approved therapy that offers a survival advantage is Sorafenib (Nexavar®). While palliative systemic chemotherapy other than Sorafenib is sometimes offered for HCC, there is no evidence that any chemotherapy has any meaningful therapeutic benefit, especially in overall survival. Subjects in the current study will either have completed at least 90 days of sorafenib treatment or are not able to receive sorafenib due to intolerability or unable to afford. Subjects will continue sorafenib as tolerated while receiving experimental therapy. The experimental dosing schedule has four segments: (1) priming, which consists of intradermal AlloStim alone; (2) vaccination, which consists of intradermal dosing of AlloStim+CRCL; (3) activation, which consists of an intravenous infusion of AlloStim; and (4) booster, which consists of monthly intradermal injections of CRCL alone
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
- •Males and females who are at least 18 years of age at time of enrollment
- •Histologically confirmed hepatocellular carcinoma with or without positive HBV and/or HCV, not candidate for local regional intervention
- •Minimum of 90 days of sorafenib treatment or ineligible for sorafenib
- •Child-Pugh Stage A-B (score ≥ 5 and ≤ 9)
- •Performance status: ECOG < 2 with no deterioration over the previous 2 weeks
- •Measurable disease (for mRECIST)
- •Lesion amenable for percutaneous tumor harvest and follow up biopsy
- •Adequate bone marrow, liver and renal function as assessed by the following:
- •Hemoglobin > 10.0 g/dl
- •Absolute neutrophil count (ANC) > 1,500/mm3
- •Platelet count > 75,000/μl
- •ALT and AST < 2.5 x ULN
- •Alkaline phosphatase < 4 x ULN
- •Serum creatinine < 1.5
- •Women of child-bearing potential: negative pregnancy test
- •Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product
- •Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate
排除标准
- •Severe ascites, massive or uncontrolled (+3 on Child-Pugh calculator)
- •Severe encephalopathy, uncontrolled (+3 on Child-Pugh calculator)
- •Participation in another clinical trial evaluating experimental treatments or procedures or receiving medication/treatment for HCC other than sorafenib
- •Any autoimmune disorder
- •Any clinical condition requiring systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry
- •HIV positive or syphilis
- •History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) or uncontrolled hypertension
- •Active clinically serious infections (> grade 2 NCI-CTCAE version 4.0)
- •History of organ or tissue allograft
- •Advanced liver cirrhosis
- •Interferon or thalidomide within 1 month prior to signing informed consent
- •Uncontrolled concurrent serious medical or psychiatric illness
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
- •History of blood transfusion reactions
- •Known allergy to murine monoclonal antibodies or bovine products or cow milk
研究组 & 干预措施
Treatment
The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject
干预措施: CRCL (Biological)
Treatment
The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject
干预措施: AlloStim (Biological)
Treatment
The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject
干预措施: AlloVax (Biological)
结局指标
主要结局
To evaluate survival compared to historical controls
时间窗: Approximately 12 months
Baseline to date of death from any cause
次要结局
- To assess AFP as surrogate end-point for response and/or survival(Approximately 6 months)
- To assess mRECIST as surrogate end-point for response and/or survival(Approximately 6 months)
- To evaluate safety in advanced HCC (adverse events)(Approximately 6 months)