EUCTR2006-002211-26-DE进行中（未招募）不适用
Heptovax - A Phase II, Open-label trial evaluating the safety and efficacy of GV1001 in advanced hepatocellular carcinoma. - Heptovax
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pharmexa A/S
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Hepatocellular carcinoma diagnosis fulfilling one of the following criteria (as per the American Association for the Study of Liver Diseases [AASLD] guidelines, see Appendix 5):
- •Nodule in a cirrhotic or non-cirrhotic liver with a biopsy showing HCC;
- •Nodule in cirrhotic liver where no biopsy is performed:
- •Nodules between 1-2 cm in a cirrhotic liver with a typical coincidal vascular pattern of HCC (i.e. hypervascular with washout in the portal/venous phase) in two dynamic studies: either CT scan, contrast ultrasound or MRI with contrast.
- •Nodule larger than 2 cm in a cirrhotic liver with a typical vascular pattern of HCC on a dynamic imaging technique.
- •Please note: HCC in a non-cirrhotic liver can only be diagnosed with a biopsy showing HCC.
- •2. Measurable disease according to modified RECIST (see Appendix 7).
- •3. At least one treatment-naïve target lesion (treatment-naïve being defined as not having been treated with local therapy, such as surgery, radiation therapy, hepatic arterial embolisation, chemoembolisation, radio-frequency ablation or cryo-ablation).
- •4. Barcelona Clinic Liver Cancer (BCLC) stage A, B or C (see Appendix 6) (Stage D is excluded).
- •5. Child-Pugh stage A (see Appendix 8).
- •6. Male or female aged 18 years or older.
- •7. Adequate haematological parameters, as demonstrated by:
- •Haemoglobin = 9.0 g/dL (SI units: 5.6 mmol/L);
- •WBC = 3.0 x 10,000,000,000/L;
- •Platelets = 75 x 10,000,000,000/L.
- •8. ALT and AST = 5 times the upper limit of normal.
- •9. Bilirubin < 2 mg/dL.
- •10. Serum creatinine = 1.5 mg/dL (SI units: 132 µmol/L).
- •11. Performance status ECOG 0 or 1.
- •12. Minimum life expectancy of 3 months at screening.
- •13. Written informed consent given prior to any study specific procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. HCC amenable to curative treatment or transplantation.
- •2. History of other malignancies in the last 5 years (10 years in the case of breast cancer), except for adequately treated non-melanoma skin cancers (Basal Cell Carcinoma, Squamous Cell Carcinoma) and carcinoma in situ of the cervix.
- •3. Known history of or co-existing autoimmune disease.
- •4. Known Central Nervous System (CNS) metastases.
- •5. Known history of human immunodeficiency virus (HIV).
- •6. Any medical condition that, in the opinion of the Investigator, may compromise the compliance of the patient to receive study treatment and follow study procedures.
- •7. Treatment with any other IMP within 4 weeks prior to cyclophosphamide administration at Day -3.
- •8. Known sensitivity to any components of cyclophosphamide, GV1001 or GM-CSF.
- •9. Concomitant treatment with the following within 4 weeks of pre-treatment with cyclophosphamide:
- •Anti-tumour treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors, and gene therapy) and vaccines.
- •Chronic corticosteroids (inhaled and topical steroids are permitted including low dose steroids at non-immunosuppressive doses e.g. 15 mg prednisolone daily for up to 7 days).
- •Herbal medicine either containing hypericum perforacum (e.g. St Johns Wort) or claiming to have anti-tumour effects (e.g. Iscador).
- •10. Pregnancy or lactation.
- •11. Women of childbearing potential not using reliable and adequate contraceptive methods, defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
- •12. Unable for any other reason to comply with the protocol (treatment or assessments).
研究者
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