EUCTR2019-003108-10-ES进行中（未招募）1 期
The GOING Study: Regorafenib followed by Nivolumab in patients with Hepatocellular Carcinoma progressing under sorafenib
Fundació Clinic per a la Recerca Biomèdica0 个研究点目标入组 60 人开始时间: 2019年11月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
入选标准
- •1. Male or female subjects 18 years of age or older.
- •2. Heptatocellular carcinoma (HCC) diagnosed according to American Association for the Study of Liver Diseases (AASLD) guideline.
- •3. Presence of a naïve target lesion.
- •4. Adequate liver function: albumin > 2.8 g/dL; total bilirubin < 3 mg/dL; alanine and aspartate aminotransferases < 5 times the upper limit of the normal range, and Child-Pugh score <7 points.
- •5. Performance status 0-1
- •6. Controlled arterial hypertension and/or stable peripheral vascular disease
- •7. Adequate hematologic profile: platelet count > 60x109/L; haemoglobin > 8.5g/dL; and prothrombin time > 50%.
- •8. Adequate renal function: serum creatinine < 1.5 times the upper limit of the normal range.
- •9. All but first-line-related dermatologic adverse events must be grade I according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Early dermatologic adverse events related to sorafenib must be resolved before starting regorafenib.
- •10. Radiological tumor progression to first-line treatment within the 2 months of inclusion in the study.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Myocardial infarction in the last year or active ischemic heart disease
- •2. Acute variceal bleeding in the last month
- •3. Severe peripheral arterial disease
- •4. Cardiac arrhythmia under treatment with drugs different from beta-blockers or digoxin
- •5. Uncontrolled ascites
- •6. Encephalopathy
- •7. Unfeasibility to fulfill the follow-up Schedule.
- •8. Co-infection with hepatitis B (HBV) and C (HCV) as evidenced by detectable HBV surface antigen or HBV DNA and HCV RNA or Hepatitis D infection in subjects with HBV.
- •9. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of PSA progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast.
- •10. Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopic, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •11. Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •12. Known active drug or alcohol abuse
- •13. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways);
- •14. Prior organ allograft or allogeneic bone marrow transplantation
- •15. All but dermatologic toxicities attributed to first-line treatment must have resolved to Grade 1 (NCI CTCAE version 5) or baseline before administration of study drug. Subjects with toxicities attributed to first-line treatment therapy that are not expected to resolve and result in long-lasting sequelad are not permitted. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 5). Dermatologic toxicities must be resolved.
- •16. Active bacterial or fungal infections requiring systemic treatment within 7 days.
- •17. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.
- •18. Known or underlying medical conditions that, in the Investigator’s opinion, would make the administration of the study drug hazardous to the subjects or obscure the interpretation of toxicity determination or adverse events.
- •19. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •20. Laboratory evidence of any underlying medical conditions that, in the Investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
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