JPRN-jRCT2031190072暂停1 期
A Phase I study of CYT001 in patients with unresectable advanced hepatocellular carcinoma - CRESCENT 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- Kato Naoya
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically confirmed hepatocellular carcinoma
- •2) Patients who are not eligible for curative surgical resection, or have not been eligible for regional therapy due to disease progression after surgery or locoregional treatment
- •3) Disease progression after at least one prior systemic regimen with Sorafenib, Lenvatinib or Atezolizumab plus Bevacizumab, or discontinuation of the regimen with Sorafenib or Lenvatinib due to intolerable toxicity
- •4) Patients who are able to undergo a biopsy as scheduled in the protocol to provide specimens
- •5) HLA-A*24:02, -A*02:01 or -A*02:06
- •6) Patients 20 years or older at the time of informed consent
- •7) ECOG PS 0-1
- •8) Child-Pugh class A liver score within 14 days prior to the first study treatment
- •9) Estimated life expectancy of >= 90 days
- •10) Adequate function of major organs, and the following laboratory parameters within 14 days prior to the first study treatment:
- •- Neutrophils >=1,500 /mm3
- •- Lymphocytes >=500 /mm3
- •- Platelet Count >=7.5x104 /mm3
- •- Hemoglobin >=8.0 g/dL
- •- Total Bilirubin <=ULNx3.0
- •- AST <=ULNx5.0
- •- ALT <=ULNx5.0
- •- Serum creatinine <=ULNx1.5, or Creatinine Clearance calculated by Cockcroft-Gault equation >=50 mL/min
- •- PT-INR <=1.7
- •- Serum Albumin >=2.8 g/dL
- •11) Recovery from previous treatment related toxicity (except for alopecia and controlled hypertension) to <= Grade 1
- •12) Measurable lesion according to RECIST v1.1
- •13) Ability to understand the study procedure and willingness to provide written consent
排除标准
- •1)CNS metastases that are symptomatic or require treatment
- •2)Regorafenib, Ramucirumab or Cabozantinib treatment recommended
- •3)Malignancies other than HCC within the past 2 years except for carcinoma in situ or intramucosal carcinoma cured by regional therapy
- •4)Use of other anticancer drugs or other investigational products within 14 days prior to the first dose of study drug, or use of antibody drugs within 28 days prior to the first study treatment
- •5)Surgery within 28 days (as for puncture or drainage, within 14 days) prior to the first dose of study drug. Patients are not excluded unless recurrent abscess after puncture or drainage occur within 14 days prior to the first study treatment.
- •6)Following medical conditions:
- •-Uncontrolled heart diseases (e.g. NYHA Class III or IV of congestive heart failure, myocardial infarction within 1 year prior to the enrollment, unstable angina pectoris, arrhythmia requiring treatment)
- •-QTcF >470 msec or familial long-QT syndrome
- •-Uncontrolled diabetes or hypertension
- •-Active infection that requires systemic therapy such as antibacterial drugs and/or antiviral drugs.
- •Patients who have active infection of hepatitis B with HBV DNA <500 IU/mL within 28 days prior to the first study treatment, and have been undergoing anti-HBV treatment (e.g. nucleotide analogues) for at least 14 days prior to the first study treatment, are not excluded as long as they agree to stay on the same antiviral treatment throughout the study.
- •-Obvious interstitial lung disease or pulmonary fibrosis
- •-Severe mental disorder including dementia
- •-Effusion (pleural effusion, ascites or pericardial effusion) requiring puncture or drainage
- •-Esophageal varix or gastric varix requiring treatment
- •7)Known human immunodeficiency virus (HIV) positive status
- •8)Active state or history of recurrent or chronic autoimmune diseases.
- •Exceptions: Type I diabetes mellitus, hypothyroidism controlled by hormone replacement therapy, skin diseases (e.g. leukoderma, psoriasis, alopecia) without requiring systemic therapy, or autoimmune diseases whose recurrence will not be expected in the absence of extrinsic influences
- •9)Active state or history of hepatic encephalopathy
- •10)History of cerebrovascular disease, thrombosis or thromboembolism (pulmonary thromboembolism or deep vein thrombosis) within 180 days prior to the first study treatment
- •11)Radiation therapy within 28 days (palliative radiotherapy for pain-relieving within 14 days) prior to the first study treatment
- •12)Women who are pregnant or breastfeeding.
- •Women of breastfeeding, who agree not to breastfeed during and after the study, are not excluded. Women of childbearing potential who had negative results in pregnancy test (serum or urine) within 14 days prior to the first study treatment, are not excluded.
- •13)Patients who cannot agree to practice an effective contraception (e.g. condom, intrauterine device or oral contraception), from informed consent to 90 days after the last study treatment. As for women who use oral contraception, barrier contraception must be used concurrently.
- •Postmenopausal women (one year has passed after last menstruation) and men or women who have received surgical contraception, are not excluded.
- •14)History of organ transplantation or hematopoietic stem cell transplantation
- •15)Prior administration of HSP70 derived peptide, GPC3 derived peptide, hLAG-3Ig or Poly-ICLC
- •16)Known hypersensitivity reactions to any ingredients of CYT001
- •17)Unsuitable conditions for the stud
研究者
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