CTIS2024-512742-42-00招募中1 期
Exploratory clinical trial to assess safety, tolerability efficacy and pharmacokinetics of CEB-01 PLGA membrane in participants with pancreatic cancer - CEB-01-RLPC01-CT
Cebiotex S.L.0 个研究点目标入组 21 人开始时间: 2024年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age =18 years., Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening., Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery., Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery., The participant or a legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures., Participants diagnosed with a single lesion of histologically or cytologically confirmed de novo carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas with only locally advanced disease, resectable or borderline resectable., Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment., Participants must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion obtained by a validate imaging technique (i.e., magnetic resonance imaging (MRI), computed tomography (CT) scan, PET scan, ultrasounds or others) that can be accurately measured., Participants should have a single surgically removable lesion., Normal liver, renal, haematological, and cardiac function as defined by biochemical and haematological parameters as follows: haemoglobin (Hb) >11 g/dL (with preoperative transfusion), platelets >80.000/mm3 with intraoperative transfusion, white blood cells (WBC) >3.000/mm3, neutrophil count >1.500/mm3, albumin >3.0 g/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2,5 times the upper limit of normality [ULN], bilirubin <2 times the ULN, creatinine <1,5 mg/dl or creatinine clearance > 60 ml/min., Participants must have fully recovered from the acute toxic effects (Grade 3 or above) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this trial., Neoadjuvant chemotherapy is allowed in borderline and/or locally advanced cases borderline completed at least 4 weeks before surgery., Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
排除标准
- •Other malignancies within past 2 years., Participants with disease of any major organ system that would compromise their ability to withstand therapy., Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued., Active bacterial, viral or fungal infection., Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion., Impossibility of ensuring adequate follow-up., Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study., Contraindication to computed tomography scan (CT)., Major surgery within 14 days prior to starting study drug or still in recovery after experiencing surgical complications; neither tumour biopsy nor central line insertion are considered a major surgery., Other relevant concomitant illnesses., Participants’ status post-allogeneic stem cell transplant are not eligible.
研究者
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