EUCTR2019-002288-84-BE进行中（未招募）1 期
Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer - TIGeR-PaC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
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. Histologically or cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent
- •2. Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team (as confirmed by CT or MRI within 30 days of the first on study treatment).
- •3. ECOG performance status 0-1
- •4. Age = 18 years
- •5. Absolute neutrophil count = 1,500/µL
- •6. Platelet count = 100,000/µL
- •7. Hemoglobin = 9.0 g/dL
- •8. Serum creatinine = 1.5 mg/dL OR creatinine clearance = 50 mL/min/1.73 m2for subjects with creatinine >1.5 mg/dL
- •9. AST and ALT = 3.0 X the upper normal limit of institution's normal range
- •10. Prior to the initiation of the first on study treatment (Cycle 1/Day 1):
- •a. Total bilirubin = 1.5 X the upper normal limit of institution's normal range, or
- •b. Total bilirubin = 2.0 X the upper normal limit of institution's normal range if biliary stent placed within 6 weeks of Cycle 1/Day 1 (see Section 6.1.4 for Dose Modifications)
- •11. PT and PTT must be = 1.5 X upper normal limit of institution's normal range
- •12. INR = 1.5
- •13. Life expectancy > 12 weeks
- •14. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day prior to administration of the first dose of chemotherapy. Women of childbearing potential should only use highly effective methods of contraception during treatment and for up to 6 months following treatment cessation.
- •15. Provide written informed consent
- •16. Subjects willing to participate in the study for at least 8 months
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •1. Any prior treatment for pancreatic cancer; however, with prior written approval from the sponsor, an exception maybe granted for subjects who have had one prior treatment cycle with gemcitabine/nab-paclitaxel since this treatment is standard of care and part of the initial induction treatment on the protocol
- •2. Any evidence of metastatic disease or another active malignancy within the past one year except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin
- •3. Prior biliary bypass surgery
- •4. Subjects unable or unwilling to have their first randomized treatment within 3 weeks of the post induction imaging and within 5 weeks of their last induction treatment
- •5. Subjects without baseline tumor imaging
- •6. Anatomy suitable for IA delivery of gemcitabine to the intended tumor site, determined by CT or MRI, as determined by the sponsor, which precludes the following:
- •a. Stenosis or occlusion in intended artery for treatment
- •b. Tortuosity preventing the delivery of the guide sheath and or RenovoCath catheter to intended site
- •c. Inability to exclude major side branches in the area of the intended RenovoCath occlusion
- •d. No suitable artery with a diameter greater than 3mm in proximity of at least one side of the tumor
- •Note: Suitable anatomy will be reviewed by RenovoRx Imaging Advisor after receipt of initial CT or MRI.
- •7. Subjects with known HIV or active viral hepatitis
- •8. Severe infections within 4 weeks prior to the first study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- •9. Signs or symptoms of infection within 2 weeks prior to the first study treatment
- •10. Received oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligible.
- •11. History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
- •12. Any anti-cancer therapy including chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to initiation of study treatment; or herbal therapy intended as anti-cancer therapy within 1 week prior to initiation of study treatment
- •13. Subjects with uncontrolled seizures
- •14. Cardiovascular disease including unstable angina or life-threatening cardiac arrhythmia, myocardial infarction, stroke; or New York Heart Association (NYHA) Class III or IV congestive heart failure within the last 3 months prior to the first study treatment. Subjects with prior history of Myocardial Infarction, congestive heart failure, coronary artery bypass grafting, or prior valve surgery need to have assessment of ejection fraction to ensure EF is not = 40%, within last 3 months prior to the first study treatment.
- •15. Life-threatening visceral disease or other severe concurrent disease
- •16. Any of the following procedures prior to initiation of study treatment:
- •a. Catheterization, endoscopy, stent or drain placement, within 48 hours, and laparoscopy without surgical intervention can be in less than 48 hours
- •b. Minor surgery requi
研究者
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