NCT04193904终止1 期
A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events
研究概览
简要总结
This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer.
Subjects will take MRx0518 daily for one week prior to the start of radiation therapy, throughout radiation and until surgical resection of the tumour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed informed consent and is willing to comply with the protocol
- •Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- •TNM stage: Tx, T1-4, N0-1 or Nx, M0
- •Potentially resectable pancreatic cancer defined as no extra-pancreatic disease, no evidence of tumor extension to the celiac axis, common hepatic artery and superior mesenteric artery, and no evidence of deformity of the superior mesenteric vein or superior mesenteric portal vein confluence
- •No evidence of distant metastases either prior to or after induction chemotherapy
- •Able to comply with instructions required for radiation therapy
- •Age 18 years or older
- •Completion of 2-6 months of standard induction chemotherapy (mFOLFIRINOX, gemcitabine and nab-paclitaxel or other)
- •Eastern Cooperative Oncology Group Score 0, 1 or 2
- •Adequate haematologic function (absolute neutrophil count ≥1500mm3; haemoglobin ≥8.0 g/dL; platelet count ≥50000mm3)
- •Adequate renal and liver function (creatinine ≤ 1.5 x upper limit of normal; total bilirubin ≤ 1.5 x upper limit of normal; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal; alkaline phosphatase ≤ 2.5 x upper limit of normal
排除标准
- •Prior radiation therapy to the abdomen that would overlap with the treatment field
- •Prior surgical resection of pancreatic tumor
- •Receiving any approved or investigational anti-cancer agent other than those provided for in this study
- •Uncontrolled or active gastric or duodenal ulcer disease within 30 days of dosing
- •Residual or ongoing ≥Grade 3 toxicity from chemotherapy
- •Contraindication to IV contrast that can't be managed with pre-medication
- •Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of consent (concurrent non-interventional trials are eligible)
- •Uncontrolled intercurrent illness including but not limited to, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, stroke, or psychiatric illness that would limit compliance with treatment
- •Second primary malignancy within the last 5 years, unless treated definitively and/or low risk in the judgement of the treating investigator
- •Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have history of infection are eligible)
- •Known intolerance or hypersensitivity to study drug
- •Subjects who are allergic to amoxicillin/clavulanic acid, erythromycin and imipenem
- •Female subjects who are breastfeeding
- •Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control for the entire study and for 30 days after last dose of MRx
- •A negative pregnancy test must be obtained within 14 days prior to start of treatment
- •Male subjects who are unwilling or unable to use an acceptable method of birth control for the entire study period and for 30 days after last dose of MRx0518
- •Serious infection requiring systemic therapy
- •Use of systemic antibiotics within 2 weeks of start of study treatment
- •Has a known inability for intake of oral capsules
研究组 & 干预措施
MRx0518 with hypofractionated preoperative radiation
Experimental
Subjects will take one capsule of MRx0518 twice daily from one week prior to radiation therapy until surgical resection (6 to 9 weeks approx.) Radiation therapy will be delivered as 30Gy/10 fractions over 2 weeks.
干预措施: MRx0518 (Drug)
MRx0518 with hypofractionated preoperative radiation
Experimental
Subjects will take one capsule of MRx0518 twice daily from one week prior to radiation therapy until surgical resection (6 to 9 weeks approx.) Radiation therapy will be delivered as 30Gy/10 fractions over 2 weeks.
干预措施: Hypofractionated Preoperative Radiation (Radiation)
结局指标
主要结局
To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events
时间窗: Up to 1 year post completion of radiation
Adverse events will be assessed as per CTCAE v5.0
次要结局
- Major pathologic response(At time of surgery)
- Local Control(6 months post radiation)
- Distant Control(6 months post radiation)
- Overall Survival (OS)(12 months post radiation)
- Margin status(At time of surgery)
- Tumour infiltrating lymphocytes (TILs)(Baseline to Surgery)
- Progression Free Survival (PFS)(12 months post radiation)
研究者
研究点 (1)
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