ACTRN12622000378729招募中2 期
Investigating the safety and efficacy of NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer, NEO-IMPACT.
Australasian Gastro-Intestinal Trials Group (AGITG)0 个研究点目标入组 20 人开始时间: 2022年3月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Pancreatic adenocarcinoma proven by histology or cytology that is resectable or borderline resectable.
- •Good performance status (ECOG 0 - 1)
- •Adequate kidney, liver and bone marrow function to be able to undergo immuno-chemotherapy
- •Body weight above 30kg
- •Life expectancy of at least 12 weeks
- •Tumour lesion on CT or MRI scan that is measurable
排除标准
- •Locally advanced or metastatic pancreatic adenocarcinoma.
- •Neuroendocrine pancreatic carcinoma.
- •Prior treatment for pancreatic cancer (including another clinical trial).
- •Complete or intermediate dihydropyrimidine dehydrogenase deficiency (DPYD deficiency)
- •Major surgical procedure within 28 days prior to the first dose of immuno-chemotherapy.
- •History of allogenic organ transplantation.
- •Active or prior autoimmune or inflammatory disorders such as inflammatory bowel disease (eg. colitis, Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis).
- •Uncontrolled intercurrent illness (such as ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrheoa, psychiatric illness/social situations that would limit compliance with study requirements).
- •History of another primary malignancy (except malignancy treated with curative intent and with no know active disease for more than 5 years, or adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma insitu without evidence of disease or history of leptomeningeal carcinomatosis or history of active primary immunodeficiency).
- •Active infection with TB, hepatitis B or hepatitis C.
- •HIV positive.
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of immunotherapy.
- •Receipt of live attenuated vaccine within 30 days prior to the first dose of immuno-chemotherapy.
- •Patients who are pregnant or breast-feeding.
- •Patients or partners of patients, who are of reproductive potential and are unwilling to use effective birth control from screening to 90 days after the last dose of immunotherapy.
- •Known allergy or hypersensitivity to any of the drugs (immuno-chemotherapy) used or their excipients.
研究者
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