ACTRN12624000455561尚未招募1 期
Safety and efficacy of Faecal Microbiota Transplantation co-delivered with chemotherapy in improving pain, symptom management and treatment efficacy in patients with pancreatic cancer
Central Adelaide Local Health Network (CALHN)0 个研究点目标入组 60 人开始时间: 2024年4月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Participants who will be included are patients with a pancreatic cancer diagnosis who underwent an initial CT scan, and whose tumour is not surgically resectable at first assessment (including borderline resectable). The patients must be:
- •Adults aged between 18 and 75 years of age
- •Seen by a participating clinician for their first assessment between the study start date and the end of recruitment date
- •Administered Folfirinox as a chemotherapy agent
- •Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-1.
- •Presenting an adequate bone marrow function with haemoglobin > 100 g/L, platelets > 100 X 10^9/L neutrophils > 1.5 X 10^9/L within 7 days of enrolment.
- •Presenting an adequate renal function, with calculated creatinine clearance >40 mL/min (Cockcroft and Gault) within 7 days of enrolment.
- •Presenting an adequate hepatic function with serum total bilirubin < 1.25 X upper limit of normal range (ULN) and alanine transaminase (ALT) or aspartate aminotransferase (AST)<2.5xULN (<5x ULN) if liver metastases present) within 7 days of enrolment
- •Presenting a magnesium close to the lower limit of normal range within 7 days of enrolment.
- •With a life expectancy of at least 12 weeks.
- •Returning a negative pregnancy test around 72 hours before commencing study treatment (women of childbearing potential only).
- •Speaking English or attending appointments accompanied with an English speaking next of kin
- •Able to provide a signed informed consent
- •Willing and able to comply with all study requirements, including treatment timing and nature of required assessments
排除标准
- •Aged under 18 years old or over 75 years old at first assessment
- •With resectable pancreatic tumour who are predicted to receive surgery
- •Already receiving chemotherapy treatment either for pancreatic cancer or another cancer
- •Who have already received chemotherapy treatment for pancreatic cancer.
- •With prior pelvic radiotherapy, systemic chemotherapy, immunotherapy, approved proteins/antibodies or any investigational agent within 4 weeks prior to commencing study treatment.
- •Who received radiotherapy within 14 days of commencing study treatment.
- •With unresolved toxicities from prior systemic therapy or radiotherapy that, in the opinion of the investigator, does not qualify the patient for study treatment.
- •Wwith medical or psychiatric conditions that compromise the patient’s ability to give informed consent or to complete the protocol.
- •With prior systemic therapy, including with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
- •Pregnant or breastfeeding women
- •Severely immunocompromised patients (neutropenic as defined by <1,500 neutrophils cells/µL; this is to optimise the safety of FMT administration)
- •With diagnosed dysphagia or other disorder affecting swallowing
- •Who received prebiotic or probiotic within 4 weeks of randomisation (to exclude recent manipulation of the gut microbiota)
- •Who used antibiotic within 8 weeks of randomisation (to exclude recent manipulation of the gut microbiota)
- •For which the pancreatic tumour(s) were identified as a secondary cancer
- •With known allergy to Creon and/ or Maxolon
- •With known anaphylactic food allergy
- •With a history of interstitial pneumonitis, pulmonary fibrosis or evidence of interstitial pneumonitis, or pulmonary fibrosis on baseline chest CT scan.
- •With a history of Gilbert syndrome.
- •With known cirrhosis, chronic active hepatitis, or chronic persistent hepatitis.
- •With active bleeding diathysis.
- •With uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
- •With active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as CTC grade 2 [CTCAE version 4.3])
- •Who receive chronic treatment with immunosuppressives.
- •Wth a known history of HIV seropositivity.
- •Who have any severe and/or uncontrolled medical conditions or infections
- •Who have a history of another primary malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse.
- •Presenting brain metastasis.
- •Women and partners of women of childbearing potential who are not using effective contraception. Adequate contraception must be used throughout study treatment and for 6 months following the completion of all study treatment.
- •With history of serious drug adverse reactions.
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