The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.
The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
This study will combine focused ultrasound to generate heat, and a heat-sensitive chemotherapy drug (ThermoDox®), delivered into the blood of participants with non-resectable pancreatic cancer. We will compare this to standard delivery of chemotherapy – the drug Doxorubicin given into the blood without the addition of ultrasound. We aim to determine whether the novel approach to delivering chemotherapy with heating the tumour by focused ultrasound can enhance the amount of drug delivered to pancreatic tumours. This will be measured by analysing a biopsy sample of treated tumour.
The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope – a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.
The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).
This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for palliation of pancreatic cancer-related pain. Patients meeting all eligibility criteria without any exclusion criteria will be offered an opportunity to participate in the study. After obtaining informed consent a baseline history, physical examination, laboratory studies, and any additional imaging studies needed will be performed.
The major theoretic risk to the patient with this procedure is the development of acute pancreatitis. If acute pancreatitis were to develop, it should become clinically evident by day 3 following HIFU ablation. Therefore, the initial phase of this pilot study is designed to allow a sufficient interval between HIFU treatments to identify whether this theoretic risk will manifest clinically. Previous clinical experience in China suggests that HIFU of pancreatic tumors is safe without risk of developing severe acute pancreatitis.
Patients treated with HIFU will have approximately 15-20% of the tumor volume treated per session. The first 5 patients (feasibility study) will receive their first HIFU treatment followed by a 3-5 day interval for observation.
Following the feasibility study the results will be reviewed with the FDA. If no serious adverse events are encountered, and the FDA agrees with continuing the study, then the next 5 patients will be treated with an interval of 2-3 days between each treatment. If no serious adverse events are encountered in this group, then the next group of 5 patients will be treated at intervals of 1-2 days between each treatment.
The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.
* Inclusion
1. Subjects who are males or females ≥ 19 years of age
2. Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma
3. Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial
4. Subjects who have the following laboratory test values:
* bilirubin ≤ 1.5 x ULN (upper limit of normal)
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
* serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault)
* partial thromboplastin time (aPTT) ≤ 1.5 x ULN
* absolute neutrophil count (ANC) ≥ 1,500 cells/µL
* platelet count ≥ 100,000/µL
* hemoglobin ≥ 9.0 g/dL
5. Subjects who have at least a 12-week life expectancy at the Investigator's discretion
6. Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1
* Exclusion
1. Subjects who were treated with surgery, radiotherapy, chemotherapy or investigational therapy within 2 weeks (note: placement of biliary stent is allowed)
2. Subjects who have uncontrolled CNS metastases (patients who require steroids should be on a stable or decreasing dose for at least 2 weeks)
3. Subjects who have any contraindications for 5-FU, leucovorin, or oxaliplatin
4. Subjects who have moderate or severe cardiovascular disease
* Subjects who have myocardial infarction, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening
* Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening
* Subjects who have increase in brain natriuretic peptide(BNP) or increase in troponin (over 99th percentile upper reference limit) at Screening (based on the normal range of relevant study center)
* Subjects who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis
* Subjects who have a history of heart or aorta surgery
5. Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening
6. Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drug(s)
7. Subjects who have received prior treatment targeting the signaling pathway of TGF-β
8. Subjects who have a disease or condition that affects the mechanism of the investigational product, or are currently using or planning to use:
* Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme (CYP) including CYP1A2, CYP2B6, or CYP3A4
* Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase (UGT) 1A1 (UGT1A1)
* Drugs that are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1
* Drugs that are strong inhibitors or inducers of CYP2D6 or CYP3A4
9. Subjects who are unable to swallow tablets
10. Subjects who have a history of or are suspected of drug abuse
11. Female subjects of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period (e.g., sterilization, intrauterine contraceptive device, combination of oral contraception and barrier contraception, combination of other hormone delivery systems and barrier contraception, contraceptive cream, combination of cream, jelly, or form and diaphragm or condom)
12. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study
13. Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-timesthe half-life of the investigational product
