[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oesophageal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oesophageal-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,59,90,116,140,173,196,231,256,283,303,331,354,380,408,432,455,488,513,545,567],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100641147","digitally-supported-prehabilitation-before-major-visceral-cancer-surgery-100641147",false,"NCT07658313","Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery","From Prehabilitation to Rehabilitation: A Feasibility Trial for Digitally Supported Prehabilitation in Major Visceral Oncologic Surgery","P2R-OncoVis","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Clinical diagnosis requiring major surgery of the pancreas, liver, bile ducts, stomach, or esophagus with curative intent\n* Confirmed indication for surgery by the multidisciplinary tumor board\n* Medical stability and physician clearance to participate in a prehabilitation exercise program\n* Willingness and ability to attend center-based prehabilitation exercise sessions three times per week, or once per week with additional tele-prehabilitation if travel time exceeds 40 minutes one way\n* Willingness and ability to perform home-based physical activities\n* Sufficient German language proficiency and digital literacy\n* Access to a smartphone or tablet device with internet connection\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Physical disability or mental impairment preventing safe participation in the study\n* Health care medical power of attorney not permitting independent consent\n* Non-elective, emergency, or revision surgery\n* Acute medical condition contraindicating participation in a structured prehabilitation program","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Major visceral oncologic surgery is associated with high postoperative morbidity, prolonged hospitalization, delayed recovery, and reduced quality of life. Patients undergoing surgery of the pancreas, liver, bile ducts, stomach, or esophagus frequently present with reduced physical fitness, malnutrition, sarcopenia, and psychological distress, all of which may negatively affect surgical outcomes and rehabilitation. Although prehabilitation has shown potential to improve functional capacity before surgery, structured prehabilitation pathways are currently not routinely implemented in Austria, and the feasibility of digitally supported perioperative care pathways remains insufficiently evaluated.\n\nThe aim of the Prehab2Rehab-OncoVis study is to evaluate the feasibility, acceptability, and safety of a multimodal, digitally supported prehabilitation intervention for patients undergoing major visceral oncologic surgery with curative intent. The study will additionally explore potential effects on clinical recovery, functional capacity, rehabilitation outcomes, and patient-reported outcomes across the perioperative pathway.\n\nPrehab2Rehab-OncoVis is designed as a prospective, single-arm feasibility cohort study conducted at the University Hospital Salzburg and the University Institute of Sports Medicine, Prevention and Rehabilitation, coordinated by the Paracelsus Medical University in cooperation with the Ludwig Boltzmann Institute for Rehabilitation Research and the Ludwig Boltzmann Institute for Digital Health and Prevention within the Prehab2Rehab consortium. Approximately 30 adult patients, with the possibility to include up to 50 participants if feasible, will be consecutively recruited.\n\nThe intervention consists of a four-week multimodal prehabilitation program combining supervised exercise training, promotion of physical activity, nutritional counseling, psycho-oncological distress screening, and health literacy support. Digital tools will support the intervention throughout the perioperative pathway, including the HERO application (Das Herz Reha-Informationstool) for patient education and health literacy, aktivplan as a digital exercise planner and training diary, and the CAATS telecommunication platform for remote supervision and tele-prehabilitation sessions where appropriate.\n\nThe exercise intervention includes supervised center-based sessions and, for participants with longer travel distances, a hybrid model combining center-based and tele-prehabilitation sessions. Nutritional counseling will follow current European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines and includes screening for malnutrition risk. Psycho-oncological distress screening will follow recommendations of the German Cancer Society and includes referral to supportive care when clinically indicated.\n\nParticipants will be assessed throughout the perioperative pathway, including at the beginning and end of prehabilitation (Prehabilitation Assessment 1 \\[PRE1\\] and Prehabilitation Assessment 2 \\[PRE2\\]), during hospitalization and rehabilitation, and at a three-month follow-up after surgery. Primary outcomes focus on feasibility, including recruitment and retention rates, adherence, fidelity, safety, data management feasibility, and acceptability and usability of the digital technologies. Secondary outcomes include clinical recovery indicators, postoperative complications, length of hospital and intensive care stay, functional independence, psychological well-being, quality of life, body composition, cardiorespiratory fitness, functional exercise capacity, and muscle strength.\n\nTo contextualize outcomes, two historical comparator cohorts will be used: a local hospital cohort of patients who previously underwent similar surgery without prehabilitation, and a national rehabilitation cohort derived from routine rehabilitation datasets matched for diagnosis, sex, and age.\n\nThe study is intended to generate feasibility data and preliminary estimates that may support the development of future adequately powered randomized controlled trials evaluating digitally supported prehabilitation and rehabilitation pathways in visceral oncologic surgery.",[27,28,29,30,31,32,33,34,35],"Gastrointestinal Neoplasms","Pancreatic Neoplasms","Liver Neoplasm","Oesophageal Cancer","Gastrointestinal Cancer","Pancreatic Cancer","Liver Cancer","Prehabilitation","Cancer Rehabilitation",[34,37,38,39,40,41,42,43,44,45],"Visceral Surgery","Oncology","Rehabilitation","Digital Health","Exercise Therapy","Teleprehabilitation","Cancer Surgery","Preoperative Care","Functional Recovery","NOT_YET_RECRUITING","2026-06-16",{"date":49,"type":50},"2026-06-18","ACTUAL",{"date":52,"type":21},"2026-06",{"date":54,"type":21},"2027-07",{"name":56,"class":57},"Ludwig Boltzmann Institute for Digital Health and Prevention","OTHER",2,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100642922","recovery-after-cancer-application-100642922","NCT07642492","REcovery After Cancer Application","REcovery After Cancer Application (RECapp) - Personalised Support After Surgery for Oesophageal and Gastric Cancer Patients","RECapp","Inclusion Criteria\n\n* Patients who have undergone invasive surgery with curative intent for oesophageal or gastric cancer (including salvage surgery)\n* ≥18 years of age\n* Ability to read, understand, and complete study materials in Swedish, including consent forms, questionnaires, and instructions\n* Access to a smartphone or tablet with personal BankID\n\nExclusion Criteria\n\n\\- Cognitive impairment",{"count":68,"type":21},250,[24],"The RECapp study is a clinical trial evaluating a digital tool designed to support patients recovering from surgery for oesophageal or stomach cancer. The goal is to reduce symptoms and improve quality of life during recovery.\n\nEach year in Sweden, around 1,400 people are diagnosed with these cancers. Although more people are surviving thanks to better treatments, recovery after surgery is often long and challenging, with lasting physical and emotional effects. At the same time, healthcare systems are under pressure to provide long-term support.\n\nRECapp is a digital platform developed together with patients and healthcare professionals. It includes a mobile app for patients and a web portal for healthcare staff. Patients can track their symptoms, receive personalised self-care advice, and get guidance on when to contact healthcare. Healthcare providers can follow patients' progress remotely.\n\nIn this study, 250 patients from across Sweden will take part. They will be randomly assigned to either standard care or standard care plus RECapp. Participants will be followed for six months after surgery, and their symptoms and quality of life will be regularly assessed through questionnaires.\n\nIf RECapp proves effective, it could become part of future cancer care in Sweden-helping patients feel better supported while also making care more efficient.",[30,72],"Gastric Cancer (Diagnosis)",[74,75,76,77,78,79],"Oesophageal cancer","Gastric cancer","Post surgery","Digital intervention","Symptom monitoring","Self-care advice","2026-06-07",{"date":82,"type":50},"2026-06-11",{"date":84,"type":21},"2026-06-15",{"date":86,"type":21},"2029-12-15",{"name":88,"class":57},"Karolinska Institutet",7,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":98,"maxAge":4,"enrollmentInfo":99,"targetDuration":101,"studyType":102,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100549908","understanding-the-variation-of-modern-endoscopic-ultrasound-use-in-patients-with-oesophageal-cancer-value-100549908","NCT06440174","Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE)","Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE): a Multi-methods Study","VALUE","Inclusion Criteria:\n\n1. Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer.\n2. Referred for EUS examination as part of standard of care investigations.\n3. Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III)\n4. MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +\u002F- neoadjuvant therapy, or definitive chemoradiotherapy)\n5. Prior staging with CT and PET-CT\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n7. Clinical staging of T1-T4, N0-N3, M0 disease\n8. Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type\n\n   Exclusion Criteria:\n9. Recurrent or residual disease\n10. Distant metastatic disease detected before EUS.\n11. Previous oesophagectomy or oesophageal radiotherapy\n12. Unable to undergo EUS examination.\n13. Concurrent malignancy e.g., second primary tumour\n14. Other histopathological cell type","16 Years",{"count":100,"type":21},160,"6 Months","OBSERVATIONAL","This is an observational trial that will look at patients undergoing endoscopic ultrasound (EUS) in patients with oesophageal cancer and to determine the proportion of cases in which EUS changes disease management in these patients.",[30],"RECRUITING","2026-04-24",{"date":108,"type":50},"2026-04-30",{"date":110,"type":50},"2024-06-27",{"date":112,"type":21},"2026-12-31",{"name":114,"class":57},"University Hospital Southampton NHS Foundation Trust",14,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100466754","phase-3-pd-1-inhibitor-combined-with-neoadjuvant-chemoradiotherapy-plus-surgery-for-locally-advanced-escc-neocrtec2101-100466754","NCT05357846","PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)","Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)","Inclusion Criteria:\n\n1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.\n2. Patients must not have received any prior anticancer therapy.\n3. More than 6 months of expected survival.\n4. Age ranges from 18 to 70 years.\n5. Absolute white blood cells count ≥4.0×109\u002FL, neutrophil ≥1.5×109\u002FL, platelets ≥100.0×109\u002FL, hemoglobin ≥90g\u002FL, and normal functions of liver and kidney.\n6. WHO PS score 0-1\n7. Signed informed consent document on file.\n\nExclusion Criteria:\n\n1. Patients have received any prior anticancer therapy.\n2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.\n3. Patients with concomitant hemorrhagic disease.\n4. Patients who cannot tolerate surgery.\n5. Pregnant or breast feeding.\n6. Patients without informed consent because of psychological, family, social or any other factors.\n7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.\n8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.\n9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control.\n10. Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.\n11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.\n12. Patients with history of interstitial lung disease or noninfectious pneumonia.\n13. Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.\n14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU \u002F mL or 104 copies \u002F mL ) or hepatitis C ( HCV antibody positive ).","70 Years",{"count":125,"type":21},422,[127],"PHASE3","The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.",[130,131,30],"Squamous Cell Esophageal Carcinoma","Esophageal Cancer",{"date":108,"type":50},{"date":134,"type":50},"2022-11-01",{"date":136,"type":21},"2031-01-31",{"name":138,"class":57},"Sun Yat-sen University",1,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":151,"conditions":152,"keywords":160,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":139},"100550437","cancer-loyalty-card-study-2-clocs-2-100550437","NCT06447064","Cancer Loyalty Card Study 2 (CLOCS-2)","Cancer Loyalty Card Study 2: a Retrospective Observational Case-Control Study","(CLOCS-2)","Inclusion Criteria (ALL):\n\n* Individuals aged \\>18 years of age\n* Individuals must be residing in the United Kingdom at the time of giving informed consent\n* Individuals must be registered with an NHS GP Practice\n* Individuals must meet the criteria of ONE of the groups. For example, to be eligible for Group 1 (Cases), individuals must have been diagnosed with one of the following cancer types in the last 24 months: Bladder, colorectal (bowel), endometrial, liver, oesophageal, ovarian, pancreatic, stomach (gastric), uterine, or vulval; whereas for Group 2 (Controls), individuals must not have received a cancer diagnosis of any type in the last 6 years (except where the diagnosis was of non-melanoma skin cancer).\n* Individuals must be a primary registered cardholder\\* of one of the loyalty cards listed below, and consent to share their loyalty card data with the study team\n* Tesco Clubcard\n* Boots Advantage Card\n* Provision of written informed consent\n* Willing and able to comply with all required study activities\n\n  * The primary registered card holder, i.e., the person who is named on the loyalty card account, must also enrol into the study, if someone other than the registered primary card holder from the same household, wants to take part in the study.\n\nExclusion Criteria (ALL):\n\n* Individuals under the age of 18 years\n* Non-UK residents, at the time of giving informed consent\n* Individuals without an eligible loyalty card, or who have no one in their household who has an eligible loyalty card\n* Individuals who are not the primary registered cardholder in their household and where the primary registered loyalty card holder is not willing to join the study, and\u002For where the primary registered cardholder does not make purchases for or on behalf of the individual\n\nExclusion Criteria (CASES):\n\n• Individuals will not be able to join as a case if:\n\n* they have been diagnosed with an eligible cancer type more than 24 months ago (except where the diagnosis was non-melanoma skin cancer).\n* they have received an ineligible cancer diagnosis within the last 6 years except where the diagnosis was non-melanoma skin cancer).\n\nExclusion Criteria (Controls):\n\n• Individuals will not be able to join as a control (Group 2) if:\n\no they have received any cancer diagnosis in the last six years (except where the diagnosis was non-melanoma skin cancer).",true,{"count":150,"type":21},2900,"Cancer is one of the leading causes of mortality worldwide and is responsible for an estimated 9.6 million deaths yearly. Cancer-related deaths can be reduced if patients are diagnosed and treated early. Delay in cancer diagnosis can occur at any point along the diagnostic spectrum, from the first observation of symptoms to the start of treatment. Diagnosing cancer when it is still at an early stage, before it has spread, gives surgery, radiotherapy and other treatments the best chance of working.\n\nTherefore, early diagnosis is the most important way to improve cancer outcomes.Most of the cancers usually presents with vague and non-alarming symptoms. Most individuals are diagnosed late when the cancer has already spread, and the prognosis is poor. There are over 200 different types of cancer that can cause many different signs and symptoms. Sometimes symptoms affect specific body areas, such as abdomen or skin. But signs can also be more general, and include weight loss, tiredness (fatigue) or unexplained pain. The type of symptoms varies from person to person.\n\nThe major reasons for not presenting to the GP with symptoms such as these are \"not wanting to waste the GP's time\" and normalisation of these symptoms.\n\nThe persistence of a symptom, social influence and awareness encourage help-seeking behaviours in primary care. However, few believe their symptom(s) might be a sign of cancer. Consequently, people might choose to self-manage their symptoms by using over-the-counter medication, and to seek advice from other sources, (pharmacists, family, internet), rather than a primary care physician.\n\nRATIONALE FOR CURRENT STUDY\n\nAn early cancer diagnosis is essential for receiving treatment as early as possible to have the best chance for successful treatment. Early diagnosis of cancer can be challenging. Sometimes, the cancer symptoms resemble common illnesses and could resolve with the use of over-the-counter medications and other remedies until they become persistent or debilitating. The present study focuses on ten cancer forms: colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic. Patients diagnosed with the cancers mentioned above often report experiencing vague symptoms (such as abdominal or back pain, indigestion, feeling full etc). They often use over-the-counter medication to manage their symptoms before seeing a doctor.\n\nInformation about how often and what products participants purchase (e.g. pain killers, digestive products and natural remedies) to care for these symptoms could help identify these cancers a few crucial weeks or months earlier and encourage people to seek help sooner from their doctors.",[32,153,30,154,33,155,156,157,158,159],"Colon Cancer","Stomach Cancer","Bladder Cancer","Uterine Cancer","Vulvar Cancer","Ovarian Cancer","Endometrial Cancer",[158,161,162,163],"Epidemiology","Observational Study","Risk Assessment","2026-03-24",{"date":166,"type":50},"2026-03-25",{"date":168,"type":50},"2026-02-04",{"date":170,"type":21},"2027-04",{"name":172,"class":57},"Imperial College London",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":139},"100488646","revolution-surgery-revolution-surgery-100488646","NCT05642819","REVOLUTION Surgery (REVOLUTION Surgery)","Routine Evaluation of People Living With Cancer - Surgery","Inclusion Criteria:\n\nInclusion Criteria (Cancer Resection)\n\n* Patients with cancer (Clinical, histological, cytological or radiological evidence) planned for surgical resection of a malignancy of the oesophagus, stomach, pancreas, colon, or rectum\n* Aged 18-years and over\n* Able to give written informed consent\n\nInclusion Criteria (Healthy Controls)\n\n* Patients identified at surgical clinic as being planned for an open abdominal operation for a non-inflammatory, benign condition (e.g. donor nephrectomy)\n* Aged 18-years and over\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and\u002For investigator\n* Presence of a concomitant inflammatory (e.g., rheumatoid arthritis, inflammatory bowel disease) or muscle wasting condition other than cancer\n* Participants who are pregnant, suffer from claustrophobia or with implanted medical devices (e.g., cardiac pacemaker, metallic foreign bodies, aneurysm clip) would not be able to undergo the additional multiparametric magnetic resonance imaging (MRI)",{"count":181,"type":21},200,"Some people with cancer suffer from muscle wasting, lose weight and feel tired. This process, termed cachexia, is a significant problem and can lead to a reduction in both quality and quantity of life.\n\nCachexia is caused by interactions between the tumour and the patient. Historically, it was considered to be a purely end-stage phenomenon of advanced cancer, however, it is now known that early signs of cachexia can even influence the outcomes of patients with potentially curative pathology, including those planned for a surgical resection.\n\nThis study aims to collect information, from patients who are at risk of cachexia, about body composition, physical activity, quality of life and the body's immune response to cancer. Previously these measures have been most frequently studied in isolation, or at one single time-point, and are therefore likely to give an incomplete picture. A more holistic characterisation of surgical patients at risk of cancer cachexia, across their treatments, is currently lacking.\n\nParticipants with cancer will be recruited to the study from surgical services in the United Kingdom (UK). A small number of 'control' patients without cancer, who are undergoing surgery for a benign condition, will also be recruited for comparison. Those recruited will have their height and weight measured, answer questionnaires about quality of life, undergo assessment of their physical function and levels of activity, have blood taken to analyse markers of inflammation and have their body composition measured by a variety of methods. A subgroup of patients will also undergo an additional magnetic resonance imaging (MRI) scan of their abdomen and thighs. At the time of their operation, participants will also have small biopsies of muscle, fat, tumour and urine taken for biochemical analysis. Patients with cancer, will be asked to return for three follow up appointments during the year after their operation where these assessments will be repeated.",[184,30,185,32,186],"Cachexia","Gastric Cancer","Colorectal Cancer","2025-12-01",{"date":189,"type":50},"2025-12-02",{"date":191,"type":50},"2023-10-01",{"date":193,"type":21},"2027-12",{"name":195,"class":57},"University of Edinburgh",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":148,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":205,"studyType":102,"phases":4,"briefSummary":206,"conditions":207,"keywords":215,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100612988","augmented-response-of-volatile-biomarkers-in-the-assessment-of-oesophagogastric-cancer-aroma2-100612988","NCT07260734","AUGMENTED RESPONSE OF VOLATILE BIOMARKERS IN THE ASSESSMENT OF OESOPHAGOGASTRIC CANCER (AROMA2)","AROMA2","Inclusion Criteria:\n\n* Aged ≥ 18 years old.\n* Participants referred from primary care according to the urgent suspected cancer referral guidelines for potential underlying oesophagogastric cancer a for the reference test (described below).\n* Willing and able to provide informed written consent to take part in study.\n\nExclusion Criteria:\n\n* Previous oesophageal or gastric resection\n* History of cancer within three years (other than non-melanoma skin cancers)\n* Co-morbidities preventing breath collection\n* Pregnant participants\n* Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid\n* Unable or unwilling to provide informed written consent.",{"count":204,"type":21},6000,"3 Months","Cancer of the stomach and oesophagus is among the world's top five cancers. Survival rates are very poor as the disease presents late and early symptoms are non-specific. The study team has developed a non-invasive test for cancers of the stomach and oesophagus based on the detection of volatile organic compounds in exhaled breath. These compounds are known to be produced by both cancers as well as cancer associated bacteria within the gut.\n\nThe proposed innovation is to improve the accuracy of this test by investigating whether simple metabolic substrates can increase the production of these volatile organic compounds by both the tumour and its associated bacteria.",[208,209,210,211,30,212,213,214],"OESOPHAGO-GASTRIC CARCINOMA","Oesophageal Adenocarcinoma","Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma","Oesophageal Cancer Nos","Oesophageal Junction Cancer","Breath Tests","Volatile Organic Compound",[216,217,218,219,220,221,222,223],"Oesophageal adenocarcinoma","Gastric adenocarcinoma","Breath testing","Microbiome","Augmentation","Volatile Organic Compounds","Volatilomics","Breathomics","2025-11-21",{"date":226,"type":50},"2025-12-03",{"date":187,"type":21},{"date":229,"type":21},"2028-11-01",{"name":172,"class":57},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":139},"100610920","phase-2-a-phase-ii-clinical-study-evaluating-ssgj-706-in-combination-therapy-for-advanced-gastrointestinal-cancers-100610920","NCT07233850","A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers","Inclusion Criteria:\n\n1. Volunteer to participate in this study, willing to follow all trial procedures, and sign the informed consent form (ICF).\n2. Age 18-75 years old, male or female.\n3. Has a life expectancy of at least 3 months\n4. ECOG score of 0-1.\n5. Locally advanced or metastatic tumors of the digestive system that cannot be curatively resected and cannot be treated with radical chemoradiotherapy, including gastric\u002Fgastroesophageal junction adenocarcinoma, colorectal cancer, pancreatic ductal adenocarcinoma, and oesophageal cancer.\n6. No prior systemic therapy in the locally advanced unresectable\u002Fmetastatic setting.\n7. Has at least 1 measurable lesion per RECIST version 1.1.\n8. Willing to provide a paraffin-embedded (FFPE) specimen or an unstained histopathological section (preferably a newly obtained tumor tissue sample).\n9. Has bone marrow, kidney, liver, blood and clotting test results required per protocol.\n10. Female subjects of childbearing age had a negative serum pregnancy test within 7 days before the first dose. Male and female subjects of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until at least 120 days after the last use of study drug and for at least 180 days after the last use of chemotherapy drugs or bevacizumab. During this period, women are not lactating, male subjects are not allowed to freeze or donate sperm, and female subjects are not allowed to donate eggs or retrieve eggs for personal use.\n\nExclusion Criteria:\n\n1. For gastric\u002Fgastroesophageal junction adenocarcinoma: HER2-positive (defined as IHC 3+, or IHC 2+ with ISH-positive).\n2. For colorectal cancer: Patients with known MSI-H or dMMR.\n3. Presence of brainstem, meningeal metastases, spinal cord metastases, or compression.\n4. Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases (such as surgery, radiotherapy) are allowed to enroll if they are clinically stable for at least four weeks after treatment (until the first dose of study drug) and corticosteroids are discontinued 3 days before the first dose of study drug; Subjects with untreated, asymptomatic brain metastases can be enrolled.\n5. Previous immunotherapy, including immune checkpoint inhibitors (e.g., PD-l\u002FL1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, OX40 antibody, etc.), immune cell therapy and any other treatment targeting the mechanism of anti-tumor immune action.\n6. Adverse reactions caused by previous anti-tumor therapy need to be restored to grade ≤1 (as judged by NCI-CTCAE 5.0 criteria), except for alopecia and fatigue.\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n8. Prior or current non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy.\n9. History of severe bleeding tendency or coagulation dysfunction.\n10. Presence of gastrointestinal perforation and\u002For fistula, intra-abdominal abscess within 6 months before the first dose.\n11. Subjects with known active tuberculosis (TB).\n12. Known history of severe allergy to any component of the trial drug, or history of severe allergic reaction to chimeric or humanized antibodies.\n13. Other conditions that, in the opinion of the investigator, may increase study-related risks or interfere with the interpretation of study results.","75 Years",{"count":239,"type":21},300,[241],"PHASE2","This study is a multicenter, open-label, phase II clinical trial evaluating the combination of SSGJ-706 with standard therapy for advanced gastrointestinal tumors. Its objective is to assess the safety, tolerability, and antitumor activity of SSGJ-706 in combination with standard treatment.",[244,245,246,30],"Gastric\u002FGastroesophageal Junction Adenocarcinoma","Metastatic Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","2025-11-14",{"date":249,"type":50},"2025-11-18",{"date":251,"type":21},"2025-11",{"date":193,"type":21},{"name":254,"class":255},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100605222","evaluation-of-seismocardiographyscg-for-assessing-fitness-and-predicting-outcomes-in-oesophageal-cancer-surgery-100605222","NCT07159711","Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery","Evaluation of Seismocardiography (SCG) as a Tool for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery","SEISMIC","Inclusion Criteria:\n\n* Age \\>=18\n* Diagnosis of Oesophageal cancer (T0-4 N0-3 M0, Oesophageal \u002F Gastro-Oesophageal Junction (GOJ) type 1-2 adenocarcinoma\n* Patients being considered for curative treatment (i.e. due to undergo NAC and Oesophagectomy \u002F Oesophago-Gastrectomy \\[open \u002F MIO \u002F hybrid \u002F robotic\\])\n* Patients able to give informed consent\n\nExclusion Criteria:\n\n* Pregnant patients.\n* Patients under the age of 18.\n* Patients undergoing primary Oesophagectomy +\u002F- Oesophago-Gastrectomy with no neoadjuvant therapy.\n* Patients undergoing Neoadjuvant chemoradiotherapy.\n* Patient's being treated with curative intent for Oesophageal Squamous cell carcinoma\n* Patients that are deemed not fit or suitable for Oesophagogastric cancer resection as part of a Multi-Disciplinary Team meeting decision.\n* Patients with implanted devices such as pacemakers or cardioverter-defibrillators.",{"count":265,"type":21},164,"Oesophageal cancer is a common cause of cancer death worldwide. Curative treatment involves chemotherapy and surgery but has significant risks. Therefore, patient selection and improving physical fitness to withstand such major treatment is important to reduce the risk of complications. Physical fitness is traditionally measured by a specialised exercise test called Cardiopulmonary exercise testing (CPET), which can take up to one hour and requires specialised staff and expensive equipment such as a graded exercise bike or treadmill. Seismofit is a small device (smaller than a smartphone) used to estimate fitness in patients in under three minutes while lying down at rest. It measures the vibrations generated by the heart and, together with patient height, weight, age, and gender, accurately estimates fitness using an algorithm developed in healthy patients. The device has never been tested in a large group of oesophageal cancer patients to see if it can be used to predict complications in patients undergoing cancer treatment.\n\nIn this study, patients undergoing Oesophageal cancer treatment with chemotherapy or chemoradiotherapy and surgery will have Seismofit measurements at various points during their treatment to see if we can predict complications and hospital stay. Secondly, this study will also evaluate the accuracy of Seismofit compared to the gold standard CPET results in cancer patients.",[30,209,34,268,269],"Oesophagectomy","Neoadjuvant Chemotherapy",[271,268,272,34,273],"oesophageal cancer","Fitness","Neoadjuvant chemotherapy","2025-08-29",{"date":276,"type":50},"2025-09-08",{"date":278,"type":21},"2025-09-15",{"date":280,"type":21},"2027-06",{"name":282,"class":57},"Guy's and St Thomas' NHS Foundation Trust",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":139},"100544105","esophageal-self-expandable-metal-stent-for-malignant-strictures-a-safety-and-efficacy-study-100544105","NCT06364553","Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study","ENTRANCE","Inclusion Criteria:\n\n* Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;\n* Requiring treatment for dysphagia (Ogilvie score of 2-41);\n* Life expectancy of less than 12 months;\n* Written informed consent;\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* Stenosis after laryngectomy;\n* Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;\n* Tumor length of more than 14 cm;\n* Previous stent placement for the same condition;\n* Coagulopathy (not corrected prior to stent placement);\n* Patients with eosinophilic esophagitis or an esophageal motility disorder;\n* Nickel titanium (Nitinol) allergy.",{"count":20,"type":21},[24],"A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.",[30],"2025-08-04",{"date":296,"type":50},"2025-08-07",{"date":298,"type":50},"2024-10-02",{"date":300,"type":21},"2025-10-01",{"name":302,"class":57},"Erasmus Medical Center",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":139},"100585785","phase-2-pulso-trial-pulsed-low-dose-rate-pldr-radiation-chemoradiation-crt-vs-standard-crt-for-esophageal-cancer-100585785","NCT06906887","PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer","Inclusion Criteria:\n\nA potential study subject who meets all of the following inclusion criteria is eligible to participate in the study.\n\n1. Age ≥ 18 years.\n2. Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).\n3. Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+\u002F- esophagectomy).\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Adequate hematologic function within 30 days prior to registration defined as follows:\n\n   1. Absolute Neutrophil Count ≥ 1,500\u002Fmcg\n   2. Hemoglobin ≥ 8 gm\u002FdL\n   3. Platelets ≥ 100,000\u002FmcL.\n6. Adequate renal function within 30 days prior to registration, defined as a creatinine clearance of ≥ 50 ml\u002Fmin as calculated by the Cockcroft-Gault equation.\n7. Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN\n\n   a. Note: patients with known Gilbert Syndrome can have a total bilirubin \\\u003C 2.5 x upper limit of normal (ULN).\n8. Female patients \\\u003C65 years of age and of childbearing potential must have a negative serum\u002Furine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months.\n9. Patients of reproductive potential must agree to use effective contraception for the duration of study treatment. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method, or intrauterine device.\n10. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\nA potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Age \\\u003C 18 years.\n2. Extensive distant metastatic cancer, defined as \\>5 metastases.\n3. Recurrent esophageal cancer.\n\n   a. Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e., treatment-associated toxicity).\n4. Prior non-approved chemotherapy for the treatment of cancer.\n5. Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.\n6. Women must not be pregnant or breast-feeding.",{"count":310,"type":21},50,[241],"This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.",[131,30,314],"GastroEsophageal Cancer",[316,317,318,319,131,30,314,320,321],"Pulsed Low-Dose-Rate Radiation","Chemoradiation","esophagitis","Esophagectomy","Pulsed reduced dose rate radiation","Pulsed radiation","2025-06-25",{"date":324,"type":50},"2025-06-29",{"date":326,"type":50},"2025-06-17",{"date":328,"type":21},"2032-06-01",{"name":330,"class":57},"Medical College of Wisconsin",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100590268","use-of-different-enteral-feeds-to-impact-on-chyle-leaks-in-oesophagectomy-100590268","NCT06965205","Use of Different Enteral Feeds to Impact on Chyle Leaks in Oesophagectomy","Impact of Enteral Feeding Approaches on Chyle Leaks in Oesophageal Cancer Surgery","Inclusion Criteria:\n\n* All adults aged over 18 years undergoing MIO or RAMIO for oesophageal cancer (adenocarcinoma and squamous cell cancer) at Beaumont Hospital will be approached for inclusion.\n\nExclusion Criteria:\n\n* Patients will be excluded if\n\n  * They are unable to provide informed consent\n  * They do not receive a feeding jejunostomy at or prior to their oesophagectomy\n  * Prior or concomitant malignancy that would interfere with this protocol",{"count":100,"type":21},[24],"Oesophagectomy (surgery to remove a cancerous portion of the oesophagus or gullet) is the cornerstone of treating oesophageal cancer. In recent years, minimally invasive techniques, including robotic assisted oesophagectomy have been introduced. These techniques reduce stress on patients, reduce pain, reduce the length of stay in hospital after their operation, without compromising cancer outcomes (and in some cases improving cancer outcomes). Any surgery carries the risk of complications. One complication that may arise with oesophagectomy is an increase in chyle leaks. Chyle is a fluid produced by the body that helps transport nutrients from the bowel to the bloodstream to allow them to be absorbed and processed. One of the channels that transports chyle, the thoracic duct, is divided as part of an oesophagectomy. Although it is clipped to reduce the risk of chyle leak, this may still occur, in up to 25% of operations. If a chyle leak occurs, a drainage tube needs to remain in the chest for a number of days, there may be alterations in the use of feeding techniques, and in a small portion of cases, there may need to be an operation to stop a leak, or a procedure in the radiology department. The goal of this study is to see whether use of a different type of post-operative feed (medium chain triglyceride or MCT feeds) can reduce the rate of chyle leak. This is already used\n\nto treat chyle leaks, and the question is whether using this as the routine post-operative feed can reduce rates of chyle leakage.",[30],[74,343,344],"chyle leak","MCT feed","2025-05-01",{"date":347,"type":50},"2025-05-11",{"date":349,"type":21},"2025-05-05",{"date":351,"type":21},"2030-12-31",{"name":353,"class":57},"Royal College of Surgeons, Ireland",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":379},"100529083","volatile-organic-compounds-as-breath-biomarkers-in-squamous-oesophageal-neoplasms-100529083","NCT06169163","Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms","ViSON","Inclusion Criteria: Participants with all the following characteristics will be eligible for inclusion in the study:\n\n1. Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC.\n2. Control cohort (n=259): Patients who have undergone or are undergoing an endoscopy (OGD) as part of their investigation for upper GI symptoms and are found to have either:\n\n   * A normal upper gastrointestinal tract\n   * Benign upper gastrointestinal disease\n\nExclusion Criteria: Participants with the following characteristics will not be eligible for inclusion in the study:\n\n1. Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC\n2. History of another cancer in the last five years\n3. Non-squamous cell oesophageal cancer\n4. Barrett's oesophagus (with or without dysplasia)\n5. Previous oesophageal or gastric resection\n6. Unable to provide written consent or lack capacity.\n7. Pregnant women","90 Years",{"count":363,"type":21},518,"Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5-year survival less than 20%). Early detection can improve survival (5-year survival \\>70%). Therefore, early detection is vital to improving survival.\n\nThere are no national screening guidelines, and an endoscopy (A camera test to look at the food pipe) is the only available test to detect OSCC.\n\nEarly detection of OSCC is challenging for many reasons. Firstly, early disease symptoms are non-specific, which patients often overlook. Secondly, 'Alarm' symptoms such as weight loss, difficulty swallowing or vomiting blood are signs of advanced stage. Lastly, endoscopy is an invasive test with associated risks and significant discomfort.\n\nThe investigators propose to develop a breath test for patients with non-specific symptoms. Breath testing has the ideal characteristics for a triage test because it is non-invasive, simple to perform, cost-effective and highly acceptable to patients. The test is based on identifying volatile organic compounds (VOCs, small molecules) that are produced by the cancer and released in breath.\n\nThe breath test will be offered by General Practitioners (GPs) to patients with non-specific symptoms. Those who test positive will be referred for an urgent camera test, and those who test negative can be reassured.",[366,30],"Oesophageal Squamous Cell Carcinoma",[368,369,74,370,371],"Breath biomarker","Early detection","Oesophageal squamous cell cancer","Volatile organic compounds","2025-04-29",{"date":374,"type":50},"2025-05-02",{"date":376,"type":50},"2023-12-01",{"date":112,"type":21},{"name":172,"class":57},13,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":387,"targetDuration":389,"studyType":102,"phases":4,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":139},"100501059","the-australia-and-new-zealand-multicentre-upper-gastrointestinal-endoscopic-tissue-resection-study-100501059","NCT05804331","The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study","ANZ UGI","Inclusion Criteria:\n\n* UGI neoplastic lesions \\> 10mm\n\n  * Lesions for ESD limited to the mucosal and\u002For submucosal layer OR\n  * Lesions for EFTR limited to the muscularis propria layer OR\n  * Lesions for STER limited to the submucosal and\u002For muscularis propria layer\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Age less than 18\n* Unable to give informed consent\n* Pregnant or lactating patients\n* Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally",{"count":388,"type":21},500,"3 Years","To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions",[392,30,185,393,394,395,396,397,398],"Cancer of Stomach","Gastric Adenocarcinoma","GI Cancer","GIST","Neuroendocrine Tumors","Gastric Neoplasm","Esophageal Neoplasms","2025-03-25",{"date":401,"type":50},"2025-03-27",{"date":403,"type":50},"2023-03-14",{"date":405,"type":21},"2028-09-14",{"name":407,"class":57},"Western Sydney Local Health District",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":431},"100360841","cardiopulmonary-toxicity-of-thoracic-radiotherapy-100360841","NCT03978377","Cardiopulmonary Toxicity of Thoracic Radiotherapy","CLARIFY","Inclusion Criteria:\n\n* Patients with oesophageal cancer in the mid or distal oesophagus and patients with NSCLC stage IIA-III or NSCLC stage IV with limited brain metastases (treatable with surgery or stereotactic radiosurgery) or SCLC limited disease (stage I-IIIB)\n* Scheduled for external-beam radiotherapy with curative intention.\n* WHO 0-2.\n* Age \\>= 18 years\n* Written informed consent.\n\nExclusion Criteria:\n\n* No heart failure in the last 2 months\n* No pulmonary embolism in the last 2 months\n* COPD gold IV\n* BMI \\>35\n* History of thoracic radiotherapy\n* Noncompliance with any of the inclusion criteria - For MRI part: Contra indications for MRI\n\nFor MRI part:\n\n• contra-indications for MRI",{"count":416,"type":21},320,"Radiotherapy improves locoregional control and survival of thoracic tumour patients. However, the associated exposure of normal tissues, often leads to side effects and possibly even reduces survival. Indeed, there is growing evidence that overall survival after radiotherapy for lung and oesophageal cancer is related to the radiation dose to heart and lungs. This suggests that thoracic radiotherapy causes mortality, which is currently not recognized as radiation-induced toxicity. So the question arises how to explain this treatment-related mortality.\n\nInterestingly, Ghobadi et al demonstrated in rats that thoracic irradiation can lead to pulmonary hypertension (PH). Histopathological analysis showed that radiation-induced PH closely resembles the pulmonary arterial hypertension (PAH) subtype. Moreover, in a clinical pilot study we confirmed early signs of PH including dose-dependent reductions in blood flow towards the lungs in radiotherapy patients.\n\nIn general PH significantly affects survival. Moreover, the PAH subtype is the most-rapidly progressive and lethal subtype. However, medical treatment can significantly slow down PAH progression, providing opportunities for secondary prevention. Yet, hard evidence that radiation-induced PH is a clinically relevant phenomenon in patients treated for thoracic tumours, is lacking.",[30,419],"Non Small Cell Lung Cancer",[421,422],"Radiotherapy","Pulmonary hypertension","2025-03-20",{"date":399,"type":50},{"date":426,"type":50},"2018-09-01",{"date":428,"type":21},"2027-04-01",{"name":430,"class":57},"University Medical Center Groningen",3,{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":139},"100547911","modulated-mid-frequency-whole-body-electromyostimulation-and-nutritional-therapy-in-gastrointestinal-cancer-patients-100547911","NCT06414122","Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients","The Efficacy of Modulated Mid-frequency (Whole-body Electromyostimulation) and Nutritional Therapy in Patients With Solid Tumors of the Gastrointestinal Tract (Excluding Liver and Pancreatic Carcinomas)","MOMENT","Inclusion Criteria:\n\n* Patients with oesophageal, gastric, duodenal, colon or rectal cancer following surgery without further therapy and with neoadjuvant and adjuvant therapy\n* medical clearance for exercise training\n* written declaration of consent from the study participant\n\nExclusion Criteria:\n\n* Participation in another study on the topic of exercise or nutrition\n* Electronic implants such as pacemakers, pumps, and coronary stents\n* Cardiac arrhythmia\n* Implants in the area of application (e.g. breast implants)\n* Pregnancy\n* Epilepsy\n* Wounds and open skin diseases in the area of application of the electrodes\n* Unhealed operations or bone fractures\n* Acute inflammatory diseases (e.g. inflammation of the intervertebral discs, bones, vessels, or soft tissue)\n* Directly after herniated discs or other instabilities such as large abdominal wall hernias\n* Blood clots (thromboses)\n* Bone diseases with high-grade osteoporosis\n* Increased risk of haemorrhage\n* Fever and illnesses that can be aggravated by physical exertion\n* Untreated high blood pressure\n* Blindness\n* Continuous parenteral nutrition\n* Metal and electronic parts in the body (e.g. prostheses, metal vascular clips, hearing aids\u002Finner ear\u002Fcochlear implants, magnetic dental prostheses, pacemakers, contraceptives)",{"count":441,"type":21},88,[24],"The purpose of this study is to assess the efficacy of modulated mid-frequency whole-body electromyostimulation (WB-EMS) combined with nutritional therapy in patients with gastrointestinal cancer.",[30,185,445,186],"Duodenal Cancer","2025-03-14",{"date":448,"type":50},"2025-03-19",{"date":450,"type":21},"2025-06",{"date":452,"type":21},"2026-09",{"name":454,"class":57},"University of Cologne",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":470,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":485,"leadSponsor":486,"locationsCount":431},"100576216","phase-2-multicenter-validation-trial-of-18falf-fapi-74-for-pet-imaging-of-cancer-associated-fibroblasts-through-fibroblast-activation-protein-inhibitors-fapi-in-different-tumor-types-100576216","NCT06782412","Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types","FAPIDO","Inclusion Criteria OGA:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.\n4. Patient underwent a \\[18F\\]FDG PET\u002FCT.\n5. TNM classification: cT1-4N0-3M0\n\nInclusion Criteria PDAC:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.\n4. Patient underwent a \\[18F\\]FDG PET\u002FCT or conventional staging with CT or MRI.\n5. TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.\n\nInclusion Criteria Clinically challenging cohort:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. Histologic or cytologic proven diagnosis of a malignancy.\n4. Patient underwent a \\[18F\\]FDG PET\u002FCT.\n5. Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.\n\nExclusion Criteria:\n\n1. Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.\n2. Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.\n3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.\n4. Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).\n5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.\n6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.\n7. Participant has a known hypersensitivity to \\[18F\\]AlF-FAPI-74 or the used excipients.",{"count":463,"type":21},109,[241,127],"The aim of the project is to demonstrate superior detection ratio of \\[18F\\]AlF-FAPI-74 PET\u002FCT compared to \\[18F\\]FDG PET\u002FCT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \\[18F\\]AlF-FAPI-74 PET\u002FCT in oncological patients with a clinically challenging situation.",[30,185,467,468,38,469],"Pancreatic Ductal Adenocarcinoma","FAP","Oncologic Disorders",[471,472,473,474,475,476,477,478,479,38,480],"Oesophagogastric adenocarcinoma","Pancreatic ductal adenocarcinoma","Clinically challenging situations","[18F]-FDG","[18F]-FAPI-74","[18F]AIF-FAPI-74","Positron emission tomography","PET","Nuclear imaging","Prospective","2025-02-06",{"date":483,"type":50},"2025-02-07",{"date":481,"type":50},{"date":193,"type":21},{"name":487,"class":57},"KU Leuven",{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":148,"sex":17,"minAge":18,"maxAge":361,"enrollmentInfo":495,"targetDuration":4,"studyType":22,"phases":497,"briefSummary":206,"conditions":498,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":139},"100470968","augmented-response-of-volatile-biomarkers-in-assessment-of-oesophagogastric-cancer-aroma-1--bioresource-100470968","NCT05412758","Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 \u002F BIORESOURCE)","Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer","AROMA 1 Inclusion Criteria:\n\n1. Aged 18-90years\n2. Oesophageal\u002Fgastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve\n3. Control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Endoscopy within 1 year • Planned endoscopy\n\nAROMA 1 Exclusion criteria:\n\nPatients with the following characteristics will not be eligible for inclusion in this study:\n\n1. Oesophageal squamous cell carcinoma\n2. Previous oesophageal and gastric resection\n3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer\n4. History of another cancer within three years\n5. Any form of oesophageal dysplasia (control cohort only)\n6. Previously diagnosed with Barrett's oesophagus (control cohort only)\n7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks\n8. Participants with co-morbidities preventing breath collection\n9. Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid\n10. Unable or unwilling to provide informed written consent\n11. Pregnant participants\n\nBIORESOURCE inclusion criteria:\n\n1. Aged 18- 90years\n2. Oesophageal\u002Fgastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve\n3. Oesophageal\u002Fgastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy\n\nBIORESOURCE exclusion criteria:\n\n1. Oesophageal squamous cell carcinoma\n2. Previous oesophageal and gastric resection\n3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer\n4. History of another cancer within five years\n5. Any form of oesophageal dysplasia (oesophageal\u002Fgastric control cohorts only)\n6. Previously diagnosed with Barrett's oesophagus (oesophageal\u002Fgastric control cohorts only)\n7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks\n8. Participants with co-morbidities preventing breath collection\n9. Unable or unwilling to provide informed written consent\n10. Pregnant participants",{"count":496,"type":21},648,[24],[221,219,499,500,30,185,501,502,503,504],"Microbioata","Breath Analysis","Volatalomics","Metabonomics\u002FLipidomics","Microbiome Analysis","Transcriptomics","2025-01-29",{"date":507,"type":50},"2025-01-31",{"date":509,"type":50},"2022-02-28",{"date":511,"type":21},"2025-10",{"name":172,"class":57},{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":17,"minAge":521,"maxAge":522,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":139},"100548546","phase-2-a-value-driven-study-on-reducing-immune-checkpoint-inhibitor-dosing-frequency-in-advanced-cancers-100548546","NCT06422403","A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers","A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)","VALUE-CHECK","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study-specific procedure\n2. Patients with one of the following:\n\n   * Cohort A: Previously untreated locally advanced\u002Fmetastatic HER2 -ve gastric\u002Fgastroesophageal junction\u002Fesophageal (PDL1 CPS ≥5% adenocarcinomas not amenable to curative surgery or radiotherapy who are above to begin platinum double and nivolumab.\n   * Cohort B: Previously untreated locally advanced\u002Fmetastatic Child's A hepatocellular carcinoma not amenable to curative surgery or radiotherapy who are above to begin atezolizumab and bevacizumab.\n   * Cohort C: Previously untreated locally advanced\u002Fmetastatic lung adenocarcinoma (PDL1 TPS≥50%, EGFR\u002FALK wildtype) not amenable to curative surgery or radiotherapy who are above to begin pembrolizumab monotherapy\n3. Measurable disease per RECIST 1.1 criteria\n4. ECOG Performance status is 0-2\n5. Normal organ and bone marrow function measured within 28 days before the study as defined below:\n\n   * Haemoglobin ≥ 8.0 g\u002FdL and no blood transfusions in the 28 days prior to entry\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   * No features suggestive of MDS\u002FAML on peripheral blood smear\n   * White blood cells (WBC) \\> 3x10\\^9\u002FL\n   * Platelet count ≥ 100 x 10\\^9\u002FL\n   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n   * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN\n   * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)\n6. A life expectancy ≥ 12 weeks in all patients.\n7. Females in childbearing age should be using adequate contraceptive measures, should not be breastfeeding and their pregnancy test prior to the start of treatment must be negative. Evidence of non-child-bearing potential is fulfilled by one of the following criteria at screening:\n8. The post-menopausal period defined as age ≥50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n9. Women \\\u003C50 years old they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range.\n10. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not a tubal ligatio\n11. Male patients should be willing to use barrier contraception\n12. The patient is willing to comply with the protocol during the study including undergoing treatment and scheduled visits and examinations including follow up.\n13. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is considered suitable for accurate repeated measurements\n\nExclusion Criteria:\n\n1. Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.\n2. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years\n3. Unstable spinal cord compression\u002Fbrain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the start of study treatment. For patients with brain metastases, gamma knife or stereotactic brain surgery is allowed prior to study treatment.\n4. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Minor surgery is allowed.\n5. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which based on investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or having active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n6. Autoimmune disorders\n7. Males and females of reproductive potential who are not using an effective method of contraception and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry\n8. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements\n9. Previous allogeneic bone marrow transplant.","21 Years","99 Years",{"count":524,"type":21},360,[241],"This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced\u002Funresectable gastric\u002Fgastroesophageal junction\u002Foesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome.",[528,393,314,30,529,530],"Carcinoma, Hepatocellular","Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma",[532,533,534,535],"Nivolumab","Atezolizumab","Pembrolizumab","Extended dosing interval","2025-01-08",{"date":538,"type":50},"2025-01-10",{"date":540,"type":50},"2024-11-25",{"date":542,"type":21},"2029-12-31",{"name":544,"class":57},"National University Hospital, Singapore",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":139},"100567002","post-oesophagectomy-outcomes-in-a-single-regional-centre-in-australia-100567002","NCT06662513","Post Oesophagectomy Outcomes in a Single Regional Centre in Australia","An Australian Regional Hospital's Oesophagectomy Outcomes","Inclusion Criteria:\n\n* patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023\n\nExclusion Criteria:\n\n* none",{"count":553,"type":21},100,"Literature review\u002Frationale for project\n\n* Oesophageal cancer is associated with a grim prognosis despite many advances in treatment. Oesophagectomy is a key component of the care of patients who are candidates for curative treatment, however it is associated with substantial morbidity.\n* Several studies have suggested that oesophagectomies performed at higher volume tertiary centres are associated with lower morbidity and mortality than lower volume centres, and this has prompted changes to policy in countries such as Great Britain, Canada and the Netherlands with regards to the centralisation of these cases. A higher volume centre within Australia is likely to perform 6 or more procedures per year.\n* Currently within Australia, centralisation on a large scale has not occurred. This has been limited in part by resource provision and geographical barriers. Therefore, oesophagectomies in Australia are still routinely performed in regional centres. However, there is a paucity of recent outcomes data from these centres.\n\nAims\u002Fobjectives\n\n* Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023)\n* Assess outcomes (long and short-term complications and mortality) and compare to morbidity and mortality rates from larger international centres",[30],[271,557],"regional surgery","2024-11-02",{"date":560,"type":50},"2024-11-05",{"date":562,"type":21},"2024-11-01",{"date":564,"type":21},"2024-11-30",{"name":566,"class":57},"Launceston General Hospital",{"id":568,"slug":569,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":580,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":139},"100399443","tgf--and-pdl-1-inhibition-in-esophageal-squamous-cell-carcinoma-combined-with-chemoradiation-therapy-100399443","NCT04481256","TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY","TAPESTRY","Inclusion Criteria:\n\n* Histologically proven squamous cell carcinoma of the esophagus or gastro esophageal junction.\n* Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen. Patients with M1 disease solely on the basis of supraclavicular metastasis are eligible. Patients with resectable tumors refusing radical surgery are eligible.\n* Locoregional recurrences without distant metastasis after surgery alone or endoscopical resection\n* Locoregional recurrences without distant metastasis after neoadjuvant chemoradiation + resection or definitive chemoradiation outside the previously irradiated area, provided that full dose of radiation can safely be delivered.\n* Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible if all other criteria are fulfilled.\n* If the tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction.\n* Age ≥ 18.\n* ECOG performance status 0-2 (cf. Appendix A).\n* Adequate hematological, renal and hepatic functions defined as:\n\n  * Neutrophils ≥ 1.5 x 109\u002FL\n  * Platelets ≥ 100 x 109\u002FL\n  * Hemoglobin ≥ 5.6 mmol\n  * Total bilirubin ≤ 1.5 x upper normal limit\n  * ASAT and ALAT ≤ 1.5 x upper normal limit, Alkaline Phosphatase ≤ 2.5 x upper normal limit.\n  * PT (INR) ≤ 1.5 x upper normal limit and aPTT ≤ 1.5 x upper normal limit.\n  * Creatinine clearance (Cockroft) \\> 60 ml\u002Fmin\n* Written, voluntary informed consent\n* Patients must be accessible to management and follow-up in the treatment center\n\nExclusion Criteria:\n\n* Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.\n* Patient with tracheo-esophageal fistula or extension into the mucosal layer of the trachea, highly at risk to develop fistula. Thus, tumor extension to the trachea is allowed, but not through the trachea.\n* Patients with pathological lymph nodes at both supraclavicular and truncus coeliacus level.\n* Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.\n* Patient (male or female) in the reproductive age is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.\n* Previous chemotherapy, radiation and\u002For treatment with checkpoint inhibitors for the currently present esophageal tumor.\n* Previous chemotherapy and\u002For treatment with targeted agents and\u002For checkpoint inhibitors for other forms of cancer within the last six months.\n* Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor.\n* Persisting grade \\>1 NCI CTCAE 5.0 toxicity (except alopecia and vitiligo) related to prior therapy; however, grade ≤2 sensory neuropathy is acceptable.\n* Presence of an esophageal stent.\n* History of bleeding diathesis or major bleeding event (grade ≥ 2) in the month prior to first dose of trial treatment.\n* Current use of direct oral anticoagulants or coumarins.\n* Clinically significant cardiovascular disease precluding safe treatment with chemoradiation.\n* Evidence of pulmonary fibrosis and\u002For clinically significant impairment of lung function precluding safe treatment with chemoradiation. In case of doubt about pulmonary function, a lung function test should be performed and, in case of abnormalities, discussed with the principle investigator.\n* Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide or cyclosporine.\n* Mental status that would prohibit the understanding and giving of informed consent.\n* Inadequate caloric- and\u002For fluid intake despite consultation of a dietician and\u002For tube feeding.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine for patients with a history of autoimmune-related hypothyroidism, insulin for patients with type 1 diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo with dermatological manifestations only are eligible to enter the study.\n* A diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg\u002Fday prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Diagnosis of HIV unless stable on antiretroviral therapy for at least 4 weeks, no evidence of multi-drug resistance, viral load of \\\u003C 400 copies\u002Fml and CD4+ T-cells ≥ 350 cells\u002Fµl.\n* Active HBV\u002FHCV. Participants on a stable dose of antiviral therapy with HBV\u002FHCV viral load below the limit of quantification are eligible.\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* An active infection requiring systemic therapy, which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.\n* Administration of a live vaccine within 30 days prior to the first dose of trial treatment. Seasonal flu vaccines that do not contain a live virus are permitted.\n* Patients with prior allogeneic stem cell or solid organ transplantation.",{"count":575,"type":21},49,[24],"The primary objective of this study is to assess the feasibility of treatment with bintrafusp alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.",[579,30],"Carcinoma, Squamous Cell",[581,582,583,584],"Definitive chemoradiation","TGF-beta inhibition","PDL-1 ihibition","feasability","2024-07-25",{"date":587,"type":50},"2024-07-26",{"date":589,"type":50},"2020-11-11",{"date":591,"type":21},"2030-09-01",{"name":593,"class":57},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]