[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digestive-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digestive-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,52,95,119,151,185,212,244,272,295],{"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":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100552612","phase-2-dose-individualization-of-chemotherapy-in-patients-with-gastrointestinal-cancers-lacking-a-specific-liver-enzyme-100552612",false,"NCT06475352","Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme","Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers","FUDOSE","Inclusion Criteria:\n\n1. Patients with pre-treatment screening based on \\[U\\] value according to INCa\u002FHAS recommendations.\n2. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2\n3. Fluoropyrimidine-naïve patients with gastrointestinal cancer starting chemotherapy combining fluoropyrimidine (5-FU or capecitabine) and oxaliplatin whatever the context (adjuvant, neoadjuvant, palliative) including the following regimens (the most frequently prescribed in gastrointestinal cancers):\n\n   * biweekly 5-FU and oxaliplatin (FOLFOX) +\u002F- targeted therapy (TT)\n   * three-weekly capecitabine and oxaliplatin (CAPOX) +\u002F- TT\n4. Age ≥ 18 years\n5. Patients eligible for full standard fluoropyrimidine and oxaliplatin doses regardless of DPD deficiency\n6. Adequate bone marrow function (cell blood count (CBC)), estimated glomerular filtration rate (DFG) ≥ 50 ml\u002Fmin, alkaline phosphatase (ALP) \u002F aspartate aminotransferase (ASAT) \u002F alanine aminotransferase (ALAT) ≤ 5 upper limit of normal (ULN), and bilirubin ≤ 50 micromol\u002FL\n7. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n8. Women of childbearing potential must have a negative serum or urine pregnancy test.\n9. Patients must agree to remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year for the duration of study treatment and within 6 months after completing treatment.\n10. Patients must be affiliated to a Social Security System (or equivalent).\n11. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Patients with complete DPD deficiency based on \\[U\\] ≥150 ng\u002FmL\n2. Any prior treatment including a fluoropyrimidine\n3. Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency\n4. Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and\u002For comorbidity regardless of a DPD deficiency\n5. Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial\n6. Recent or concomitant treatment with brivudine\n7. Pregnant or breastfeeding woman.\n8. Participation in another therapeutic trial within 30 days prior to inclusion.\n9. Persons deprived of their liberty or under protective custody or guardianship.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to establish guidelines for fluoropyrimidine dose reduction according to uracilemia in patients with DPD deficiency in the treatment of digestive cancers. The main question it aims to answer is:\n\n\\- Which reduction dose of fluoropyrimidine is needed for patient with DPD deficiency?\n\nParticipants will:\n\n* Take the treatment with the reduction of dose stated by the protocol\n* Visit the clinic once every 2-3 weeks for checkups and tests for collection of adverse events",[27,28],"Digestive Cancer","Colorectal Cancer",[30,31,32,33,34,35,36,37,38],"Fluoropyrimidine","FOLFOX","CAPOX","Adjuvant","Metastatic","Recurrent","Colorectal","digestive","Cancer","RECRUITING","2026-04-22",{"date":42,"type":43},"2026-04-23","ACTUAL",{"date":45,"type":43},"2025-01-20",{"date":47,"type":21},"2030-01",{"name":49,"class":50},"UNICANCER","OTHER",41,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":79,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100571099","target-specific-immunopet-imaging-of-digestive-system-carcinoma-100571099","NCT06715839","Target-specific immunoPET Imaging of Digestive System Carcinoma","Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma","Inclusion Criteria:\n\n1. Aged 18-75 years old and of either sex；\n2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;\n3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Pregnancy；\n2. Severe hepatic and renal insufficiency;\n3. History of serious surgery in the last month;\n4. Allergic to antibody or single-domain antibody radiopharmaceuticals.","75 Years",{"count":20,"type":21},[62],"NA","The aim of this study is to establish and optimize the target-specific PET\u002FCT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.",[65,27,66,67,68,69,70,71,72,73,74,75,76,77,78],"Malignancy","Digestive System Neoplasm","Digestive System Carcinoma","Digestive System Cancer","Liver Cancer","Stomach Cancer","Colon Cancer","Rectum Cancer","Pancreatic Cancer","Esophagus Cancer","Gallbladder Carcinoma","Small Intestine Cancer","Appendix Cancer","Bile Duct Carcinoma",[80,81,82,83,84],"human epidermal growth factor receptor 2 (HER2)","Trophoblast cell surface antigen 2 (TROP2)","Glypican-3 (GPC3)","Glycoprotein A33 (gpA33)","Nectin cell adhesion molecule-4 (Nectin-4)","2025-12-25",{"date":87,"type":43},"2025-12-31",{"date":89,"type":43},"2024-12-04",{"date":91,"type":21},"2027-09",{"name":93,"class":50},"RenJi Hospital",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":94},"100403253","interest-of-circulating-tumor-dna-in-digestive-and-gynecologicbreast-cancer-100403253","NCT04530890","Interest of Circulating Tumor DNA in Digestive and Gynecologic\u002FBreast Cancer","Inclusion Criteria:\n\n* Digestive or gynecological \u002F breast cancer proven or suspected, requiring oncological treatment (chemotherapy or immunotherapy)\n* Major patient\n* Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party\n* Information note and collection of non-opposition after clear and fair information about the study\n\nExclusion Criteria:\n\n* Linguistic or psychological refusal or inability to understand and \u002F or sign the information and no-objection note\n* History of a cancer other than that allowing inclusion in the 5 years preceding inclusion",{"count":102,"type":21},1000,[62],"Circulating tumor DNA (ctDNA) offers the possibility of accessing the tumor genome from circulating blood through a simple blood test. It is currently used for diagnostic, prognostic and predictive purposes of response or resistance to oncological treatments. These advances in ctDNA have been made possible by major developments in molecular biology techniques in recent years, as the detection of ctDNA requires very sensitive techniques such as Next Generation Sequencing (NGS).\n\nCtDNA overcomes this problem of very limiting tumor heterogeneity during a solid biopsy. All of these applications make circulating DNA an increasingly essential tool in the management of cancer patients. The studies are currently in most cases on small numbers and are retrospective.\n\nIn addition, exosomes are also a biomarker of the future that can also be detected in the bloodstream . Exosomes are nanovesicles 50 to 200 nm in diameter released into the extracellular environment via the endosomal pathway by fusion with the plasma membrane. They are very informative since they transport tumor genetic material in the form of DNA, mRNA and miRNA, but also adhesion proteins, immunostimulatory molecules and cytoskeleton, enzymes and Heats shock proteins ( HSP).\n\nThe aim of the ADIGYN study is to set up a large prospective cohort to assess the diagnostic, prognostic and predictive impact of ctDNA and exosomes in digestive and gynecological \u002F breast cancers. From the circulating DNA, we characterize the ActDNA on the molecular level thanks to the study of different point mutations usually used but also of new described mutations having a therapeutic impact and the search for other genetic alterations having an impact on the therapeutic strategy (such as microsatellite instability) or the study of exosomes and their composition. To assess resistance to oncological treatments, ctDNA will be analyzed at the start of treatment, during treatment, during progression and \u002F or relapse and also during monitoring or treatment break",[106,27,107,108,109],"Breast Cancer","Gynecologic Cancer","Circulating Tumor DNA","Exosomes","2025-12-17",{"date":112,"type":43},"2025-12-24",{"date":114,"type":43},"2021-03-08",{"date":116,"type":21},"2032-03",{"name":118,"class":50},"Poitiers University Hospital",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100612979","association-between-composition-of-the-gut-microbiota-and-nutritional-status-in-digestive-oncology-100612979","NCT07260617","Association Between Composition of the Gut Microbiota and Nutritional Status in Digestive Oncology","Study of the Association Between the Composition of the Gut Microbiota and Nutritional Status in Patients Treated With Chemotherapy in Digestive Oncology","ONCONUTRIBIOTA","* Inclusion Criteria \\* :\n* Adult patient\n* Patient with digestive cancer, including:\n\n  * Borderline or locally advanced pancreatic adenocarcinoma\n  * Metastatic pancreatic adenocarcinoma without symptomatic peritoneal carcinomatosis\n  * metastatic colon\u002Frectal cancer without symptomatic peritoneal carcinomatosis\n* Patients with an indication for chemotherapy (induction treatment or treatment of metastatic disease)\n* Patients able to eat orally at the time of inclusion in the study\n* Patients with a performance status (PS) score ≤2\n* Patients who agree to provide stool and saliva samples\n* Patients who have given their written informed consent\n* Patients affiliated with the French social security system\n* Exclusion Criteria :\n* Pregnant or breastfeeding women\n* Patients who have received antibiotics within 3 weeks prior to the first chemotherapy treatment (excluding antibiotic prophylaxis administered in the context of surgery or endoscopy).\n* Individuals receiving psychiatric care that may interfere with their ability to respond to questionnaires (in the investigator's opinion)\n* Persons deprived of their liberty or subject to legal protection measures (guardianship, curatorship)\n* Patients participating in another interventional study with medication\n* Patients who have undergone chemotherapy for another malignant tumor in the last 12 months.\n* Patients with another synchronous malignant tumor, with the exception of adequately treated carcinoma in situ of the cervix or squamous cell carcinoma of the skin, or limited basal cell or squamous cell skin cancer. This cancer must then be adequately controlled.\n* Patients with symptomatic brain and\u002For meningeal metastases.\n* Patients who have undergone digestive resection (excluding appendectomy or cholecystectomy \\>12 months ago).\n* Patients with symptomatic peritoneal carcinomatosis prior to the start of chemotherapy.",{"count":128,"type":21},150,"OBSERVATIONAL","Nutritional status represents a crucial issue in the management of cancer patients, as between 40% and 60% of them suffer from malnutrition at the time of diagnosis. This condition worsens morbidity, increases treatment-related adverse effects, infections, and hospitalizations, and can lead to death in 10% to 20% of cases, independently of tumor progression. Anticancer treatments often exacerbate malnutrition due to their side effects, such as loss of appetite or taste alterations.\n\nAlthough international guidelines (ESPEN, ESMO, ASCO) recommend a multimodal nutritional intervention combining nutritional support and physical activity. The effectiveness of these approaches varies among patients. This variability can be explained by several factors, including individual differences in dietary intake response, metabolic status, and digestive tolerance to treatments.\n\nThe intestinal and oral microbiota appear to be key cofactors in regulating these various parameters, influencing appetite, host metabolism, and intestinal absorption. Alterations in the microbiota-particularly a decrease in bacterial diversity and an increase in Candida albicans-have been associated with appetite loss and taste perception disorders, especially in patients with digestive cancers. Therefore, the intestinal microbiota constitutes a potential therapeutic and diagnostic target to improve nutritional strategies in oncology.\n\nInterventions targeting the microbiota (such as probiotic supplementation or fecal microbiota transplantation) have already demonstrated an impact on nutritional parameters in preclinical models of malnourished cancer-bearing mice; however, clinical data remain scarce and limited.\n\nThe ONCONUTRIBIOTA-cohort study aims to characterize and investigate the oral and intestinal microbiota of patients initiating chemotherapy for digestive cancer, in relation to their nutritional status clinical characteristics and food preferences, in order to identify potential biomarkers or therapeutic targets to optimize their nutritional management.\n\nPatients will be followed during two of their routine care visits: on the day of the first chemotherapy treatment and at the end of the first cycle of chemotherapy. During these visits, stool and saliva samples will be collected, completed by additional assessments including global quality of life and nutritional quality of life questionnaires, olfactory and gustatory tests, and measurements of parameters used to determine the presence of malnutrition, general health status and oncological evaluation.",[27],[133,134,135,136,137,138,139],"oral and fecal microbiota","digestive cancer","colorectal cancer","pancreatic cancer","chemotherapy","malnutrition","microbiome","NOT_YET_RECRUITING","2025-11-21",{"date":143,"type":43},"2025-12-03",{"date":145,"type":21},"2025-12-01",{"date":147,"type":21},"2027-12-01",{"name":149,"class":50},"Hospices Civils de Lyon",3,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":170,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":94},"100417430","multicomponent-prehabilitation-and-outcomes-in-elderly-patients-with-frailty-100417430","NCT04715581","Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty","Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study","Inclusion criteria:\n\n1. Age ≥65 years but \\\u003C90 years;\n2. Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract;\n3. Clinical Frailty Scale ≥5;\n4. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;\n2. Inability to communicate due to coma, profound dementia, or language barrier;\n3. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;\n4. Inability to take oral diet due to preoperative gastrointestinal disease or other disease;\n5. Severe heart dysfunction (left ventricular ejection fraction \\\u003C30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher;\n6. Other reasons that are considered unsuitable for study participation.","65 Years","89 Years",{"count":161,"type":21},540,[62],"The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.",[165,27,166,167,168,169],"Old Age; Debility","Surgery","Preoperative Rehabilitation","Nutrition Therapy","Outcomes",[171,172,134,173,174,175],"older patients","frailty","prehabilitation","nutrition therapy","outcomes","2025-07-29",{"date":178,"type":43},"2025-07-31",{"date":180,"type":43},"2021-11-25",{"date":182,"type":21},"2028-12",{"name":184,"class":50},"Peking University First Hospital",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100383091","phase-2-efficacy-of-neoadjuvant-chemotherapy-in-terms-of-dfs-in-patients-with-localized-digestive-neuroendocrine-carcinomas-100383091","NCT04268121","Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas","Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas","NEONEC","Inclusion Criteria:\n\nPhase II\n\n1. Histologically proven digestive CNE, (the WHO 2017 classification: poorly differentiated and Ki 67 \\> 20%),\n2. Patients with localized CNE, without metastasis (computed tomography \\[CT\\], thoraco-abdominopelvic CT scan \\[TAP\\] according to RECIST 1.1; examinations performed no later than 21 days before starting the study treatment, possible locoregional lymph node involvement defined according to the TNM classification),\n3. Positron emission tomography (PET) and CT for lymph node status and elimination of secondary visceral and\u002For bone disorders, 4. Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,\n\n5\\. Age ≥ 18 years, 6. Written informed consent obtained from the patient, willing and able to comply with the protocol, 7. Registration in a National Health Care System (Protection Universelle Maladie \\[PUMa\\] included), 8. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment.\n\nMen and women are required to use a reliable and adequate birth control during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration.\n\nProspective cohort\n\n1. Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67\\> 20%),\n2. Localized, without metastasis on computed tomography \\[CT\\], thoracoabdominopelvic CT scan \\[TAP\\] RECIST 1.1, and\u002For locoregional lymph node involvement,\n3. Age ≥ 18 years,\n4. Written informed consent obtained from the patient, willing and able to comply with the protocol,\n5. Registration in a National Health Care System (PUMa - Protection Universelle Maladie included),\n6. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment.\n\nMen and women are required to use a reliable and adequate birth control methods during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration.\n\nExclusion Criteria:\n\nPhase II\n\n1. Well-differentiated NEC, whatever the grade,\n2. Metastatic disease,\n3. Cancer of unknown primary\n4. Organ failure that does not allow chemotherapy treatment,\n5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ\n6. Tumor with a mixed component (component accounts for ≥ 30%),\n7. Patient impossible to follow-up,\n8. Other than platinum-etoposide chemotherapy administrated,\n9. Tutelage or guardianship or patient protected by law\n\nProspective cohort\n\n1. Well-differentiated NEC, whatever the grade,\n2. Metastatic disease,\n3. Cancer of unknown primary\n4. Organ failure that does not allow chemotherapy treatment,\n5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ\n6. Tumor with a mixed component (component accounts for ≥ 30%),\n7. Patient impossible to follow-up,\n8. Other than platinum-etoposide chemotherapy administrated,\n9. Tutelage or guardianship or patient protected by law.",{"count":194,"type":21},78,[24],"NEONEC is a single-phase, phase II study evaluating the efficacy of the 12-month neoadjuvant chemotherapy in patients with locally differentiated digestive NEC. The recommended chemotherapy is based on the current reference combination of platinum (cisplatin or carboplatin) and etoposide (VP16). For anorectal locations, radiochemotherapy is proposed to avoid the morbidity of conventional surgery.\n\nThe objective of the study is to improve relapse-free survival (RFS) in NEC patients treated with neoadjuvant chemotherapy followed by surgery or chemoradiotherapy.\n\nIn parallel, we will perform a prospective cohort study with patients whose diagnosis is made during surgery, who have not received neoadjuvant treatment, and who are offered an adjuvant treatment of the same type (combination of platinum and platinum salts and etoposide).",[198,27],"Neuroendocrine Carcinoma",[200,201],"Neoadjuvant treatment","Adjuvant treatment","2025-07-22",{"date":204,"type":43},"2025-07-23",{"date":206,"type":43},"2021-01-05",{"date":208,"type":21},"2031-01",{"name":210,"class":50},"GERCOR - Multidisciplinary Oncology Cooperative Group",14,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":229,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},"100473299","targeted-therapy-drug-monitoring-in-digestive-oncology-100473299","NCT05443087","TARGETed Therapy Drug MONITOring in DIGestive Oncology","Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future","TARGETMONITO","Inclusion Criteria:\n\n1. Patient aged 18 years or over\n2. Advanced digestive cancer (histologically confirmed or confirmed by imaging for HCC) for which a standard treatment (according to each drug SmPC and as per standard of care) planned with:\n\n   * Regorafenib for GIST, mCRC, and HCC,\n   * Everolimus for gepNET,\n   * Sunitinib for pNET or GIST,\n   * Cabozantinib for HCC,\n   * Encorafenib - cetuximab for mCRC\n3. Life expectancy of greater than 3 months - at the discretion of the investigator\n4. Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)\n5. Patients must be affiliated to a Social Security System (or equivalent)\n6. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n\nExclusion Criteria:\n\n1. Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied\n2. Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy\u002Fprocedure excluding alopecia and peripheral neuropathy\n3. Prior treatment with the same MKI molecule(s) planned to be given in the cohort. If different MKI molecules (from the one(s) planned in the study) have been previously taken, a wash out period of 2 weeks before treatment should be observed.\n4. Other invasive malignancies either currently active or active in the last 3 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin\n5. Any condition that may jeopardize patient participation in the study as well as non contraception for male and female with child-bearing potential, pregnancy or breast feeding.\n6. Patient unwilling or unable to comply with the medical follow-up required by the standard treatment taken (including PK sampling during treatment phase and vital status collection during follow-up phase) because of psychosocial, familial, social or geographical reasons\n7. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product which have a marketed authorisation, used as per the SmPC for the given indication)\n8. Patient deprived of their liberty or under protective custody or guardianship",{"count":221,"type":21},330,[62],"Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.",[27,225,226,227,228],"Metastatic Colorectal Cancer","Hepatocellular Carcinoma","GIST","Neuroendocrine Tumors",[230,231,232,233,234],"multi kinases inhibitors","therapeutic drug monitoring","pharmacokinetics","pharmacodynamics","advanced digestive cancers","2025-03-25",{"date":237,"type":43},"2025-03-30",{"date":239,"type":43},"2022-08-29",{"date":241,"type":21},"2027-06",{"name":49,"class":50},29,{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":94},"100505944","psychoneurological-symptom-cluster-in-oncology-100505944","NCT05867966","Psychoneurological Symptom Cluster in Oncology","Evolution and Management of a Psychoneurological Symptom Cluster in Patients Who Had a Breast Cancer or a Digestive Cancer","Inclusion critera for WP1:\n\n* Diagnosis of non-metastatic breast cancer, or digestive cancer (i.e., anal, colorectal, gastric, esophageal, liver, pancreatic cancers).\n* ≥ 18 years old.\n* No history of cancer, and not currently in relapse.\n* Having completed the active treatments (i.e., surgery, chemotherapy, radiotherapy) for 5 years maximum, based on the methodology and recommendations of studies on symptom clusters in oncology\n\nAdditional inclusion criteria for WP2:\n\n* No history of severe psychiatric disorders (e.g., schizophrenia, dissociative episodes) or substance abuse (to avoid severe dissociation during hypnosis).\n* Score ≥ 4 for the core symptom selected to design the intervention, as suggest by previous interventional studies, and measured on a visual analogue scale from 0 to 10.",{"count":252,"type":21},500,[62],"A psychoneurological symptom cluster is increasingly documented in oncology. It is composed of cancer-related fatigue, sleep difficulties, pain, emotional distress, and cognitive difficulties. These symptoms are linked by strong but complex relationships, and reinforce each other, negatively impacting patients' quality of life and survival. The configuration of this cluster (i.e., the relationships between the symptoms) seems different according to the cancer diagnosis or moment in the cancer journey. It has however been very little studied. Network analysis is an innovative method that allows a deeper understanding of the interactions between these symptoms. It also allows to compare patterns of clustering between distinct populations or measurement times. Finally, it allows to determine one core symptom in a cluster (i.e., the one with the strongest associations with the other symptoms), which could represent a target of choice for interventions aiming to improve the whole symptom cluster. This innovative project has then two main goals. First, the investigators will assess the evolution of the psychoneurological symptom cluster in two populations of patients with cancer: women with breast cancer, and patients with digestive cancer, over two years. Second, the investigators will test the feasibility and preliminary benefits of a new mind-body group intervention specifically designed to address the core symptom of the cluster, determined with network analysis in each population. As suggested by many authors, the proposed intervention will be based on the common-sense model of self-regulation developed by Leventhal and focus on cognitive-behavioral, self-care and mind-body (i.e., hypnosis) empowering strategies. The aim is to assess the satisfaction of the participants regarding the intervention, as well as its impact on the symptoms involved in the cluster.",[38,106,27],[257,258,259,260,261,262],"cancer","oncology","symptoms","quality of life","hypnosis","self-care","2025-03-18",{"date":265,"type":43},"2025-03-21",{"date":267,"type":43},"2024-01-16",{"date":269,"type":21},"2027-12-31",{"name":271,"class":50},"University of Liege",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":94},"100320242","development-of-clinical-and-biological-database-100320242","NCT03449264","Development of Clinical and Biological Database","Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas","BCBInstitut","Inclusion Criteria:\n\n* Age\\> at 18 years old,\n* Patient with invasive or in situ tumor pathology (proven or suspected) any stage confounded,\n* Patient in ICM at diagnosis\n\n  * a digestive cancer (esophagus, stomach, pancreas, colon, rectum, anal canal) or\n  * gynecological cancer (ovary, endometrium, cervix) or\n  * breast cancer or\n  * sarcoma.\n* Naïve patient of any treatment for the present cancer,\n* Patient requiring treatment involving at least one (or more) tumor surgery (s)\n* Patient who has accepted supplementary blood samples,\n* Patient having given his informed, written and express consent.\n\nExclusion Criteria:\n\n* Patient not affiliated to a social protection scheme,\n* Patient whose regular follow-up is a priori impossible for psychological, familial, social or geographical reasons,\n* Pregnant and \u002F or nursing women,\n* Subject under tutelage, curatorship or safeguard of justice,\n* Patient in an emergency situation.",{"count":281,"type":21},4000,[62],"The BCB is a tool:\n\n* for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;\n* to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;\n* to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.\n\nThe creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects.",[27,107,106,285],"Sarcoma","2025-02-11",{"date":288,"type":43},"2025-02-12",{"date":290,"type":43},"2017-07-27",{"date":292,"type":21},"2037-11",{"name":294,"class":50},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":306,"conditions":307,"keywords":314,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":94},"100513103","early-phase-1-a-clinical-study-on-oncolytic-virus-injection-r130-ov-for-the-treatment-of-advanced-solid-tumors-100513103","NCT05961111","A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors","An Open, Single-armed, Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients with solid tumors clearly diagnosed by histology and\u002For cytology.\n2. Failure of standard treatment or patient unwillingness to receive other antitumor therapy.\n3. Age 18 to 75 years.\n4. Subjects with ECoG score of 0-2.\n5. Expected survival of 3 months or more.\n6. Have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral or intraperitoneal drug delivery.\n7. Subjects must have appropriate organ function, and laboratory tests during the screening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelets (PLT) ≥ 80 × 109\u002FL, and hemoglobin (Hb) ≥ 85 g\u002FL; b) serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values; c) serum c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases do not exceed 5 times the upper limit of normal values; e) activated partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit of normal values.\n8. No absolute or relative centasis contraindiction.\n9. Eligible patients of childbearing potential must agree to use a reliable method of contraception with their partner for the duration of the trial and for at least 180 days after the last dose; female patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to enrollment.\n10. Subjects voluntarily sign an informed consent form and are in good compliance.\n\nExclusion Criteria:\n\n1. Have had any serious adverse reactions associated with immunotherapy.\n2. Subjects with any severe and\u002For uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification \\> 1.0 g.\n3. Patients with past history of type I diabetes mellitus or HIV.\n4. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.\n5. Patients with severe prior interstitial lung changes (as determined by the investigator).\n6. Patients with active tuberculosis and a strong positive OT test.\n7. Patients with active bleeding or severe coagulation dysfunction.\n8. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.\n9. Have not recovered to CTCAE 4.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy.\n10. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.\n11. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have not healed within 4 weeks prior to enrollment.\n12. Pregnant, lactating and planning to have children within six months.\n13. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.",{"count":303,"type":21},20,[305],"EARLY_PHASE1","20 participants are expected to be enrolled for this open，Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with advanced solid tumors.",[285,308,27,106,309,310,311,107,312,313],"Carcinoma","Lung Cancer","Brain Cancer","Melanoma","Head and Neck Cancer","Kidney Cancer",[315,316],"Oncolytic virus","Herpes simplex virus type 1","2023-07-25",{"date":319,"type":43},"2023-07-27",{"date":321,"type":43},"2023-06-24",{"date":323,"type":21},"2026-06",{"name":325,"class":326},"Shanghai Yunying Medical Technology","INDUSTRY"]