[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-bowel-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-bowel-adenocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,64,96,137,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100580291","phase-2-study-of-nalirifox-in-advanced-unresectable-small-bowel-tumors-100580291",false,"NCT06835387","Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors","Phase II Study of NALIRIFOX (Nanoliposomal Irinotecan + Oxaliplatin With Fluorouracil and Folinic Acid) in Advanced Unresectable Small Bowel Tumors","Inclusion Criteria:\n\n1. Subject has been informed about the nature of the study, and has agreed to participate in the study, and signed the ICF prior to participation in any study-related activities. Also, as determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of ≤ 1 within 28 days prior to registration.\n4. Histological or cytologically confirmed small bowel adenocarcinoma per AJCC staging manual, 8th edition that has not been previously treated in the metastatic setting. Subjects treated in the adjuvant setting who completed treatment \\> 6 months prior to registration and do not have residual toxicities \\> Grade 1 are eligible. NOTE: Subjects with only localized disease or disease which will likely become resectable after chemotherapy (per investigator discretion) are NOT eligible.\n5. Mismatch repair proficient (MMRp) and\u002For microsatellite stable (MSS) disease per institutional standard of care testing.\n6. Subject has one or more metastatic lesion(s) measurable by CT scan (or MRI, if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria. Lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.\n7. Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.\n\n   * Platelets (Plt) ≥ 100,000 cells\u002Fmm3\n   * Absolute Neutrophil Count (ANC) ≥ 1,500 cells\u002Fmm3; without the use of hemopoietic growth factors\n   * Hemoglobin (Hgb) ≥ 9 g\u002FdL\n   * Calculated creatinine clearance ≥ 30 mL\u002Fmin; Cockcroft-Gault formula for actual body weight should be used for calculation. For subjects with a body mass index (BMI) \\> 30 kg\u002Fm2, adjusted body weight should be used instead\n   * Total bilirubin ≤ 1.5 × ULN\n   * Aspartate aminotransferase (AST) ≤ 2 × ULN; \\\u003C 5× with liver metastases\n   * Alanine aminotransferase (ALT) ≤ 2 × ULN; \\\u003C 5× with liver metastases\n   * Albumin ≥ 2.5 gm\u002FdL\n   * PT\u002FINR and aPTT ≤ 1.5 x ULN; subjects on warfarin or other vitamin K antagonists should be discussed with the sponsor-investigator.\n   * Urinalysis: Urinalysis results without clinically significant abnormalities, per the investigator's assessment\n8. Electrocardiogram (ECG) without any clinically significant findings (QT interval corrected by Fridericia's formula (QTcF) ≤450 msec and no known arrhythmias) and per the investigator's assessment.\n9. Females of childbearing potential must have a negative urine or serum pregnancy test within ≤ 7 days prior to registration. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n10. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.\n11. Subjects with known human immunodeficiency virus (HIV) are eligible if they meet all the following criteria:\n\n    * CD4 count is ≥350 cells\u002FuL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications;\n    * Probable long-term survival with HIV if cancer were not present;\n    * Stable on a highly active antiretroviral therapy (HAART) regimen for ≥ 4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study;\n    * HIV is not multi-drug resistant;\n    * Taking medication and\u002For receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication.\n\n    NOTE: Testing for HIV is not required at screening unless mandated by local policy. If a subject is known to be HIV positive, testing is required as described above to meet eligibility requirements.\n12. Subjects with known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured. For subjects with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. NOTE: Testing for HBV and HCV is not required at screening unless mandated by local policy. If a subject is known to have an HBV and\u002For HCV infection, testing is required as described above to meet eligibility requirements.\n\nExclusion Criteria:\n\n1. Adenocarcinoma originating in the ampulla or appendix (duodenal tumors that involve the ampulla but originate in the duodenum are eligible).\n2. Neuroendocrine or any other histology different than adenocarcinoma.\n3. Prior treatment with irinotecan.\n4. Prior treatment of small bowel adenocarcinoma (SBA) in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy:\n\n   * Palliative radiotherapy is permitted but lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.\n   * Placement of biliary stent\u002Ftube is permitted.\n   * Palliative surgery (for example to treat obstruction)\n5. Known history of central nervous system (CNS) metastases. (subjects on a stable or decreasing dose of steroids and deemed clinically stable as per the investigator's assessment are eligible).\n6. Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, diarrhea \\> Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, or bowel obstruction.\n7. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.\n8. Subjects with an active malignancy in the last 2 years. The following subjects may be eligible: Subjects with prior history of in-situ cancer or basal or squamous cell skin cancer. Subjects with a history of other malignancies but have been continuously disease free for at least 2 years without treatment prior to registration.\n9. Known hypersensitivity to any of the components of nanoliposomal irinotecan, other liposomal products, or any components of 5-FU, LV or oxaliplatin.\n10. Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease, including:\n\n    * Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before registration\n    * High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year prior to registration\n    * New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure\n11. Active infection or an unexplained fever \\>38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled), which in the investigator's opinion might compromise the subject's participation in the study or affect the study outcome.\n12. Major surgery, other than diagnostic surgery, within 4 weeks prior to registration.\n13. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. Subjects are ineligible if:\n\n    * they are unable to discontinue the use of strong inhibitors of CYP3A, CYP2C8 and UGT1A1 at least 1 week prior to registration;\n    * they are unable to discontinue the use of strong CYP3A and CYP2C8 inducers at least 2 weeks prior to registration;\n14. There is presence of any contraindications outlined in the Contraindications or Warnings and Precautions sections of the IB for nanoliposomal irinotecan, or in the prescribing information for 5-FU, LV or oxaliplatin.\n15. Subjects who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.\n16. History of systemic connective tissue disorders (e.g. lupus, scleroderma, arteritis nodosa).\n17. Subjects who have received a live vaccine within 4 weeks prior to registration.\n18. History of the following: interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies, and peripheral artery disease (e.g. claudication, Leo Buerger's disease).\n19. Known low or absent dihydropyridine dehydrogenase (DPD) or UGT1A1activity. Testing for DPD or UGT1A1 deficiency is not mandatory but where required by local regulations, testing must be performed using a validated method which is recommended by local health authorities.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg\u002Fm2, followed by oxaliplatin 60 mg\u002Fm2, followed by leucovorin at 400 mg\u002Fm2 30 minutes after completion of oxaliplatin, followed by 5-FU 2400 mg\u002Fm2 60 minutes after leucovorin completion. Subjects will receive up to 6 cycles of NALIRIFOX then based on response and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue. Subjects will continue de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician\u002Fsubject choice to discontinue.",[26],"Small Bowel Adenocarcinoma","RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":31},"2025-06-30",{"date":35,"type":20},"2028-08",{"name":37,"class":38},"Tiago Biachi de Castria","OTHER",7,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100625042","phase-1-gucy2c-prime-boost-vaccination-for-advanced-colorectal-and-small-bowel-adenocarcinomas-100625042","NCT07417488","GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarcinomas","A Phase I, Single-Center, Dose Escalation Trial of Heterologous Prime-Boost Vaccination With Ad5.F35-hGUCY2C-PADRE and Lm-GUCY2C Vaccines in Adults With Advanced Colorectal and Small Bowel Adenocarcinomas","Inclusion Criteria:\n\n* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n  1. Males or females aged ≥ 18 years\n  2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n  3. Histologically or cytologically diagnosed, locally advanced or metastatic adenocarcinomas of colorectum or small bowel that have progressed after standard of care therapy or for which no standard therapy exists. Patients for whom standard therapies are intolerable or considered clinically inappropriate by the Investigator are eligible. If a patient refused available standard therapy or Investigator determined standard therapy was inappropriate, the reason for refusal or Investigator determination should be documented.\n  4. Patients with MSS CRC or small bowel adenocarcinoma must have received at least 1) a fluoropyrimidine, 2) oxaliplatin or irinotecan, and 3) a VEGF\u002FVEGF receptor inhibitor unless deemed clinically inappropriate, refused by the patient, or not considered standard practice per institutional standards.\n  5. Patients with MSI-H and\u002For dMMR CRC or small bowel adenocarcinoma must have received a programmed death-1 or programmed death-ligand 1 (PD-L1) inhibitor unless deemed clinically inappropriate, refused by the patient, or not considered standard practice.\n  6. Have an anticipated life expectancy of greater than 12 weeks\n  7. Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Exceptions may be made to this inclusion if a patient has biochemical evidence (ctDNA) of disease upon discussion with principal investigator provided other eligilbity criteria are fulfilled.\n  8. Adequate venous access by peripheral vein evaluation\n  9. Have adequate hematologic function at screening, as evidenced by:\n\n     1. ANC ≥ 1500 cells\u002FmL; no growth factor support within 14 days prior to Screening assessment\n     2. Platelets ≥ 75,000 \u002FmL; no transfusion within 14 days prior to Screening assessment\n     3. Hemoglobin ≥ 9.0 g\u002FdL; no transfusion or erythyropoietin support within 14 days prior to Screening assessment.\n  10. Patients must have adequate hepatic function, as evidenced by:\n\n      1. Albumin ≥ 3.0 mg\u002FdL; no albumin support within 14 days prior to Screening assessment,\n      2. Total bilirubin ≤ 2.0 x upper limit of normal (ULN), except in patients with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤ 1.5 x ULN is required)\n      3. Aspartate aminotransferase (AST) AND alanine aminotransferase ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver metastases.\n      4. Serum creatinine \\\u003C 2.0 mg\u002FdL\n      5. For other blood and urine tests including blood chemistry, hepatic and renal functions, test results should not be worse than grade 1 levels of abnormalities defined by CTCAE, NCI version 5 (CTCAEv5) issued by the US Department of Health and Human Services.\n  11. For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormonal implants) or abstinence must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects \\[male and female\\], regardless of other methods unless abstinent.) A negative serum or urine pregnancy test is required as part of screening. Subjects capable of becoming pregnant include any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and who are not postmenopausal. Also, subjects assigned female sex at birth who are physiologically still able to become pregnant by similar definitions detailed here. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002Fml.\n  12. Be willing to comply with all the study procedures. All subjects must be able to comprehend and sign a written informed consent document\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. History of splenectomy\n  2. History of infection with listeriosis or has prior serious reaction to adenovirus\n  3. Infection requiring systemic antibiotics within 1 week prior to administration of study intervention\n  4. Concurrent use of systemic steroids or immunosuppressive drugs (including TNF pathway inhibitors) with exceptions including:\n\n     * Topical, ocular, intra-articular, intranasal, and inhalation corticosteroids (with minimal systemic absorption)\n     * Adrenal replacement steroid dose \\\u003C 10 mg daily prednisone\n     * A brief (fewer than three days) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction cause by a contrast allergen)\n  5. Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g., artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)). Chest wall infus-a-port catheter may be used for treatment administration and will not be subject to this exclusion.\n  6. Has any immunodeficiency disease or immunocompromised state (e.g., use of immunosuppressive agents including TNF pathway inhibitors, chemotherapy, PI3 kinase inhibitors or radiation therapy within four weeks of study treatment)\n  7. Has active or history of autoimmune disease (including inflammatory bowel disease), or is a transplant recipient requiring immunosuppressive treatment\n  8. Has received a diagnosis of HIV, hepatitis B, or hepatitis C (subjects who are hepatitis C positive may be enrolled if they are confirmed with negative viral load at screening)\n  9. Other malignancy within last 2 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ (eg, cervix, bladder, breast), or prostate cancer in remission\n  10. Known active central nervous system metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are:\n\n      1. Radiologically stable, ie, without evidence of progression for at least 12 weeks by repeat imaging\n      2. Clinically stable per investigator assessment\n      3. Without requirement of steroid treatment for at least 14 days prior to first dose of study vaccine\n  11. Has an intercurrent illness that is either life-threatening or of clinical importance such that it might limit study compliance (such illnesses include, but are not limited to, ongoing or active infection, metabolic or neurologic disease, peripheral vascular disease, or psychiatric illness)\n  12. Has insufficient peripheral venous access to permit completion of the study phlebotomy regimen or infusion of study vaccine\n  13. Concurrent use of illicit drugs (e.g., opioids, cocaine, amphetamines, hallucinogens, etc.) that could potentially interfere with adherence to study procedures or requirements.\n  14. Be pregnant or breastfeeding\n  15. Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to grade 1 or less or baseline except for the following Grade 2 AEs that are considered chronic or irreversible: alopecia, peripheral neuropathy, endocrinopathies stable on therapy, and thromboembolic events stable on anticoagulation with no recurrence for \\> 6 months. Other Grade 2 AEs may be permitted upon discussion with the PI if not otherwise specified in the protocol.\n  16. Are currently enrolled in an ongoing clinical trial or trial that could interfere with the protocol-specified requirements\n  17. There are no restrictions on concurrent or prior use of preventative vaccines for infectious diseases including influenza or COVID-19, however it is required to include at least one week interval between vaccines and study agent administration.",{"count":48,"type":20},18,[50],"PHASE1","This is an open-label, non-randomized, single-center, dose-escalation Phase 1 trial using a heterologous prime-boost strategy of vaccination with Ad5.F35-hGUCY2C-PADRE and recombinant Listeria monocytogenes (Lm-GUCY2C) vaccines in patients with advanced solid tumors including colorectal cancer, and small bowel adenocarcarcinomas who have progressed on available standard therapies. The study treatment will begin with Ad5.F35-hGUCY2C-PADRE vaccine administered intramuscularly (IM) once at the recommended Phase 2 dose (RPTD) dose, followed four weeks later by two administrations of Lm-GUCY2C intravenously (IV) at one of three escalating dose levels, four weeks apart. Treatment-related toxicity and development of immune responses will be evaluated every four weeks through week 8 after initial Lm-GUCY2C vaccination. Primary endpoints will include maximum tolerated dose (MTD) and safety and tolerability as measured by treatment emergent adverse events (TEAEs) and clinically significant changes in safety laboratory tests in the dose limiting toxicity (DLT) evaluation period defined as 4 weeks after the initial Lm-GUCY2C vaccination.",[53,26],"Colorectal Cancer","2026-05-04",{"date":56,"type":31},"2026-05-08",{"date":58,"type":31},"2026-04-21",{"date":60,"type":20},"2028-04",{"name":62,"class":38},"Thomas Jefferson University",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":85,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":63},"100493350","videocapsule-endoscopy-in-lynch-syndrome-100493350","NCT05704010","Videocapsule Endoscopy in Lynch Syndrome","Role of Videocapsule Endoscopy in Lynch Syndrome: a Multicenter Italian Registry Study","Inclusion Criteria:\n\n* Pathogenic germline variant in one of the MMR genes (MLH1, MSH2\u002FEpcam, MSH6, or PMS2).\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Patients unwilling or unable to provide informed consent\n* Patients with prior small bowel surgery\n* Patients with a contraindication to VCE",true,{"count":73,"type":20},100,[75],"NA","Background Lynch syndrome is caused by a pathogenic variant in one of the four Mismatch Repair genes (MMR): MLH1, MSH2\u002FEpcam, MSH6, or PMS2. These pathogenic variants confer a higher risk of developing colorectal and other cancers, including small bowel cancer. The risk of developing a small bowel adenocarcinoma is about 100 times higher compared to individuals without Lynch syndrome, and the lifetime risk of small bowel cancer is estimated at 4,2%.\n\nThe diagnosis of a small bowel cancer depends on videocapsule endoscopy (VCE). This device is swalled so that it can record images of the small bowel, which are then stored on a wearable device for about 8 hours. The capsule is then expelled in the feces while the images are transferred to a computer to be analysed. To date, there is conflicting evidence on the efficacy of small bowel cancer screening with VCE\n\nRationale: this registry study will collect prospective data from patients with LS undergoing VCE\n\nAim: evaluate the incidence of neoplastic and pre-neoplastic lesions in patients with LS during a VCE-based small bowel cancer screening study\n\nDesign: this is a multicentric, observational study that analyzes data from diagnostic techniques already approved. Patients will not undergo diagnostic procedures beyond what would be recommended by clinical practice.",[78,79,80,81,82,83,84,26],"Lynch Syndrome","Lynch Syndrome I","Lynch Syndrome II","MLH1 Gene Mutation","MSH2 Gene Mutation","MSH6 Gene Mutation","PMS2 Gene Mutation",[86,87],"Videocapsule","Small bowel",{"date":89,"type":31},"2026-04-22",{"date":91,"type":31},"2018-11-01",{"date":93,"type":20},"2029-12-31",{"name":95,"class":38},"San Raffaele University",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":63},"100629285","small-bowel-capsule-endoscopy-in-lynch-syndrome-100629285","NCT07472686","Small Bowel Capsule Endoscopy in Lynch Syndrome","Small Bowel Capsule Endoscopy for (Pre)Neoplastic Lesion Screening in Patients With Lynch Syndrome","iCARE4Lynch","Inclusion Criteria:\n\n* Patient carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM)\n* Capsule endoscopy screening for (pre)neoplastic lesions of the small intestine\n* No opposition to the reuse of healthcare data for research purposes\n\nExclusion Criteria:\n\n* Absence of documented MMR gene variant\n* Opposition to the study",{"count":105,"type":20},400,"OBSERVATIONAL","The impact of small bowel (SB) capsule endoscopy (CE) on the screening (followed by diagnosis and treatment) of (pre)neoplastic lesions of the small bowel in Lynch syndrome (LS) patients is unknown.\n\nThe iCARE4Lynch study is a retrospective cohort of patients carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM) who had had at least one SBCE for screening of small bowel (pre)neoplastic lesions between January 1st 2000 and December 31 2024.",[109,110,111,78,112],"MMR Mutation","Small Bowel Adenoma","Small-bowel Adenocarcinoma","Cancer",[112,114,115,116,87,117,118,119,120,121,122,123,124,125,126,127],"Lynch syndrome","Capsule endoscopy","Screening","Small-bowel adenoma","Small-bowel adenocarcinoma","Small-bowel cancer","Small-bowel capsule endoscopy","pathogenic variant","DNA mismatch repair gene (MMR)","MLH1","MSH2","MSH6","PMS2","EPCAM","2026-03-11",{"date":130,"type":31},"2026-03-16",{"date":132,"type":31},"2025-06-16",{"date":134,"type":20},"2026-12",{"name":136,"class":38},"Assistance Publique - Hôpitaux de Paris",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":157,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100541703","phase-2-dostarlimab-for-locally-advanced-or-metastatic-cancer-non-colorectalnon-endometrial-with-tumor-dmmrmsi-100541703","NCT06333314","Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal\u002FNon-endometrial) With Tumor dMMR\u002FMSI","Dostarlimab as First-line Treatment for Patients With dMMR\u002FMSI (Non-colorectal\u002FNon-endometrial) Locally Advanced or Metastatic Cancer: a Randomized Phase 2 Trial (Cohort Pan-MSI ACSE) With Crossover in the Standard Arm at Progression","Pan-MSI-ACSE","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent form prior any trial specific procedures. -\n2. 18 years or older patients.\n3. Documented locally advanced or metastatic disease with no previous systemic anti-cancer treatment in these settings and not suitable for complete surgical resection.\n4. Histologically proven, dMMR\u002FMSI-H solid tumors that are not colorectal or endometrial cancers and including one of the following: duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction adenocarcinoma with CPS\\\u003C5, pancreatic adenocarcinoma, ampulla of Vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade 3) all primary, and soft tissue sarcoma except Gastro-Intestinal Stromal Tumor (GIST).\n5. If patient received adjuvant therapy for non-metastatic disease, this therapy should be completed more than 6 months before the diagnosis of metastatic or recurrent disease.\n6. Availability of minimum 1 block of tumor tissue or 20 slides (archival (\\\u003C2 years) or fresh biopsy specimen of primary and or metastasis) for centralized confirmation of MMR\u002FMSI status by IHC or NGS\u002FPCR, and for Translational Research.\n7. Patients with dMMR\u002FMSI tumor analyzed by IHC, PCR (for Gastric and OGJ adenocarcinoma, and duodenum and small bowel adenocarcinoma only), and\u002For NGS at the recruiting center should be confirmed by central review within 24h (every anonymized patient analysis reporting will be provided for central review). Patients should not be included in the study until the dMMR\u002FMSI status is confirmed by the review committee.\n\n   NB: In case of ambiguous result of IHC (lack of positive internal control, heterogeneous loss of MMR protein expression, ambiguous loss of only one protein including HMSH6 and PMS2), the MSI-H status will be assessed by PCR or NGS for gastric and OGJ adenocarcinoma, and duodenum and small bowel adenocarcinoma, and by NGS for other primary. Based on IHC and PCR or NGS results (NGS will be centrally performed in this case ), the sponsor will decide if inclusion is possible;\n8. Presence of at least one measurable lesion within 28 days before the start of treatment according to RECIST v1.1.\n9. Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1.\n10. Haematological status: absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL; platelets ≥100 x 10⁹\u002FL; haemoglobin ≥9 g\u002FdL.\n11. Adequate renal function: serum creatinine level \\\u003C120 µM, or clearance \\>50 ml\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\] or Cockcroft and Gault).\n12. Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless liver metastases are present, in which case they must be ≤ 5× ULN.\n13. For patients not taking warfarin: International normalised ratio (INR) \\\u003C1.5 or prothrombin time (PT) \\\u003C1.5 x ULN and either partial thromboplastin time (PTT) or activated PTT (aPTT) \\\u003C1.5 x ULN. Participants taking warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5.\n14. Women of childbearing potential must have a negative serum pregnancy test performed within 72 hours before the date of randomization.\n15. Men, and women of childbearing potential must agree to use adequate contraception for the duration of trial participation and for 4 months after the last dose of dostarlimab (used in first line or at crossover) or for at least 6 months after the last administration of the chemotherapy agent(s) used in the control arm if no crossover with dostarlimab (according to the current version of the summary of product characteristics (SmPC) of each chemotherapy agent). Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n16. Registration in a National Health Care System.\n17. Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.\n\nExclusion Criteria:\n\n1. Colorectal and endometrial cancer and all primary tumor not listed in inclusion criterion #4.\n2. Previous exposure to anti-PD-1 or PD-L1 or anti-CTL-4 antibodies or treatment with immunotherapy.\n3. Previous exposure to any investigational drug within 4 weeks (6 weeks for monoclonal antibodies) before the first dose in the study.\n4. Previous exposure to any systemic anti-cancer therapy or radiation therapy for the cancer for which the patient is being enrolled.\n5. Active autoimmune disease: Active autoimmune disease requiring systemic treatment in the past 2 years (excluding replacement therapy) or any history of interstitial lung disease (patients with ancient auto-immune disease with stable endocrine oral substitution are eligible).\n6. Uncontrolled central nervous system metastases or carcinomatous meningitis or other concurrent illness or ongoing or active infections.\n7. Patients with HER2-positive gastric carcinoma.\n8. Other serious and uncontrolled non-malignant disease or is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n9. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n10. Has received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of adjuvant treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n\n    Note 1: Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled into the study after approval of the Medical Contact.\n\n    Note 2: patients are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses including doses \\>10 mg daily prednisone are permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.\n11. Other concomitant or previous malignancy other than the disease under study, except as noted below:\n\n    i. adequately treated in-situ carcinoma of the uterine cervix, ii. basal or squamous cell carcinoma of the skin, iii. cancer from which the patients was in complete remission for \\>2 years.\n12. Known Human Immunodeficiency Virus (HIV) infection.\n13. Received live vaccine within 14 days.\n14. Patient has documented presence of HBsAg \\[or HBcAb\\] at pre-inclusion visit or within 3 months prior to first dose of study intervention.\n\n    Participant has a positive hepatitis C virus (HCV) antibody test result at pre-inclusion visit or within 3 months prior to first dose of study intervention. Note: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled, only if a confirmatory negative HCV RNA test is obtained.\n\n    Participant has a positive HCV RNA test result at pre-inclusion visit or within 3 months prior to first dose of study intervention. Note: The HCV RNA test is optional and participants with negative HCV antibody test are not required to undergo HCV RNA testing as well\n15. Known prior severe hypersensitivity to investigational product or any component in its formulation.\n16. Pregnant or breast feeding women.\n17. Participation in another clinical trial within 30 days prior to the first study treatment administration or concomitantly with the trial.\n18. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n19. Person deprived of their liberty or under protective custody or guardianship.\n\nPatient randomized to receive SOC (Arm B) may crossover to receive dostarlimab (Arm A) in case of documented progressive disease according to RECIST v1.1.\n\nInclusion and exclusion are the same for the crossover except for the inclusion criteria #3 and #4.\n\nThe criterion #3 for crossover is: Patient included in the protocol and randomized in the arm \"standard of care\" with documented progressive disease by RECIST v1.1 on standard of care (defined in the protocol).\n\nThe criterion #4 for crossover is: Previous exposure to chemotherapy for locally advanced or metastatic disease.",{"count":146,"type":20},120,[23],"The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)\u002Fmicrosatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.\n\nAdult patients (aged ≥18 years) with histologically confirmed dMMR\u002FMSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\\\u003C5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).\n\nPatients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A.",[150,151,152,153,154,26,155,156],"Pancreatic Adenocarcinoma","Ampulla of Vater Carcinoma","Adrenocortical Carcinoma","Neuroendocrine Carcinoma","Soft Tissue Sarcoma","Duodenum Adenocarcinoma","Gastric Adenocarcinoma",[158,159,160],"Immunotherapy","locally advanced or metastatic cancer","dMMR\u002FMSI (non-colorectal\u002Fnon-endometrial) cancer","2025-11-24",{"date":163,"type":31},"2025-12-02",{"date":165,"type":31},"2024-07-23",{"date":167,"type":20},"2030-09",{"name":169,"class":38},"UNICANCER",22,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100534090","molecularly-redefining-small-bowel-adenocarcinoma-to-accelerate-precision-patient-care-100534090","NCT06234306","Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care","SBAMOL","Inclusion criteria:\n\nPatients with histologically verified small bowel adenocarcinoma Patients older than 18 years\n\nExclusion criteria:\n\nInsufficient material for molecular testing Patients registered in Vævsanvendelsesregistret\\&\n\nVævsanvendelsesregistret; refers to a central Danish registry where patients can opt out of allowing their biological material to be used for purposes other than their own disease management.",{"count":179,"type":20},500,"Small bowel adenocarcinoma is a rare malignancy, and there is limited knowledge about its optimal clinical management and molecular background. The SBAMOL study is an observational biomarker study that aims to identify prognostic and predictive biomarkers. This effort is intended to lay the groundwork for personalized medicine tailored to this specific patient group.",[26],[183,184,185,186],"Small bowel adenocarcinoma","messenger RNA","DNA","T-cell receptor sequencing","2024-01-29",{"date":189,"type":31},"2024-01-31",{"date":191,"type":31},"2024-01-01",{"date":193,"type":20},"2033-12-31",{"name":195,"class":38},"Copenhagen University Hospital at Herlev",3]