[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mismatch-repair-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mismatch-repair-deficiency":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,93,133,156,180,255,280,306],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100585553","phase-2-toripalimab-plus-celecoxib-for-dmmrmsi-h-locally-advanced-colorectal-cancer-100585553",false,"NCT06903858","Toripalimab Plus Celecoxib for dMMR\u002FMSI-H Locally Advanced Colorectal Cancer","Toripalimab Plus Celecoxib With Response-adapted Non-operative Management for Mismatch Repair-deficient or Microsatellite Instability-high Locally Advanced Colorectal Cancer (PICC-3): a Multicenter, Single-arm, Phase 2 Trial","PICC-3","Inclusion Criteria:\n\n1. Signed informed consent and willingness\u002Fcompliance with study procedures.\n2. Age ≥18 years.\n3. Histologically confirmed colorectal adenocarcinoma.\n4. ECOG performance status 0-1.\n5. Locally advanced primary tumor (T3\u002FT4 and\u002For N+) confirmed by CT\u002FMRI (pelvic MRI for rectal cancer).\n6. dMMR (IHC) or MSI-H (PCR) status.\n7. No prior anti-cancer therapy for colonrectal cancer (surgery\u002Fchemotherapy\u002Ftargeted therapy\u002Fradiation).\n8. Adequate organ function\n9. For women of childbearing potential: negative pregnancy test and contraception use during and for 3 months post-treatment. Male participants with fertile partners must use contraception.\n10. Willingness to adhere to study requirements.\n\nExclusion Criteria:\n\n1. Presence of distant metastases (M1) confirmed by CT\u002FMRI or PET-CT (at least covering the chest, abdomen, and pelvis).\n2. Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.\n3. Inability to achieve complete resection of the primary colorectal tumor.\n4. History or concurrent active malignancy (except malignancies cured ≥5 years ago or adequately treated carcinoma in situ).\n5. Prior treatment with anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, or other drugs\u002Fantibodies targeting T-cell co-stimulation or checkpoint pathways.\n6. Major surgery (e.g., laparotomy, thoracotomy, organ resection via laparoscopy) or severe trauma within 4 weeks before enrollment (surgical incision must be fully healed).\n7. Thromboembolic events (e.g., cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis) within 12 months before enrollment.\n8. Active coronary artery disease, severe\u002Funstable angina, or newly diagnosed angina\u002Fmyocardial infarction within 12 months before enrollment.\n9. New York Heart Association (NYHA) Class II or higher congestive heart failure (see Appendix 3).\n10. HIV infection, AIDS, or untreated active hepatitis (HBV-DNA ≥500 IU\u002FmL; HCV-RNA above detection limit).\n11. Active inflammatory bowel disease or other colorectal disorders causing chronic diarrhea.\n12. Active, known, or suspected autoimmune disease (exceptions: stable conditions like type 1 diabetes, hypothyroidism on hormone replacement, or skin disorders without systemic treatment, e.g., vitiligo, psoriasis, alopecia).\n13. Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia).\n14. Residual toxicity ≥Grade 2 (per CTCAE v5.0) from prior therapies (except anemia, alopecia, skin pigmentation).\n15. Known or suspected hypersensitivity to any study-related drugs.\n16. Pregnancy or lactation.\n17. Women of childbearing potential (last menstruation \\\u003C2 years ago) or fertile men unwilling to use effective non-hormonal contraception.\n18. Any unstable medical condition compromising safety or protocol compliance.","ALL","18 Years",{"count":20,"type":21},105,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The PICC-3 study is a multicentre, single-arm, phase II trial evaluating toripalimab plus celecoxib in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced colorectal cancer. The trial uses a response-adapted treatment strategy, whereby patients with clinical complete response (cCR) after therapy may enter a non-operative management pathway, while patients without cCR proceed to surgery. Response assessment is based on imaging, endoscopy, biopsy evaluation, and ctDNA analysis.",[27,28,29],"Colorectal Cancer","Microsatellite Instability High","Mismatch Repair Deficiency",[31,32,33,34,35],"PD-1 blockade","Toripalimab","COX-2 inhibitor","Celecoxib","Non-operative Management","RECRUITING","2026-05-20",{"date":39,"type":40},"2026-05-22","ACTUAL",{"date":42,"type":40},"2025-06-01",{"date":44,"type":21},"2031-04-01",{"name":46,"class":47},"Sun Yat-sen University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":78,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100543937","phase-1-a-study-of-oral-7hp349-alintegimod-in-combination-with-ipilimumab-followed-by-nivolumab-monotherapy-100543937","NCT06362369","A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","A Phase 1b\u002F2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","Inclusion and Exclusion Criteria for Phase 1b\n\nInclusion Criteria\n\n1. Adult patients (age 18 or older)\n2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1\u002FPD-L1.\n3. ANC ≥ 1000\u002FµL without use of G-CSF, Hgb ≥ 9 g\u002FdL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000\u002FµL without transfusions for at least 5 days prior to pretreatment baseline.\n4. ECOG performance status of 0 or 1.\n5. Has a life expectancy of \\> 12 weeks.\n6. Renal and hepatic function requirements:\n\n   * a. Renal function with either an eCrCL ≥ 60 mL\u002Fmin (modified Cockcroft-Gault) or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (using MDRD or CKD-EPI or similar equations).\n   * b. Hepatic function with ALT\u002FAST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST\u002FALT≤ 5 x ULN will be allowed.\n7. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n8. All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).\n9. All patients must have measurable disease by applicable RECIST criteria.\n10. Willing to allow blood samples to be used for research.\n\nExclusion Criteria:\n\n1. Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \\\u003C 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.\n2. Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.\n3. Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.\n4. Persistent toxicity of NCI CTCAE version 5 Grade \\> 1 severity that is related to prior therapy.\n\n   Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (e.g., diabetes or hypertension) are permitted.\n5. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates; consider a dose reduction of such substrates and monitor for signs of toxicities of co-administered sensitive CYP3A substrates (see listing of strong inhibitors and inducer drugs in FDA tables). An alternative is to replace such agents with drugs that are not CYP3A4 metabolized if at all feasible.\n6. The patient has cardiac conditions as follows:\n\n   * a) myocarditis;\n   * b) uncontrolled hypertension (blood pressure \\> 160\u002F100) despite optimal therapy;\n   * c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);\n   * d) prior or current cardiomyopathy;\n   * e) uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm); unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly);\n   * f) concomitant medication with drugs known to cause Torsades de Pointes;87\n   * g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \\[ECG\\]) at screening.\n7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).\n8. Concurrent malignancies are permitted if they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or with agreement from the Principal Investigator (PI), patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n9. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WOCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n10. The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n11. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:\n\n    * a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;\n    * b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg\u002Fday of prednisone or equivalent.\n    * c) Corticosteroid premedication for infusion and\u002For hypersensitivity reactions.\n    * d) Patients may be treated with a short (\\\u003C24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents.\n12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.\n13. Serious autoimmune disease at the discretion of the treating Investigator: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's Granulomatosis) are excluded from participation in this study\n14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted.\n15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least.\n16. Use of mechanical ventilation or having a resting O2 saturation \\\u003C 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and\u002For severe hepatic sinusoidal obstruction syndrome.\n17. Proven or suspected ongoing systemic infection requiring IV antibiotics.\n18. Women who are pregnant or lactating.\n\n    Note: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the following:\n    * a) Postmenopausal with \\> 1 year since last menses and:\n    * 1\\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \\> 40 mIU\u002FmL.\n    * 2\\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \\> 30 mIU\u002FmL.\n    * 3\\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).\n    * b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).\n\n    Note: Tubal ligation is not considered a form of permanent sterilization.\n19. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.\n20. Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed\n21. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1).\n\n    Note: Patients who switch from a high dose to a dose of ≤30 µg\u002Fday are eligible for study entry.\n22. Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.\n23. Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral drug absorption.\n24. Patients with known soy allergy.",{"count":57,"type":21},126,[59,24],"PHASE1","This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.\n\nCurrently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b",[62,63,64,65,66,67,68,29,27,69,70,71,72,73,74,75,76,77],"Advanced Cancer","Advanced Solid Tumor","Melanoma","Metastasis","Pleural Mesothelioma","Renal Cell Carcinoma","MSI-High","Hepatocellular Carcinoma","Hepatocellular Cancer","Renal Cell Cancer","Kidney Cancer","Skin Cancer","Non Small Cell Lung Cancer","NSCLC","Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","ALK Genomic Tumor Aberrations",[79,80,81],"Phase 1","Phase 1b","7 Hills Pharma","2026-04-07",{"date":84,"type":40},"2026-04-13",{"date":86,"type":40},"2024-08-23",{"date":88,"type":21},"2028-12-31",{"name":90,"class":91},"7 Hills Pharma, LLC","INDUSTRY",5,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100627590","liquid-biopsy-and-machine-learning-for-early-colorectal-cancer-adenomas-lynch-cancers-and-residual-disease-detection-100627590","NCT07450612","Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection","BEACON","Inclusion Criteria:\n\n* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.\n* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Inflammatory bowel disease",true,{"count":102,"type":21},1200,"OBSERVATIONAL","This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.",[27,106,107,108,109,110,111,112,113,114,115,116,29,117,118,119,120,121,122],"Adenoma Colon","Adenoma Colon Polyp","Colon Adenoma","Colo-rectal Cancer","Colon Disease","Colon Neoplasm","Lynch Syndrome","Lynch Syndrome I","Lynch Syndrome II","Lynch Syndrome I (Site-specific Colonic Cancer)","LYN Gene Mutation","Mismatch Repair Gene Mutation","MLH1 Gene Mutation","MSH2 Gene Mutation","MSH6 Gene Mutation","PMS2 Gene Mutation","EPCAM Gene Mutation","2026-02-27",{"date":125,"type":40},"2026-03-04",{"date":127,"type":40},"2024-01-01",{"date":129,"type":21},"2031-08-15",{"name":131,"class":47},"San Raffaele University",4,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":48},"100622609","phase-1-pilot-study-of-navigated-focused-ultrasound-and-pembrolizumab-in-the-treatment-of-recurrent-who-grade-4-idh-wildtype-glioblastoma-with-mismatch-repair-deficiency-100622609","NCT07385846","Pilot Study of Navigated Focused Ultrasound and Pembrolizumab in the Treatment of Recurrent WHO Grade 4 IDH-Wildtype Glioblastoma With Mismatch Repair Deficiency","Pilot Study for the Use of Navigated Focused Ultrasound and Pembrolizumab in the Treatment of Recurrent WHO Grade 4 IDH-Wildtype Glioblastoma With Mismatch Repair Deficiency: A Phase I Clinical Trial","Inclusion Criteria:\n\n1. Patient previously diagnosed with WHO grade 4 IDH-wildtype GBM, determined through genomic and\u002For histopathological analysis.\n2. Prior treatment for GBM with surgical resection and standard of care TMZ and radiation therapy.\n3. Patient who has undergone repeat surgery (including biopsy or resection) for rGBM.\n4. MMR deficiencies confirmed per standard of care immunohistochemical analysis or Next Generation Sequencing (NGS) of the patient's surgical sample from the time of initial GBM diagnosis or recurrence.\n5. Area of sonication using the NaviFUS platform is \\>30 mm from the skull surface, assessed on the Investigator's review of the screening MRI.\n6. Age ≥18 years.\n7. Karnofsky Performance Scale (KPS) \\>70.\n8. Adequate organ and marrow function:\n\n   Leukocytes ≥2,500\u002Fmm3 Absolute Neutrophil Count ≥1,500\u002Fmm3 Absolute Lymphocyte Count ≥800\u002Fmm3 Platelets ≥100,000\u002Fmm3 Hemoglobin ≥8 g\u002FdL\n9. Negative serum or urine pregnancy test in a female patient of childbearing potential.\n10. Patient or a legally-authorized representative must provide study-specific informed consent.\n\nExclusion Criteria:\n\n1. Multifocal or leptomeningeal disease observed at the time of GBM recurrence.\n2. Patient for whom the repeat surgical cavity is ≤30 mm from the skull surface or otherwise not reasonably accessible for sonification using the NaviFUS platform, assessed on screening MRI.\n3. Patient with a prior or concurrent malignancy that is deemed to be clinically significant in the context of rGBM.\n4. Patient receiving concurrent treatment with an immune checkpoint inhibitor, other investigational agent, or live vaccine administered within 14 days prior to the first dose of trial treatment.\n5. Prior treatment with an immune checkpoint inhibitor agent.\n6. Period of less than 28 days from the time of the patient's receipt of other systemic anti-cancer therapies to the proposed date of first trial treatment.\n7. Treatment with systemic corticosteroids at an increased dose or dose of ≥10 mg of prednisone (or equivalent) daily within the 5 days prior to starting trial treatment, or treatment with systemic corticosteroids for other indications.\n8. Patient with a history of organ transplant or autoimmune disorder requiring active immunosuppression.\n9. Patient with current recreational drug use or a history of substance use disorder.\n10. Patient with an active concurrent comorbidity that, in the opinion of the Investigator, would pose a safety concern for the patient's participation in this clinical trial.",{"count":141,"type":21},8,[59],"Navigated Focused Ultrasound and Pembrolizumab in the Treatment of Recurrent WHO Grade 4 IDH-Wildtype Glioblastoma with Mismatch Repair Deficiency.",[145,29],"Glioblastoma","NOT_YET_RECRUITING","2026-01-26",{"date":149,"type":40},"2026-02-04",{"date":151,"type":21},"2026-06-01",{"date":153,"type":21},"2030-06-01",{"name":155,"class":47},"Jennifer Leddon",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":164,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":178,"locationsCount":4},"100621389","phase-2-immunotherapy-for-surgery-avoidance-in-vulnerable-dmmr-endometrial-cancer-100621389","NCT07369986","Immunotherapy for Surgery Avoidance in Vulnerable dMMR Endometrial Cancer","A Phase 2b, Open-Label Study of Iparomlimab and Tuvonralimab to Facilitate Surgery Avoidance in Women With Resectable, Mismatch Repair-Deficient Endometrial Cancer","IMMUNE-SAVE","Inclusion Criteria:\n\n1. Age:18 years or older.\n2. Histologically confirmed endometrial cancer (excluding carcinosarcoma).\n3. FIGO (2009) stage I to IIIC2 disease that is considered surgically completely resectable.\n\nConfirmed dMMR or MSI-H, defined by either loss of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6 or MSI-H) for by immunohistochemistry, or MSI-H status confirmed by polymerase chain reaction assay.\n\n5)No prior systemic anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or immunotherapy) within the past 5 years.\n\n6)Eastern Cooperative Oncology Group Performance Status of 0 or 1. 7)Laboratory test results within 7 days prior to the first dose must meet the following criteria. Laboratory values are not valid if the patient received granulocyte colony-stimulating factor or a blood transfusion within 14 days prior to sample collection.\n\nWhite blood cell count ≥2,000\u002Fmm3 and absolute neutrophil count ≥1,500\u002Fmm3. Platelet count ≥100,000\u002Fmm3. Hemoglobin ≥9.0 g\u002FdL.\n\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0-fold of the upper limit of normal (ULN) (or ≤5.0-fold the ULN of the study site in patients with liver metastases). Total bilirubin ≤1.5-fold of the ULN.\n\nCreatinine ≤1.5-fold of the ULN or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) ≥ 45 mL\u002Fmin.\n\n8)Women of childbearing potential:\n\n* Must agree to use contraception from the time of informed consent until at least 5 months after the last dose of the investigational product.\n* Must agree not to breastfeed from the time of informed consent until at least 5 months after the last dose.\n\nExclusion Criteria:\n\n1)Multiple primary malignancies, except for: adequately resected basal cell or squamous cell carcinoma of the skin (Stage I), superficial bladder cancer, or any other malignancy that has been disease-free for over 5 years.\n\nHistory of severe hypersensitivity to any monoclonal antibody. 3)Known hypersensitivity to iparomlimab and tuvonralimab or any of their excipients.\n\n4)Concurrent or history of clinically significant autoimmune disease. 5)Current or prior interstitial lung disease or pulmonary fibrosis documented by imaging or clinical assessment. Patients with radiation pneumonitis may be enrolled if it is confirmed to be stable (beyond the acute phase) and without anticipated recurrence.\n\n6)Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease. 7)Symptomatic pericardial effusion, pleural effusion, or ascites requiring treatment.\n\n8)Uncontrolled tumor-related pain. 9)Transient ischemic attack, cerebrovascular accident, or thromboembolism within 180 days prior to enrollment.\n\n10)Uncontrolled or clinically significant cardiovascular disease, defined as any of the following within 180 days prior to enrollment:\n\n* Myocardial infarction;\n* Unstable angina pectoris;\n* Congestive heart failure of New York Heart Association (NYHA) Class III or IV\n* Poorly controlled hypertension despite appropriate treatment (e.g., sustained systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg for ≥ 24 hours)\n* Arrhythmia requiring treatment 11)Requirement for ongoing therapeutic anticoagulation (low-dose aspirin or other antiplatelet therapy is permitted).\n\n  12)Poorly controlled diabetes mellitus. 13)Active systemic infection requiring treatment. Systemic corticosteroid therapy (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before enrollment.\n\n  15)Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular targeted therapy agents, or immunotherapy agents) within 28 days before randomization.\n\n  16)Surgical pleurodesis or pericardium within 28 days prior to enrollment. 17)Major surgery within 4 weeks or minor surgery within 7 days before the first dose, without full recovery. Patients scheduled for major surgery during the study period are excluded (video-assisted thoracoscopic surgery or diagnostic procedures are not considered exclusions if recovery is adequate).\n\n  18)Administration of any therapeutic radiopharmaceutical within 56 days prior to enrollment (diagnostic use is permitted).\n\n  19)Active tuberculosis. 20)Positive serology for human immunodeficiency virus (HIV-1\u002F2 antibody), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody. Patients who are HBsAg-positive may be enrolled if hepatitis B virus DNA is below the lower limit of detection.\n\n  21)Any other severe medical or psychiatric condition, or abnormal laboratory findings, that in the investigator's judgment would increase the risk of study participation, compromise protocol compliance, or interfere with the interpretation of study results.\n\n  22)Participation in another clinical trial and receipt of an investigational product within 4 weeks prior to the first dose.\n\n  23)Pregnancy, lactation, or intention to become pregnant during the study period.\n\n  24)Positive urine pregnancy test within 72 hours before treatment initiation (if urine test is positive or indeterminate, a confirmatory serum pregnancy test is required).","FEMALE",{"count":166,"type":21},30,[24],"Efficacy evaluate of iparomlimab and tuvonralimab (a PD-1\u002FCTLA-4 bispecific antibody) in patients with surgically resectable dMMR endometrial cancer.",[170,171,29],"Endometrial Cancer","Immunotherapy","2026-01-18",{"date":174,"type":40},"2026-01-27",{"date":176,"type":21},"2026-03-01",{"date":88,"type":21},{"name":179,"class":47},"Women's Hospital School Of Medicine Zhejiang University",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":186,"targetDuration":188,"studyType":103,"phases":4,"briefSummary":189,"conditions":190,"keywords":229,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100320510","synergy-ai-artificial-intelligence-based-precision-oncology-clinical-trial-matching-and-registry-100320510","NCT03452774","SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry","Inclusion Criteria:\n\n* Pts with solid and hematological malignancies;\n* Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2, HER2\u002FNeu, Tumor mutational burden\u002Fload (TMB), ABL1, ACVR1B, AKT1, AKT2, AKT3, ALK, APC, AR, ATM, ATRX, AURKA, AURKB, BAP1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BTK, CCND1, CCND2, CCND3, CDK4, CDK6, CDKN1A\u002FB, CEBPA, CHEK1, CHEK2, CSF1R, CTNNB1, DAXX, DDR1\u002F2, DNMT3A, EGFR, ERBB2, ERBB3, ERBB4, ERCC4, ER, ESR1, FANCA, FAS, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GATA3, GATA6, GNAS, HDAC1, HGF, HRAS, IDH1, IDH2, IGF1R, JAK1, JAK2, JAK3, KDR (VEGFR2), KIT, KRAS, MAP2K2 (MEK2), MAP3K1, MCL1, MDM2, MDM4, MEN1, MET, MSH2, MSH3, MSH6, MTOR, MUTYH, MYC, MYCL (MYCL1), NF1, NF2, NOTCH1, NPM1, NRAS, NTRK1, NTRK2, NTRK3, PALB2, PARP1, PARP2, PARP3, PBRM1, PDCD1 (PD1), PDCD1LG2 (PD-L2), PDGFRA, PDGFRB, PIK3C, PMS2, POLD1, POLE, PRDM1, PTCH1, PTEN, RAF1, RB1, RET, RICTOR, ROS1, RPTOR, SDHA\u002FB\u002FC, SMAD, SMARC, SMO, STK11, TGFBR2, TP53, TSC1, TSC2, VEGFA, VHL, WT1, ZNF217, ZNF703, CEACAM, NRG1, among others.\n\nThese biomarkers should be determined by local laboratory, external vendor, or next generation sequencing platform\n\n* Decision to consider clinical trial pre-screening enrollment (CTE) by primary provider and\u002For patient\n\nExclusion Criteria:\n\n* ECOG PS \\> 2;\n* Abnormal organ function;\n* Hospice enrollment",{"count":187,"type":21},50000,"36 Months","International registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.",[191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,29,211,212,213,74,214,145,215,64,216,217,218,170,219,220,221,222,223,224,225,226,227,228],"Cancer, Metastatic","Cancer","Cancer of Pancreas","Cancer of Liver","Cancer of Stomach","Cancer Liver","Cancer of Rectum","Cancer of Kidney","Cancer of Esophagus","Cancer of Cervix","Cancer of Colon","Cancer of Larynx","Cancer, Lung","Cancer, Breast","Cancer, Advanced","Cancer Prostate","Cancer of Neck","Cancer of Skin","Neuroendocrine Tumors","Carcinoma","BRCA Gene Rearrangement","Non Hodgkin Lymphoma","Leukemia","Cholangiocarcinoma","Central Nervous System Tumor","Urothelial Carcinoma","Bladder Cancer","Ovarian Cancer","Testicular Cancer","Breast Cancer","COVID","Myelofibrosis","Myeloproliferative Neoplasm","Myeloproliferative Disorders","Follicular Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Myelodysplastic Syndromes",[230,231,232,233,234,235,236,237,238,239,240,241,242,243,244],"artificial intelligence","virtual tumor board","clinical trial","clinical trial matching","electronic medical record","machine learning","cost of care","targeted therapy","immunotherapy","precision medicine","precision oncology","cancer","value based care","real world data","data analytics","2025-10-25",{"date":247,"type":40},"2025-10-28",{"date":249,"type":40},"2018-01-01",{"date":251,"type":21},"2040-06",{"name":253,"class":91},"Massive Bio, Inc.",68,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100532659","neoadjuvant-immunotherapy-for-t4-dmmr-colon-cancer-100532659","NCT06215677","Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer","Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial","NITDC","Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. ECOG score 0-2;\n3. Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;\n4. Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;\n5. Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration;\n6. No evidence of distant metastasis;\n7. Newly treated patients who have not received treatment including chemotherapy and surgery;\n8. Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery;\n9. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.\n\nExclusion Criteria:\n\n1. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;\n2. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;\n3. Patients with a history of severe mental illness, immune disease, hormone medication;\n4. Patients contraindicated by immunotherapy or surgery;\n5. Participated in other clinical researchers in the past 3 months;\n6. Any other circumstances that the investigator considers inappropriate for inclusion.","75 Years",{"count":265,"type":21},18,[267],"NA","Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.",[270,29,171],"Colon Cancer","2025-08-30",{"date":273,"type":40},"2025-09-05",{"date":127,"type":40},{"date":276,"type":21},"2030-02-10",{"name":278,"class":47},"Peking Union Medical College Hospital",2,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":164,"minAge":18,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":48},"100558341","pd-1-inhibitor-combined-with-progesterone-treatment-in-fst-for-patients-with-mmrd-endometrial-cancer-100558341","NCT06549855","PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer","PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer","Inclusion Criteria:\n\n* Be between the ages of 18-45 years old;\n* Stage IA (FIGO 2009) ;\n* Confirmed diagnosis of endometrial adenocarcinoma G1-G2 based upon D\\&C or hysteroscopy;\n* Molecular classification of MMRd, determined by immunohistochemical (IHC) for MMR proteins and by the second generation sequencing (NGS) or microsatellite polymerase chain reaction (PCR);\n* With a strong desire for fertility preservation;\n* Sign the informed consent.\n\nExclusion Criteria:\n\n* Stage IB(FIGO 2009) and above；\n* Tumour differentiation of G3 or non-endometrioid adenocarcinoma；\n* Complicated with any other malignancy；\n* Contraindicated to conservative treatment or the use of pharmaceuticals.\n* Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.","45 Years",{"count":289,"type":21},10,[267],"The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.",[170,293,29],"Endometrioid Carcinoma",[295,293,296],"Fertility preservation","PD-1 inhibitor","2024-08-08",{"date":299,"type":40},"2024-08-12",{"date":301,"type":21},"2024-10",{"date":303,"type":21},"2029-10",{"name":305,"class":47},"Peking University People's Hospital",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":321,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":141},"100495320","phase-2-perioperative-chemotherapy-plus-toripalimab-for-dmmr-locally-advanced-gastric-or-esophagogastric-junction-adenocarcinoma-100495320","NCT05729646","Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma","Perioperative S-1 Plus Oxaliplatin Combined With Toripalimab or Toripalimab Monotherapy Versus S-1 Plus Oxaliplatin for Treatment of dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: a Prospective, Multi-center, Randomized Controlled Study","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).\n2. Participants were ambulatory male or female. Age: ≥ 18 years and ≤ 80 years old.\n3. Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma.\n4. Mismatch repair deficient (dMMR) adenocarcinoma, which was determined by immunohistochemistry (ICH) test of endoscopic biopsy specimen. dMMR was defined as loss of nuclear expression of one or more MMR proteins.\n5. cT2-4bN+\u002F-, M0 according to the American Joint Committee on Cancer and Union for International Cancer Control (AJCC-UICC) TNM classification for carcinoma of the stomach (8th edition).\n6. Participants had Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1 within 7 days before the first dose of study treatment.\n7. Life expectancy ≥ 6 months.\n8. Agreement of providing baseline and surgical specimens for biomarker analysis.\n9. The functions of the vital organs meet requirements as follows (within 14 days before the first dose of study treatment, meanwhile, participants had not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):\n\n1). Hematological function#\n\n-White blood cell count (WBC): 3.5 × 10\\^9\u002FL \\~12.0 × 10\\^9\u002FL\n\n-Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n\n-Platelet count (PLT) ≥ 100 × 10\\^9\u002FL\n\n* Hemoglobin (Hb) ≥ 90g\u002FL. 2). Hepatic function\n* Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal); -Aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n* Albumin (ALB) ≥ 30g\u002FL. 3). Renal function\n* Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml \u002F min for those with creatinine level \\> 1.5 × ULN.\n\n  4). Coagulation function#\n  * International normalized ratio (INR) ≤ 1.5;\n  * Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n    10\\. Female participants of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. Male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 180 days after the last dose of chemotherapy, whichever is longer).\n\nExclusion Criteria:\n\n1. HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.\n2. Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).\n3. Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).\n4. Participants with gastric outlet obstruction, or unable to oral take, or severe gastrointestinal bleeding.\n5. Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).\n6. Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).\n7. Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.\n8. Participants with active tuberculosis.\n9. Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.\n10. Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.\n11. Participants who need long-term systemic steroid therapy (\\> 10 mg\u002Fd prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.\n12. Concurrent or previous have severe allergic reaction to any antibody- based drugs.\n13. Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.\n14. Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.\n15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n16. Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.\n17. Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.","80 Years",{"count":315,"type":21},90,[24],"This study is a prospective, multi-center, randomized controlled phase II trial to compare the efficacy of perioperative SOX plus toripalimab, toripalimab monotherapy with SOX regimen in participants with dMMR locally advanced gastric or esophagogastric junction adenocarcinoma",[319,320,29],"Adenocarcinoma of the Stomach","Adenocarcinoma of Esophagogastric Junction",[322,323,324,32],"Gastric Adenocarcinoma","Esophagogastric Junction Adenocarcinoma","Perioperative Chemotherapy","2023-07-24",{"date":327,"type":40},"2023-07-25",{"date":329,"type":40},"2023-05-31",{"date":331,"type":21},"2029-02-28",{"name":333,"class":47},"Yu jiren"]