[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mismatch-repair-deficient-or-msi-high-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mismatch-repair-deficient-or-msi-high-solid-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,87,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100641077","mmr-status-modulates-the-predictive-value-of-lymphatic-invasion-for-lymph-node-metastasis-in-gastric-cancer-100641077",false,"NCT07625735","MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer","Mismatch Repair (MMR) Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer","Inclusion Criteria:\n\n1. Upfront surgery cohort\n\n   * Patients who underwent radical surgery for gastric cancer at Zhongshan Hospital, Fudan University.\n   * Patients who did not receive neoadjuvant chemotherapy, radiotherapy, immunotherapy, or other antitumor treatments that may affect the pathological assessment of the primary tumor or lymph node metastasis before surgery.\n   * Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after surgery, including Siewert type II and III tumors only.\n   * Patients with definite pathological assessment of lymphatic invasion and regional lymph node status.\n   * Patients with available and definite MMR status.\n2. ESD cohort\n\n   * Patients who underwent ESD for gastric cancer at Zhongshan Hospital, Fudan University.\n   * Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after ESD, including Siewert type II and III tumors only.\n   * Patients with complete post-ESD pathological information, including histological type, depth of invasion, tumor size, ulcerative findings, lymphatic invasion status, venous invasion status, horizontal margin status, and vertical margin status.\n   * Patients with available and definite MMR status.\n\nExclusion Criteria:\n\n1. Upfront surgery cohort\n\n   * Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.\n   * Patients who received neoadjuvant treatment before surgery, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other systemic antitumor treatments.\n   * Patients with missing postoperative pathological information, resulting in inability to determine lymphatic invasion or regional lymph node metastasis status.\n   * Patients with missing or indeterminate MMR status.\n   * Patients with concurrent malignancies that may interfere with the determination of the origin of lymph node metastasis.\n2. ESD cohort\n\n   * Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.\n   * Patients with missing post-ESD pathological information that precludes eCURA classification, eCURA risk score calculation, or assessment of lymphatic invasion status.\n   * Patients with missing or indeterminate MMR status.","ALL","18 Years","95 Years",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","Brief Summary\n\nLymph node metastasis (LNM) is a key factor influencing treatment decisions and prognosis in patients with gastric cancer. Lymphatic invasion (LI) is an important pathological predictor of LNM and a core component of the eCURA risk scoring system after endoscopic submucosal dissection (ESD) for early gastric cancer. However, whether LI has the same predictive value for LNM across different mismatch repair (MMR) statuses remains unclear. Compared with proficient mismatch repair (pMMR) gastric cancer, deficient mismatch repair (dMMR) gastric cancer has distinct molecular pathological features and an immune-enriched tumor microenvironment. In early gastric cancer, if LI is associated with a lower LNM risk in dMMR tumors than in pMMR tumors, existing LI-based eCURA risk assessment may overestimate LNM risk in patients with dMMR early gastric cancer and consequently affect decisions regarding additional surgery after ESD. Therefore, this study aims to systematically evaluate the impact of MMR status on the association between LI and LNM using upfront-surgery and post-ESD additional-surgery cohorts from our center, and to explore the potential clinical value of MMR status in refining eCURA-based risk stratification for early gastric cancer.",[25,26,27,28],"Gastric \u002F Gastroesophageal Junction Adenocarcinoma","Mismatch Repair Deficient or MSI-High Solid Tumors","Lymph Node Metastasis","Lymphatic Invasion","NOT_YET_RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-18","ACTUAL",{"date":35,"type":21},"2026-07-01",{"date":37,"type":21},"2027-07-31",{"name":39,"class":40},"Shanghai Zhongshan Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":62,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100613133","phase-1-eik1005-002-a-clinical-research-study-evaluating-eik1005-a-werner-helicase-inhibitor-as-monotherapy-and-in-combination-with-pembrolizumab-in-participants-with-advanced-solid-tumors-including-microsatellite-instability-high-msi-h-tumors-100613133","NCT07262619","EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors","A Multicenter, Multi-Part, Phase 1\u002F2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors","Key Inclusion Criteria:\n\n1. is ≥ 18 years of age at the time of signing the informed consent.\n2. has a life expectancy of at least 3 months.\n3. has histologically or cytologically documented advanced (unresectable and\u002For metastatic) solid tumor. Part 1A: recommend that participants have archival tissue not more than 3 years old. Part 1B and Part 2: participant has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor. Participant must have archival tumor tissue (not more than 3 years old) for retrospective confirmation of MSI-H or dMMR tumor by a central laboratory.\n4. In Part 1A, has received and then progressed after or is intolerant to at least 1 standard treatment regimen in the advanced setting. The participant does not have alternative therapeutic options per PI's medical judgement. Preference should be given to: (1) participants with MSI-H or dMMR cancers that have progressed after checkpoint inhibitor (CPI) therapy and (2) participants with microsatellite stable cells (MSS) cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy.\n5. has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI.\n6. has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n7. has an adequate organ and marrow function.\n\nKey Exclusion Criteria:\n\n1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs).\n2. has received prior treatment with Werner (WRN) inhibitor.\n3. has a history of relevant drug hypersensitivity, ascertained or presumptive allergy\u002Fhypersensitivity to the active drug substance and\u002For formulation ingredients, history of serious allergic reactions leading to hospitalization, or any other allergic reaction in general.\n4. In Parts 1B and Part 2 Rescue: diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n5. has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n6. has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment.\n7. has mean resting QTcF \\> 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).\n8. has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Participants may enroll with the following conditions: Type 1 diabetes, hypothyroidism requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia not requiring systemic treatment).\n9. has history of (non-infectious) pneumonitis\u002Fpneumonitis\u002Finterstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease.\n10. has active tuberculosis.\n11. has any active infections requiring systemic therapy.",{"count":49,"type":21},160,"INTERVENTIONAL",[52,53],"PHASE1","PHASE2","The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.",[56,57,58,59,60,61,26],"Advanced Solid Tumors","MSI-H or dMMR Advanced Solid Tumors","MSI-H\u002FdMMR Gastric Cancer","MSI-H\u002FdMMR Colorectal Cancer","MSI-H\u002FdMMR Gastroesophageal-junction Cancer","Endometrial Cancer",[63,64,65,66,67,68,56,69,70,71,72,73,74],"Werner helicase","WRN","MSI-H","dMMR","DNA mismatch repair","EIK1005","Metastatic","MSI-H\u002FdMMR Endometrial Cancer","MSI-H\u002FdMMR Prostate Cancer","Pembrolizumab","Mismatch Repair Deficient (dMMR)","Microsatellite Instability High (MSI-H)","RECRUITING","2026-04-06",{"date":78,"type":33},"2026-04-08",{"date":80,"type":33},"2026-01-20",{"date":82,"type":21},"2029-03",{"name":84,"class":85},"Eikon Therapeutics","INDUSTRY",10,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":50,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100613395","phase-2-adebrelimab-combined-with-induction-chemotherapy-or-shr-8068-for-mismatch-repair-deficientmicrosatellite-instability-high-dmmrmsi-h-locally-advanced-gastricgastroesophageal-junction-adenocarcinomaa-randomized-non-comparative-phase-2-study-100613395","NCT07266025","Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient\u002FMicrosatellite Instability-High (dMMR\u002FMSI-H) Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study","CATALIS","Inclusion Criteria:\n\n* Male or female, age ≥ 18 years\n* Pathologically confirmed gastric or gastro-oesophageal-junction adenocarcinoma (Siewert II and III only)\n* dMMR confirmed by IHC or MSI-H confirmed by PCR\n* Investigator-assessed potentially curative resection feasible before study entry\n* CT or MRI clinical stage cT ≥ 2 N any M0 per AJCC 8th edition; laparoscopy with peritoneal washing cytology (and peritoneal biopsy if indicated) recommended to exclude peritoneal metastasis\n* ECOG performance status 0-2\n* Able to swallow tablets\n* Expected survival ≥ 6 months\n* Laboratory values within 7 days before randomisation:\n\nANC \\> 1.5 × 10⁹\u002FL, Hb ≥ 80 g\u002FL, PLT ≥ 75 × 10⁹\u002FL Serum creatinine ≤ 1.5 × ULN or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m² ALT and AST ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN (or TBIL \\> 1.5 × ULN with direct bilirubin ≤ ULN); albumin ≥ 25 g\u002FL INR or PT ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN (or on anticoagulation within therapeutic range)\n\n* Signed written informed consent; able to comply with protocol visits, treatment, labs, biospecimen collection\n* WOCBP must have negative serum pregnancy test within 72 h before randomisation, not breastfeeding, and use highly effective contraception from screening until 2 months after last adebrelimab\u002FSHR-8068 or 6 months after last chemotherapy, whichever is longer\n* Men with pregnant partners or WOCBP partners must be surgically sterile or use highly effective contraception during study and for same post-treatment periods; no sperm donation allowed\n\nExclusion Criteria:\n\n* Tumour histology squamous-cell, neuro-endocrine, or other non-adenocarcinoma types\n* Unresectable disease (tumour-related or surgical contraindication) or subject refuses surgery\n* Tumour requiring transthoracic surgical approach\n* CNS metastases and\u002For carcinomatous meningitis\n* Prior anti-gastric-cancer therapy (surgery, radiotherapy, chemotherapy, targeted, immunotherapy) except bypass for obstruction\n* Previous malignancy or concurrent malignancy except completely excised basal\u002Fsquamous skin cancer, superficial bladder cancer, or in-situ prostate\u002Fcervix\u002Fbreast cancer disease-free ≥ 5 years\n* Cardiac conditions:\n\nNYHA class \\> II or LVEF \\\u003C 50 % on echo Unstable angina MI within 1 year Resting QTc \\> 450 ms (M) or \\> 470 ms (F) Clinically significant ECG abnormalities, complete LBBB, 3rd-degree AV block, 2nd-degree AV block, PR \\> 250 ms Risk factors for QT prolongation (HF, hypokalaemia, congenital long-QT syndrome, family history of long QT or sudden death \\\u003C 40 y, concomitant QT-prolonging drugs)\n\n* History of GI perforation, intra-abdominal abscess, or bowel obstruction within 3 months or imaging\u002Fclinical signs of obstruction\n* Clinically significant bleeding or bleeding diathesis within 3 months (e.g. GI bleeding, haemorrhagic gastritis, vasculitis); positive faecal occult blood must be endoscopically cleared if still positive on repeat testing (unless gastroscopy within 3 months shows no lesion)\n* Arterial or venous thrombo-embolic event within 6 months (stroke, TIA, intracranial haemorrhage, cerebral infarction)\n* Hypersensitivity to any study-drug component\n* Severe hypersensitivity history to any monoclonal antibody\n* Pregnant or lactating women\n* Positive HIV antibody\n* Active hepatitis (HBsAg positive with HBV DNA ≥ 500 IU\u002FmL; HCV antibody positive with HCV RNA \\> ULN)\n* Prior therapy targeting CTLA-4\u002FPD-1\u002FPD-L1 or other T-cell co-stimulatory\u002Fimmune-checkpoint pathways (including therapeutic vaccines)\n* Active autoimmune disease or autoimmune disease with relapse risk within 2 years (except stable hypothyroidism on replacement or well-controlled type 1 diabetes on insulin)\n* History of idiopathic pulmonary fibrosis, drug-related pneumonia, organising pneumonia (BOOP\u002FCOP), or CT evidence of active pneumonia at screening\n* Live attenuated vaccine within 4 weeks before first study dose or expected need during study\n* Immunodeficiency disorder or chronic systemic corticosteroids or other immunosuppressive therapy within 7 days before first dose (includes prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF agents)\n* Any condition that, in the investigator's opinion, increases study risk, interferes with protocol conduct, or compromises informed consent or compliance",{"count":95,"type":21},30,[53],"This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR\u002FMSI-H gastric or gastroesophageal junction adenocarcinoma.",[99,100,26,101],"Gastric Adenocarcinoma","Gastroesophageal Adenocarcinoma","Immunotherapy","2026-01-24",{"date":104,"type":33},"2026-01-27",{"date":106,"type":21},"2026-01-30",{"date":108,"type":21},"2030-06-30",{"name":39,"class":40},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":50,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100612891","phase-2-factors-influencing-immunotherapy-response-in-dmmrmsi-h-gastricgastroesophageal-junction-adenocarcinoma-100612891","NCT07259473","Factors Influencing Immunotherapy Response in dMMR\u002FMSI-H Gastric\u002FGastroesophageal Junction Adenocarcinoma","Factors Influencing Immunotherapy Response in Mismatch Repair Deficiency (dMMR) \u002F Microsatellite Instability-High (MSI-H) Gastric\u002FGastroesophageal Junction Adenocarcinoma","Pre-CATALIS","Inclusion Criteria:\n\n* Male or female, aged 18 to 85 years.\n* Histologically confirmed gastric cancer or adenocarcinoma of the esophagogastric junction (only Siewert types II and III are included).\n* dMMR status confirmed by immunohistochemistry (IHC) or MSI-H status confirmed by PCR\u002FNGS.\n* Tumor clinical staging meeting the following criteria:\n\ncT≥2, any N, M0, assessed by the investigator as potentially resectable and planned for preoperative treatment followed by surgery.\n\n* Willing to receive treatment with immune checkpoint inhibitors (including, but not limited to, various PD-1 inhibitors, PD-L1 inhibitors, CTLA-4 inhibitors, PD-1\u002FCTLA-4 bispecific antibodies, etc.), which may be combined with or without standard chemotherapy regimens for gastric cancer.\n\nExclusion Criteria:\n\n* Tumor histology other than adenocarcinoma, such as squamous cell carcinoma, neuroendocrine carcinoma, etc.\n* Presence of central nervous system metastases and\u002For leptomeningeal carcinomatosis.\n* Prior antitumor therapy directed at the current gastric cancer (excluding palliative gastrointestinal bypass surgery performed to relieve obstructive symptoms).","85 Years",{"count":120,"type":21},15,[53],"dMMR\u002FMSI-H is a key molecular subtype of gastric cancer, found in 8-22% of cases. It is typically associated with older age, female sex, distal tumor location, and intestinal histology (Lauren classification). While this subtype predicts better survival in locally advanced disease, its prognostic role in metastatic settings is less clear.\n\nNotably, dMMR\u002FMSI-H tumors are often resistant to conventional chemotherapy. Conversely, they demonstrate exceptional sensitivity to immunotherapy. This has led to effective strategies using immune checkpoint inhibitors, either alone or combined with chemotherapy, in both neoadjuvant and advanced disease settings.\n\nHowever, key challenges remain. Prospective data are largely from Western populations, leaving the efficacy in Asian patients-who bear a high disease burden-less defined. Furthermore, about half of dMMR\u002FMSI-H patients exhibit primary or acquired resistance to immunotherapy. A deeper understanding of the tumor-immune dynamics during treatment is crucial to uncover resistance mechanisms and improve patient outcomes.",[25,26,101],"2026-01-02",{"date":126,"type":33},"2026-01-07",{"date":128,"type":21},"2026-01-31",{"date":130,"type":21},"2029-12-30",{"name":39,"class":40}]