[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649230":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":29,"collaborators":33,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":11,"eligibilityCriteria":42,"healthyVolunteers":39,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":11,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL",null,[13],"Drug: Sintilimab monotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Sintilimab monotherapy","Sintilimab monotherapy 200mg，Q3W",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Linlin Bo, Doctor","CONTACT","86+18811552683","bo_lin_lin@163.com",{"name":27,"role":23,"phone":11,"phoneExt":11,"email":28},"Yiqin Wang, Doctor","emily_wang92@163.com",{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Wang Jianliu","Director of the Institute of Obstetrics and Gynecology, Principal Investigator, Clinical Professor",[34],{"name":35,"class":36},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY","100649230","phase-2-sintilimab-monotherapy-in-patients-with-stage-i-ii-msi-hdmmr-endometrial-cancer-100649230",false,"NCT07731607","Sintilimab Monotherapy in Patients With Stage I-II MSI-H\u002FdMMR Endometrial Cancer","Inclusion Criteria:\n\n1. Aged 18-75 years.\n2. Histopathologically confirmed endometrial cancer, with pathological types including endometrioid, serous, clear cell, undifferentiated, dedifferentiated, or carcinosarcoma.\n3. Laboratory-confirmed dMMR (mismatch repair deficient) endometrial cancer (loss of MLH1\u002FPMS2\u002FMSH2\u002FMSH6 protein expression by immunohistochemistry) or MSI-H (microsatellite instability-high by PCR or NGS).\n4. Stage I-II according to the FIGO 2023 staging system.\n5. At least one measurable lesion (RECIST 1.1 criteria).\n6. ECOG performance status 0-1, with a life expectancy of ≥12 months.\n7. Strong desire for uterine preservation, conservative treatment, or fertility preservation, or inability to tolerate standard surgery due to comorbidities.\n8. Adequate organ function within 14 days prior to enrollment.\n9. Good follow-up conditions and signed informed consent.\n\nExclusion Criteria:\n\n1. Presence of active autoimmune disease, or long-term requirement for immunosuppressive agents;\n2. Prior treatment with immune checkpoint inhibitors;\n3. Concurrent persistent or active infections, such as hepatitis B, hepatitis C, etc.;\n4. Concurrent severe dysfunction of vital organs including heart, lung, liver and kidney: alanine aminotransferase\u002Faspartate aminotransferase elevated more than 3 times the upper limit of normal (ULN) and unresponsive to liver-protective therapy; serum creatinine ≥1.5 × ULN; abnormal thyroid function; history of heart failure, unstable angina pectoris, severe arrhythmia, myocarditis, interstitial lung disease, non-infectious pneumonitis or active pulmonary infection, etc.;\n5. Other active malignant tumors (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);\n6. Known hypersensitivity to any component of the study drug;\n7. Pregnant or breastfeeding women;\n8. Any severe or unstable concomitant disease that, in the investigator's judgment, renders the subject ineligible for this study.","FEMALE","18 Years","75 Years",{"count":47,"type":48},48,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","To investigate the efficacy and safety of immune checkpoint inhibitors as a non-surgical (surgery-avoiding) treatment in patients with stage I-II MSI-H\u002FdMMR endometrial cancer.",[54],"MMRd Endometrial Cancer of Stage I~II",[56,57,58],"endometrial cancer","stage I~II","MMRd","NOT_YET_RECRUITING","2026-07-25",{"date":62,"type":63},"2026-07-28","ACTUAL",{"date":65,"type":48},"2026-07-20",{"date":67,"type":48},"2030-07-20",{"name":31,"class":6}]