[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657691":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":55,"studyPopulation":47,"armGroups":56,"interventions":66,"overallOfficials":47,"centralContacts":86,"locations":95,"responsibleParty":112,"collaborators":47,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":47,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":47,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":98,"whyStopped":47,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological Complete Response Rate","Pathological assessment of the surgical resection specimen; pCR is defined as no residual viable cancer cells after treatment (ypT0N0M0).","At curative surgery, following completion of neoadjuvant therapy",[14,17,21,24,28,32,36,39,43],{"measure":15,"description":16,"timeFrame":12},"Major Pathological Response Rate","Pathological assessment of the surgical resection specimen; MPR is defined as residual viable tumor cells ≤10%.",{"measure":18,"description":19,"timeFrame":20},"3-Year Event-Free Survival","Time from enrollment to first radiographic disease progression or death, whichever occurs first.","From enrollment up to 3 years",{"measure":22,"description":23,"timeFrame":20},"3-Year Overall Survival","Time from enrollment to death from any cause.",{"measure":25,"description":26,"timeFrame":27},"Concordance of ctDNA Status With Pathological Complete Response","Preoperative ctDNA status will be compared with postoperative pathological complete response results.","After 3-4 cycles of PD-1 inhibitor monotherapy (21-day cycles) and at curative surgery; for persistent ctDNA positivity, every 2 cycles of PD-1 plus CTLA-4 inhibitor therapy (21-day cycles; up to 4 cycles).",{"measure":29,"description":30,"timeFrame":31},"Concordance Between ctDNA Dynamics and Imaging Assessment","ctDNA positivity, clearance, and dynamic changes will be compared with RECIST version 1.1 imaging response assessments.","Baseline through curative surgery, up to 24 weeks (each cycle is 21 days).",{"measure":33,"description":34,"timeFrame":35},"Number of Participants With Treatment-Emergent Adverse Events, as Assessed by CTCAE v5.0","Number and proportion of participants with at least one treatment-emergent adverse event, including treatment-related and immune-related adverse events.","From first dose through 30 days after the last dose.",{"measure":37,"description":38,"timeFrame":35},"Number of Participants With Grade 3 or Higher Treatment-Related Adverse Events, as Assessed by CTCAE v5.0","Number and proportion of participants with at least one Grade 3 or higher treatment-related adverse event.",{"measure":40,"description":41,"timeFrame":42},"Number of Participants With Serious Adverse Events","Number and proportion of participants with at least one serious adverse event.","From first dose through 90 days after the last dose.",{"measure":44,"description":45,"timeFrame":46},"Number of Participants With Treatment-Related Delay of Curative Surgery","Number and proportion of participants whose curative surgery is delayed because of treatment-related toxicity, as determined by the investigator.","From first dose through curative surgery up to 24 weeks",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":47,"timePerspective":47,"maskingInfo":53},"NA","SINGLE_GROUP","All participants initially receive PD-1 inhibitor monotherapy. ctDNA status after 3-4 cycles guides subsequent treatment: participants with ctDNA clearance undergo curative surgery, whereas those with persistent ctDNA positivity escalate to PD-1 plus CTLA-4 inhibitor therapy before surgery.","TREATMENT",{"masking":54,"maskingDescription":47,"whoMasked":47},"NONE","This prospective, multicenter, single-arm phase II study evaluates the clinical utility of longitudinal circulating tumor DNA (ctDNA) monitoring to guide neoadjuvant immunotherapy and surgical decision-making in patients with dMMR\u002FMSI-H colon cancer.\n\nEligible participants will initially receive neoadjuvant PD-1 inhibitor monotherapy. Peripheral-blood ctDNA will be assessed at baseline and after 3 to 4 treatment cycles. Participants with ctDNA clearance will proceed to curative surgery. Participants with persistent ctDNA positivity will be considered to have potential resistance to PD-1 inhibitor monotherapy and will escalate to combined PD-1 and CTLA-4 inhibitor therapy. ctDNA will be reassessed every 2 cycles during combination therapy. Participants will undergo curative surgery after ctDNA clearance or after no more than 4 cycles of combination treatment, regardless of final ctDNA status.\n\nAll participants will undergo postoperative ctDNA\u002Fminimal residual disease (MRD) testing 1 month after surgery. The study will evaluate pathological response, survival outcomes, the concordance of ctDNA with pathological and imaging assessments, and treatment- and surgery-related safety.",[57],{"label":58,"type":59,"description":60,"interventionNames":61},"ctDNA-Guided Neoadjuvant Immunotherapy |","EXPERIMENTAL","Participants receive PD-1 inhibitor monotherapy. ctDNA testing after 3-4 cycles determines whether they proceed to curative surgery or escalate to PD-1 plus CTLA-4 inhibitor therapy; all participants subsequently undergo curative surgery.",[62,63,64,65],"Drug: PD-1 inhibitor","Drug: CTLA-4 inhibitor","Diagnostic Test: ctDNA\u002FMRD testing","Procedure: Curative Surgery",[67,72,76,81],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":47},"DRUG","PD-1 inhibitor","200 mg intravenously on Day 1 of each 3-week cycle. All participants receive initial monotherapy.",[58],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":47},"CTLA-4 inhibitor","1 mg\u002Fkg intravenously on Day 1 of each 3-week cycle. Administered with the PD-1 inhibitor only to participants with persistent ctDNA positivity after 3-4 cycles of monotherapy.",[58],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":47},"DIAGNOSTIC_TEST","ctDNA\u002FMRD testing","Peripheral-blood ctDNA testing at baseline and after 3-4 cycles of monotherapy; every 2 cycles during combination therapy, when applicable; and 1 month after surgery.",[58],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":47},"PROCEDURE","Curative Surgery","Curative surgery after ctDNA clearance or after no more than 4 cycles of combination treatment.",[58],[87,92],{"name":88,"role":89,"phone":90,"phoneExt":47,"email":91},"Junjie Peng, MD, PhD","CONTACT","86-18017317122","pengjj@shca.org.cn",{"name":93,"role":89,"phone":47,"phoneExt":47,"email":94},"Yaqi Li, MD, PhD","yaqili702@shca.org.cn",[96],{"facility":97,"status":98,"city":99,"state":47,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","200000","China","CN",{"type":104,"coordinates":105},"Point",[106,107],121.45806,31.22222,{"lat":107,"lon":106},[110],{"name":93,"role":89,"phone":111,"phoneExt":47,"email":94},"86-15902194450",{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"PRINCIPAL_INVESTIGATOR","Junjie Peng","Professor","100657691","phase-2-ctdna-guided-immunotherapy-for-dmmrmsi-h-colon-cancer-100657691",false,"NCT07841236","ctDNA-Guided Immunotherapy for dMMR\u002FMSI-H Colon Cancer","A Single-Arm Phase II Study of Circulating Tumor DNA-Guided Neoadjuvant Immunotherapy for dMMR\u002FMSI-H Colon Cancer","Inclusion Criteria:\n\n* Written informed consent obtained before any study-related procedures.\n* Age 18 to 75 years, inclusive.\n* Histologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma, with the tumor located at least 15 cm from the anal verge.\n* dMMR\u002FMSI-H status confirmed by immunohistochemistry, polymerase chain reaction, or next-generation sequencing.\n* Eastern Cooperative Oncology Group performance status of 0 or 1 and an expected survival of at least 3 months.\n* Adequate hematologic, hepatic, renal, coagulation, thyroid, and cardiac function, as defined in the protocol.\n* Negative pregnancy test for women of childbearing potential; agreement to use highly effective contraception, when applicable.\n\nExclusion Criteria:\n\n* Prior treatment with a PD-1 inhibitor, CTLA-4 inhibitor, or other immunotherapy.\n* Symptomatic or high-risk bowel obstruction, bleeding, perforation, pneumonitis, or other conditions that may compromise safe study participation.\n* Another malignancy diagnosed within 5 years before the first study treatment, except for specified definitively treated low-risk malignancies.\n* Current participation in another interventional clinical study, or receipt of another investigational drug or investigational device within 4 weeks before the first study treatment.\n* Active autoimmune disease requiring systemic treatment within 2 years before the first study treatment, or recent systemic corticosteroid or other immunosuppressive therapy.\n* Uncontrolled pleural effusion or ascites, prior allogeneic organ transplantation (except corneal transplantation), or allogeneic hematopoietic stem cell transplantation.\n* Known hypersensitivity to any study drug component.\n* Toxicities or complications from prior treatment not recovered to Grade 1 or baseline, except for specified conditions.\n* HIV infection, untreated active hepatitis B infection, or active hepatitis C infection.\n* Receipt of a live vaccine within 30 days before the first study treatment.\n* Pregnancy or breastfeeding.\n* Any serious or uncontrolled systemic disease, active infection, clinically significant laboratory abnormality, or other condition that may interfere with study participation or place the participant at unacceptable risk, as judged by the investigator.","ALL","18 Years","75 Years",{"count":127,"type":128},23,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","This prospective, multicenter, single-arm phase II interventional study evaluates whether longitudinal circulating tumor DNA (ctDNA) monitoring can guide neoadjuvant immunotherapy and surgical decision-making in dMMR\u002FMSI-H colon cancer. Participants with ctDNA clearance proceed to curative surgery, whereas those with persistent ctDNA positivity escalate to combined PD-1 and CTLA-4 inhibitor therapy.",[134,135,136],"Colon Cancer","Deficient Mismatch Repair","Microsatellite Instability-High (MSI-H)",[138,139,140,141,142],"Circulating Tumor DNA","dMMR\u002FMSI-H Colon Cancer","Neoadjuvant Immunotherapy","Pathological Complete Response","Minimal Residual Disease","2026-09-24",{"date":145,"type":146},"2026-09-25","ACTUAL",{"date":148,"type":128},"2026-09-14",{"date":150,"type":128},"2030-12-31",{"name":5,"class":6},1]