[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-metastatic-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-metastatic-rectal-cancer":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100487619","ctdna-and-organ-preservationpathologic-cr-in-rectal-cancer-100487619",false,"NCT05629442","ctDNA and Organ Preservation\u002FPathologic CR in Rectal Cancer","A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation or Pathologic Complete Response After Neoadjuvant Therapy for Rectal Cancer","Inclusion Criteria:\n\n* Participants with T3, T4, or node-positive non-metastatic rectal cancer.\n* Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.\n* Participants must be 18 years of age or older.\n* ECOG 0-2.\n* Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX\u002FFOLFOXIRI, or CAPOX\n* Participants must be eligible for long course chemoradiation to 40-54 Gy.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants must not have any other organ cancer evident at the time of enrollment.\n* Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.\n* Participants must not be actively or planning to be pregnant or breastfeeding","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","OBSERVATIONAL","This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.\n\nThis research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care\n\nC2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.",[24,25],"Rectal Cancer","Non Metastatic Rectal Cancer",[24,25],"NOT_YET_RECRUITING","2026-06-29",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":20},"2026-10-01",{"date":35,"type":20},"2030-06",{"name":37,"class":38},"Massachusetts General Hospital","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100606444","phase-2-ql1706-with-short-course-radiotherapy-and-chemotherapy-for-mss-rectal-cancer-100606444","NCT07175636","QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer","A Multicenter, Prospective, Phase II Clinical Trial of Short-Course Radiotherapy Followed by QL1706 Plus mFOLFOX6 as Total Neoadjuvant Therapy for Patients With pMMR\u002FMSS Locally Advanced Rectal Cancer","Inclusion Criteria:\n\nAge 18-75 years, male or female.\n\nHistologically confirmed rectal adenocarcinoma.\n\nLocally advanced disease (cT3-4 and\u002For N+, M0) based on pelvic MRI and\u002For CT.\n\nTumor located within 12 cm from the anal verge.\n\nProven microsatellite stability (MSS) or proficient mismatch repair (pMMR) status.\n\nECOG performance status 0-1.\n\nAdequate organ function:\n\nAbsolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n\nPlatelet count ≥ 100 × 10⁹\u002FL\n\nHemoglobin ≥ 90 g\u002FL\n\nALT\u002FAST ≤ 2.5 × ULN\n\nTotal bilirubin ≤ 1.5 × ULN\n\nSerum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin\n\nNo prior pelvic radiotherapy, chemotherapy, immunotherapy, or targeted therapy for rectal cancer.\n\nSigned written informed consent\n\nExclusion Criteria:\n\nEvidence of distant metastasis.\n\nPrevious or concurrent malignant tumor (except cured basal cell carcinoma of skin or cervical carcinoma in situ).\n\nActive autoimmune disease requiring systemic immunosuppressive therapy.\n\nActive infection including hepatitis B, hepatitis C, HIV, or tuberculosis.\n\nKnown allergy or hypersensitivity to study drugs or excipients.\n\nUncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure, arrhythmia).\n\nPregnant or breastfeeding women.\n\nAny condition judged by investigators to make the patient unsuitable for the study.","75 Years",{"count":48,"type":20},66,"INTERVENTIONAL",[51],"PHASE2","This is a multicenter, prospective, phase II study evaluating total neoadjuvant therapy (TNT) consisting of short-course radiotherapy (SCRT; 5×5 Gy) followed by QL1706 (a bifunctional MabPair antibody targeting PD-1 and CTLA-4, code name only) plus mFOLFOX6 chemotherapy in patients with locally advanced rectal cancer (LARC) with proficient mismatch repair\u002Fmicrosatellite-stable (pMMR\u002FMSS) biology. Patients with pMMR\u002FMSS disease derive limited benefit from immune checkpoint inhibition alone. Preclinical and clinical evidence suggests that SCRT and oxaliplatin-based chemotherapy can enhance antitumor immunity (e.g., antigen release, T-cell infiltration), providing a biological rationale for combining QL1706 with SCRT-primed TNT.\n\nEligible adults with cT3-4 and\u002For N+ mid-to-low rectal adenocarcinoma (without distant metastasis), confirmed pMMR\u002FMSS, and ECOG 0-1 will receive: SCRT (total 25 Gy over 5 fractions), then several cycles of QL1706 plus mFOLFOX6 as neoadjuvant systemic therapy. Definitive total mesorectal excision (TME) is planned per multidisciplinary assessment; a watch-and-wait approach may be considered for patients achieving a stringent clinical complete response per institutional criteria. Standard perioperative care and postoperative follow-up will be performed.\n\nPrimary endpoint is pathologic complete response (pCR, ypT0N0) rate at surgery. Key secondary endpoints include: clinical complete response (cCR) rate, major pathologic response rate, R0 resection rate, tumor downstaging, radiologic response, disease-free survival (DFS), overall survival (OS), organ preservation rate (for patients managed non-operatively), surgical morbidity, and safety\u002Ftolerability (CTCAE v5.0). Exploratory endpoints include correlations between efficacy and baseline clinicopathologic features; optional translational analyses may investigate immune-inflammation markers related to response and resistance.\n\nThis trial aims to determine whether SCRT-primed QL1706 plus mFOLFOX6 TNT can improve tumor eradication and organ preservation while maintaining acceptable safety in pMMR\u002FMSS LARC-a population with unmet need for effective immunotherapy-based strategies.",[54,55,56],"Locally Advanced Rectal Cancer (LARC)","Mismatch Repair-Proficient (pMMR) Rectal Cancer","Non-metastatic Rectal Cancer","2025-09-09",{"date":59,"type":31},"2025-09-16",{"date":61,"type":20},"2025-09-20",{"date":63,"type":20},"2029-09-20",{"name":65,"class":38},"Sun Yat-sen University"]