[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"msi-hdmmr-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:msi-hdmmr-colorectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,85],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100624667","phase-3-neoadjuvantadjuvant-ak104-in-microsatellite-instability-high-or-mismatch-repair-deficient-resectable-colon-cancer-100624667",false,"NCT07412613","Neoadjuvant\u002FAdjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant\u002FAdjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","Inclusion Criteria:\n\n1. Voluntarily sign a written ICF.\n2. ≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.\n3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.\n4. Life expectancy greater than 2 years.\n5. Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy.\n6. Participants with resectable stage IIB-III colon cancer according to the AJCC 8th staging, as assessed by imaging (enhanced CT or enhanced MRI) .\n7. Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17S250, or combinations of other guidelines and clinically recognized site) , or mismatch repair detection demostrates dMMR (evaluating the expression of 4 MMR proteins: MLH1, MSH2, MSH6, PMS2 by immunohistochemistry, and positive expression is localized to the nucleus).\n8. Before enrollment, the participant needs to be evaluated by the responsible surgeon to confirm whether he\u002Fshe is eligible for radical R0 resection, and does not require combined organ resection based on medical history.\n9. Female participants of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result is negative. If a female participant of childbearing potential has sex with a male partner who is not sterilized, the participant must use an acceptable method of contraception from screening and must agree to use a contraceptive method continuously until 120 days after the last dose of study drug; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.\n10. If a non-sterilized male participant has sex with a female partner of childbearing potential, the participant must take an effective method of contraception from the beginning of screening until 120 days after the last dose; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.\n\nExclusion Criteria:\n\n1. Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.\n2. Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).\n3. Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.\n4. History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.\n5. Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection.\n6. Known history of allograft organ transplantation or allograft hematopoietic stem cell transplantation.\n7. Previous history of pneumonitis\u002Finterstitial lung disease requiring systemic corticosteroid treatment or currently having pneumonitis.\n8. Experiencing severe infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; having received systemic anti-infection treatment for active infection within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or hepatitis C).\n9. Subjects with active hepatitis B (HBsAg positive and HBV-DNA over 1000 copies\u002Fml (200 IU\u002Fml) or above the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive antiviral treatment throughout the study.\n10. Pregnant or breastfeeding women.\n11. Previously or currently having any disease, treatment, or abnormal laboratory test results that could confound study results, affect full participation in the study, or make participation not in the best interest of the participant.","ALL","18 Years","75 Years",{"count":20,"type":21},386,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant\u002Fadjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H\u002FdMMR colon cancer.",[27,28],"Resectable Colon Cancer","MSI-H\u002FdMMR Colorectal Cancer","RECRUITING","2026-04-20",{"date":32,"type":33},"2026-04-22","ACTUAL",{"date":35,"type":33},"2026-04-15",{"date":37,"type":21},"2031-03-15",{"name":39,"class":40},"Akeso","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":54,"conditions":55,"keywords":62,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"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":50,"type":21},160,[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.",[56,57,58,28,59,60,61],"Advanced Solid Tumors","MSI-H or dMMR Advanced Solid Tumors","MSI-H\u002FdMMR Gastric Cancer","MSI-H\u002FdMMR Gastroesophageal-junction Cancer","Endometrial Cancer","Mismatch Repair Deficient or MSI-High Solid Tumors",[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)","2026-04-06",{"date":77,"type":33},"2026-04-08",{"date":79,"type":33},"2026-01-20",{"date":81,"type":21},"2029-03",{"name":83,"class":40},"Eikon Therapeutics",10,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":41},"100593646","phase-2-ql1706-plus-bevacizumab-for-unresectable-or-metastatic-msi-hdmmr-crc-100593646","NCT07009145","QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H\u002FdMMR CRC","An Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Bevacizumab for the Treatment of Unresectable or Metastatic MSI-H\u002FdMMR Colorectal Cancer","Inclusion Criteria:\n\n* Voluntarily signs the informed consent form.\n* Aged between 18 and 80 years (inclusive) at the time of consent; no gender restriction.\n* Histologically confirmed unresectable locally advanced or metastatic colorectal cancer.\n* At least one measurable target lesion according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No prior immunotherapy for unresectable locally advanced or metastatic colorectal cancer.\n* If previously treated with standard neoadjuvant or adjuvant therapy, the interval from the last dose to the first study treatment must be ≥ 6 months.\n* Willing and able to provide tumor tissue and blood samples for MSI, RAS, BRAF, and PD-L1 testing.\n* Estimated life expectancy of ≥ 12 months.\n* Appropriate laboratory values must be met at screening.\n* Female participants must be non-lactating, and have a negative pregnancy test result prior to enrollment.\n* Participants of childbearing potential must agree to use effective contraception from the time of informed consent until at least 180 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Known history of severe allergic reactions to iparomlimab and tuvonralimab or bevacizumab.\n* Active malignancy other than colorectal cancer within 5 years prior to first treatment.\n* Large tumor lesions, especially those previously irradiated, with signs of bleeding.\n* Imaging showing tumor invasion of major blood vessels (e.g., pulmonary artery or superior vena cava), including encasement or invasion of the vessel lumen.\n* Brain metastases (asymptomatic or treated symptomatic brain metastases stable for \\>4 weeks allowed).\n* Active autoimmune disease requiring systemic treatment.\n* Active pulmonary diseases such as tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction during screening.\n* Requirement for long-term or high-dose NSAIDs (aspirin \\>325 mg) or anticoagulant therapy.\n* History of severe gastrointestinal events within 6 months prior to first treatment.\n* Severe intestinal obstruction symptoms or signs and unretrieved intestinal stents at screening.\n* Cardiovascular or cerebrovascular diseases including but not limited to: NYHA class \\> II heart failure; unstable or severe angina; myocardial infarction or stroke within 6 months; atrial fibrillation or other arrhythmias requiring treatment; symptomatic superior vena cava syndrome; prolonged QT interval (male QT \\> 450 ms; female QTc \\> 470 ms); uncontrolled hypertension despite medication (SBP \\>140 mmHg and\u002For DBP \\>90 mmHg) or history of hypertensive crisis or encephalopathy.\n* Known bleeding disorders or coagulopathies.\n* Uncontrolled pleural, pericardial, or ascitic effusions requiring drainage.\n* Active infection or unexplained fever \\>38.5°C at screening (cancer-related fever allowed).\n* Use of systemic broad-spectrum antibiotics within 30 days prior to first treatment.\n* Systemic corticosteroids (\\>10 mg prednisone equivalent daily) or immunosuppressants within 14 days prior to first treatment, or immunostimulants within 4 weeks.\n* Major surgery, severe fractures, or therapeutic clinical trials within 4 weeks prior to first treatment; herbal treatment within 2 weeks.\n* Ongoing adverse events from prior antitumor therapy greater than grade 1.\n* HIV infection, other congenital or acquired immunodeficiencies, or history of organ or allogeneic bone marrow transplantation (except corneal transplantation).\n* Positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with HBV DNA \\>10⁴ copies\u002FmL (\\~2000 IU\u002FmL); or positive hepatitis C antibody with HCV RNA \\>10³ copies\u002FmL; co-infection with HBV and HCV excluded.\n* Vaccination with live or attenuated vaccines within 30 days prior to first treatment.\n* Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137).\n* Prior adjuvant targeted therapy against EGFR, VEGF, or VEGFR (e.g., bevacizumab, cetuximab, panitumumab, apatinib, regorafenib, anlotinib).\n* Psychiatric disorders, epilepsy, dementia, or substance abuse that may affect compliance.\n* Other conditions or lab abnormalities that may interfere with study participation or confound results as judged by investigators or sponsors.","80 Years",{"count":94,"type":21},22,[53],"This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Eligible participants who meet the inclusion and exclusion criteria will provide written informed consent and receive QL1706 at 5.0 mg\u002Fkg and bevacizumab at 7.5 mg\u002Fkg on Day 1 of every 3-week cycle (Q3W), until disease progression or completion of 2 years of treatment. The primary endpoint of this study is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), PFS and OS rates at 6, 12, and 24 months, and safety.",[98,99,28],"Unresectable Colorectal Cancer","Metastatic Colorectal Cancer (CRC)",[101,102,103],"QL1706","CRC","MSI-H\u002FdMMR","NOT_YET_RECRUITING","2025-05-28",{"date":107,"type":33},"2025-06-06",{"date":109,"type":21},"2025-06-27",{"date":111,"type":21},"2027-12-31",{"name":113,"class":114},"Qianfoshan Hospital","OTHER"]