[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624138":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigator-Selected Maintenance Therapy + Lubiprostone","EXPERIMENTAL","Participants receive investigator-selected standard-of-care maintenance therapy plus lubiprostone (24 μg orally twice daily) during the maintenance period, until disease progression, unacceptable toxicity, withdrawal, or other protocol-defined discontinuation criteria.",[13],"Drug: maintenance therapy plus lubiprostone",{"label":15,"type":16,"description":17,"interventionNames":18},"Investigator-Selected Maintenance Therapy","ACTIVE_COMPARATOR","Participants receive investigator-selected standard-of-care maintenance therapy during the maintenance period, until disease progression, unacceptable toxicity, withdrawal, or other protocol-defined discontinuation criteria.",[19],"Drug: maintenance therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","maintenance therapy plus lubiprostone","In experiment arm, participants receive investigator-selected standard-of-care maintenance therapy plus lubiprostone (24 μg orally twice daily) during the maintenance period, until disease progression, unacceptable toxicity, withdrawal, or other protocol-defined discontinuation criteria.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"maintenance therapy","In active comparator arm, participants receive investigator-selected standard-of-care maintenance therapy during the maintenance period, until disease progression, unacceptable toxicity, withdrawal, or other protocol-defined discontinuation criteria.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Guangzhao Lv, MD, PhD","CONTACT","+86 020 87343920","lvgz@sysucc.org.cn",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Pei-Rong Ding","Director, Department of Colorectal Surgery; Professor","100624138","phase-2-lubiprostone-combined-with-maintenance-therapy-for-prevention-of-postoperative-recurrence-in-peritoneal-metastatic-colorectal-cancer-100624138",false,"NCT07405736","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer, A Randomized Controlled Phase II Study","Inclusion Criteria:\n\n* Voluntarily participates and provides written informed consent.\n* Histologically confirmed colon\u002Frectal adenocarcinoma with molecular status confirmed as pMMR or MSS.\n* Cytoreductive surgery (CRS) achieves CC0\u002FCC1 cytoreduction.\n* No extraperitoneal metastasis prior to treatment.\n* ECOG performance status 0-1 with adequate organ function per protocol requirements.\n\nExclusion Criteria:\n\n* Extensive multisystem metastases on baseline imaging assessment.\n* Tumor carrying BRAF V600E mutation.\n* dMMR\u002FMSI-H, or confirmed pathogenic POLE\u002FPOLD1 mutation(s).\n* Cachexia or decompensated organ dysfunction.\n* History of another malignancy within the past 5 years.\n* Known or suspected hypersensitivity\u002Fallergy to the study drug or related formulations.\n* Multiple primary cancers.\n* Any serious disease or other medical, psychological, or social condition that, in the investigator's judgment, may compromise participant safety or affect study results.","ALL","18 Years","75 Years",{"count":52,"type":53},124,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","The goal of this phase II randomized controlled clinical trial is to evaluate whether adding lubiprostone to standard postoperative maintenance therapy can delay disease progression and recurrence in adult patients with colorectal cancer and peritoneal metastases (PM-CRC) who have undergone cytoreductive surgery with or without HIPEC after systemic treatment. The main questions it aims to answer are:\n\nDoes lubiprostone plus maintenance therapy improve the 1-year progression-free survival (PFS) rate compared with maintenance therapy alone?\n\nIs lubiprostone safe and feasible for long-term use during the maintenance period in this PM-CRC population?\n\nResearchers will compare lubiprostone + maintenance therapy versus maintenance therapy alone to see if the addition of lubiprostone prolongs PFS, reduces the risk of distant metastasis, improves overall survival, and maintains or improves quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive maintenance therapy with lubiprostone or maintenance therapy alone after surgery (CRS ± HIPEC) and prior systemic therapy, according to the study protocol.\n\nUndergo scheduled follow-up assessments for disease status (progression\u002Frecurrence), survival outcomes, treatment-related toxicity, and quality of life using the EORTC QLQ-C30 (v3.0) questionnaire.",[59,60,61,62,63],"Colorectal Cancer Metastatic","Peritoneal (Metastatic) Cancer","Peritoneal Metastasis","Colorectal Cancer (CRC)","MSS Metastatic Colorectal Cancer",[65,66,67,68,69,70],"Peritoneal metastasis","Colorectal cancer","Maintenance therapy","Lubiprostone","Cytoreductive Surgery","Progression-free survival","NOT_YET_RECRUITING","2026-02-10",{"date":74,"type":75},"2026-02-12","ACTUAL",{"date":77,"type":53},"2026-02-24",{"date":79,"type":53},"2028-06-01",{"name":5,"class":6}]