[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575979":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":25,"responsibleParty":44,"collaborators":18,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":18,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":18,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":70,"whyStopped":18,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"S-1 Maintenance Therapy","EXPERIMENTAL","S-1 monotherapy",[13],"Drug: S-1",{"label":15,"type":16,"description":17,"interventionNames":18},"Observation Only","NO_INTERVENTION","Participants in this arm will undergo follow-up observation according to the trial protocol, without receiving any antineoplastic drugs for maintenance therapy.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","S-1","Tegafur, Gimeracil, and Oteracil Potassium (S-1) 40-60 mg per dose, orally (p.o.), twice daily (BID), from Day 1 to Day 28, with a 6-week cycle, for a total of 8 cycles; or from Day 1 to Day 14, with a 3-week cycle, for a total of 16 cycles.",[9],[26],{"facility":5,"status":18,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Nanjing","Jiangsu","025","China","CN",{"type":33,"coordinates":34},"Point",[35,36],118.77778,32.06167,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Min Tu, Master","CONTACT","13585181045","tumin1215@163.com",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Min Tu","Associate Chief Physician","100575979","phase-4-maintenance-chemotherapy-with-s-1-vs-observation-after-adjuvant-therapy-for-resected-pancreatic-cancer-with-high-risk-of-recurrencemetastasis-100575979",false,"NCT06779318","Maintenance Chemotherapy With S-1 vs. Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence\u002FMetastasis","A Real-World Study Comparing Maintenance Chemotherapy With Tegafur, Gimeracil, and Oteracil Potassium (S-1) Versus Follow-Up Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence\u002FMetastasis (MSPAC-1)","Inclusion Criteria:\n\n1. Histologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium);\n2. Meets one of the following conditions: Pathologically confirmed as moderately differentiated, moderately to poorly differentiated, or poorly differentiated; or pathologic staging as: T3N0M0, T1-3N1-2M0, T4N0-2M0; or one or more surgical margins are R1 resected (R0 resection if no tumor cells are found more than 1mm from the margin, otherwise R1 resection); or involvement of the portal vein and\u002For superior mesenteric vein resection; or pre-adjuvant chemotherapy CA19-9 \\> 90 U\u002FmL; or pre-adjuvant chemotherapy ctDNA testing positive;\n3. Completed standard treatment: Received radical resection, postoperative adjuvant therapy (including adjuvant chemotherapy based on gemcitabine or fluorouracil), and radiotherapy (if applicable);\n4. Eligible for oral medication;\n5. Age ≥18 and ≤75, male or female;\n6. ECOG performance status: 0 to 2;\n7. Normal function of major organs as per the following criteria within 14 days prior to starting treatment:① Neutrophil count ≥ 1.5×10\\^9\u002FL;② Platelet count ≥ 75×10\\^9\u002FL;③ Hemoglobin ≥ 9.0 g\u002FdL;④ AST ≤ 2.5×UNL (upper normal limit) (if liver metastasis present, AST ≤ 5×UNL);⑤ ALT ≤ 2.5×UNL (if liver metastasis present, ALT ≤ 5×UNL);⑥ Total bilirubin ≤ 1.5×UNL;⑦ Creatinine clearance (calculated using the Cockcroft-Gault formula) \\> 60 mL\u002Fmin or serum creatinine ≤ 1.5×UNL;\n8. Women of childbearing potential must have used reliable contraception within 7 days prior to enrollment and have a negative pregnancy test, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of the investigational drug. For men, they must be surgically sterile or agree to use appropriate contraception during the study and for 3 months after treatment;\n9. Expected survival time ≥6 months;\n10. Voluntary participation in the study, signed informed consent, and demonstrated good compliance and cooperation during follow-up.\n\nExclusion Criteria:\n\n1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor;\n2. Incomplete macroscopic resection (R2 resection);\n3. Presence of distant metastasis (including malignant ascites and pleural effusion, peritoneal metastasis) or locally recurrent pancreatic cancer;\n4. CA19-9 \\> 180 U\u002FmL within 21 days before enrollment;\n5. Severe liver dysfunction (AST\u002FALT \\> 3.5 times the upper limit of normal, alkaline phosphatase \\> 6 times the upper limit of normal), with liver drainage;\n6. Known peripheral neuropathy (CTCAE ≥ Grade 2);\n7. Participation in another clinical trial of cytotoxic drugs, targeted therapies, immunotherapies, etc., within the past 4 weeks, or received systemic chemotherapy, radiotherapy, or biological therapy within the past 4 weeks;\n8. Concurrent or metachronous cancers with disease-free survival ≥ 5 years (excluding pancreatic cancer), except for cancers that have been cured or can be potentially cured with local excision (e.g., esophageal cancer, gastric cancer, colorectal cancer, cervical cancer, non-melanoma skin cancer, bladder cancer);\n9. Factors that significantly affect oral drug absorption, such as difficulty swallowing, chronic diarrhea, or gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;\n10. Clinically symptomatic serous effusions (including pleural effusion, ascites, pericardial effusion) requiring symptomatic treatment;\n11. Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to take effective contraceptive measures;\n12. Known allergy to the investigational drug, the class of the investigational drug, or its components;\n13. Need for systemic corticosteroid treatment (except for local steroid pre-treatment);\n14. History of interstitial lung disease (including interstitial pneumonia, pulmonary fibrosis, etc.) or CT findings of interstitial lung disease;\n15. Active local or systemic infection requiring treatment;\n16. Heart failure NYHA classification ≥ II or severe heart disease;\n17. Known HIV infection or history of acquired immunodeficiency syndrome (AIDS) or active hepatitis B or C;\n18. Toxicity not recovered (CTCAE \\> Grade 1) or previous anticancer surgery not fully recovered;\n19. Patients deemed unsuitable for this study by the investigator.","ALL","18 Years","75 Years",{"count":59,"type":60},464,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","The goal of this real-world study is to learn if maintenance chemotherapy with Tegafur, Gimeracil, and Oteracil Potassium (S-1) can improve disease-free survival (DFS) compared to follow-up observation in patients with resected pancreatic cancer at high risk of recurrence or metastasis after adjuvant therapy. The main questions it aims to answer are:\n\n* Does maintenance therapy with S-1 improve disease-free survival (DFS) compared to follow-up observation after standard treatment for resected high-risk pancreatic cancer?\n* Does S-1 maintenance therapy improve overall survival (OS), distant disease-free survival (DDFS), and local recurrence-free survival (LRFS) compared to observation?\n* What are the safety and tolerability profiles of S-1 maintenance therapy compared to observation? Researchers will compare two groups: the S-1 maintenance therapy group and the observation-only group, to see if S-1 improves survival outcomes and safety.\n\nParticipants will:\n\n* Receive maintenance chemotherapy with S-1 based on body surface area dosing or be assigned to the observation group without drug intervention.\n* Undergo imaging evaluations every 12 weeks to monitor for disease recurrence or metastasis.\n* Report side effects and any adverse events during the study.",[66,67,68],"Pancreatic Cancer","Postoperative Adjuvant Therapy","Maintenance Therapy",[68,22],"NOT_YET_RECRUITING","2025-04-02",{"date":73,"type":74},"2025-04-03","ACTUAL",{"date":76,"type":60},"2025-07",{"date":78,"type":60},"2028-07",{"name":5,"class":6},1]