[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhifeng Zhao, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100646999","phase-2-zanidatamab-combined-with-chemotherapy-as-neoadjuvantconversion-therapy-for-her2-positive-ihc-3-or-ihc-2-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-a-phase-ii-open-label-study-100646999",false,"NCT07685704","Zanidatamab Combined With Chemotherapy as Neoadjuvant\u002FConversion Therapy for HER2-Positive (IHC 3+ or IHC 2+) Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Phase II Open-Label Study","A Phase II Open-Label Study Evaluating the Efficacy and Safety of Zanidatamab Combined With Chemotherapy as Neoadjuvant\u002FConversion Therapy in Patients With HER2-Positive (IHC 3+ or IHC 2+) Locally Advanced or Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent (ICF).\n2. Histologically and radiologically (CT\u002FMRI) confirmed gastric or gastroesophageal junction adenocarcinoma.\n\n   * Neoadjuvant cohort: Clinical stage III (cT3-4aN+M0) or locally advanced unresectable (cT4bNany M0) assessed by MDT as not amenable to R0 resection, or technically resectable but with high-risk factors (e.g., bulky nodal fusion, invasion of critical structures).\n   * Conversion cohort: Not amenable to direct surgery (e.g., invasion of adjacent organs or vessels) or with distant metastases, including liver metastases (C-GCLM type I and II), confirmed retroperitoneal lymph node metastases, or other single-organ metastases.\n3. HER2-positive by IHC (3+; or 2+ with FISH testing). No time window restriction on FISH.\n4. Age 18-75 years, male or female.\n5. ECOG performance status 0-1; no contraindication to surgery.\n6. Adequate organ function for successful abdominal surgery.\n7. Life expectancy \\>= 3 months.\n8. Laboratory parameters within 7 days before enrollment:\n\n   1. WBC \\> 4.0 x 10\\^9\u002FL and \\\u003C 15 x 10\\^9\u002FL; ANC \\> 1.5 x 10\\^9\u002FL; Hb \\>= 90 g\u002FL; PLT \\>= 100 x 10\\^9\u002FL.\n   2. Total bilirubin \\\u003C= 1.5 x ULN; AST and ALT \\\u003C= 2.5 x ULN.\n   3. Creatinine \\\u003C= 1.5 x ULN, or CrCl \\> 60 mL\u002Fmin (Cockcroft-Gault).\n   4. No anticoagulation: INR and aPTT \\\u003C= 1.5 x ULN. On stable anticoagulation: maintain stable dose.\n9. Good compliance; able to complete protocol-specified examinations and specimen collection.\n10. Female patients of childbearing potential must agree to contraception from ICF signing through at least 5 months after last dose and refrain from breastfeeding. Male patients must agree to contraception from first dose through at least 7 months after last dose.\n\nExclusion Criteria:\n\n1. Synchronous or metachronous malignancies of other organs, or recurrent disease.\n2. Prior systemic therapy for gastric cancer (neoadjuvant cohort).\n3. History of malignancy within 5 years before screening, except those with \\> 90% 5-year overall survival.\n4. Significant cardiopulmonary dysfunction.\n5. Major surgery within 4 weeks before study treatment initiation, or anticipated major surgery during study period (excluding diagnostic procedures).\n6. Severe infection within 4 weeks before study treatment initiation.\n7. Prior chemotherapy or molecular targeted therapy (neoadjuvant cohort).\n8. Known hypersensitivity to study drugs or excipients, or history of severe allergic reactions to monoclonal antibodies.\n9. Factors affecting oral medication intake (e.g., dysphagia \\>= grade 2, chronic diarrhea).\n10. Significant uncontrolled comorbidities that may affect protocol compliance or interpretation of outcomes.\n11. Pregnancy or breastfeeding, or planning pregnancy during the study.\n12. Diagnosis of immunodeficiency or receiving systemic corticosteroid (\\> 10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 2 weeks before first dose.\n13. Active hepatitis B (HBV DNA \\>= 1 x 10\\^3 copies\u002FmL or \\>= 200 IU\u002FmL), positive anti-HCV, or positive HIV.\n14. Participation in another anti-tumor clinical trial within 28 days before first dose.\n15. Any condition that in the investigator's judgment may lead to premature study termination (e.g., serious illness including psychiatric disorders requiring concomitant treatment, severe laboratory abnormalities, family\u002Fsocial factors affecting subject safety or data collection).\n16. Patient or family refusal to sign informed consent.","ALL","18 Years","75 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase II open-label study to evaluate the efficacy and safety of zanidatamab combined with chemotherapy as neoadjuvant\u002Fconversion therapy in patients with HER2-positive (IHC 3+ or IHC 2+) locally advanced or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma. The study consists of two cohorts: a neoadjuvant cohort (Simon's two-stage design, n=46) for treatment-naive stage III locally advanced disease, and an exploratory conversion cohort for oligometastatic disease. Patients receive zanidatamab (30 mg\u002Fkg Q3W) plus oxaliplatin-based chemotherapy, with or without PD-1 inhibitor (tislelizumab or sintilimab). The primary endpoint is pathological complete response (pCR).",[27,28,29],"Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","HER2-positive Gastric Cancer",[31,32,33,34,35,36,37],"zanidatamab","HER2","neoadjuvant therapy","conversion therapy","gastric cancer","gastroesophageal junction adenocarcinoma","bispecific antibody","NOT_YET_RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-06","ACTUAL",{"date":44,"type":21},"2026-07",{"date":46,"type":21},"2028-12",{"name":48,"class":49},"Zhifeng Zhao, PhD","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100554980","phase-1-evaluation-of-fluoxetine-for-refractory-constipation-with-somatic-symptom-disorder-features-100554980","NCT06506136","Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features","Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Fluoxetine in Patients With Refractory Constipation Exhibiting Somatic Symptom Disorder Features","REFLECT","Participants in this study were recruited from a real-world outpatient constipation patient registry platform, which provides a comprehensive case database to support evidence-based research. Based on the characteristics of the primary target population identified in previous studies of fluoxetine, participants with refractory constipation were selected from the registry according to the following criteria:\n\nAll participants were required to meet the Rome IV diagnostic criteria for functional constipation.Specifically: 1) At least two of the following symptoms must be present during more than 25% of defecations: straining; lumpy or hard stools; sensation of incomplete evacuation; sensation of anorectal obstruction\u002Fblockage; manual maneuvers to facilitate defecation; fewer than three spontaneous bowel movements per week; 2) Loose stools are rarely present without the use of laxatives; 3) The criteria for IBS were not met.\n\nSymptoms must have been present for at least six months prior to diagnosis, with the diagnostic criteria fulfilled during the last three months. Participants who met the diagnostic criteria were further assessed against the inclusion and exclusion criteria outlined below. Patients who did not meet any inclusion criteria or met any exclusion criteria were not recruited.\n\nInclusion criteria\n\n1. Diagnosis of Functional Constipation (FC): Participants must meet the diagnostic criteria for functional constipation according to Rome IV criteria.\n2. Low CSBM Frequency: During the 2-week screening period, participants must experience Complete Spontaneous Bowel Movements (CSBM) ≤ 2 times per week.\n3. Unsatisfactory Previous Treatments: Participants must have been dissatisfied with previous treatments for functional constipation, having undergone at least 3 months of treatment, including laxatives or other prokinetic agents.\n4. Diagnosis of Somatic Symptom Disorder (SSD): Participants must meet the diagnostic criteria for Somatic Symptom Disorder (SSD) according to DSM-5. All participants will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.\n\n   4.1. Criterion A: One or more physical symptoms that cause significant discomfort and\u002For disruption in daily life.\n\n   4.2. Criterion B: At least one of the following: 1) Excessive and persistent thoughts about the severity of symptoms. 2) Persistent high anxiety about health or symptoms. 3) Excessive time and energy spent on health concerns or symptoms.\n\n   4.3. Criterion C: The symptoms have persisted for at least 6 months.\n5. Age Range: Participants must be between the ages of 18 and 60 years.\n6. Not Participating in Other Ongoing Trials: Participants must not be involved in any other clinical trials during the study period.\n7. Informed Consent: Participants must voluntarily agree to participate in the study and sign an informed consent form.\n\nExclusion criteria\n\n1. Organic Diseases: Participants with organic diseases (e.g., tuberculosis, Crohn's disease, tumors, congenital megacolon), endocrine disorders (e.g., hypothyroidism), metabolic diseases (e.g., diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease).\n2. Use of Medications Affecting Bowel Function: Participants who require long-term use of medications that may affect bowel function or induce constipation, such as Parkinson's medications, except for routine laxatives, antidiarrheal agents, and intestinal stimulants. Note: During the trial, participants are only allowed to use the specified emergency medications, and all medication use must be carefully recorded.\n3. Chronic Pain or Substance Abuse: Participants with a history of chronic pain lasting more than 6 months or with a pain score ≥4 (based on the visual analog scale), or a history of substance abuse.\n4. Mental Health Disorders: Participants diagnosed with psychiatric disorders before the study and continuously using psychiatric medications for more than 3 months, or those with a history of using psychiatric medications and\u002For corticosteroids for more than 3 months before the study.\n5. Self-harm or Suicide Risk: Participants with a risk of self-harm or suicide, as assessed by a psychologist, or those requiring psychophysical interventions.\n6. Allergic Reactions or Contraindications to Psychiatric Medications: Participants with a history of allergy to psychiatric medications, including fluoxetine, or those with liver or kidney dysfunction, or any contraindications for fluoxetine, such as prolonged QT interval on ECG.\n7. Pregnant or Breastfeeding Women: Pregnant or breastfeeding women.\n8. Other Malignant or Benign Tumors: Participants with other malignant or benign tumors or autoimmune diseases.\n9. Chronic Diseases Impacting Life Quality: Participants with cardiovascular diseases, clotting disorders (e.g., those on long-term warfarin or heparin therapy), liver or kidney diseases, organ failure, cognitive disorders, aphasia, or any other chronic diseases requiring long-term medication, which may significantly affect their quality of life and the evaluation of treatment outcomes.","60 Years",{"count":61,"type":21},194,[63,24],"PHASE1","The purpose of this randomized, double-blind, placebo-controlled trial is to determine whether fluoxetine is effective and safe for adults with refractory constipation that exhibits Somatic Symptom Disorder (SSD) features-namely, persistent preoccupation with bowel function, heightened perception of defecatory discomfort, and clinically significant somatic symptom burden (PHQ-15 ≥ 10) in the absence of IBS-C abdominal pain criteria.\n\nThe study will address three primary questions:\n\nEfficacy-Bowel Function:\n\n• Does 12 weeks of fluoxetine increase Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency compared with placebo?\n\nEfficacy-Somatic Symptom Burden:\n\n• Does fluoxetine reduce SSD severity, as measured by the Patient Health Questionnaire-15 (PHQ-15) and the Somatic Symptom Scale-8 (SSS-8)?\n\nSafety and Tolerability:\n\n• What adverse events occur during fluoxetine treatment, and how do their incidence and intensity compare with placebo?",[66,67,68],"Refractory Constipation","Somatic Symptom Disorder (DSM-5)","Functional Constipation (FC)",[70,71,72,73],"refractory constipation","fluoxetine","somatic symptom disorder","functional constipation","2025-08-03",{"date":76,"type":42},"2025-08-06",{"date":78,"type":21},"2025-09-01",{"date":80,"type":21},"2027-05-30",{"name":48,"class":49},""]