[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551578":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":35,"locations":45,"responsibleParty":65,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":11,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Serplulimab Combined with Thymalfasin and SOX","EXPERIMENTAL",null,[13,14,15,16],"Drug: Serplulimab","Drug: thymalfasin","Drug: Oxaliplatin","Drug: Tegafur",[18,23,27,31],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Serplulimab","300 mg, i.v., D1, Q3W",[9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"thymalfasin","4.8mg,sc,biw",[9],{"type":19,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Oxaliplatin","130 mg\u002Fm2, i.v., D1, Q3W",[9],{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Tegafur","oral administration: body surface area \\\u003C 1.25, 40 mg each time; body surface area ≥ 1.25 to \\\u003C 1.5, 50 mg each time; body surface area ≥ 1.5, 60 mg each time, twice daily for each treatment cycle at D1-D14",[9],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Hao Xu, MD","CONTACT","+86 13851530117","hxu@njmu.edu.cn",{"name":42,"role":38,"phone":43,"phoneExt":11,"email":44},"Hongda Liu, MD","+86 17521597055","Liuhongda@njmu.edu.cn",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":11,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The First Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":54,"coordinates":55},"Point",[56,57],118.77778,32.06167,{"lat":57,"lon":56},[60,62,64],{"name":61,"role":38,"phone":43,"phoneExt":11,"email":44},"Hongda Liu",{"name":37,"role":63,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"name":61,"role":63,"phone":11,"phoneExt":11,"email":11},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Zekuan Xu","Professor","100551578","phase-2-efficacy-and-safety-of-anti-pd-1-thymalfasin-and-sox-in-neoadjuvant-treatment-of-cstage-iii-gastricgastroesophageal-junction-adenocarcinoma-100551578",false,"NCT06461910","Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric\u002FGastroesophageal Junction Adenocarcinoma","The Efficacy and Safety of Anti-PD-1 Combined With Thymalfasin and SOX in Neoadjuvant Treatment of cStage III Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Open-label, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n* Age and Diagnosis:\n\nPatients aged 18-75 years with gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma, regardless of gender.\n\n* Stage and Diagnosis Confirmation:\n\nAccording to the 8th edition of AJCC staging for gastric cancer, patients must be assessed via abdominal CT as cStage III (cT3-4aN1-3M0).\n\nDiagnosis must be confirmed by endoscopy and pathology as G\u002FGEJ adenocarcinoma (HER-2 negative).\n\nOnly patients with Siewert type III and type II (who do not require combined thoracic surgery) GEJ cancer are eligible.\n\n* Surgical Assessment:\n\nTumors must be deemed resectable with curative intent (R0 resection) as determined by a gastrointestinal surgeon and a radiologist.\n\nPatients must agree to undergo radical surgery and be deemed operable by a surgeon.\n\n* Previous Treatments:\n\nPatients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy.\n\n* Survival Expectancy:\n\nExpected survival of at least 3 months.\n\n* Measurable Disease:\n\nTumors must be measurable according to RECIST v1.1 criteria.\n\n* Performance Status:\n\nECOG PS score of 0-1 within 7 days prior to the first dose.\n\n* Cardiac Function:\n\nGood cardiac function, suitable for curative surgery. Preoperative evaluation by a cardiologist is required if there are clinical indications of underlying ischemic, valvular, or other severe heart diseases.\n\n* Organ Function:\n\nNormal function of major organs, meeting the following laboratory criteria:\n\nAbsolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL without granulocyte colony-stimulating factor for the past 14 days.\n\nPlatelet count ≥ 100 x 10\\^9\u002FL without transfusion for the past 14 days. Hemoglobin \\> 9 g\u002FdL without transfusion or erythropoietin use for the past 14 days.\n\nTotal bilirubin ≤ 1.5 x upper limit of normal (ULN); if \\> 1.5 x ULN, direct bilirubin must be ≤ ULN.\n\nAST and ALT ≤ 2.5 x ULN. Serum creatinine ≤ 1.5 x ULN and creatinine clearance (using Cockcroft-Gault formula) ≥ 60 ml\u002Fmin.\n\nNormal coagulation function (INR or PT ≤ 1.5 x ULN). Normal thyroid function (TSH within normal range, or normal T3\u002FFT3 and FT4 if baseline TSH is out of range).\n\nNormal myocardial enzyme spectrum (clinical judgment for non-significant lab abnormalities is acceptable).\n\n* Weight:\n\nBody weight ≥ 40 kg or BMI \\> 18.5.\n\n* Female Patients:\n\nMust be post-menopausal (no menses for at least one year without other causes) or surgically sterilized (removal of ovaries and\u002For uterus).\n\nWomen of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose.\n\nAgree to use highly effective contraception (annual failure rate \\\u003C 1%) or abstain from heterosexual intercourse from the time of informed consent until at least 120 days after the last dose of the study drug or 9 months after surgery.\n\n* Male Patients:\n\nMust agree to use contraception or abstain from heterosexual intercourse from the time of informed consent until at least 120 days after the last dose of the study drug or 9 months after surgery.\n\nRegular abstinence (e.g., calendar, ovulation, basal body temperature, or post-ovulation methods) and withdrawal are not acceptable forms of contraception.\n\n* Informed Consent:\n\nPatients must read, understand, and sign the informed consent form.\n\nExclusion Criteria:\n\n* Other Malignancies:\n\nPatients with a history of other malignancies within the past 5 years or concurrent malignancies. Exceptions include cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, and stage I colorectal cancer.\n\nTransplant Patients:\n\nPatients planning to undergo or having previously undergone organ or bone marrow transplantation.\n\nBlood Transfusions and Bleeding:\n\nPatients who have received a blood transfusion within 2 weeks before the first dose, have a history of bleeding, or experienced any severe bleeding events (grade 3 or higher per CTCAE 4.0) within 4 weeks before screening.\n\nCoagulation Disorders:\n\nPatients with coagulation abnormalities and bleeding tendencies (INR \\> 1.5 without anticoagulants). Patients on anticoagulants or vitamin K antagonists like warfarin, heparin, or similar drugs can participate if INR ≤ 1.5, small-dose warfarin (1 mg\u002Fday) or aspirin (≤ 100 mg\u002Fday) is allowed for preventive use.\n\nThromboembolic Events:\n\nPatients with arterial\u002Fvenous thromboembolic events within 6 months before screening, such as stroke (including transient ischemic attacks), deep vein thrombosis (excluding cases resolved post-chemotherapy), and pulmonary embolism.\n\nCardiac Conditions:\n\nPatients with myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females, using the Fridericia formula) within 6 months before the first dose.\n\nNYHA class III-IV heart failure or LVEF \\\u003C 50% on echocardiogram.\n\nProteinuria:\n\nUrinalysis indicating proteinuria ≥ ++ and 24-hour urine protein \\> 1.0 g.\n\nOral Drug Absorption Issues:\n\nFactors affecting oral drug absorption (e.g., inability to swallow, chronic diarrhea, bowel obstruction).\n\nPleural or Peritoneal Effusion:\n\nClinically significant pleural or peritoneal effusion requiring intervention.\n\nHIV Infection:\n\nPatients with HIV infection.\n\nActive Tuberculosis:\n\nPatients with active tuberculosis.\n\nNon-Healing Wounds or Fractures:\n\nPatients with long-standing unhealed wounds or incomplete healing of fractures.\n\nLung Diseases:\n\nPatients with interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function that could interfere with the detection and treatment of suspected drug-related pulmonary toxicity.\n\nAutoimmune Diseases:\n\nPatients with known active or suspected autoimmune diseases, except those in a stable state without systemic immunosuppressive treatment.\n\nChronic Autoimmune Diseases:\n\nSevere chronic autoimmune diseases such as systemic lupus erythematosus; patients with a history of ulcerative colitis, Crohn's disease, or irritable bowel syndrome; history of sarcoidosis or tuberculosis; active hepatitis B or C, and HIV infection.\n\nWell-controlled non-severe autoimmune diseases like dermatitis, arthritis, psoriasis can be included. Patients with hepatitis B virus titers \\\u003C 500 copies\u002Fml can participate.\n\nImmunosuppressive Treatment:\n\nPatients requiring systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or other immunosuppressive drugs within 14 days before the first dose or during the study. Localized topical or inhaled steroids or adrenal hormone replacement therapy (≤ 10 mg\u002Fday prednisone equivalent) are allowed.\n\nActive Infections:\n\nActive infections requiring systemic treatment within 14 days before the first dose. Preventive antibiotic treatment (e.g., for urinary tract infection or COPD) is allowed.\n\nLive Vaccines:\n\nPatients who have received live vaccines within 28 days before the first dose. Inactivated viral vaccines for seasonal flu are allowed.\n\nPrevious Checkpoint Inhibitors:\n\nPatients previously treated with checkpoint inhibitors like PD-1, PD-L1, or CTLA-4 inhibitors.\n\nImmunomodulatory Treatments:\n\nPatients who received immunomodulatory treatments (e.g., thymopentin, thymalfasin, interferons, CAR-T therapy) within 6 months before the first dose.\n\nOther Clinical Studies:\n\nPatients currently receiving other clinical study treatments or planning to start this study treatment within one month of completing a previous clinical study treatment.\n\nDrug Allergies:\n\nKnown allergy or intolerance to any study drug or its components.\n\nSubstance Abuse:\n\nHistory of alcohol, drug, or substance abuse. Patients who have stopped drinking can be included.\n\nCompliance Issues:\n\nPatients who are non-compliant with medical instructions, prescribed medications, or have incomplete records affecting efficacy or safety assessments.\n\nPregnancy and Breastfeeding:\n\nPregnant or breastfeeding women.\n\nHigh-Risk Factors:\n\nPatients with conditions increasing the risk of study participation or study drug use, or other severe, acute, or chronic diseases deemed unsuitable by the investigator.\n\nInvestigator Discretion:\n\nAny other conditions that the investigator deems unsuitable for the clinical trial.","ALL","18 Years","75 Years",{"count":80,"type":81},30,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.",[87,88],"Gastric Cancer","Esophagogastric Junction Adenocarcinoma",[90,91,92,93],"neoadjuvant","PD-1","Thymalfasin","Chemotherapy","2026-02-28",{"date":96,"type":97},"2026-03-03","ACTUAL",{"date":99,"type":97},"2024-06-14",{"date":101,"type":81},"2027-12",{"name":67,"class":6},1]