[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658974":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":16,"armGroups":31,"interventions":41,"overallOfficials":16,"centralContacts":59,"locations":68,"responsibleParty":86,"collaborators":90,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":16,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":16,"studyType":112,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":118,"whyStopped":16,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Anhui Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological Complete Response Rate","Pathological complete response is defined as no viable tumor cells identified in the primary tumor and regional lymph nodes in the surgical resection specimen after neoadjuvant treatment, corresponding to ypT0N0. The pCR rate is defined as the proportion of participants achieving pCR among participants included in the primary efficacy analysis set.","At the time of definitive surgery after completion of neoadjuvant treatment",[14,18,20,22],{"measure":15,"description":16,"timeFrame":17},"Major Pathological Response Rate",null,"At definitive surgery",{"measure":19,"description":16,"timeFrame":17},"Tumor Regression Grade",{"measure":21,"description":16,"timeFrame":17},"Pathological Downstaging Rate",{"measure":23,"description":16,"timeFrame":17},"R0 Resection Rate",{"allocation":25,"interventionModel":26,"interventionModelDescription":16,"primaryPurpose":27,"observationalModel":16,"timePerspective":16,"maskingInfo":28},"NA","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":16,"whoMasked":16},"NONE","This study is designed as a multicenter, prospective, single-arm, exploratory clinical study to evaluate the preliminary efficacy, safety, and clinical feasibility of sintilimab combined with induction chemotherapy, concurrent chemoradiotherapy, and optional consolidation chemotherapy as neoadjuvant treatment in patients with locally advanced gastroesophageal junction cancer. In addition, imaging data obtained before treatment will be collected to develop a radiomics-based predictive model and to explore its predictive value for pathological complete response (pCR) after neoadjuvant treatment.\n\nThe study consists of a screening period, neoadjuvant treatment period, surgical treatment period, and follow-up period. The screening period begins after the participant signs the informed consent form and ends no more than 28 days before the first administration of study treatment. The neoadjuvant treatment period includes an induction treatment phase with sintilimab plus XELOX, a concurrent chemoradiotherapy phase with sintilimab plus capecitabine, and an optional consolidation treatment phase with sintilimab plus XELOX. Whether consolidation treatment is administered will be determined based on the participant's treatment response, recovery from toxicity, nutritional status, surgical feasibility, and multidisciplinary team (MDT) assessment. The neoadjuvant treatment period will continue until completion of the protocol-specified treatment, determination by the MDT that the participant is eligible for surgery, disease progression, occurrence of intolerable toxicity, withdrawal of informed consent, death, or study completion, whichever occurs first. Participants will subsequently enter the surgical treatment period and follow-up period, including safety follow-up and survival follow-up.\n\nAfter signing the informed consent form and being confirmed to meet all eligibility criteria, participants will first receive one cycle of induction therapy with sintilimab plus XELOX. The induction regimen consists of sintilimab 200 mg administered by intravenous infusion on Day 1; oxaliplatin 130 mg\u002Fm² administered by intravenous infusion on Day 1; and capecitabine 1,000 mg\u002Fm² administered orally twice daily on Days 1-14. Each treatment cycle is 21 days.\n\nAfter completion of induction therapy, participants will enter the concurrent chemoradiotherapy phase and receive sintilimab plus capecitabine concurrent with radiotherapy. Intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) will be used. The radiation field will include the primary tumor and regional lymphatic drainage areas, with a total dose of 45 Gy delivered in 25 fractions, five fractions per week over 5 weeks. Concurrent chemotherapy will consist of capecitabine 825 mg\u002Fm² administered orally twice daily on radiotherapy days only as a radiosensitizing agent. Sintilimab 200 mg will be administered by intravenous infusion once every 3 weeks.\n\nAfter completion of concurrent chemoradiotherapy, the investigator will determine whether to administer one cycle of consolidation therapy with sintilimab plus XELOX based on the participant's treatment response, recovery from toxicity, nutritional status, surgical feasibility, and MDT assessment. The consolidation regimen consists of sintilimab 200 mg administered by intravenous infusion on Day 1; oxaliplatin 130 mg\u002Fm² administered by intravenous infusion on Day 1; and capecitabine 1,000 mg\u002Fm² administered orally twice daily on Days 1-14. Each treatment cycle is 21 days. Participants with a favorable treatment response who have already achieved surgical eligibility, as well as those with insufficient recovery from toxicity, poor nutritional status, or a high risk of surgical delay, may not receive consolidation therapy and may proceed directly to preoperative evaluation and surgical preparation.\n\nAfter completion of neoadjuvant treatment, participants will undergo preoperative imaging examinations, gastroscopy and\u002For endoscopic ultrasonography, as appropriate, within the protocol-specified time frame. The treatment response and feasibility of radical surgery will then be assessed by the MDT. Participants who are considered eligible for surgery will, in principle, undergo radical resection of the gastroesophageal junction tumor and regional lymph node dissection within 4-8 weeks after completion of neoadjuvant treatment.\n\nDuring the study, radiological tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). Pathological outcomes will be evaluated based on postoperative pathological examination, including pathological complete response (pCR), major pathological response (MPR), tumor regression grade (TRG), pathological downstaging rate, and R0 resection rate. The primary endpoint of the study is the pathological complete response rate (pCR rate).\n\nAt the same time, pretreatment imaging data will be collected for radiomics analysis. Radiomics features will be extracted from pretreatment imaging data to develop and validate a radiomics-based predictive model for pCR after neoadjuvant treatment. The predictive value of the model for treatment response stratification and its potential role in supporting individualized treatment decisions will be further explored.\n\nFor participants who develop disease progression, intolerable toxicity, or who are considered unsuitable for continued treatment with the original regimen based on MDT assessment, study treatment will be discontinued. The investigator will determine subsequent optimal treatment according to the participant's individual clinical condition. If a participant voluntarily withdraws informed consent, is lost to follow-up, dies, or if the investigator determines that continued participation is not in the participant's best interest, study treatment will be discontinued or the participant will be withdrawn from the study, as appropriate.\n\nSafety monitoring will be performed throughout the treatment period and after completion of study treatment. The investigator will assess adverse events (AEs) according to their severity, onset, and relationship to study treatment and will take appropriate management measures to ensure participant safety. After the last administration of study treatment, each participant will undergo safety follow-up for at least 30 days for AEs and at least 90 days for serious adverse events (SAEs). After completion of surgery and the safety follow-up period, participants will undergo regular survival follow-up according to the protocol. Information regarding disease recurrence, disease progression, death, and subsequent antitumor treatment will be collected to preliminarily evaluate long-term outcomes, including disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS).",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"Neoadjuvant Sintilimab-Based Multimodal Therapy","EXPERIMENTAL","Participants receive one cycle of sintilimab plus XELOX induction therapy, followed by sintilimab plus capecitabine concurrent chemoradiotherapy. After concurrent chemoradiotherapy, one cycle of sintilimab plus XELOX consolidation therapy may be administered according to treatment response, toxicity recovery, nutritional status, surgical feasibility, and multidisciplinary team assessment. Eligible participants subsequently undergo radical surgery.",[37,38,39,40],"Drug: Sintilimab","Drug: Capecitabine","Drug: Oxaliplatin","Radiation: Radiation",[42,47,51,54],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":16},"DRUG","Sintilimab","Oxaliplatin 130 mg\u002Fm² administered by intravenous infusion on Day 1 of a 21-day cycle during induction and optional consolidation XELOX treatment.",[33],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":16},"Capecitabine","During induction and optional consolidation XELOX treatment, capecitabine is administered at 1000 mg\u002Fm² orally twice daily on Days 1-14 of each 21-day cycle. During concurrent chemoradiotherapy, capecitabine is administered at 825 mg\u002Fm² orally twice daily on radiotherapy days as a radiosensitizer.",[33],{"type":43,"name":52,"description":45,"armGroupLabels":53,"otherNames":16},"Oxaliplatin",[33],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":16},"RADIATION","Radiation","Intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) to the primary tumor and regional lymphatic drainage areas, with a total dose of 45 Gy in 25 fractions, administered 5 days per week for 5 weeks.",[33],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":16,"email":64},"qifeng ling","CONTACT","+86 18255573620","2545011827@stu.ahmu.edu.cn",{"name":66,"role":62,"phone":67,"phoneExt":16,"email":16},"yongxiang Li","+86 1361560 1088",[69],{"facility":70,"status":16,"city":71,"state":72,"zip":16,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"The First Affiliated Hospital of Anhui Medical University","Hefei","Anhui","China","CN",{"type":76,"coordinates":77},"Point",[78,79],117.28083,31.86389,{"lat":79,"lon":78},[82],{"name":83,"role":62,"phone":84,"phoneExt":16,"email":85},"beicheng sun","+86 0551 3001","sunbc@ahmu.edu.cn",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Ling qifeng","Medical practitioner",[91,93,95,97],{"name":92,"class":6},"The Second Hospital of Anhui Medical University",{"name":94,"class":6},"Suzhou Municipal Hospital",{"name":96,"class":6},"First Affiliated Hospital of Wannan Medical College",{"name":98,"class":6},"Fuyang people's hospital","100658974","sintilimab-combined-with-chemoradiotherapy-as-neoadjuvant-therapy-for-locally-advanced-gastroesophageal-junction-cancer-100658974",false,"NCT07859410","Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Locally Advanced Gastroesophageal Junction Cancer","A Multicenter Prospective Clinical Study of Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Treatment for Locally Advanced Gastroesophageal Junction Tumors","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of sex, willing to participate in the study and able to provide written informed consent.\n\nHistologically confirmed gastroesophageal junction adenocarcinoma. Tumor classification meeting the definition of Siewert type I, II, or III gastroesophageal junction adenocarcinoma.\n\nLocally advanced, resectable or potentially resectable disease based on baseline imaging, with clinical stage cT2-4aN0-3M0 or cT1N+M0.\n\nNo previous surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy for the current gastroesophageal junction tumor.\n\nMeasurable\u002Fevaluable primary tumor and\u002For regional lymph node lesions on baseline imaging.\n\nConsidered suitable by a multidisciplinary team for sintilimab plus XELOX induction therapy, sintilimab plus capecitabine concurrent chemoradiotherapy, and optional sintilimab plus XELOX consolidation therapy, with the potential to undergo radical surgery.\n\nECOG performance status of 0-1. Adequate major organ function to receive study treatment and subsequent surgery.\n\nAble to understand and comply with the study treatment, assessments, surgery, and follow-up procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients considered unsuitable by the multidisciplinary team for neoadjuvant chemoradiotherapy, immunotherapy, or subsequent radical surgery.\n\nDefinite distant metastasis, peritoneal dissemination, or other M1 disease. Previous surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy for the current gastroesophageal junction tumor.\n\nPrevious radiotherapy to the mediastinum, upper abdomen, or gastroesophageal junction region that may affect radiotherapy administration or safety assessment.\n\nSevere hypersensitivity to sintilimab, oxaliplatin, capecitabine, or related components.\n\nUnhealed gastrointestinal perforation, gastrointestinal fistula, active gastrointestinal bleeding, complete obstruction, or other severe gastrointestinal disease that may substantially increase treatment risk.\n\nActive autoimmune disease or a history of autoimmune disease requiring systemic immunosuppressive treatment that may increase the risk of immunotherapy.\n\nGrade ≥2 peripheral sensory neuropathy at baseline. Uncontrolled serious infection, including active hepatitis B, hepatitis C, HIV infection, or other infection considered clinically significant by the investigator.\n\nSerious cardiovascular or cerebrovascular events within 6 months before enrollment, uncontrolled arrhythmia, or NYHA class III-IV heart failure.\n\nUncontrolled hypertension, severe hepatic or renal dysfunction, severe pulmonary disease, active interstitial lung disease, or other serious underlying disease that may affect treatment or surgical safety.\n\nPregnant or breastfeeding women, or individuals of childbearing potential unwilling to use effective contraception during study treatment and for the protocol-specified period after the last dose.\n\nOther malignancy within the previous 5 years, except specified low-risk malignancies.\n\nPsychiatric disorders, substance abuse, or other conditions that may interfere with informed consent, treatment adherence, or follow-up.\n\nParticipation in another interventional clinical study or any other condition considered inappropriate for study participation by the investigator.","ALL","18 Years","75 Years",{"count":110,"type":111},50,"ESTIMATED","INTERVENTIONAL",[25],"This is a multicenter, prospective, single-arm, open-label exploratory clinical study evaluating sintilimab combined with neoadjuvant chemotherapy, concurrent chemoradiotherapy, and optional consolidation chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma. Eligible participants will receive one cycle of sintilimab plus XELOX induction therapy, followed by sintilimab plus capecitabine concurrent radiotherapy. Optional consolidation with sintilimab plus XELOX may be administered according to treatment response, toxicity recovery, nutritional status, surgical feasibility, and multidisciplinary team assessment. Patients who are considered suitable for surgery will undergo radical resection and regional lymph node dissection. The primary endpoint is pathological complete response rate.",[116],"Gastroesophageal Junction Adenocarcinoma",[116,44,56],"NOT_YET_RECRUITING","2026-09-30",{"date":121,"type":122},"2026-10-05","ACTUAL",{"date":124,"type":111},"2026-10-01",{"date":126,"type":111},"2028-10-01",{"name":5,"class":6},1]