[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542913":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":48,"centralContacts":70,"locations":76,"responsibleParty":93,"collaborators":48,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":48,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":48,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":79,"whyStopped":48,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",[8,16,21,25,28,32,35,39],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction\u002Fgastric adenocarcinoma","EXPERIMENTAL","patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy",[13,14,15],"Radiation: Hypofractionated radiotherapy\u002FSBRT（5-10Gy\u002Ffx，3-5 fx）","Drug: Anti-PD-1 monoclonal antibody","Drug: Oxaliplatin and Capecitabine",{"label":17,"type":18,"description":19,"interventionNames":20},"ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction\u002Fgastric adenocarcinoma","PLACEBO_COMPARATOR","patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy",[13,14,15],{"label":22,"type":10,"description":11,"interventionNames":23},"ARM B: Liver adenocarcinoma",[13,14,24],"Drug: Anti-VEGF 15mg\u002Fkg",{"label":26,"type":18,"description":19,"interventionNames":27},"ARM B*: Liver adenocarcinoma",[13,14,24],{"label":29,"type":10,"description":11,"interventionNames":30},"ARM C: Malignant tumors of the biliary system",[13,14,31],"Drug: Gemcitabine and Cisplatin",{"label":33,"type":18,"description":19,"interventionNames":34},"ARM C*: Malignant tumors of the biliary system",[13,14,31],{"label":36,"type":10,"description":11,"interventionNames":37},"ARM D:Colorectal cancer",[13,14,15,38],"Drug: Anti-VEGF 7.5mg\u002Fkg",{"label":40,"type":18,"description":19,"interventionNames":41},"ARM D*:Colorectal cancer",[13,14,15,38],[43,49,54,58,62,66],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"RADIATION","Hypofractionated radiotherapy\u002FSBRT（5-10Gy\u002Ffx，3-5 fx）","RT: one primary or metastatic focus was selected for hypofractionated radiotherapy\u002FSBRT (5-10 Gy\u002Ffx, 3-5 fx) in each round, the target area included only the GTV of the visible tumor lesion, and the GTV was expanded by 5-10 mm to generate the PTV, and the prophylactic lymphatic drainage area could not be irradiated.",[17,9,26,22,33,29,40,36],null,{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":48},"DRUG","Anti-PD-1 monoclonal antibody","Sintilimab 200mg d1 iv q3w",[17,9,26,22,33,29,40,36],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":48},"Oxaliplatin and Capecitabine","Oxaliplatin130mg\u002Fm2 d1 iv；Capecitabine1000mg\u002Fm2 d1-d14",[17,9,40,36],{"type":50,"name":59,"description":60,"armGroupLabels":61,"otherNames":48},"Anti-VEGF 15mg\u002Fkg","Bevacizumab 15mg\u002Fkg d1 iv q3w",[26,22],{"type":50,"name":63,"description":64,"armGroupLabels":65,"otherNames":48},"Anti-VEGF 7.5mg\u002Fkg","Bevacizumab 7.5mg\u002Fkg d1 iv q3w",[40,36],{"type":50,"name":67,"description":68,"armGroupLabels":69,"otherNames":48},"Gemcitabine and Cisplatin","Gemcitabine1000mg\u002Fm2 d1 d8 iv；Cisplatin 25mg\u002Fm2 d1 d8 iv q3w",[33,29],[71],{"name":72,"role":73,"phone":74,"phoneExt":48,"email":75},"zhu ji","CONTACT","13501978674","zhuji@zjcc.org.cn",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":48,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Zhengjiang Cancer Hospital","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":85,"coordinates":86},"Point",[87,88],120.16142,30.29365,{"lat":88,"lon":87},[91],{"name":92,"role":73,"phone":74,"phoneExt":48,"email":75},"Ji Zhu",{"type":94,"investigatorFullName":92,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"PRINCIPAL_INVESTIGATOR","Professor","100542913","a-randomized-multicenter-phase-ii-basket-study-of-hypofractionated-radiotherapystereotactic-body-radiotherapy-followed-by-immunotherapy-based-systemic-therapy---l-rhamnosus-m9-for-the-first-line-treatment-of-advanced-digestive-system-malignancies-100542913",false,"NCT06349044","A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy\u002FStereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +\u002F- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies.","A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy\u002FStereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +\u002F- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies","Inclusion Criteria:\n\n* histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract (including Her-2 negative adenocarcinoma of the gastroesophageal junction\u002Fgastric adenocarcinoma, hepatocellular carcinoma, malignant tumors of the biliary system, colorectal cancer);\n* advanced patients evaluated as initially non-operable resectable who have not received any antitumor therapy;\n* have at least one measurable or evaluable lesion according to RECIST v1.1 criteria in addition to the primary lesion, with non-operable resectable lymph node metastases to the liver, lung, bone, pelvis, retroperitoneum and\u002For superficial sites (except for brain metastases), as evaluated by discussion in the framework of the MDT\n* age 18-75 years;\n* ECOG score of 0-1;\n* be able to accept the treatment regimen during the study;\n* sign a written informed consent.\n\nExclusion Criteria:\n\n* a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder of clinical severity that, in the judgment of the investigator, may preclude the signing of an informed consent form or interfere with the patient's adherence to oral medication;\n* prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies;\n* clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months;\n* organ transplantation requiring immunosuppressive therapy;\n* a history of other malignant disease within the last five years;\n* persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;\n* Subjects whose baseline blood routine and biochemical indexes do not meet the following criteria: hemoglobin ≥80g\u002FL; absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C1 times the upper limit of normal; and serum creatinine \\\u003C1 times the upper limit of normal. times the upper limit of normal;\n* the patient currently has active gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;\n* persons with active bleeding or bleeding tendencies;\n* women who are pregnant or breastfeeding;\n* allergy to any of the study drug ingredients.","ALL","18 Years","75 Years",{"count":107,"type":108},120,"ESTIMATED","INTERVENTIONAL",[111],"NA","Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors.",[114,115,116,117],"Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction\u002FGastric Adenocarcinoma","Hepatocellular Carcinoma","Biliary Tract Carcinoma","Colorectal Adenocarcinoma",[119,120,121],"radiotherapy","immunotherapy","L. rhamnosus M9","2024-08-22",{"date":124,"type":125},"2024-08-27","ACTUAL",{"date":127,"type":125},"2024-03-20",{"date":129,"type":108},"2025-12-31",{"name":5,"class":6},1]