[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stomach-cancer-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stomach-cancer-recurrent":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,125],{"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":106,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171",false,"NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","ALL","18 Years","99 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"NA","Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Liver Cancer","Colon Cancer","Biliary Tract Cancer","Stomach Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[107,108,109,110,111],"Virtual Reality","VR","support","GI cancer","cancer pain","RECRUITING","2026-02-18",{"date":115,"type":116},"2026-02-20","ACTUAL",{"date":118,"type":116},"2021-10-05",{"date":120,"type":21},"2027-03-16",{"name":122,"class":123},"Cedars-Sinai Medical Center","OTHER",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":140,"conditions":141,"keywords":147,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":124},"100557029","phase-1-til-therapy-combined-with-pembrolizumab-for-advanced-or-metastatic-refractory-stomach-and-esophageal-cancer-100557029","NCT06532799","TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab (Keytruda) Immunotherapy in Patients With Advanced or Metastatic Refractory Stomach and Esophageal Cancer","BAH250","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Cancer\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to the follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.","16 Years","90 Years",{"count":136,"type":21},75,[138,139],"PHASE1","PHASE2","This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.",[36,59,142,143,144,145,146],"Stomach Cancer, Adenocarcinoma","Esophageal Cancer","Esophageal Cancer Metastatic to Bone","Esophageal Cancer Metastatic to Lung","Esophageal Cancer Metastatic to Liver",[148,149,150,151,152,153,154,155],"CAR-T Cell Therapy","CAR-T","Tumor Infiltrating Lymphocytes","Advanced or Metastatic Refractory","Immunotherapy","TIL","Biological Therapy","Pembrolizumab","2024-11-10",{"date":158,"type":116},"2024-11-12",{"date":160,"type":116},"2024-09-10",{"date":162,"type":21},"2026-12-28",{"name":164,"class":123},"Essen Biotech"]