[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreas-cancer-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreas-cancer-stage-iv":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100645718","phase-1-a-study-of-more-frequent-dosing-of-vcn-01-combined-with-standard-chemotherapy-in-patients-with-newly-diagnosed-metastatic-pancreatic-cancer-100645718",false,"NCT07701486","A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer","A Phase IIa, Single-arm, Single-center, Open Label, Proof-of-concept Trial Evaluating Increased Frequency Dosing of VCN-01 (Zabilugene Almadenorepvec) in Combination With Nab-Paclitaxel\u002FGemcitabine (GnP) in Patients With Newly-Diagnosed Metastatic Pancreatic Cancer","VIRAGE2","Inclusion Criteria:\n\n* Written informed consent obtained prior to initiating any trial-specific procedures or assessments.\n* Male or female patients aged 18 years or over.\n* Patients with histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic (stage IV) at diagnosis and who have not received any treatment for their pancreatic cancer.\n* Patients must be able to receive their first dose of VCN-01 ≤6 weeks after their metastatic pancreatic cancer diagnosis.\n* Patients must have at least one measurable tumor lesion that can be imaged for assessments according to RECIST 1.1.\n* ECOG performance status of 0 or 1 at enrollment.\n* Must be willing to comply with the trial intervention, including prophylactic medications, and procedures.\n* Adequate baseline organ function (hematologic, liver, renal) within the 7 days prior to enrollment:\n\nHematology:\n\n* Leukocytes ≥3.0x103 mcL\n* Absolute neutrophil count ≥1.5x10⁹\u002FL\n* Hemoglobin ≥9 g\u002FdL\n* Platelets ≥100x10⁹\u002FL\n\nCoagulation:\n\n* Prothrombin time or international normalized ratio ≤1x upper limit of normal (ULN)\n* Activated partial thromboplastin time ≤1.2xULN\n\nHepatic:\n\n* Total bilirubin ≤1.5xULN\n* ALT and AST ≤2.5xULN (\\\u003C5xULN is acceptable if liver metastases are present)\n\nRenal:\n\n* Serum creatinine ≤1.5xULN; or,\n* If serum creatinine \\>1.5xULN, an estimated creatinine clearance \\>50 mL\u002Fmin using the Cockcroft and Gault formula\n\nNutritional:\n\n• Serum Albumin ≥30 g\u002FL\n\n\\- Adequate left ventricular ejection fraction (LVEF) ≥ 50% measured by ECHO or MUGA and QT interval corrected by Fridericia (QTcF) assessment ≤ 450 ms for men or ≤ 470 ms for women.\n\nExclusion Criteria:\n\n* Unwillingness to complete the trial procedures for geographic, psychiatric, or social reasons.\n* Patient has previously received treatment for their metastatic pancreatic cancer with surgery, radiotherapy, chemotherapy or investigational therapy; except that:\n* Palliative radiotherapy for pain is permitted;\n* Placement of a biliary stent\u002Ftube is permitted.\n* Patients who, in the opinion of the investigator, have symptoms or signs suggesting clinically unacceptable deterioration during the Screening Period.\n* Active infection or other serious illness or autoimmune disease at the moment of enrollment. Active infection includes:\n\n  • Tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice.\n* Patients with past or resolved TB are eligible to participate.\n\n  • Hepatitis B Virus (HBV; positive HBV surface antigen \\[HBsAg\\] result).\n* HBV carriers (patients positive for HBsAg without an active infection) are not eligible to participate;\n* Patients requiring antiviral medicines for HBV prophylaxis or treatment are not eligible to participate;\n* Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HBsAg) are eligible to participate provided that blood HBV DNA is negative at enrollment.\n\n  • Hepatitis C Virus (HCV; positive HCV Ribonucleic acid \\[RNA\\]).\n* Patients requiring antiviral medicines for HCV prophylaxis or treatment are not eligible to participate;\n* Patients positive for HCV antibody are eligible to participate (only if polymerase chain reaction is negative for HCV RNA).\n\n  * Human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n\nActive infection or other serious illness or autoimmune disease at the moment of enrollment. Active infection includes:\n\n* Tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice.\n\n  \\- Patients with past or resolved TB are eligible to participate.\n* Hepatitis B Virus (HBV; positive HBV surface antigen \\[HBsAg\\] result).\n\n  * HBV carriers (patients positive for HBsAg without an active infection) are not eligible to participate;\n  * Patients requiring antiviral medicines for HBV prophylaxis or treatment are not eligible to participate;\n  * Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HBsAg) are eligible to participate provided that blood HBV DNA is negative at enrollment.\n* Hepatitis C Virus (HCV; positive HCV Ribonucleic acid \\[RNA\\]).\n\n  * Patients requiring antiviral medicines for HCV prophylaxis or treatment are not eligible to participate;\n  * Patients positive for HCV antibody are eligible to participate (only if polymerase chain reaction is negative for HCV RNA).\n* Human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n\n  * Known chronic liver disease (e.g. liver cirrhosis, liver fibrosis, chronic hepatitis); except that:\n  * Patients with fatty liver disease are eligible to participate if their liver transaminases meet inclusion criterion 8.\n  * Concurrent malignant hematologic or solid disease; except that:\n  * Patients with a prior history of cancer are eligible to participate if they are in complete remission from their prior cancer for at least 3 years.\n  * Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.\n  * Patients with untreated brain metastases and\u002For leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage; except that:\n  * Patients with brain metastases with stable symptoms are eligible to participate.\n  * Patients with previous pneumonitis or interstitial lung disease.\n  * Patients with pre-existing sensory neuropathy \\>G1\n  * Clinical evidence of deep vein thrombosis, pulmonary embolism or arterial thromboembolic event during the Screening Period.\n  * Patients with superficial vein thrombosis are eligible to participate.\n  * Patients with uncontrolled coagulopathy.\n  * Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection\u002Finflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical trial due to concerns over safety or potential non-compliance with clinical trial procedures.\n  * A female patient, who is pregnant or lactating.\n  * Female patients of reproductive potential must agree to use a highly effective method of birth control. Male patients must agree to use condoms.\n  * Treatment with live attenuated vaccines in the last 3 weeks before the administration of the IMP.\n  * Treatment with an adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of the IMP.\n  * Treatment with another investigational agent within five of that investigational agent's half-lives prior to the administration of the IMP.\n  * Chronic immunosuppressive therapy; except that:\n  * Inhaled corticosteroids are permitted;\n  * Oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent\u002Fday are permitted;\n  * Dexamethasone up to a maximum dose of 1 mg\u002Fday is permitted.\n  * Known allergy or hypersensitivity to any of the trial-specific interventions or any of their excipients.\n  * Subjects, for whom first line treatment options other than the combination nab-paclitaxel\u002Fgemcitabine are recommended by the investigator.","ALL","18 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to learn if the new administration regimen of VCN-01, given together with the standard chemotherapy drugs gemcitabine and nab-paclitaxel (GnP), is safe and well tolerated. The behaviour of VCN-01 in the organism will be assessed, together with the possible benefits of this administration regimen. This study includes adults with newly diagnosed pancreatic ductal adenocarcinoma (PDAC) that has spread to other parts of the body (stage IV) and who have not received prior treatment for pancreatic cancer.\n\nParticipants will receive three planned doses of VCN-01, given once every 56 days. Each dose of VCN-01 is followed one week later by two cycles of standard chemotherapy with gemcitabine and nab-paclitaxel. Participants will be monitored throughout the study for safety and side effects.",[28,29,30],"Pancreas Cancer, Metastatic","Pancreas Cancer, Stage IV","Ductal Adenocarcinoma of the Pancreas",[32,33,34,35],"VCN-01","mPDAC","gemcitabine","nab-paclitaxel","RECRUITING","2026-07-24",{"date":39,"type":40},"2026-07-27","ACTUAL",{"date":42,"type":21},"2026-08-03",{"date":44,"type":21},"2027-12-01",{"name":46,"class":47},"Theriva Biologics SL","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":140,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":48},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","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","99 Years",{"count":58,"type":21},360,[60],"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.",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,29,28,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"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, 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",[141,142,143,144,145],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":148,"type":40},"2026-02-20",{"date":150,"type":40},"2021-10-05",{"date":152,"type":21},"2027-03-16",{"name":154,"class":155},"Cedars-Sinai Medical Center","OTHER"]