[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stomach-cancer-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stomach-cancer-stage-iv":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100598359","phase-2-ivonescimab-in-comb-with-folfox-in-advanced-her2-neg-gea-100598359",false,"NCT07070466","Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA","A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas","Inclusion Criteria:\n\n* Patients must have a pathologically confirmed diagnosis of adenocarcinoma of the esophagus, gastroesophageal junction, stomach. Squamous cell tumors are excluded. Patients with locally tested HER2 positive tumors (HER2+) tumors are excluded.\n* Participants must have disease that can be evaluated radiographically. This includes disease that may be measurable or non-measurable as per RECIST version 1.1.\n* Patients may not have received prior therapy for Stage IV disease. Patients may have received prior adjuvant therapy if more than 6 months have elapsed between the end of adjuvant therapy and registration.\n* Age ≥18 years old. Because there is no dosing or adverse event data for ivonescimab with FOLFOX in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG Performance status of 0-2\n* Participants must meet the following organ and marrow function as defined below:\n\n  1. absolute neutrophil count ≥1,500\u002FmcL\n  2. hemoglobin \\> 9.0 g\u002FdL\n  3. platelets ≥100,000\u002FmcL\n  4. total bilirubin ≤ 1.5x institutional upper limit of normal (ULN). For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN\n  5. AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN. For patients with liver metastases, AST and ALT ≤ 5 × ULN\n  6. Creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL\u002Fmin.\n  7. Urine protein \\\u003C 2+ or 24-hour protein quantification \\\u003C 1.0 grams.\n  8. Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy) This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with brain metastases (active brain metastases) or leptomeningeal disease are not eligible. Patients with treated brain metastases who are off systemic steroids \\> 2 weeks and have documented radiographic stability over 4 weeks since initial brain metastasis diagnosis may be considered in discussion with the overall principal investigator.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* The effects of ivonescimab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception should continue for 9 months from the last dose of any study medication.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 9 months after completion of ivonescimab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with a PD-1 or PD-L1 inhibitor is exclusionary unless this therapy was completed \\> 6 months prior to the time of enrollment as part of adjuvant therapy.\n* Major surgical procedures or serious trauma within 4 weeks prior to enrolment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.\n* Participants who have not recovered from adverse events due to prior adjuvant anti-cancer therapy except for alopecia or peripheral neuropathy grade 1 or less.\n* Participants who are receiving any other investigational agents for this condition are not eligible.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab. Patients with prior oxaliplatin and\u002For 5FU allergic reactions during adjuvant therapy are allowed if they have undergone prior desensitization with allergy and documented tolerance at standard dosing after desensitization.\n* Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with ivonescimab. These potential risks may also apply to other agents used in this study.\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization.\n* Clinically significant hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* History of any grade arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to randomization.\n* Participants with a documented history of impaired wound healing are excluded.\n* Participants with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Participants with uncontrolled intercurrent illness that would interfere with ability to participate in the opinion of the treating investigator.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia).\n* Subjects with any condition requiring systemic treatment with either corticosteroids (\\>2mg daily dexamethasone equivalent) or other immunosuppressive medications within 14 days of treatment. Premedication for hypersensitivity reactions (e.g. to contrast for CT or gadolinium for MRI) is allowed.\n* Active systemic infection requiring intravenous antibiotics or intravenous monoclonal antibody treatments within 7 days of cycle 1 day 1.\n* Participants with a known history of Human Immunodeficiency Virus (HIV) infection are excluded unless they meet all of the following criteria:\n\n  * Stable antiretroviral therapy (ART) for at least 12 weeks prior to enrollment\n  * No history of AIDS-defining conditions.\n  * CD4+ T-cell count ≥ 350 cells\u002Fmm³ at screening\n  * HIV viral load ≤ 50 copies\u002FmL at screening.\n  * No significant comorbidities associated with HIV infection that could interfere with the safety or efficacy of the investigational treatment.\n  * No concurrent use of prohibited medications that may interfere with the study drug or cancer therapy\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed)\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* History of non-infectious pneumonitis requiring therapy within 4 weeks of registration.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.",[26,27,28],"Stomach Cancer Stage IV","Esophagus Cancer","Stomach Cancer",[30,31,32,33],"stomach cancer","esophageal cancer","Phase 2","Immunotherapy","RECRUITING","2026-03-04",{"date":37,"type":38},"2026-03-06","ACTUAL",{"date":40,"type":38},"2025-10-10",{"date":42,"type":20},"2028-09-01",{"name":44,"class":45},"Massachusetts General Hospital","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":136,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"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":55,"type":20},360,[57],"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.",[60,61,62,63,64,65,66,67,68,28,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,26,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,27,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Liver Cancer","Colon Cancer","Biliary Tract 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 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, 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",[137,138,139,140,141],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":144,"type":38},"2026-02-20",{"date":146,"type":38},"2021-10-05",{"date":148,"type":20},"2027-03-16",{"name":150,"class":45},"Cedars-Sinai Medical Center",1]