[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pathologic-stage-iv-gastric-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pathologic-stage-iv-gastric-cancer-ajcc-v8":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,66],{"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":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100387804","phase-1-pipac-for-the-treatment-of-peritoneal-carcinomatosis-in-patients-with-ovarian-uterine-appendiceal-colorectal-or-gastric-cancer-100387804",false,"NCT04329494","PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer","Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC\n* Prior IP chemotherapy is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3\n* Platelets \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 9 g\u002Fdl\n* Serum total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to have chronic liver disease (hepatitis) in which case AST and ALT must be =\\\u003C 5 x ULN\n* Alkaline phosphatase =\\\u003C 2 x ULN\n* Serum creatinine (sCr) =\\\u003C 1.5 x ULN, or creatinine clearance (Ccr) \\>= 40 ml\u002Fmin as calculated by the Cockcroft-Gault formula\n* No contraindications for a laparoscopy\n* The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy\n* Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is define as:\n\n  * Amenorrhea \\>= 12 consecutive months without another cause or\n  * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL\n  * Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential\n* INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:\n\n  * PIPAC access is feasible\n  * There is room for aerosol therapy\n  * There is no evidence of impending bowel obstruction\n  * =\\\u003C 5 L of ascites\n  * Not a candidate for cytoreduction and HIPEC\n\nExclusion Criteria:\n\n* Gastric and colorectal\u002Fappendiceal:\n\n  * Extra-peritoneal metastatic disease\n* Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones\n* Arm 2 (colorectal\u002Fappendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency\n* Arm 2 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds\n* Arm 2 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 2 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 2 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 2 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 2 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 2 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 2 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 2 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 2 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 2 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 2 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Progression on first- AND second-line systemic therapy\n* Arm 3 (colorectal\u002Fappendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Intolerance to prior 5-FU at 2400mg\u002Fm\\^2 IV every 2 weeks or to irinotecan at 180mg\u002Fm\\^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of \\> 1 week due to toxicity\n* Arm 3 (colorectal\u002Fappendiceal): Known DPD deficiency\n* Arm 3 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 3 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 3 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 3 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 3 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 3 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 3 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 3 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 3 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 3 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 3 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy","ALL","18 Years",{"count":19,"type":20},49,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and\u002For to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Malignant Uterine Neoplasm","Metastatic Appendix Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Malignant Neoplasm in the Peritoneum","Metastatic Malignant Solid Neoplasm","Metastatic Ovarian Carcinoma","Pathologic Stage IV Gastric Cancer AJCC v8","Peritoneal Carcinomatosis","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Stage IV Appendix Carcinoma AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Appendix Carcinoma AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Appendix Carcinoma AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Stage IVC Appendix Carcinoma AJCC v8","Stage IVC Colorectal Cancer AJCC v8","RECRUITING","2026-08-19",{"date":56,"type":57},"2026-08-20","ACTUAL",{"date":59,"type":57},"2020-08-21",{"date":61,"type":20},"2028-01-05",{"name":63,"class":64},"City of Hope Medical Center","OTHER",3,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":5},"100379539","radiation-therapy-for-the-treatment-of-metastatic-gastrointestinal-cancers-100379539","NCT04221893","Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers","Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)","Inclusion Criteria:\n\n1. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).\n2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.\n3. Patients must have at least one metastasis which is progressing as per RECIST criteria.\n4. Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:\n\n   * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea\n   * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise\n5. Evaluation by a radiation oncologist within 28 days of study registration.\n6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.\n7. Age \\>= 18 years.\n8. Life expectancy exceeding 6 months.\n9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \\>= 50.\n10. Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation therapy. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration.\n\n    a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.\n2. Administration of radiation therapy within 4 weeks prior to study enrollment.\n3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.\n4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.",{"count":74,"type":20},28,[76],"NA","This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.",[79,80,81,82,83,84,85,86,87,88,89,90,91,31,92,32,93,94,95,96,97,36,98,99,100,101,102,103,38,104,105,106,107,108,109,110,111,40,112,44,113,48,114,52],"Stage IV Esophageal Adenocarcinoma","Stage IV Esophageal Squamous Cell Carcinoma","Stage IV Gastric Cancer","Stage IV Adenocarcinoma of the Gastroesophageal Junction","Stage IVA Esophageal Adenocarcinoma","Stage IVA Esophageal Squamous Cell Carcinoma","Stage IVA Gastric Cancer","Stage IVA Adenocarcinoma of the Gastroesophageal Junction","Stage IVB Esophageal Adenocarcinoma","Stage IVB Esophageal Squamous Cell Carcinoma","Stage IVB Gastric Cancer","Stage IVB Gastroesophageal Junction Adenocarcinoma","Metastatic Anal Canal Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Digestive System Neoplasm","Metastatic Small Intestinal Carcinoma","Pancreatobiliary Carcinoma","Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Stage IV Anal Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","2026-08-12",{"date":117,"type":57},"2026-08-14",{"date":119,"type":57},"2020-08-07",{"date":121,"type":20},"2028-04-30",{"name":123,"class":64},"University of California, San Francisco"]