[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-esophageal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-esophageal-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,97,132],{"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":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100638129","phase-1-bms-986504-in-combination-with-pemetrexed-for-the-treatment-of-metastatic-solid-tumors-with-mtap-deletion-100638129",false,"NCT07594626","BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion","A Phase Ib\u002FII Basket Study of BMS-986504 in Combination With Pemetrexed for Metastatic Solid Tumors With MTAP Deletion","Inclusion Criteria:\n\n* COHORT A (INCLUDING SAFETY RUN IN, STAGE I AND STAGE II) AND COHORT B:\n* Patients must have pathologically or cytologically confirmed metastatic solid tumor of gastrointestinal origin with MTAP deletion including pancreatic cancer, biliary cancer, esophageal cancer and colon cancer (Cohort A) or other metastatic solid malignancy with MTAP deletion (Cohort B) confirmed by validated next generation sequencing tissue techniques only\n\n  * NOTE: Both internal and external validated next generation sequencing (NGS) panels are acceptable\n* Progressive disease (PD) after one previous standard of care line of treatment\n\n  * NOTE: symptoms from clinical evaluation for PD will be sufficient\n* Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, measured preferably by computed tomography (CT) scan\n\n  * Note: Tumor lesions in a previously irradiated area are not considered measurable unless they show unequivocal progression\n  * NOTE: There is no limit on previous treatment lines\n* Patients who have received any neoadjuvant or systemic chemotherapy are eligible\n\n  * Note: treatment cannot have included prior pemetrexed unless in the case of non-small cell lung cancer (NSCLC) cancer type. Any prior intravesical therapy, or immunotherapy is allowed. At least 3 weeks (21 days) wash-out period from treatment since prior chemotherapy or radiation therapy or targeted agent is required\n* Patients must be aged ≥ 18 years\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (growth factor allowed and can be added at the discretion of the treating oncologist\n\n  * Growth factors are excluded from being used during the DLT observation period (cycle 1) unless they are being used to treat a grade 4 adverse event which will be counted as a DLT. If growth factors are being used for grade ≤ 3 toxicity, then patients will not be evaluable for DLT assessment\n* Hemoglobin (Hgb) ≥ 8.5 g\u002FdL (without the need for transfusion within the previous one week)\n* Platelets (PLT) ≥ 100,000\u002FmL (without the need for platelet transfusion within the previous one week)\n* Total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome or liver metastases, who must have a baseline total bilirubin ≤ 3.0 mg\u002FdL\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present\n* Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 using the standard Cockcroft and Gault formula\n* Patients must have the ability to comply with folic acid, vitamin B12 and steroids as directed by study team and as per standard of care for pemetrexed use\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Pemetrexed is known to be teratogenic. Reproductive toxicology studies with MRTX1719 have not been performed. The investigator or designee shall counsel patients of childbearing potential (POCBP) participants and male (as assigned at birth) participants who are sexually active with POCBP on the importance of pregnancy prevention, the implications of an unexpected pregnancy, and the potential of fetal toxicity occurring due to transmission of study intervention present in seminal fluid to a developing fetus, even if the participant has undergone a successful vasectomy or if the partner is pregnant. If needed, participants should be advised to seek advice about egg or sperm donation and cryopreservation of germ cells before treatment\n\n  * Patients of childbearing potential POCBP\n\n    * A POCBP is any patient with an egg-producing reproductive tract who meets the following criteria:\n\n      * Has not undergone a hysterectomy or bilateral oophorectomy\n      * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n    * POCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception. POCBP must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \\\u003C 1% per year) during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer\n    * POCBP participants must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period\n    * Male (as assigned at birth) participants will be required to always use a latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with POCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male (as assigned at birth) participants should continue to use a condom during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer\n    * POCBP partners of male (as assigned at birth) participants should be advised to use a highly effective method of contraception during the intervention period and for at least 6 months after the last dose of study intervention for the male participant, or according to approved local product label requirements for pemetrexed, whichever is longer\n    * Male (as assigned at birth) participants with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer\n    * Male (as assigned at birth) participants must refrain from donating sperm during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer\n    * Breastfeeding partners of male (as assigned at birth) participants should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms\n    * POCBP must have a negative pregnancy test prior to registration on study\n* The ability to interrupt nonsteroidal antiinflammatory drugs (NSAIDS) or aspirin at higher dose (\\> 1.3 g daily) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed\n\nExclusion Criteria:\n\n* STAGE I AND II, COHORT A (INCLUDING SAFETY RUN IN) AND B:\n* Patients who received prior pemetrexed containing chemotherapy (apart from NSCLC)\n* Patients with prior treatment with a PRMT5 or MAT2A inhibitor therapy\n* Patients with pre-existing clinically significant interstitial lung disease (ILD)\n* Patients who have had chemotherapy or radiotherapy ≤ 21 days prior to planned treatment start date.\n\n  * Note: seven days or fewer of palliative radiotherapy for non-CNS disease, is permitted. No wash-out is required\n* 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 and neuropathy per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0\n* Patients who are receiving any other investigational agents or devices. Patients start of study treatment will be based on their discontinuation and recovery from clinically significant adverse events from their most recent therapy or intervention prior to study enrollment\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n  * Ongoing or active infection requiring systemic treatment\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification\n\n  * Note: To be eligible for this trial, patients should be class 2B or better\n* Patients with presence of third space fluid which cannot be controlled by drainage\n\n  * Note: For patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing. However, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy\n* Patients who are not able to understand and voluntarily sign a written informed consent and is not willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures\n* Patients who are pregnant or nursing\n* Patients with history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications\n* Patients with Fridericia's formula-corrected QT interval (QTcF) prolongation \\> 480 msec, except for right bundle branch block, per the investigator's assessment\n* Patients with ongoing need for a medication with a known risk of Torsade's de Pointes that cannot be switched to an alternative treatment prior to study entry\n* Patients with ongoing need for a medication known as a strong inhibitor or strong inducer of cytochrome P450 3A4 (CYP3A4) and\u002For P-glycoprotein (P-gp) or a proton-pump inhibitor and potassium-competitive acid blockers that cannot be switched to an alternative treatment prior to study entry\n\n  * NOTE: The following drug interaction databases and other literature can be utilized to determine the CYP3A4\u002FP-gp inhibitors and inducers\n  * Note: Please consult with the manufacturer for any uncertainties regarding potential CYP3A4 and P-gp modulators\n* Patients with inability to comply with restrictions and prohibited treatments\n* Patients taking any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study within 4 weeks prior to treatment. The concurrent use of any botanical preparation is not permitted while on study\n* Patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration. Please note this lab is not a requirement for eligibility, however, if it has been completed previously as part of the patient's health care, it should be documented for eligibility\n* Patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Please note this lab is not a requirement for eligibility; however if it has been completed previously as part of the patient's health care, it should be documented for eligibility\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Please note this lab is not a requirement for eligibility; however if it has been completed previously as part of the patient's health care, it should be documented for eligibility\n* Patients who take live\u002Fattenuated vaccine received within 30 days of first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction\n* Patient has not received the final dose of any of the following treatments\u002F procedures with the specified minimum intervals before first dose of study drug:\n\n  * Surgery with general anesthesia - within 7 days of first dose of study drug\n  * Surgery with local anesthesia - with 3 days of first dose of study drug","ALL","18 Years",{"count":19,"type":20},72,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase Ib\u002FII trial tests the safety and side effects of BMS-986504 in combination with pemetrexed and how well the combination works in treating patients with solid tumors with MTAP deletion and that has spread from where it first started (primary site) to other places in the body (metastatic). The MTAP gene helps cells recycle important parts needed to make deoxyribonucleic acid (DNA), which is needed for cell growth and function. MTAP deletion means that the MTAP gene is missing. BMS-986504, a PRMT5 inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Giving BMS-986504 in combination with pemetrexed may be safe, tolerable, and\u002For effective in treating patients with metastatic solid tumors with MTAP deletion.",[27,28,29,30,31,32,33,34],"Metastatic Biliary Tract Carcinoma","Metastatic Colon Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Malignant Digestive System Neoplasm","Metastatic Malignant Solid Neoplasm","Metastatic Pancreatic Carcinoma","Stage IV Colon Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","NOT_YET_RECRUITING","2026-05-13",{"date":38,"type":39},"2026-05-19","ACTUAL",{"date":41,"type":20},"2027-12-09",{"date":43,"type":20},"2030-12-09",{"name":45,"class":46},"Northwestern University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100542959","immune-checkpoint-inhibitor-response-in-solid-tumors-using-a-live-tumor-diagnostic-platform-100542959","NCT06349642","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","ELEPHAS-04","Inclusion Criteria:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n* LOCALLY ADVANCED\u002FMETASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",{"count":57,"type":20},324,"OBSERVATIONAL","This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.",[61,62,63,64,65,66,29,67,68,69,31,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"Early Stage Triple-Negative Breast Carcinoma","Metastatic Bladder Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Liver Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Skin Neoplasm","Resectable Lung Non-Small Cell Carcinoma","Early Stage Lung Non-Small Cell Carcinoma","Resectable Malignant Solid Neoplasm","Resectable Triple-Negative Breast Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Recurrent Cervical Carcinoma","Recurrent Colorectal Carcinoma","Recurrent Endometrial Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Liver Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Recurrent Malignant Skin Neoplasm","Recurrent Malignant Solid Neoplasm","RECRUITING","2026-03-11",{"date":89,"type":39},"2026-03-12",{"date":91,"type":39},"2024-04-24",{"date":93,"type":20},"2027-05",{"name":95,"class":46},"Mayo Clinic",3,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":118,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":47},"100493464","phase-2-olanzapine-for-the-management-of-cancer-associated-appetite-loss-in-patients-with-advanced-esophagogastric-hepatopancreaticobiliary-colorectal-or-lung-cancer-100493464","NCT05705492","Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer","ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia","Inclusion Criteria:\n\n* Willingness to provide written informed consent\n* Individuals \\>= 18 years of age\n* Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks of screening\n* Patients with weight loss as defined by international consensus criteria (documented or patient-reported):\n\n  * ≥ 5% weight loss over the past 6 months\n  * ≥ 2% weight loss with body mass index (BMI) \\\u003C20 kg\u002Fm\\^2 or sarcopenia\n* Planned or ongoing first-line palliative antineoplastic therapy (cytotoxic chemotherapy, targeted therapy, immunotherapy, combinations) with or without radiation therapy and have not started the second cycle of first-line palliative antineoplastic therapy. Patients may have received adjuvant antineoplastic therapy at least 6 months prior to screening\n* Able to ambulate independently with or without assistive devices (e.g., cane, walker)\n* In the case of brain metastases, the individual must be asymptomatic or previously treated with a full cycle of therapy with recovery from any acute effects of radiation therapy or surgery before screening. Such individuals must have discontinued corticosteroid treatment and be neurologically stable for at least 4 weeks before screening\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Able and willing to discontinue the use of any drug or over-the-counter (OTC) product that may interact with the study drug (within a period sufficient for wash-out per the principal investigators \\[PI's\\] discretion) and thereafter while on the study\n* Willingness to comply with restrictions on chest\u002Fbreastfeeding\n* Individuals capable of childbearing and contributing viable sperm must be willing to comply with contraception requirements and not donate ova or sperm while on the study and for 1 month after that\n* A negative pregnancy test at baseline (BL) must be obtained for individuals capable of childbearing\n\nExclusion Criteria:\n\n* Plan for, or history of (within 30 days of enrollment), the use of an antipsychotic drug, including, but not limited to, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone. This limitation does not include prochlorperazine and other phenothiazines as antiemetic therapy. The use of antipsychotics concurrent with protocol therapy will not be allowed\n* Current use of medications or supplements with the goal of enhancing appetite within ≥14 days, including:\n\n  * megestrol acetate\n  * cannabinoids (including, but not limited to dronabinol, medical cannabis, over the counter \\[OTC\\] cannabinoid products), and\u002For\n  * Corticosteroids (defined as ≥ 5mg of prednisone \\[or equivalent per day\\]), except for standard-of-care chemotherapy-induced nausea and vomiting prophylaxis\n* Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg\u002FdL or recent hemoglobin A1≥ 8. Individuals with diabetes will undergo hemoglobin A1c (HbA1c) blood testing if they do not have HbA1c results 12 weeks prior to enrollment\n* Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent:\n\n  * Total bilirubin ≥5x upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SPGT\\]) ≥5X ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases)\n  * Primary investigator (PI) discretion will determine continued eligibility after randomization occurs in the event the liver function test results are above the proposed ULN\n  * Renal disease requiring dialysis or calculated glomerular filtration rate (GFR) ≤ 30 mL\u002Fminute\u002F1.73 m\\^2 as calculated by the modification of diet in renal disease (MDRD) equation\n* Tube feeding or parenteral nutrition at the time of screening\n* Any condition that may negatively impact oral absorption of the study drug (including, but not limited to dysphagia, mucositis, gastrectomy, colitis, bowel obstruction, high output ileostomy) or any plan to undergo an intervention that will render such a condition\n* Recurrent ascites unresponsive to medical interventions and requires therapeutic paracentesis\n* Uncontrolled symptoms at randomization make the individual unsuitable for the study in the judgment of the PI. If uncontrolled symptoms can be effectively palliated for ≥1 week prior, enrollment may be considered at the discretion of the PI\n* Uncontrolled infection, including coronavirus disease 2019 (COVID-19), at time of randomization. Individuals with the uncontrolled infection will not be eligible as the symptomology of infection may obscure the outcomes of this study\n* Other medical or psychiatric condition, including recent (within 1 year) or active suicidal ideation\u002Fbehavior or laboratory abnormality, may increase the risk of study participation or, in the PI's judgment, makes the participant inappropriate for the study",{"count":105,"type":20},66,[24],"This phase II trial tests how well olanzapine works in managing cancer cachexia in patients experiencing esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) -associated appetite loss while receiving non-curative cancer therapy. Loss of appetite (\"anorexia\") in the setting of cancer is a key feature of \"cachexia,\" a syndrome associated with loss of weight and muscle as well as weakness and fatigue. Olanzapine is a drug that targets key neurotransmitters (a type of molecule in the central nervous system that transmits messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life (QOL).",[109,110,111,29,112,113,114,115,116,117],"Advanced Malignant Solid Neoplasm","Advanced Biliary Tract Carcinoma","Advanced Esophageal Carcinoma","Locally Advanced Colorectal Carcinoma","Locally Advanced Esophageal Carcinoma","Locally Advanced Gastric Carcinoma","Metastatic Colorectal Carcinoma (mCRC)","Advanced Lung Carcinoma","Locally Advanced Hepatocellular Carcinoma",[119,120,121,122],"cancer","cachexia","weight loss","loss of appetite","2026-01-19",{"date":125,"type":39},"2026-01-21",{"date":127,"type":39},"2024-07-17",{"date":129,"type":20},"2026-12-31",{"name":131,"class":46},"OHSU Knight Cancer Institute",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"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 two metastases which are individually progressing as per RECIST criteria, one of which can be safely unirradiated as adjudicated by the treating radiation oncologist (e.g. lesions for which small increases in dimensions are unlikely to precipitate significant symptoms).\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":140,"type":20},28,[142],"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.",[145,146,147,148,149,150,151,152,153,154,155,156,157,65,29,158,159,160,30,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185],"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 Gastric Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Small Intestinal Carcinoma","Pancreatobiliary Carcinoma","Pathologic Stage IV Gastric Cancer AJCC v8","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 Gastric Cancer 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 Colorectal Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2025-09-30",{"date":188,"type":39},"2025-10-06",{"date":190,"type":39},"2020-08-07",{"date":192,"type":20},"2028-04-30",{"name":194,"class":46},"University of California, San Francisco",2]