[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-junction-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-junction-carcinoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,101,128,152,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100614772","studying-the-pagoda-algorithm-for-chemotherapy-dose-changes-to-prevent-unplanned-treatment-delays-100614772",false,"NCT07283939","Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays","PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays","Inclusion Criteria:\n\n* \\* REGISTRATION ELIGIBILITY CRITERIA (STEP 1)\n\n  * Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract\n  * Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)\n  * Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin\n  * Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted\n  * The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg\u002Fm\\^2) and infusional 5-FU (2400 mg\u002Fm\\^2\u002F46 hours). Use of the 5-FU bolus is at the discretion of the treating physician\n  * Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible\n  * History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Total bilirubin ≤ 3 x upper limit of normal (ULN)\n  * AST (SGOT)\u002FALT (SGPT) ≤ 5 x upper limit of normal (ULN)\n  * Calc. creatinine clearance ≥ 30 mL\u002Fmin\n  * Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required\n  * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n  * Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration\n  * Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration\n  * Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy\n  * Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II\n  * Patients with a known history of congenital long QT syndrome are ineligible\n  * Patients with known DPD deficiency are ineligible\n* \\* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:\n\n  * The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study\n  * The non-patient participant must be proficient in the English language\n  * The non-patient participant must be age 21 years or older",true,"ALL","18 Years",{"count":20,"type":21},420,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.",[27,28,29,30,31,32,33,34,35,36],"Ampulla of Vater Carcinoma","Appendix Carcinoma","Carcinoma of Unknown Primary With Gastrointestinal Profile","Colon Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Gastroesophageal Junction Carcinoma","Malignant Digestive System Neoplasm","Rectal Carcinoma","Small Intestinal Carcinoma","RECRUITING","2026-07-01",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2026-02-13",{"date":45,"type":21},"2030-05-02",{"name":47,"class":48},"Alliance for Clinical Trials in Oncology","OTHER",344,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\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 and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":58,"type":21},27,[60],"PHASE2","This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[63,64,65,66,67,68,69,70,71,33,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Melanoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":93,"type":41},"2026-05-18",{"date":95,"type":41},"2025-12-18",{"date":97,"type":21},"2026-12-18",{"name":99,"class":48},"Mayo Clinic",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":5},"100626181","phase-2-givastomig-combined-with-nivolumab-and-chemotherapy-in-adults-with-cldn182-positive-metastatic-gastric-cancer-giva-2-100626181","NCT07432295","Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)","A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Treatment-naïve for advanced\u002Fmetastatic disease (prior adjuvant\u002Fneoadjuvant therapy allowed if ≥6 months since last dose).\n* CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).\n* PD-L1 positive (CPS ≥1).\n* At least 1 measurable lesion per RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Adequate organ function, including:\n\n  * Hematologic: WBC ≥2,000\u002FμL; ANC ≥1,500\u002FμL; platelets ≥100,000\u002FμL; hemoglobin ≥9 g\u002FdL\n  * Hepatic: AST\u002FALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)\n  * Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL\u002Fmin\u002F1.73 m²\n* Life expectancy ≥90 days.\n* Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.\n* Willing and able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* HER2-positive tumors.\n* Second malignancy within 3 years, except certain skin or cervical cancers.\n* Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.\n* Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.\n* Active pneumonitis or history requiring steroids\u002Fimmunosuppressive therapy within 3 years.\n* Participation in another therapeutic clinical trial.\n* Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.\n* Radiotherapy within protocol-specified timeframes without adequate recovery.\n* Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).\n* Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA\u002Fstroke, or major cardiac procedures within 6 months).\n* Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).\n* Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.\n* Active infection requiring parenteral therapy.\n* Known hypersensitivity to study drug components (e.g., DPD deficiency).\n* Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.",{"count":109,"type":21},180,[60],"The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and\u002For esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:\n\n* Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?\n* What toxicities do participants experience when taking givastomig?\n\nParticipants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.\n\nUp to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.\n\nParticipants will:\n\n* Visit the study treatment center for infusions and\u002For check-ups and tests every 1-3 weeks\n* Report any changes in their symptoms to their study doctors\n* Have scans to check for any changes in their cancer every 8-12 weeks",[113,114,115,116,33,117],"Solid Tumor","Advanced Cancer","Metastatic Cancer","Gastric Cancer","Esophageal Adenocarcinoma","2026-05-11",{"date":120,"type":41},"2026-05-14",{"date":122,"type":41},"2026-02-11",{"date":124,"type":21},"2030-08",{"name":126,"class":127},"I-Mab Biopharma US Limited","INDUSTRY",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100431646","phase-1-study-of-tj033721-givastomig-in-subjects-with-advanced-or-metastatic-solid-tumors-100431646","NCT04900818","Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors","A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.\n\nPart 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;\n\nPart 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma;\n\nPart 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function\n* Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)\n\nFor dose expansion and Part 2, Part 3, Part 4 Combination subjects:\n\n• Must have CLDN18.2-positive tumor expression\n\nExclusion Criteria\n\n* Prior exposure to CLDN18.2 -targeted therapy\n* Prior exposure to 4-1BB agonists\n* Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ\n* Known active or chronic Hepatitis B or Hepatitis C, other hepatitides\n* Unstable\u002Factive ulcer or digestive tract bleeding within 6 weeks\n* Active autoimmune disease requiring systemic treatment within the past 2 years\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;\n* New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe\u002Funstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months\n* Diagnosis of immunodeficiency such as known active HIV\n* Any active infection requiring parenteral treatment\n\nFor Part 2, 3, 4 Combination subjects:\n\n• Prior treatment with anti-PD-1 or PD-L1 agent",{"count":136,"type":21},330,[138],"PHASE1","This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.",[113,114,115,116,33,117,141,142],"PDAC - Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","2026-03-03",{"date":145,"type":41},"2026-03-05",{"date":147,"type":41},"2021-06-29",{"date":149,"type":21},"2027-12",{"name":126,"class":127},21,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":177},"100482571","phase-2-a-phase-ii-trial-to-evaluate-the-effect-of-itraconazole-on-pathologic-complete-response-rates-in-resectable-esophageal-cancer-100482571","NCT05563766","A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant chemoradiation and curative intent esophagectomy\n* World Health Organization (WHO)\u002FECOG performance status (PS) of 0-2 at enrollment\n* Adequate renal and liver function as judged by the treating physician\n\nExclusion Criteria:\n\n* Inability to provide Informed Consent\n* NYHA class III or IV CHF\n* LFT\\>3X upper limit of normal\n* Drug allergy to itraconazole\n* Positive pregnancy test\n* Those with QTc\\>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant",{"count":159,"type":21},78,[60],"Esophageal cancer, which has a low 5-year overall survival rate (\\\u003C20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.",[117,163,33],"Esophageal Squamous Cell Carcinoma",[165,166],"Itraconazole","Neoadjuvant","2025-11-03",{"date":169,"type":41},"2025-11-05",{"date":171,"type":41},"2024-10-01",{"date":173,"type":21},"2029-06-15",{"name":175,"class":176},"VA Office of Research and Development","FED",7,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":187,"phases":4,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100443825","oracle-observation-of-residual-cancer-with-liquid-biopsy-evaluation-100443825","NCT05059444","ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation","ORACLE","Inclusion Criteria:\n\n* Age \\> 18 years old AND\n* Initial treatment is given with curative\u002Fradical intent AND\n* Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND\n* Provided written informed consent to participate in the study AND\n* Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND\n* Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND\n* Have at least one Landmark blood sample\n\nHave a histologically confirmed Index Cancer that qualifies for inclusion, defined as:\n\nPrimary Study Cohorts\n\n* Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),\n* Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III):\n\nCohort 2A: Resectable OR Cohort 2B: Unresectable,\n\n* Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:\n\nCohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive\u002FHER2-negative invasive breast carcinoma,\n\n* Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,\n* Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),\n* Cohort 6: Gastric adenocarcinoma (stage II-III),\n* Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,\n* Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus cancers),\n* Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology),\n* Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III),\n* Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent)\n\nExploratory Cohort\n\n* Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen\n\nExclusion Criteria:\n\n* History of allogeneic organ or tissue transplant\n* Index cancer has predominantly neuroendocrine histology\n* History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers, and stage I papillary thyroid carcinoma, and participants with bilateral\u002Fmultifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment\n* Known distant metastasis at time of enrollment (with the exception of participants with limited\u002Fresectable stage IV cutaneous melanoma or RCC)",{"count":186,"type":21},2020,"OBSERVATIONAL","The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.",[66,190,191,192,193,194,31,33,195,196,197,198,71,70,88,199],"Ureter Carcinoma","Renal Pelvis Carcinoma","Non-small Cell Lung Cancer","Invasive Breast Carcinoma","Cutaneous Melanoma","Gastric Adenocarcinoma","Pancreatic Adenocarcinoma","Squamous Cell Carcinoma of the Head and Neck","Epithelial Ovarian Carcinoma","Rectal Adenocarcinoma","2025-08-18",{"date":202,"type":41},"2025-08-22",{"date":204,"type":41},"2021-09-07",{"date":206,"type":21},"2029-08",{"name":208,"class":127},"Guardant Health, Inc.",57]