[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-carcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,50,82,107,132,155,181,203,238,261,281,307,328,354],{"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":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100592628","the-vanguard-study-testing-a-new-way-to-screen-for-cancer-100592628","NCT06995898","The Vanguard Study: Testing a New Way to Screen for Cancer","Inclusion Criteria:\n\n* Ages 45-75 years old\n* Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment\n* Agree to allow collection of information from their medical records for study-related purposes\n* Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic\n\n  * Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion\n\nExclusion Criteria:\n\n* Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years\n\n  * Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible\n* Ongoing cancer diagnostic work-up\n* Ongoing participation in another study of an investigational cancer screening test or technology\n* Currently breastfeeding or pregnant, or planning to become pregnant in the next year","45 Years","75 Years",{"count":59,"type":21},24000,[24],"The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).",[63,64,65,31,32,66,67,68,69,70,71],"Bladder Carcinoma","Breast Carcinoma","Colorectal Carcinoma","Liver Carcinoma","Lung Carcinoma","Malignant Solid Neoplasm","Ovarian Carcinoma","Pancreatic Carcinoma","Prostate Carcinoma","2026-06-30",{"date":38,"type":41},{"date":75,"type":41},"2025-06-18",{"date":77,"type":21},"2029-06-30",{"name":79,"class":80},"National Cancer Institute (NCI)","NIH",38,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100634666","association-between-microplastic-exposure-and-the-pathological-progression-of-gastric-carcinogenesis-100634666","NCT07542652","Association Between Microplastic Exposure and the Pathological Progression of Gastric Carcinogenesis","Association of Microplastic Exposure With Pathological Stages of Gastric Mucosal Carcinogenesis: A Cross-Sectional Study","Inclusion Criteria:\n\n* Aged between 18 and 75 years old, gender is not restricted\n* Having a clear diagnosis result within the recent three months and being diagnosed with chronic non - atrophic gastritis, precancerous lesions of gastric cancer, or gastric cancer for the first time\n* Have clear Helicobacter pylori (Hp) test results\n* Be in normal mental state and able to independently complete the questionnaire survey\n\nExclusion Criteria:\n\n* Patients with a history of malignant tumors in other parts\n* Patients who have previously undergone upper gastrointestinal surgery, chemotherapy, or radiotherapy\n* Patients with severe diseases of major organs such as the heart, lungs liver, and kidneys\n* Patients who are currently receiving psychological intervention or taking psychiatric drugs\n* Pregnant or lactating women\n* Patients with severe missing clinical data or questionnaire information\n* Refusing to sign the informed consent form",{"count":90,"type":21},450,"OBSERVATIONAL","The objective of this clinical trial is to explore the correlation between the level of microplastic exposure and the risk of gastric mucosal carcinogenesis, and to evaluate the strength of its effect as an independent risk factor. The main questions it aims to answer include: Does the level of microplastic exposure increase the risk of gastric mucosal carcinogenesis? Can the correlation between the level of microplastic exposure and gastric mucosal carcinogenesis, as well as the sources of high - risk microplastic exposure, be explored through a questionnaire on external microplastic exposure? Researchers will complete a design structured questionnaire and ask participants to fill it out carefully and truthfully to determine whether the level of microplastic exposure increases the risk of gastric mucosal carcinogenesis.",[32,94,95,96],"Gastritis Chronic","Intestinal Metaplasia","Gastric Precancerous Lesions","2026-04-25",{"date":99,"type":41},"2026-04-30",{"date":101,"type":41},"2026-03-31",{"date":103,"type":21},"2026-12-31",{"name":105,"class":48},"Yongquan Shi",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":131},"100583931","phase-1-a-study-to-test-different-doses-of-bi-765049-in-people-with-advanced-cancer-of-the-colon-rectum-stomach-or-pancreas-100583931","NCT06882746","A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas","A Phase I, Open-label, Non-randomised, Multi-center Dose Escalation Trial of BI 765049 Administered by Parenteral Route in Patients With Advanced, Unresectable, and\u002For Metastatic Colorectal Carcinoma (CRC), Gastric Carcinoma (GC), or Pancreatic Ductal Adenocarcinoma (PDAC) to Determine the MTD and the RP2D and to Determine the Dosing Regimen for Further Development of BI 765049","Inclusion criteria:\n\n* For all patients, signed and dated informed consent form (ICF)2\u002Fmain ICF describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.\n* Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature on the ICFs (ICF1\u002Fscreening ICF and ICF2\u002Fmain ICF).\n* In US: Patients with a histologically or cytologically confirmed diagnosis of colorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductal adenocarcinoma (PDAC).\n* In Europe: Patients with a histologically or cytologically confirmed diagnosis of CRC.\n* Patients with advanced, unresectable, and\u002For metastatic disease. Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Patient with a history of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's and\u002For Medical Monitor's assessment).\n* Previous or concomitant malignancies other than the one treated in this trial within the last 5 years except:\n\n  * Effectively treated non-melanoma skin cancers\n  * Effectively treated carcinoma in situ of the cervix\n  * Effectively treated ductal carcinoma in situ\n  * Other effectively treated malignancy that is considered cured by local treatment\"\n* Patient with known leptomeningeal disease or spinal cord compression due to disease.\n* Patient requiring anticoagulant treatment which cannot be safely interrupted, if medically needed based on the opinion of the Investigator.\n\nFurther exclusion criteria apply.",{"count":115,"type":21},135,[117],"PHASE1","This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists.\n\nThe study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer.\n\nParticipants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment and can tolerate it. Participants in this study also get additional medication before and after treatment with BI 765049 for better tolerability. If participants take this medication at home, they have daily phone visits.\n\nParticipants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within the time from when a person first receives the intended target dose, until one week after they receive it for the second time.",[65,32,120],"Pancreatic Ductal Adenocarcinoma","2026-03-16",{"date":123,"type":41},"2026-03-17",{"date":125,"type":41},"2025-03-28",{"date":127,"type":21},"2027-05-12",{"name":129,"class":130},"Boehringer Ingelheim","INDUSTRY",3,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":16,"sex":17,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":106},"100547457","risk-assessment-evaluation-for-identifying-participants-at-high-risk-for-stomach-cancer-100547457","NCT06408220","Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer","OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 40 years to ≤ 80 years\n* Identify as a racial minority either Asian, Hispanic, or Black American\n* Willingness to:\n\n  * Provide blood samples and undergo upper endoscopy\n\nExclusion Criteria:\n\n* Identify as Non-Hispanic White\n* History of gastric cancer\n* Known premalignant lesions of the stomach\n* History of upper endoscopy within 2 years\n* Women of childbearing potential: Pregnant\u002F nursing\n* An employee who is under the direct\u002Findirect supervision of the principal investigator (PI)\u002Fa coinvestigator\u002Fthe study manager\n* A direct study team member","40 Years","80 Years",{"count":142,"type":21},240,[24],"This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. People with H. pylori infections may be more likely to develop cancer in the stomach. H. pylori breath testing can help identify the presence of H. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. An endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. This allows the doctor to see and look for abnormal areas that may need to be biopsied. Risk assessment including H. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.",[32],"2026-03-11",{"date":148,"type":41},"2026-03-13",{"date":150,"type":41},"2024-06-27",{"date":152,"type":21},"2029-10-09",{"name":154,"class":48},"City of Hope Medical Center",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":163,"targetDuration":165,"studyType":91,"phases":4,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":106},"100603661","the-clinical-significance-of-examining-metastatic-lymph-nodes-in-individual-gastric-mesenteries-in-the-patients-with-gastric-cancer-undergoing-gastrectomy-100603661","NCT07139418","The Clinical Significance of Examining Metastatic Lymph Nodes in Individual Gastric Mesenteries in the Patients With Gastric Cancer Undergoing Gastrectomy","The Clinical Significance of Examining Metastatic Lymph Nodes in Respective Gastric Mesenteries in the Gastric Cancer Patients Who Received D2 Lymphadenectomy Plus Complete Mesogastric Excision","Inclusion Criteria:\n\n1. Aged older than 18 years and younger than 85 years\n2. Primary gastric adenocarcinoma confirmed by preoperative pathology result\n3. cT2-4aN0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition\n4. Patients who received gastrectomy with D2 lymphadenectomy plus complete mesogastric excision\n5. American Society of Anesthesiologists (ASA) class I, II, or III\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Negative preoperative biopsy\n2. Too late tumour stage or metastasis (cT4b\u002FM1)\n3. BMI\\>30 kg\u002Fm2\n4. Total gastrectomy or proximal gastrectomy\n5. previous neoadjuvant chemotherapy or radiotherapy\n6. Previous upper abdominal surgery\n7. Combined with other malignant diseases\n8. Reject operation","85 Years",{"count":164,"type":21},400,"1 Month","This study aims to examine the predictive value of metastatic gastric mesenteries, which contains metastatic lymph node, in 6 gastric mesenteries; and importantly, to further evaluate the relationship between the number of metastatic gastric mesenteries and prognosis in the gastric cancer patients who received D2+complete mesogastric excision (CME).",[32],[169,170,171,172],"Gastric cancer","Complete mesogastric excision","Gastric mesentery","Lymph node metastasis","2026-03-08",{"date":146,"type":41},{"date":176,"type":41},"2025-10-07",{"date":178,"type":21},"2030-08-30",{"name":180,"class":48},"Jichao Qin",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":106},"100617217","phase-3-a-study-of-disitamab-vedotin-combined-with-trastuzumab-and-tislelizumab-versus-chemotherapy-combined-with-trastuzumab-with-or-without-pembrolizumab-in-her2-high-expression-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100617217","NCT07315750","A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma With HER2-high Expression","Inclusion Criteria:\n\n* Voluntarily consent to participate in the study and sign the informed consent form\n* Expected survival period \\>12 weeks\n* ECOG Performance Status 0 or 1\n* Histologically confirmed unresectable locally advanced or metastatic --gastric\u002Fgastroesophageal junction adenocarcinoma\n* No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant\u002Fadjuvant therapy\n* HER2-high expression\n* At least one assessable lesion according to RECIST v1.1 criteria\n* Adequate organ function\n* Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.\n* Able to understand the study requirements and willing to comply with the study and follow-up procedures\n\nExclusion Criteria:\n\n* Presence of central nervous system (CNS) metastasis and\u002For carcinomatous meningitis\n* Peripheral neuropathy \\> Grade 1\n* Tumor lesions with a tendency to bleed\n* Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption\n* Bone metastases with a risk of paraplegia\n* Past or current interstitial lung disease, or severely impaired lung function\n* Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment\n* Pregnant or breastfeeding women",{"count":189,"type":21},555,[191],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma with HER2-high Expression.",[32],"2026-01-20",{"date":196,"type":41},"2026-01-21",{"date":198,"type":21},"2026-01-01",{"date":200,"type":21},"2030-12-31",{"name":202,"class":130},"RemeGen Co., Ltd.",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":215,"conditions":216,"keywords":225,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":106},"100565717","early-phase-1-pet-imaging-of-two-vartumabs-in-patients-with-solid-tumors-100565717","NCT06645808","PET-imaging of Two Vartumabs in Patients With Solid Tumors","The Safety, Tolerability and Biodistribution of a Single Intravenous Administration of Two Zirconium-89 Labelled Vartumabs (F8scFV or C9scFv) in Patients With Solid Tumors - a Phase 0, Open Label, PET\u002FCT Molecular Imaging Basket Trial","VARTUTRACE","General Inclusion Criteria:\n\n1. Willing to adhere to the prohibitions and restrictions specified in this protocol.\n2. Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol.\n3. Patients aged ≥ 18 years at moment of signing informed consent form.\n4. Life expectancy of \\> 12 weeks.\n5. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n6. BMI ≥ 18.0 and ≤ 35.0 kg\u002Fm2 and weight at least 50 kg and no more than 120 kg at screening.\n7. Overtly healthy based on medical history, physical findings, vital signs, ECG at the time of screening, as judged by the Investigator. Note: one retest of vital functions and ECG is allowed within the screening window.\n8. Adequate liver- and kidney function, defined by the following laboratory results obtained during screening visit:\n\n   * AST, ALT, and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN) as determined by the UMCG laboratory reference values.\n   * Serum bilirubin ≤ 2.0x ULN as determined by the UMCG laboratory reference values. Patients with known Gilbert disease who have serum bilirubin level ≤ 3x ULN may be enrolled.\n   * INR or APTT ≤ 1.5x ULN as determined by the UMCG laboratory reference values. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n   * eGFR (based on plasma-creatinine) = \\>30 mL\u002Fmin.\n   * Serum albumin \\>35 g\u002FL.\n9. No other clinically significant laboratory abnormalities as determined by the investigator. Note: one retest of lab tests is allowed within the screening window.\n10. Female patients should be at least 1 year post-menopausal (amenorrhea \\>12 months and\u002For follicle-stimulating hormone \\>30 mIU\u002FmL) at screening or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation).\n11. Male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control, and must not donate sperm, until 3 months after administration of 89Zr-DFO-N-Suc-scFv (F8 or C9).\n\nMedical inclusion Criteria:\n\nColon Carcinoma:\n\n1. Patients diagnosed with colon carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of colon carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nRectal Carcinoma:\n\n1. Patients diagnosed with rectal carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of rectal carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBone- and soft-tissue sarcoma\n\n1. Patients diagnosed with a bone- or soft-tissue sarcoma stage I-IV, according to AJCC staging for Sarcoma.\n2. Histologically confirmed diagnosis of sarcoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBreast carcinoma\n\n1. Patients diagnosed with breast carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of breast carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nLung Carcinoma:\n\n1. Anticipated diagnosis of Non-Small Cell Lung Carcinoma (NSCLC) stage I-IV, according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)\u002FCT or based on cytology.\n2. Neo-adjuvant treatment according to the standard of care.\n\nHead and Neck Squamous Cell carcinoma (HNSCC):\n\n1. Patients diagnosed with HNSCC of the oral cavity, oropharynx, nasal cavity, nasopharynx, hypopharynx and larynx.\n2. Histologically confirmed diagnosis of HNSCC.\n3. Neo-adjuvant treatment according to the standard of care.\n\nOesophageal and gastric carcinoma:\n\n1. Patients diagnosed with oesophagus carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n2. Patients diagnosed with gastric carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n3. Histologically confirmed diagnosis of oesophageal- or gastric carcinoma.\n4. Neo-adjuvant treatment according to the standard of care.\n\nPancreas carcinoma:\n\n1. Anticipated diagnosis of pancreas carcinoma stage I-IV according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)\u002FCT or based on cytology.\n2. Histologically or cytologically confirmed diagnosis of pancreas carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBladder carcinoma:\n\n1. Patients diagnosed with invasive bladder carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of bladder carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nGlioblastoma:\n\n1. Anticipated diagnosis of a high-grade glioma (glioblastoma, grade 4 according to the WHO classification) based on imaging modalities such as MRI and\u002For CT or a biopsy.\n2. Karnofsky performance status of at least 70%.\n3. Neo-adjuvant treatment according to the standard of care.\n\nGeneral Exclusion Criteria:\n\n1. Behavioral or cognitive impairment or psychiatric disease that, in the investigator's opinion, affects the patient's ability to understand and cooperate with the study protocol.\n2. Insufficient venous access for the study procedures.\n3. Close affiliation with the investigator, e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of surgery or nuclear department of the UMCG,TRACER or affiliates.\n4. Any finding in the medical examinations or medical history giving, in the opinion of the investigator, reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications.\n5. Participation in an interventional clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins and minerals) or medical device.\n\nMedical Exclusion Criteria:\n\n1. The existence of a second concomitant active malignancy or treatment for a second malignancy within 1 year prior to IMP-administration that is not a solid tumor indication included in the VARTUTRACE study, except for localized basal or squamous cell cancer that has been cured at least 90 days before screening.\n2. Cardiac impairment with an estimated LVEF \\\u003C35 % Prolonged QTcF (\\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator.\n3. Any abnormalities in the vital signs of the patient, as judged by the investigator, as a result of which the patient cannot participate. Note: One retest of vital functions is allowed within the screening window.\n4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.\n5. Major surgical procedure other than for the included diagnosis within four weeks before IMP administration. Disease-related procedures, e.g. the placement of a port-a-cath, placement of a drain, ERCP, are allowed.\n6. Current evidence or history of bacterial, viral or fungal infections within 7 days before 89Zr-DFON-Suc-scFv (F8 or C9) administration as judged by the Investigator.\n\n   * T \\> 38.0°C or lab confirmed viral\u002Fbacterial\u002Ffungal infection (PCR) or symptoms suggestive of an infection)\n   * Received oral or IV antibiotics within \\\u003C7 days before administration.\n7. Any planned major surgery within the duration of the study (until follow-up visit) that is not related to the tumor, with the exception of any emergency surgeries.\n8. Prior allogeneic bone marrow transplantation or solid organ transplant.\n9. A history of anaphylaxis, history of allergic reaction(s), known allergy to one of the drugs or excipients administered as part of this study. Mild allergies without angio-edema or treatment need can be acceptable if deemed not of clinical significance (including allergy to animals or mild seasonal hay fever).\n10. Any other diseases, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.",{"count":212,"type":21},32,[214],"EARLY_PHASE1","VARTUTRACE is a first-in-human PET\u002FCT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS).\n\nOncofetal CS are tumor-specific carbohydrate motifs present in proteoglycans and identified by VAR2 Pharmaceuticals as expressed during fetal development. Oncofetal CS reappears in the vast majority of cancers while remaining largely absent from normal tissues.\n\nVAR2 Pharmaceuticals recently developed antibodies specific for oncofetal CS. VARTUTRACE uses two of these as radiolabeled antibody fragments to study biodistribution, tumor accumulation, pharmacodynamics and clearance pathways in a diverse patient population.",[217,30,35,218,219,67,220,31,32,221,63,222,223,224],"Solid Tumor","Osteosarcoma","Chondrosarcoma","Head and Neck Squamous Cell Carcinoma","Pancreas Carcinoma","Glioblastoma","Soft Tissue Sarcoma (STS)","Breast Cancer",[226,227,228],"Basket-trial","Oncology","Solid tumors","2025-12-19",{"date":231,"type":41},"2025-12-29",{"date":233,"type":41},"2024-12-10",{"date":235,"type":21},"2026-09",{"name":237,"class":130},"Var2 Pharmaceuticals",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":246,"targetDuration":165,"studyType":91,"phases":4,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":106},"100572713","exploration-of-lymph-node-metastasis-and-tumor-deposit-in-the-posterior-gastric-mesentery-for-distal-gastric-cancer-100572713","NCT06736847","Exploration of Lymph Node Metastasis and Tumor Deposit in the Posterior Gastric Mesentery for Distal Gastric Cancer","Exploration of Lymph Node Metastasis and Tumor Deposit in the Posterior Gastric Mesentery Following D2 Lymphadenectomy Plus Complete Mesogastric Excision in Patients Who Received Distal Gastrectomy: A Prospective Observational Study","zydgc001","Inclusion Criteria:\n\n1. Aged older than 18 years and younger than 85 years\n2. Primary gastric adenocarcinoma confirmed by preoperative pathology result\n3. cT2-4N0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 7th Edition\n4. Patients who received distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision\n5. American Society of Anesthesiologists (ASA) class I, II, or III\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Negative preoperative biopsy\n2. Too late tumour stage or metastasis (cT4b\u002FM1)\n3. BMI\\>30 kg\u002Fm2\n4. Total gastrectomy or proximal gastrectomy\n5. previous neoadjuvant chemotherapy or radiotherapy\n6. Previous upper abdominal surgery\n7. Combined with other malignant diseases\n8. Reject operation",{"count":247,"type":21},200,"This study aims to evaluate lymph node metastasis and tumor deposit in the posterior gastric mesentery following distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer.",[32],[169,251,252,172],"Lymph node dissection","Posterior gastric mesentery","2025-08-25",{"date":255,"type":41},"2025-09-02",{"date":257,"type":41},"2024-05-01",{"date":259,"type":21},"2027-12-31",{"name":180,"class":48},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":269,"targetDuration":271,"studyType":91,"phases":4,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":280,"locationsCount":106},"100572101","analysis-of-tumor-deposit-at-the-fusion-site-of-the-right-gastric-mesentery-and-left-gastric-mesentery-in-the-patients-with-gastric-cancer-who-received-proximal-gastrectomy-100572101","NCT06728891","Analysis of Tumor Deposit at the Fusion Site of the Right Gastric Mesentery and Left Gastric Mesentery in the Patients With Gastric Cancer Who Received Proximal Gastrectomy","Tumor Deposit at the Fusion Site of the Right Gastric Mesentery and Left Gastric Mesentery in the Patients With Gastric Cancer Who Received Proximal Gastrectomy With D2 Lymphadenectomy Plus Complete Mesogastric Excision for Gastric Cancer: A Prospective Observational Study","zypg001","Inclusion Criteria:\n\n1. Aged older than 18 years and younger than 85 years\n2. Primary gastric adenocarcinoma confirmed by preoperative pathology result\n3. cT2-4aN0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition\n4. Patients undergoing proximal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision\n5. American Society of Anesthesiologists (ASA) class I, II, or III\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Negative preoperative biopsy\n2. Too late tumour stage or metastasis (cT4b\u002FM1)\n3. BMI\\>30 kg\u002Fm2\n4. previous neoadjuvant chemotherapy or radiotherapy\n5. Previous upper abdominal surgery\n6. Combined with other malignant diseases\n7. Reject operation",{"count":270,"type":21},100,"3 Years","This study aims to evaluate the tumor deposit at the fusion site of the right gastric mesentery and left gastric mesentery in the patients with gastric cancer who received proximal gastrectomy.",[32],[169,251,275,276],"Right gastric mesentery","Tumor deposit",{"date":255,"type":41},{"date":257,"type":41},{"date":259,"type":21},{"name":180,"class":48},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":106},"100601312","phase-1-detection-of-upper-gastrointestinal-tumour-depth-and-demarcation-using-systemic-administration-of-indocyanine-green-during-endoscopic-submucosal-dissection-100601312","NCT07108855","Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection","Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection","BRIGHT","Inclusion Criteria:\n\n* Patients with confirmed superficial esophageal and\u002For gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG;\n* Age of 18 years or older;\n* Able to provide written informed consent.\n\nExclusion Criteria (contraindications for indocyanine green):\n\n* Known allergy to indocyanine green;\n* Known allergies to iodine, shellfish and\u002For clams;\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n* Pregnancy or breastfeeding;\n* Hyperthyroidism.\n\n  * Severe liver disease (ascites and cirrhosis).",{"count":290,"type":21},10,[117,292],"PHASE2","Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and\u002For gastric adenocarcinoma (T1)) during ESD.",[31,32],[296,297],"Indocyanine Green (ICG)","Fluorescence Molecular Endoscopy","2025-08-04",{"date":300,"type":41},"2025-08-07",{"date":302,"type":21},"2025-09-01",{"date":304,"type":21},"2027-08-01",{"name":306,"class":48},"University Medical Center Groningen",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":319,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":106},"100588676","phase-3-a-study-of-disitamab-vedotin-combined-with-tislelizumab-and-chemotherapy-versus-tislelizumab-combined-with-chemotherapy-in-her2-low-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100588676","NCT06944496","A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase III, Randomized Trial Comparing RC48 Plus Chemotherapy and Tislelizumab With Tislelizumab Plus Chemotherapy as First-line Treatment in Participants With HER2 Low Advanced Gastric or Gastrioesophageal Junction Adenocarcinoma (RC48-C039)","Inclusion Criteria:\n\n* Voluntarily consent to participate in the study and sign the informed consent form\n* Expected survival period \\>12 weeks\n* ECOG Performance Status 0 or 1\n* Histologically confirmed unresectable locally advanced, metastatic, or recurrent gastric or gastroesophageal junction adenocarcinoma\n* No prior systemic therapy for locally advanced or metastatic gastric cancer\n* HER2-low expression\n* At least one assessable lesion according to RECIST v1.1 criteria\n* Adequate organ function\n* For female subjects: They should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment. A blood pregnancy test must be negative within 7 days before the study medication is administered, and they must not be breastfeeding\n* For male subjects: They should be surgically sterilized or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment\n* Able to understand the study requirements and willing to comply with the study and follow-up procedures\n\nExclusion Criteria:\n\n* Presence of central nervous system (CNS) metastasis and\u002For carcinomatous meningitis\n* Peripheral neuropathy \\> Grade 1\n* Tumor lesions with a tendency to bleed\n* Uncontrolled diarrhea\n* Bone metastases with a risk of paraplegia\n* Past or current interstitial lung disease, or presence of drug-induced pneumonia, radiation pneumonia, or severely impaired lung function\n* Other malignancies within 5 years before the first dose, except for those expected to be cured with treatment (e.g., adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)\n* Pregnant or breastfeeding women",{"count":315,"type":21},616,[191],"The purpose of this study is to evaluate the efficacy and safety of \\*\\*Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX\\*\\* as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.",[32],"NOT_YET_RECRUITING","2025-04-23",{"date":322,"type":41},"2025-04-25",{"date":324,"type":21},"2025-05-15",{"date":326,"type":21},"2030-05-15",{"name":202,"class":130},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":106},"100576987","phase-1-xnw27011-study-of-advanced-solid-tumor-subjects-who-failed-standard-therapies-100576987","NCT06792435","XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.","A Phase I\u002FⅡ, First-in-Human Study of XNW27011 in Patients with Locally Advanced And\u002For Metastatic Solid Tumors","Inclusion Criteria:\n\n* Phase I (Dose Escalation)：\n\n  1. Patients are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.\n  2. Age ≥18 years old when signing the informed consent form.\n  3. Patients with a histologically or cytologically-confirmed, locally advanced or metastatic solid tumor, which has failed on standard therapy or is intolerable to available standard therapy, or there is no available standard therapy for the tumor. The advanced solid tumors include but are not limited to gastric and gastroesophageal junction adenocarcinoma, pancreatic adenocarcinoma, esophageal adenocarcinoma, ovarian cancer, lung cancer, colorectal cancer, andbiliary tract cancer.\n  4. The enrollment is not restricted to patients with tumor expressing CLDN18.2. However patients are required to provide tumor tissue sections for CLDN18.2 expression confirmation.\n  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n  6. Estimated life expectancy \\> 12 weeks.\n  7. At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n  8. Adequate organ function, evidenced by the following laboratory results:\n\n     1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n     2. Platelet count ≥ 100 × 109\u002FL.\n     3. Hemoglobin ≥ 9.0 g\u002FdL.\n     4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).\n     5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN (if liver metastases are present, ≤ 3 × ULN).\n     6. Creatinine clearance (Ccr) ≥60 mL\u002Fminute as calculated using themodified Cockcroft-Gault equation.\n     7. QTc prolongation to ≤480 milliseconds (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT\u002F(RR0.33).\n     8. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.\n  9. Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.\n\n     1. Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause or permanently sterilized (e.g., has undergone bilateral tubal occlusion\u002Fligation, hysterectomy, bilateral oophorectomy, bilateral salpingectomy).\n     2. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \\\u003C1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or a vasectomized partner.\n  10. Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control during the study, and for 180 days after the last dose of study medication. Sexual abstinence, vasectomy, or a condom used with a spermicide are medically acceptable birth control methods for males. Male subjects must agree not to donate sperm for a period of 180 days after the last dose of study treatment.\n\nPHASE Ⅱ (DOSE EXTENSION)：\n\n1. Subjects are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.\n2. Age ≥18 years old when signing the informed consent form.\n3. Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, which have failed on standard therapy, or are intolerable to available standard therapy, or for which there is no available standard therapy.\n\n   Patients are grouped by anatomic locations of solid tumors:\n\n   Group A: gastric adenocarcinoma\u002Fgastroesophageal junction adenocarcinoma. Group B: pancreatic adenocarcinoma. Group C: ovarian cancer. Group D: other cancer including esophagus adenocarcinomas, lung cancer, colorectal cancer, and biliary tract cancer.\n4. Only patients with tumor expressing CLDN 18.2 will be enrolled. The most recently available tumor samples of patients will be examined by IHC at a central laboratory. If no archived tumor samples are available or the archived tumor samples are deemed to be inappropriate for the confirmation of CLDN18.2 expression, a new biopsy must be performed to obtain the tumor sample to confirmation of CLDN18.2 expression.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n6. Estimated life expectancy \\> 12 weeks.\n7. At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n8. Adequate organ function, evidenced by the following laboratory results:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n   2. Platelet count ≥ 100 × 109\u002FL.\n   3. Hemoglobin ≥ 9.0 g\u002FdL.\n   4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5× ULN (if liver metastases are present, ≤ 3 × ULN).\n   6. Creatinine clearance (Ccr) ≥50 mL\u002Fminute as calculated using the modified Cockcroft-Gault equation.\n   7. QTc prolongation to ≤ 480 millisecond (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT\u002F(RR0.33).\n   8. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.\n9. Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study and for at least 180 days following the last dose of study medication.\n\n   1. Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause or permanently sterilized (e.g., has undergone bilateral tubal occlusion\u002Fligation, hysterectomy, bilateral oophorectomy, bilateral salpingectomy).\n   2. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \\\u003C1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or a vasectomized partner.\n10. Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control for 180 days following the last dose of study medication. Sexual abstinence, vasectomy, or a condom used with a spermicide are medically acceptable birth control methods for males. Male subjects must agree not to donate sperm for a period of 180 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* PHASE I (DOSE ESCALATION)：\n\n  1. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.\n  2. Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any excipient in the XNW27011 formulation.\n  3. Having any of the following medical conditions in the past or at present:\n\n     1. Acquired or congenital immunodeficiency diseases or organ transplantation.\n     2. Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade Ⅲ or IV heart failure, uncontrollable hypertension (Systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg at rest).\n     3. Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the tests, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung fibrosis, kidney failure, and uncontrolled diabetes(HbA1c\\>8%).\n     4. History of or currently suffering from uncontrolled primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.\n     5. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of the XNW27011.\n     6. Past or current mental illness that is difficult to control.\n     7. Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection. Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.\n     8. Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.\n     9. Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.\n     10. Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).\n  4. History of treatment:\n\n     1. Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.\n     2. Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapy or biological therapy,) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor medicinal herb or proprietary Chinese traditional medicines within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks.\n     3. Received major surgical or interventional treatment within 4 weeks prior to the first dose of XNW27011, with the exception of tumor biopsy, puncture, etc.\n     4. Received systemic steroid therapy for a long period of time (≥20 mg of prednisone\u002Fday or equivalent for \\>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the first dose of XNW27011 can be selected).\n     5. Received live vaccines within 4 weeks prior to the first dose of XNW27011 or plan to take any live vaccine during the study period.\n     6. Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.\n  5. Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female patients who underwent hysterectomy, bilateral tubal occlusion\u002F ligation, bilateral salpingectomy, or bilateral oophorectomy in the past, or women with resection or amenorrhea ≥12 months).\n  6. Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator. PHASE Ⅱ (DOSE EXTENSION)：\n\n  \u003C!-- -->\n\n  1. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.\n  2. Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any excipient in the XNW27011 formulation.\n  3. Having any of the following medical conditions in the past or present:\n\n     1. Acquired or congenital immunodeficiency diseases or organ transplantation.\n     2. Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade Ⅲ or IV heart failure, uncontrollable hypertension (Systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg at rest).\n     3. Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the study, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung fibrosis, kidney failure, and uncontrolled diabetes (HbA1c\\>8%).\n     4. Previously or currently suffering from uncontrollable primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.\n     5. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of XNW27011.\n     6. Past or current mental illness that is difficult to control.\n     7. Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection.\n\n        Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.\n     8. Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.\n     9. Has multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated.\n     10. Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.\n     11. Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).\n  4. History of treatment:\n\n     1. Patients who have previously been treated with ADCs or CAR-T targeting CLDN18.2, or participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.\n     2. Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapyor biological therapy) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor medicinal herb or proprietary Chinese traditional medicines within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks.\n     3. Have received major surgical or interventional treatment within 4 weeks prior to the first dose of XNW27011, with the exception for tumor biopsy, puncture, etc.\n     4. Received systemic steroid therapy for a long period of time (≥20 mg of prednisone\u002Fday or equivalent for \\>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the first dose of XNW27011 can be selected).\n     5. Received live vaccines within 4 weeks prior to the first dose of XNW27011or planned to take any live vaccine during the study period.\n     6. Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.\n  5. Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female patients who underwent hysterectomy, bilateral tubal occlusion\u002Fligation, bilateral salpingectomy, or bilateral oophorectomy in the past and women with resection or amenorrhea ≥12 months).\n  6. Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator.",{"count":142,"type":21},[117,292],"This is a global, multi-center, open-label, Phase I\u002FII first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and\u002For metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions. The study consists of 2 parts: Part 1 is the dose-escalation phase (Phase I), and Part 2 is the does-expansion phase (Phase II). In phase I part of the study, approximately 42 patients with locally advanced and\u002For metastatic solid tumors will be enrolled, irrespective of CLDN18.2 expression. However, the most recently available tumor tissue specimen will be collected (if available) for a retrospective CLDN18.2 expression confirmation. In phase II part of the study, only patients with confirmed CLDN18.2 expression by IHC in the central laboratory will be enrolled.The phase II part of the study will consist of the following four groups，Up to three dose cohorts for each patient group are planned currently. Each dose cohort will include approximately 20 patients. Approximately 240 patients evaluable will be enrolled in Phase Ⅱ part of the study.",[339,340,341,342,343,32,344],"Pancreatic Adenocarcinoma Metastatic","Lung Cancer (NSCLC)","Ovarian Cancer","Colorectal Cancer Metastatic","Biliary Tract Cancer","Gastroesophageal Junction Adenocarcinoma","2025-02-05",{"date":347,"type":41},"2025-02-07",{"date":349,"type":41},"2023-07-27",{"date":351,"type":21},"2025-12-31",{"name":353,"class":130},"Evopoint Biosciences Inc.",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":271,"studyType":91,"phases":4,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":374,"locationsCount":106},"100570087","the-correlation-between-blood-concentration-of-sintilimab-and-efficacy-and-adverse-reactions-in-patients-with-advanced-gastric-cancer-100570087","NCT06702683","The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer","Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer","Inclusion Criteria:\n\nA. Patients who were diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; B. Patients who plan to be treated with Sintilimab; C.ECOG score of 0-2; D. Expected survival ≥3 months; E. The patient who have good compliance, follow-up, and can cooperate with relevant treatment and examination; F. Agree to participate in the study and sign the informed consent\n\nExclusion Criteria:\n\nA. Patients who clinical information and data are incomplete; B. Patients who treated with immune checkpoint inhibitors within 6 months",{"count":362,"type":21},112,"Compared with other anti-tumor drugs, immune checkpoint inhibitors (ICIs) have their own unique pharmacokinetics (PK) and pharmacodynamics (PD), and affect patient clinical outcomes. However, at present, the data on the PK and PD characteristics of ICIs in the Chinese population are still lacking, thus further clinical trials are needed to verify them. At the same time, a large proportion of patients have no response to ICIs or the efficacy is poor, and even bring greater side effects, so it is particularly important to find effective biomarkers to predict the efficacy and adverse reactions of patients with ICIs treatment.The purpose of this study is to explore the correlation between blood concentration of Sintilimab and related predictors with efficacy and adverse reactions in patients with advanced gastric cancer so as to provide clinical reference for individualized treatment of patients with gastric cancer.",[32,365,366,367],"Gastric Neoplasm","Gastric (cardia, Body) Cancer","Gastric Cancer Adenocarcinoma Metastatic","2024-11-21",{"date":370,"type":41},"2024-11-25",{"date":372,"type":41},"2023-02-17",{"date":351,"type":21},{"name":375,"class":48},"Lin Liu"]