[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-cancer-metastatic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100588144","early-phase-1-cdh17-car-t-therapy-in-advanced-malignant-solid-tumors-100588144",false,"NCT06937567","CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors","Exploratory Study on the Safety and Preliminary Efficacy of UCLH80-1 Cells in Patients With CDH17-Positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Histopathologically confirmed malignant solid tumors, including but not limited to colorectal cancer, gastric cancer, pancreatic cancer, and biliary tract tumors.\n* Patients must have failed standard treatments, be intolerant to standard treatments, or lack effective treatment options.\n* At least one measurable lesion as defined by RECIST v1.1 criteria.\n* Tumor tissue must be available either from prior tumor biopsy or by providing new tumor specimens.\n* Tumor specimens must be confirmed as CDH17-positive by immunohistochemistry (IHC) or immunocytochemistry (ICC) staining.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival time ≥ 3 months.\n* Appropriate organ function: hematological: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹\u002FL. Hemoglobin (HGB) ≥ 80 g\u002FL; Platelet count (PLT) ≥ 75 × 10⁹\u002FL. Liver Function: aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3.0 × ULN (≤ 5.0 × ULN for patients with primary liver tumors or liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for patients with primary liver tumors or liver metastases; ≤ 3 × ULN for Gilbert's syndrome with direct bilirubin ≤ 1.5 × ULN). Coagulation: international normalized ratio (INR) ≤ 1.5 × ULN (unless on therapeutic anticoagulants); activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless on therapeutic anticoagulants). Renal Function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL\u002Fmin (based on Cockcroft-Gault formula). Cardiac Function: left ventricular ejection fraction (LVEF) ≥ 50% (confirmed by echocardiography). Pulmonary Function: resting oxygen saturation (SpO₂) \\> 92% without supplemental oxygen.\n* Female participants of childbearing potential must have a negative pregnancy test.\n* Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use effective contraception during the study and for 1 year after the final cell infusion.\n* Willingness to sign the informed consent form, demonstrating understanding of the study and agreement to comply with study procedures.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding.\n* Positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) with peripheral HBV DNA levels above the lower limit of detection.\n* Positive hepatitis C virus (HCV) antibody with peripheral HCV RNA levels above the lower limit of detection.\n* Positive HIV antibody.\n* Positive syphilis-specific and non-specific antibody tests.\n* Non-hematological toxicity from prior treatment (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has not resolved to ≤ CTCAE grade 1 (except for hair loss and peripheral sensory neuropathy).\n* Prior allogeneic tissue or organ transplant (including bone marrow, stem cell, liver, kidney, etc.), except for transplants not requiring immunosuppression (e.g., corneal or hair transplantation).\n* Patients who have previously received CDH17 CAR-T therapy, except those who received CAR-T infusion within this study.\n* Underwent major surgery within 4 weeks prior to signing informed consent and has not fully recovered, or has a history of serious unresolved trauma.\n* Known central nervous system (CNS) metastases (with exceptions for asymptomatic brain metastases or stable clinical symptoms).\n* Severe active infections or pulmonary diseases requiring systemic corticosteroid treatment within 6 months prior to signing informed consent.\n* Symptomatic congestive heart failure (NYHA class II-IV), severe aortic stenosis, or symptomatic mitral stenosis.\n* ECG showing QTc \\> 450 ms or QTc \\> 480 ms with bundle branch block.\n* Uncontrolled hypertension (SBP ≥ 160 mmHg and\u002For DBP ≥ 100 mmHg).\n* Cerebrovascular accidents within 6 months prior to signing informed consent.\n* Active, chronic, or recurrent severe autoimmune diseases requiring immunosuppressive treatment (with exceptions).\n* Any form of primary or secondary immunodeficiency.\n* Risk of organ perforation or bleeding as judged by the investigator.\n* Severe systemic hypersensitivity reactions to study drugs\u002Fcomponents. - Received live attenuated vaccines within 4 weeks prior to signing informed consent.\n* Participated in another clinical study within 4 weeks prior to signing informed consent.\n* History of another malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer or in situ cancers.\n* Diagnosed with neuropsychiatric disorders or any condition deemed by the investigator as unsuitable for participation.","ALL","18 Years","70 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity.\n\nThis study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.",[27,28,29,30,31],"Biliary Tract Cancer","Colorectal Carcinoma","Gastric Cancer, Metastatic","Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)","Multiple Cancer",[33,34],"CAR-T","CDH17","RECRUITING","2026-05-20",{"date":38,"type":39},"2026-05-26","ACTUAL",{"date":41,"type":39},"2024-12-26",{"date":43,"type":21},"2028-05-30",{"name":45,"class":46},"Zhejiang University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100632078","phase-1-phase-12-window-of-opportunity-study-of-trop2-caril-15-tgfbr2-ko-nk-cells-delivered-intraperitoneally-for-the-management-of-gastric-cancer-metastatic-to-the-peritoneum-100632078","NCT07509008","Phase 1\u002F2 Window Of Opportunity Study Of TROP2 CAR\u002FIL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Management Of Gastric Cancer Metastatic To The Peritoneum","Inclusion Criteria:\n\n1. Subjects must be 18 years or older. Because no dosing or adverse event data are currently available on the use of CAR NK cells in combination with our standard of care approaches of cytoreductive surgery with intraperitoneal chemotherapy in patients \\\u003C18 years of age, children are excluded from this study.\n2. Subjects must be willing and able to provide informed consent.\n3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. A female participant is eligible to participate if at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR\n   2. A WOCBP who agrees to follow the contraceptive guidelines in Appendix 1 during the treatment period and for at least 3 months after the last dose of study treatment.\n5. Subjects must have histology confirming diagnosis of adenocarcinoma of the stomach or gastroesophageal junction with pathology reviewed at MD Anderson Cancer Center.\n6. Subjects must have histology confirming diagnosis of Stage IV adenocarcinoma of the stomach or gastroesophageal junction metastatic to the peritoneum based on either positive cytology (peritoneal washings\u002Fascites) or peritoneal biopsy, with pathology reviewed at MD Anderson Cancer Center. Ovarian metastases are considered peritoneal metastases. Disease outside the peritoneal cavity is allowed as long as metastases are present within the peritoneal cavity.\n7. Subjects must be at least 4 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Zolbetuximab may be continued during the peritoneal-directed treatment and NK cell therapy.\n8. Subjects must be willing and able to undergo a minimally invasive staging cytoreductive surgery with intraperitoneal port placement and scheduled peritoneal fluid and peripheral blood draws.\n9. Subjects must have adequate organ function as defined in the following table (Table 1).\n\nSpecimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 3 months after the last dose of trial treatment. WOCBP must have a negative serum pregnancy test within 72 hours of admission prior to lymphodepleting chemotherapy (see Appendix 1).\n2. Has received systemic anti-cancer therapy including investigational agents within 4 weeks of starting lymphodepleting chemotherapy.\n3. If a participant received previous systemic or targeted therapy, immunotherapy, or major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment. In patients receiving standard of care zolbetuximab, this therapy may be continued.\n4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n6. Is currently receiving another investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n7. Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n9. Active autoimmune disease that has required systemic treatment in the past 2 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n10. History of interstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n11. Serious active infection, as determined by Principal Investigator or treating physician, requiring intravenous systemic therapy.\n12. Known history of uncontrolled Human Immunodeficiency Virus (HIV) infection. Patients with HIV infection and undetectable viral load may participate.\n13. Known history of chronic Hepatitis B or Hepatitis C virus infection.\n14. Known history of active TB (Bacillus Tuberculosis).\n15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n16. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n17. Has had an allogenic tissue\u002Fsolid organ transplant.\n18. Clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular event, or cardiac arrhythmia associated with hemodynamic instability. Note: medically controlled arrhythmia would be permitted.\n19. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. Subject with known deep vein thrombosis\u002Fpulmonary embolism that are under appropriate anti-coagulation treatment are eligible.\n20. Radiographic distribution of disease that in the investigator's opinion would impart excessive risk to participation in this protocol.\n21. Active peritonitis or diverticulitis.\n22. Medical or surgical history that in the treating physician's opinion would make the subject not a suitable candidate for intraperitoneal therapy. Examples would include surgically documentedextensive intraperitoneal adhesions or large volume ascites.\n23. History of severe hypersensitivity reaction with biologic therapy (e.g. monoclonal antibodies)",{"count":55,"type":21},10,[57,58],"PHASE1","PHASE2","The goal of this clinical research study is to study the recommended dose of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells that can be given intraperitoneally (infused directly into the stomach area) to participants with adenocarcinoma of the stomach that has spread to the peritoneum. The safety and effectiveness of this treatment will also be studied.",[29],"NOT_YET_RECRUITING","2026-04-29",{"date":64,"type":39},"2026-05-05",{"date":66,"type":21},"2026-09-01",{"date":68,"type":21},"2030-07-01",{"name":70,"class":46},"M.D. Anderson Cancer Center",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100537845","phase-2-a-clinical-study-of-biottt001-in-combination-with-sox-and-toripalimab-in-patients-with-gastric-cancer-100537845","NCT06283121","A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer","A Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Combination With SOX and Toripalimab in Patients With Peritoneal Metastases From Gastric Cancer","Inclusion Criteria:\n\n1. Male or female, age≥ 18 years；\n2. Patients with a diagnosis of gastric cancer by histopathology or cytology, accompanied by peritoneal metastasis, without systemic therapy, or for patients who have received neoadjuvant\u002Fadjuvant chemotherapy before, the time from last treatment to disease recurrence \\> 6 months;\n3. Tumor Her2 negative (IHC 0\u002F1＋ or IHC 2＋ and FISH-).\n4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors （RECIST) 1.1;\n5. WBC≥3.0×10\\^9 \u002FL; ANC≥1.5×10\\^9 \u002FL; HB≥90 g\u002FL; PLT≥75×10\\^9 \u002FL;\n6. ALT and AST≤3×ULN (≤5×ULN with liver metastasis); ALB≥20g\u002FL; Cr≤1.5×ULN or CCr\\>50 mL\u002Fmin; TBIL≤1.5×ULN; APTT≤1.5×ULN and INR or PT≤1.5×ULN (without anticoagulation therapy)\n7. LVEF≥50%; male QTc≤450 mms, female QTc≤470 mms;\n8. ECOG 0\\~1；\n9. Expected survival ≥ 3 months;\n10. Consent to contraception；\n11. Understand and voluntarily sign a written ICF and be willing to comply with all trial requirements.\n\nExclusion Criteria:\n\n1. History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration;\n2. Patients with central nervous system metastases with clinical symptoms;\n3. Patients who have been treated with high-dose systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent doses) or other immunosuppressants within 2 weeks before the first dose of BioTTT001;\n4. Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001;\n5. Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 14 days before the first dose of BioTTT001;\n6. Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia );\n7. Patients with primary immunodeficiency;\n8. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia);\n9. Patients with active infection requiring systemic anti-infective therapy;\n10. HBsAg positive, and blood HBV DNA≥100 IU\u002FmL; anti-HCV positive; HIV positive; active syphilis;\n11. Patients with active tuberculosis or drug-induced interstitial lung disease；\n12. Patients with active inflammatory bowel disease ；\n13. NYHA≥ grade 3；\n14. Known allergy to the investigational drug or its components;\n15. Patients with prior organ transplants;\n16. Pregnant or lactating women;\n17. Other reasons judged by the investigator.",{"count":79,"type":21},30,[58],"This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.",[29],[84,85,86,87],"oncolytic virus","IL-12","gastric cancer","peritoneal metastases","2024-02-27",{"date":90,"type":39},"2024-02-29",{"date":92,"type":21},"2024-04-02",{"date":94,"type":21},"2027-11-30",{"name":96,"class":46},"China Medical University, China"]