[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":47},"100516305","phase-2-safety-and-efficacy-of-pd-1--mfolfox6-neoadjuvant-therapy-in-local-advanced-smpcc-100516305","NCT06002789","Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC","Safety and Efficacy of PD-1 Monoclonal Antibody With or Without mFOLFOX6 Neoadjuvant Therapy in Patients With Local Advanced Deficient Mismatch Repair\u002FMicrosatellite Instability-high Synchronous Multiple Primary Colorectal Cancer (sMPCC)","Inclusion Criteria:\n\n1. Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);\n2. Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and PMS2; or at least one tumor lesion identified MSI-H by polymerase chain reaction or next-generation sequencing technique;\n3. Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI;\n4. Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI;\n5. No intestinal obstruction symptom，or obstruction relieved after proximal colostomy;\n6. No colorectal surgery history;\n7. No chemotherapy or radiotherapy history;\n8. No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment;\n9. No endocrinotherapy history restriction;\n10. informed consent assigned.\n\nExclusion Criteria:\n\n1. Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) \\> NYHA grade II;\n2. Severe hypertension not well controlled by drugs;\n3. HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA);\n4. Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen;\n5. Other active clinical severe infection(NCI-CTC AE V5.0);\n6. Outside pelvic distant metastasis evidences;\n7. Dyscrasia, organ dysfunction;\n8. Pelvic or abdominal radiotherapy history;\n9. Epilepsy need treatments(Steroid or anti-epilepsy therapy);\n10. Other malignant tumor history within 5 years;\n11. Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results;\n12. Any active autoimmune disease or autoimmune disease history (including but not restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators);\n13. Any anti-infection vaccine injection 4 weeks before inclusion;\n14. Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\\>10mg\u002Fday prednisolone or equivalent hormone);\n15. Known or suspicious allergy to any study related drugs;\n16. Any unstable state might cause damage to the safety and compliance of patients;\n17. Pregnant or breast feeding women who has ability to have children while without contraception;\n18. Refuse to sign informed consent.","80 Years",{"count":57,"type":21},17,[59],"PHASE2","At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line\u002Ffirst-line treatment of dMMR\u002FMSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum. The recent large-scale, single-center retrospective study of the investigator showed that compared with single primary colorectal cancer (SPCRC)patients, the incidence of dMMR\u002FMSI-H was significantly higher in sMPCC patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors at the same time. There is no standard regimen for this patients so far. This study intends to treat the MSI-H\u002FMSS (dMMR\u002FpMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the guideline, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.",[31,62],"Colorectal Cancer",[64,65,66,67],"Synchronous multiple primary colorectal cancer","PD-1","Neoadjuvant treatment","MSI-H","2026-04-23",{"date":70,"type":39},"2026-04-27",{"date":72,"type":39},"2022-05-01",{"date":74,"type":21},"2028-12-01",{"name":76,"class":46},"Sixth Affiliated Hospital, Sun Yat-sen University"]