[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Pudong Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100601095","phase-2-standard-second-line-therapy-with-ongericimab-and-toripalimab-in-pmmrmss-colorectal-cancer-a-single-arm-phase-ii-trial-100601095",false,"NCT07106034","Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR\u002FMSS Colorectal Cancer: a Single-arm Phase II Trial","Clinical Study of Second-Line Standard Therapy Combined With Ongericimab and Toripalimab in Patients With MSS\u002FpMMR Colorectal Cancer Following First-Line Treatment Failure","ONTOP","Inclusion Criteria:\n\n1. Subjects aged 18-75 years (inclusive of 18 and 75 years) at the time of signing the informed consent, regardless of gender.\n2. Histologically confirmed MSS\u002FpMMR colorectal or rectal cancer, who have progressed on first-line fluoropyrimidine - based combination therapy (including progression during maintenance therapy). If FOLFOXIRI was received in the first - line, screening is not allowed; if progression occurred during neoadjuvant\u002Fadjuvant therapy or within 6 months after the last dose, it is considered first-line treatment failure, and the patient is eligible for enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n4. Predicted survival ≥ 12 weeks.\n5. At least 1 measurable lesion according to RECIST 1.1 evaluation criteria.\n6. Adequate organ function；\n7. Female or male subjects with childbearing potential must agree to have no childbearing plans within 6 months after the end of the last dose during the study period and be willing to take highly effective contraceptive measures together with their partners. For female subjects with childbearing potential, the serum pregnancy test must be negative within 7 days before the first dose, and they must be non - lactating.\n8. Be able to provide a signed informed consent form, including complying with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal metastasis; presence of active brain metastasis, defined as untreated and\u002For having clinical symptoms, or requiring glucocorticoids or antiepileptic drugs to control related symptoms. For those who have received local treatments such as surgery or radiotherapy, if the screening - period imaging assessment shows no evidence of progression for at least four weeks and symptoms disappear (except for residual signs or symptoms related to brain metastasis), no glucocorticoid treatment is needed for at least 2 weeks, and the acute toxicities related to previous treatments have recovered, enrollment is allowed.\n2. Presence of pleural effusion, peritoneal effusion, or pericardial effusion with clinical symptoms or requiring repeated management (such as puncture or drainage).\n3. History of immunodeficiency disorders, including positive detection of human immunodeficiency virus (HIV), or known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n4. History of severe cardiovascular diseases, including but not limited to: myocardial infarction within 6 months before the first study drug administration, severe\u002Funstable angina pectoris, congestive heart failure (NYHA heart function class ≥2), severe supraventricular or ventricular arrhythmia, aortic aneurysm requiring surgical repair, any arterial thromboembolic event, grade 3 or above venous thromboembolic event, transient ischemic attack, cerebrovascular accident.\n5. Presence of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first drug administration.\n6. Severe infection within 28 days before the first study drug administration (CTCAE 5.0 ≥ grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active infection requiring intravenous anti-infection treatment or unexplained fever \\> 38.5°C within 2 weeks before the first study drug administration (judged by the researcher; fever caused by the tumor in the subject can be enrolled).\n7. Presence of active tuberculosis, hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive and HBV DNA higher than the lower limit of detection of the research center), hepatitis C (HCV Ab positive and HCV RNA higher than the lower limit of detection of the research center).\n8. History of another primary malignant tumor, except for those who have received radical treatment before the first administration of the study intervention, have no known active disease (for more than 5 years), and have a low potential recurrence risk (such as skin basal cell carcinoma and cutaneous squamous cell carcinoma that have received curative treatment).\n9. The following situations do not allow screening:\n\n   1. Screening period imaging shows that the tumor encircles important blood vessels or has obvious necrosis and cavity, and the researcher deems it may cause bleeding risk;\n   2. Clinical signs or symptoms of intestinal obstruction and\u002For gastrointestinal obstruction within 6 months before the first drug administration, including incomplete obstruction related to the underlying disease;\n   3. Presence of severe, unhealed, or ruptured wounds, active ulcers, or untreated fractures;\n   4. Clinically significant hemoptysis (≥1\u002F2 tea spoon) or tumor bleeding for any reason within 1 month before the first drug administration;\n   5. Presence of poorly controlled hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), or history of hypertensive emergency or hypertensive encephalopathy;\n   6. Other situations judged by the researcher as unsuitable for receiving oral chemotherapy.\n10. Previous antineoplastic treatment toxicity has not recovered to grade 1 specified in CTCAE 5.0 or the level specified in the enrollment\u002Fexclusion criteria. Except for the following situations: if the researcher judges that the related toxicity is well-controlled and does not affect the safety and compliance of the subject using the study drug, screening is allowed.\n11. Previous occurrence of drug-related adverse events leading to permanent drug discontinuation during treatment with bevacizumab and similar drugs.\n12. Received the following drugs or treatments before the first drug administration:\n\n    1. Received chemotherapy, immunotherapy, radiotherapy, and other antineoplastic treatments within 21 days before the first drug administration; received oral fluoropyrimidines, small molecule targeted drugs, antineoplastic vaccines, and intravesical administration (such as BCG for bladder cancer) within 14 days before the first drug administration; started palliative radiotherapy for painful lesions within 7 days before the first drug administration;\n    2. Underwent needle biopsy or other minor surgeries (excluding placement of vascular access devices) within 28 days before the first drug administration;\n    3. Subjects who used systemic corticosteroids (≥10 mg prednisone equivalent per day) or other immunosuppressants for systemic treatment within 2 weeks before the first drug administration; inhalation or local use of corticosteroids or preventive medication (such as for infusion reaction\u002Fhypersensitivity reaction) is allowed;\n    4. Received any live vaccine or attenuated vaccine within 28 days before the first drug administration, or need to receive live vaccines during the study period.\n13. Used antiplatelet therapy or anticoagulant therapy for therapeutic purposes within 10 days before the first drug administration.\n14. Pregnant or lactating women.\n15. Presence of other severe physical or mental diseases or abnormal laboratory examinations, which may increase the risk of participating in the study, affect treatment compliance, or interfere with the study results, and are judged by the researcher as unsuitable for participating in the study.","ALL","18 Years","75 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The ONTOP study is a prospective, single-arm, open-label phase II clinical trial. A total of 32 patients with advanced MSS\u002FpMMR colorectal cancer who have failed first-line treatment will receive second-line standard treatment combined with Ongericimab and toripalimab. Among them, patients who received irinotecan-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFOX. Patients who received oxaliplatin-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFIRI. Treatment will continue until disease progression, initiation of new anti-tumor treatment, active request of the subject, or determination by the investigator that study drug administration needs to be terminated. The primary study endpoint is the objective response rate (ORR), and the secondary study endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety, etc.",[28],"Advanced Colorectal Cancer",[30,31,32,33],"Toripalimab","Ongericimab","colorectal cancer","pMMR\u002FMSS","RECRUITING","2026-06-23",{"date":37,"type":38},"2026-06-26","ACTUAL",{"date":40,"type":38},"2025-08-31",{"date":42,"type":22},"2028-07-31",{"name":44,"class":45},"Shanghai Pudong Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100554599","phase-1-anti-cdh17-car-t-cell-injection-in-patients-with-cdh17-positive-advanced-malignant-solid-tumors-100554599","NCT06501183","Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors","Exploratory Study to Evaluate the Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. 18 to 70 years old (including cut-off value), gender is not limited.\n2. Solid tumors that histological diagnosis of malignancy refractory to, or relapsing after standard therapy, including but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract cancer.\n3. At least one measurable lesion according to RECIST v1.1.\n4. CDH17 should be positive confirmed by Immunohistochemistry\u002FImmunocytochemistry (IHC\u002FICC) in tumor tissue samples.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy ≥ 3 months.\n7. Organ function must meet protocol requirements\n8. Female participants of childbearing potential must undergo a pregnancy test and the results must be negative. Female participants of childbearing potential or male participants whose sex partner has childbearing potential must be willing to use effective methods of contraception from screening period to at least 1 year after infusion.\n9. Participants must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.\n\nExclusion Criteria:\n\n1. Patients have received systemic therapy with cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent; Patients have received systemic glucocorticoids (prednisone at a dose of ≥10 mg per day or equivalent) or other immune-suppressive therapy within 2 weeks prior to signing informed consent; Patients have received systemic antitumor therapy with a biologic agent or other approved targeted small-molecule inhibitor within 1 week or five half-lives (which is shorter) prior to signing informed consent; Patients have received Chinese herbal medicine or Chinese patent medicine with anti-tumor indication within 1 week prior to signing informed consent.\n2. Pregnant or lactating women.\n3. Patients with hepatitis B surface antigen (HBsAg) positive. Patients who is hepatitis B core antibody (HBcAb) positive and the quantification of HBV DNA in peripheral blood is higher than the lower limit of detection. Patients who is hepatitis C virus (HCV) antibody positive and quantification of HCV DNA in peripheral blood is higher than the lower limit of detection. Patients with human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive.\n4. The toxicities caused by the prior therapy (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) have not recovered to grade 1 according to CTCAE, except for hair loss and peripheral sensory nerve disorders.\n5. Have received any allogeneic tissue\u002Forgan transplantation (including bone marrow transplantation, stem cell transplantation, liver transplantation, kidney transplantation), except for the transplantation that does not require immunosuppressive therapy (such as: corneal transplantation, hair transplantation.)\n6. Patients have received anti-CDH17 CAR-T cell therapy.\n7. Patients who have history of major surgery and unrecovered severe trauma within 4 weeks prior to signing informed consent; or plan to have major surgery within 12 weeks of cell therapy.\n8. Presence of known central nervous system metastases, but the following patients will be allowed: a) Asymptomatic brain metastases; b) Clinically stable (no radiographic progression within 4 weeks before apheresis and return of any neurologic symptoms to baseline), and with no need for corticosteroids or other treatment for brain metastases for ≥ 4 weeks.\n9. Patients with clinically significant systemic disease (such as: severe active infection or significant cardiac, pulmonary, hepatic, nervous system, or other organ dysfunction) that evaluated by the investigator would impair the patients' ability to tolerate the treatments used in this study or significantly increase the risk of complications.\n\n   * Uncontrolled severe active infection (sepsis, bacteremia, viremia, etc.);\n   * Lung disease requiring systemic hormone therapy;\n   * Congestive heart failure with New York Heart Association (NYHA) functional class \\> 1;\n   * Clinically significant severe aortic stenosis and symptomatic mitral stenosis;\n   * Electrocardiogram QTc \\> 450 msec or QTc \\> 480 msec in patients with bundle-branch block;\n   * Uncontrolled clinically significant arrhythmia within 6 months prior to signing informed consent;\n   * Acute coronary syndrome (such as: unstable angina, myocardial infarction) within 6 months prior to signing informed consent;\n   * Drug-uncontrolled hypertension (systolic pressure ≥ 160 mmHg and\u002For diastolic pressure ≥ 100 mmHg) or pulmonary hypertension;\n   * Cerebrovascular accident occurred within 6 months prior to signing informed consent, including transient ischemic attack (TIA), cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage;\n   * A history of active, chronic, or recurrent (within 1 year prior to signing informed consent) severe autoimmune disease or immune-mediated disease requiring steroids or other immunosuppressive therapy, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, autoimmune thyroid disease, multiple sclerosis. Exceptions: hypothyroidism that can be controlled only by hormone replacement therapy, skin diseases (such as: vitiligo, psoriasis) that do not require systemic treatment, coeliac disease that has been controlled;\n   * Any form of primary or secondary immunodeficiency, such as severe combined immunodeficiency (SCID);\n   * Possibility of bleeding from esophageal or gastric varices evaluated by the investigator.\n10. History of severe systemic hypersensitivity reaction to the drugs\u002Fingredients \\[fludarabine, cyclophosphamide, dimethyl sulfoxide (DMSO), low molecular dextran, human serum albumin (HSA), etc.\\] used in this study.\n11. Patients have received attenuated vaccine within 4 weeks prior to signing informed consent.\n12. Patients have received other clinical trials within 4 weeks prior to signing informed consent.\n13. History of another malignancy tumor within the previous five years, except for adequately treated non-melanoma skin cancer, carcinoma in situ of bladder, stomach, colon, cervix\u002Fdysplasia, melanoma, or breast.\n14. History of neuropsychiatric diseases diagnosed by the ICD-11 criteria or evaluated by investigator, including but not limited to epilepsy, schizophrenia, dementia, drug and alcohol addictions.\n15. For any other reasons, the patients are believed not suitable for participation in this study by investigators.","70 Years",{"count":56,"type":22},17,[58],"PHASE1","This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-CDH17 CAR-T cell injection in patients with CDH17-positive advanced malignant solid tumors.",[61],"CDH17-positive Advanced Malignant Solid Tumors","2024-07-08",{"date":64,"type":38},"2024-07-15",{"date":62,"type":38},{"date":67,"type":22},"2026-05-30",{"name":44,"class":45},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":46},"100553537","phase-1-ix001-tcr-t-in-the-treatment-of-advanced-pancreatic-cancer-and-colorectal-cancer-induced-by-kras-mutations-100553537","NCT06487377","IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations","A Clinical Study of IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations","Inclusion Criteria:\n\n1. Voluntary signing of an informed consent form (ICF);\n2. Males or females, aged 18-70 years (inclusive);\n3. Pathologically diagnosed with advanced pancreatic cancer or colorectal cancer, having failed or intolerant to at least two lines of standard of care, including metastatic tumors (having received conventional chemotherapy), recurrent tumors (having undergone surgery and adjuvant chemotherapy in the past), or locally advanced tumors with disease progression after neoadjuvant treatment;\n4. At least one measurable lesion (according to RECIST1.1\\[The Response Evaluation Criteria In Solid Tumors\\] criteria);\n5. Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A\\*11, C\\*01:02, or C\\*08:02 subtypes;\n6. ECOG (Eastern Cooperative Oncology Group)≤2;\n7. Life expectancy ≥3 months;\n8. Absolute neutrophil count ≥1×10E9\u002FL;\n9. Platelet count ≥50×10E9\u002FL, hemoglobin\\>90g\u002FdL;\n10. Absolute lymphocyte count ≥0.5×10E9\u002FL;\n11. Adequate functional reserve of organs:\n\n    1. Aspartate aminotransferase ≤2.5×ULN (upper limit of normal);\n    2. Aspartate transaminase ≤2.5×ULN;\n    3. Creatinine clearance ≥60mL\u002Fmin;\n    4. Total serum bilirubin ≤1.5×UNL;\n    5. The subject has left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography;\n    6. No clinically significant electrocardiographic abnormality;\n    7. Basic oxygen saturation is \\>92% under the indoor natural air environment.\n12. Women of childbearing age must be negative for blood HCG (Human Chorionic Gonadotropin) pregnancy test (by immunofluorescence method) at screening and baseline periods, and agree to use effective contraception for at least 1 year after infusion; and male subjects whose partners are women of childbearing age must agree to use effective barrier contraception methods and avoid sperm donation for at least 1 year after infusion. Contraception must include one highly effective and one additional effective (barrier) method, initiated from screening until at least 1 year after IX001 infusion or until two consecutive flow cytometry tests show the absence of TCR-T cells (whichever occurs later).\n\nExclusion Criteria:\n\n1. Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer);\n2. A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;\n3. Poorly controlled hypertension with drug (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>90 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart diseases within one year prior to signing the ICF; QTc interval \\>450 ms for males or QTc interval \\>470 ms for females during screening (QTc interval calculated using the Fridericia formula);\n4. Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, indwelling catheter, bile drainage tube or pleural\u002Fperitoneal\u002Fpericardial catheter), except any dedicated central venous catheter;\n5. A history of or any central nervous system disorders, such as epileptic seizure, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;\n6. A positive result obtained in any of the following virological tests:\n\n   1. Antibody to human immunodeficiency virus (HIV antibody);\n   2. Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA);\n   3. Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) copies;\n   4. Treponema pallidum antibody (TP antibody); patients may be enrolled after additional examinations are performed to exclude active syphilis where necessary;\n7. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration;\n8. Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders;\n9. Patients with a history of severe allergy or allergic constitution;\n10. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive\u002Fsystemic disease-modulating drugs in the past 2 years;\n11. Interstitial lung disease (such as pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases during screening;\n12. History of organ transplantation;\n13. Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis;\n14. Receipt of gene therapy or other cell therapies with the same target within the past 6 months;\n15. Participation in any other clinical trial within 4 weeks prior to signing the informed consent form, or the date of signing the informed consent form still within 5 half-lives of the drug from the last dose in the last clinical trial (whichever is longer);\n16. Patients with poor compliance due to physiological, family, social, geographic and other factors, and failure to follow the study protocol and the follow-up plan;\n17. Patients with contraindications to cyclophosphamide, fludarabine, IL-2, or other drugs related to the study treatment;\n18. Comorbidities requiring treatment with systemic corticosteroids (dexamethasone at a dose of ≥5 mg\u002Fday or other corticosteroids at the equivalent dose) or other immunosuppressive drugs within 12 weeks after the study treatment starts as judged by the investigator;\n19. Women who are breastfeeding and are unwilling to stop breastfeeding;\n20. Any other conditions that are, in the opinion of the investigator, not suitable for enrollment.",{"count":77,"type":22},12,[58],"This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal cancer induced by KRAS (Kirsten Rat Sarcoma Viral Oncogene) mutations. A total of 6-18 evaluable patients are planned to be enrolled. The study will include 4 dose groups, using a '3+3' dose escalation design.",[81,82],"Pancreatic Cancer","Colorectal Cancer",[84],"KRAS-G12V or G12D","2024-07-02",{"date":87,"type":38},"2024-07-05",{"date":89,"type":22},"2024-07",{"date":91,"type":22},"2026-12",{"name":44,"class":45},""]