[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Converd Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100593410","phase-2-recombinant-human-il-21-expressing-oncolytic-vaccinia-virus-injection-hv01-in-advanced-pancreatic-cancer-100593410",false,"NCT07006077","Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer","A Phase II Trial to Evaluate the Efficacy of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Pancreatic Tumors","Inclusion Criteria:\n\n* Signing an informed consent form.\n* Men or women aged 18 to 75 years.\n* Histologically and\u002For cytologically confirmed advanced malignant advanced pancreatic tumors refractory or failed to respond to standard therapy (including disease progression and\u002For intolerable toxicities).\n* At least one measurable lesion according to RECIST v1.1 criteria, which can be injected intratumorally either directly or with the assistance of Endoscopic ultrasound. The baseline longest diameter (shortest diameter for lymph node lesions) of the lesion targeted for injection should be more than 1.5 cm, and the lesion also meets the requirements of the relevant dosing volume.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Required baseline laboratory data include:\n\n  a) Hematology: absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL, platelet (PLT) count ≥ 75×10\\^9\u002FL, hemoglobin (Hb) ≥90 g\u002FL (without supportive therapy within 14 days prior to laboratory test); b) Liver function: serum total bilirubin (TBIL) ≤1.5×ULN (or ≤3×ULN for patients with liver metastasis); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (or\\\u003C5×ULN for patients with primary liver cancer or liver metastasis); c) Renal function: serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance (Cockcroft-Gault method) ≥45 mL\u002Fmin. For men: creatinine clearance = \\[\\[140-age(yr)\\]×weight (kg)\\]\u002F\\[0.818×creatinine (μmol\u002FL)\\]; For women: creatinine clearance = \\[\\[140-age(yr)\\]×weight (kg)×0.85\\]\u002F\\[0.818×creatinine (μmol\u002FL)\\]; d) Coagulation test: activated partial thromboplastin time (APTT) ≤1.5×ULN; international normalized ratio (INR) ≤1.5×ULN.\n* Female patients of childbearing age must have a negative serum pregnancy test. Female patients of childbearing age and male patients whose partners are of childbearing age must agree to use medically approved contraceptive measures (hormonal or barrier methods or abstinence) throughout the treatment period and also within 3 months after the last dose of the investigational drug. Male patients must also avoid sperm donation.\n\nExclusion Criteria:\n\n* Receiving any of the following anti-tumor treatments within a specified time period:\n\n  a) Systemic anti-tumor treatment, including chemotherapy, large-molecule targeted therapy, immunotherapy, and endocrine therapy within 4 weeks before first dose (within 6 weeks of dosing for nitrosourea or mitomycin C); b) Small-molecule targeted therapy within 2 weeks before first dose or within 5 half-lives of the small-molecule targeted drug (whichever is longer); c) Traditional Chinese medicine or Chinese herbal medicine used as anti-tumor agent within 2 weeks before first dose; d) Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose; e) Prior oncolytic virus treatment.\n* Acute toxic effects from prior treatments not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v5.0) grade 1 or below, except for toxicities deemed safe by the investigator, such as alopecia.\n* Patients with clinical symptoms of central nervous system (CNS) metastasis or meningeal metastasis, or other evidence indicating that CNS or meningeal metastases are not controlled.\n* Known or suspected active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and Hashimoto's thyroiditis).\n* History of severe cardiovascular and cerebrovascular diseases, including:\n\n  a) Acute coronary syndrome (including myocardial infarction, severe or unstable angina), myocarditis, congestive heart failure, cerebrovascular accidents, or other cardiovascular events of CTCAE (v5.0) grade 3 or higher within 12 months of dosing; b) Severe arrhythmia requiring clinical intervention (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes), corrected QT interval (QTc) \\>450 ms for males or \\>470 ms for females, or a family history of long QT syndrome; c) New York Heart Association (NYHA) classification of class II or above, or left ventricular ejection fraction (LVEF) \\\u003C50%; d) Uncontrolled hypertension (as judged by the investigator) or hypotension despite standard treatment.\n* Any uncontrolled active infection requiring systemic anti-infective therapy (graded 2 or higher according to CTCAE v5.0), including but not limited to active tuberculosis, sepsis, bacteremia, fungemia, and viremia.\n* Any of the following infections: human immunodeficiency virus (HIV), syphilis spirochete(TP), active hepatitis C (positive HCV RNA test) or active hepatitis B (positive HBsAg and HBV DNA ≥ 2000 IU\u002FmL or ≥10\\^4 copies\u002FmL).\n* Use of immunomodulatory drugs within 2 weeks of dosing, including but not limited to thymosin, interleukin, interferon.\n* Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main goal of this clinical trial is to preliminary evaluate the efficacy of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced pancreatic cancer.And the secondary purpose is to evaluate the safety of hV01.",[27],"Advanced Pancreatic Cancer",[29,30,31,32],"phase Ⅱ","vaccinia virus","IL-21","Pancreatic Tumors","RECRUITING","2026-02-25",{"date":36,"type":37},"2026-02-27","ACTUAL",{"date":39,"type":37},"2025-05-29",{"date":41,"type":21},"2029-03-05",{"name":43,"class":44},"Hangzhou Converd Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100607183","a-study-to-evaluate-combination-therapy-of-oncolytic-vaccinia-virus-hv01-and-pd-1-inhibitor-in-advanced-solid-tumors-100607183","NCT07185243","A Study to Evaluate Combination Therapy of Oncolytic Vaccinia Virus (hV01) and PD-1 Inhibitor in Advanced Solid Tumors.","A Study Evaluating the Safety and Efficacy of hV01, a Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus, in Combination With the PD-1 Inhibitor Tislelizumab for Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Signing an informed consent form.\n2. Men or women aged 18 to 75 years.\n3. Histologically and\u002For cytologically confirmed advanced solid tumors refractory or failed to respond to standard therapies.\n4. At least one measurable lesion according to RECIST v1.1 criteria, which is suitable for intratumoral injection of hV01 either directly or with the assistance of B-ultrasound, or CT scan. The baseline longest diameter of the lesion targeted for injection should be more than 1.5 cm.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Life expectancy of at least 6 months.\n7. Required baseline laboratory data include: (1) Hematology: absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL, platelet (PLT) count ≥ 75×10\\^9\u002FL, hemoglobin (Hb) ≥90 g\u002FL; (2) Liver function: serum total bilirubin (TBIL) ≤1.5×ULN (or ≤3×ULN for patients with Gilbert's syndrome or liver metastasis); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (or\\\u003C5×ULN for patients with primary liver cancer or liver metastasis); (3) Renal function: serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance (Cockcroft-Gault method) ≥45 mL\u002Fmin. For men: creatinine clearance = \\[\\[140-age(yr)\\]×weight (kg)\\]\u002F\\[0.818×creatinine (μmol\u002FL)\\]; For women: creatinine clearance = \\[\\[140-age(yr)\\]×weight (kg)×0.85\\]\u002F\\[0.818×creatinine (μmol\u002FL)\\]; (4) Coagulation test: activated partial thromboplastin time (APTT) ≤1.5×ULN; international normalized ratio (INR)≤1.5×ULN.\n8. Female patients of childbearing age must have a negative serum pregnancy test. Note: non-childbearing potential as defined by at least one of the following criteria: surgeries resulted in permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or are post-menopausal; For females aged 50 or older, they will be considered menopausal if they are in amenorrhea, defined as the absence of menstruation for the previous 12 months before screening, which is not caused by any disease; For females younger than 50 years, they will be considered menopausal if they satisfy all the following requirements during screening: they are in amenorrhea, defined as the absence of menstruation for the previous 12 months after termination of hormone treatment, and they have a serum FSH level within the laboratory's reference range for postmenopausal females.\n\nExclusion Criteria:\n\n1. Receiving any of the following anti-tumor treatments within a specified time period: (1) Systemic anti-tumor treatment, including chemotherapy, large-molecule targeted therapy, immunotherapy, and endocrine therapy within 4 weeks before first dose of hV01 (within 6 weeks of dosing for nitrosourea or mitomycin C); (2) Small-molecule targeted therapy within 2 weeks before first dose of hV01 or within five half-lives of the small-molecule targeted drug (whichever is longer); (3)Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose of hV01. (4) previous treatment with an oncolytic virus.\n2. Receiving any investigational drugs for clinical trials within 4 weeks prior to the first dose of hV01.\n3. Patients with clinical symptoms of central nervous system (CNS) metastasis or meningeal metastasis, or other evidence indicating that CNS or meningeal metastases are not controlled.\n4. Known or suspected active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and Hashimoto's thyroiditis).\n5. Patients who have received an allogeneic stem cell transplant or organ transplant.\n6. Patients with a history of severe cardiovascular and cerebrovascular diseases, including: (1) Acute coronary syndrome (including myocardial infarction, severe or unstable angina), myocarditis, congestive heart failure, cerebrovascular accidents, or other cardiovascular events of CTCAE (v5.0) grade 3 or higher within 12 months of first hV01 dosing; (2) Severe arrhythmia requiring clinical intervention; (3) New York Heart Association (NYHA) classification of class II or above, or left ventricular ejection fraction (LVEF) \\\u003C50%; (4) Uncontrolled hypertension or hypotension despite standard treatment.\n7. Clinically significant and\u002For rapidly accumulating pericardial and\u002For pleural effusion.\n8. Bleeding symptoms of great clinical significance or clear bleeding tendency within six months prior to the initial dose of hV01.\n9. Severe inflammatory skin diseases that require treatment with medicines (e.g., eczema or psoriasis requiring systematic treatment).\n10. Any uncontrolled active infection requiring systemic anti-infective therapy (graded 2 or higher according to CTCAE v5.0), including but not limited to active tuberculosis, sepsis, bacteremia, fungemia, and viremia.\n11. Any of the following infections: human immunodeficiency virus (HIV), syphilis spirochete(TP), active hepatitis C (positive HCV RNA test), or active hepatitis B (positive HBsAg and HBV DNA ≥ 2000 IU\u002FmL or ≥10\\^4 copies\u002FmL).\n12. Receiving therapeutic dosages of corticosteroids such as prednisone or its equivalent \\>10 mg daily within two weeks prior to the first dose of hV01, or having any coexisting diseases that might require systemic corticosteroids or any other immune suppressors during the study (assessed by the investigators) with the following exceptions: local administration of glucocorticoid (e.g. topical routes such as for eyes, intra-articular, intranasal, or inhaled); or usage of glucocorticoids for a short period of time for preventive purposes such as for the prevention of contrast media hypersensitivity).\n13. Receiving any of the live vaccines within four weeks of the first dose of hV01.\n14. Patients with a history of severe allergies.\n15. Mental disorders that could potentially impact the participant's ability to comply with the study requirements.",{"count":54,"type":21},24,[56],"NA","The purpose of this study is to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21-expressing oncolytic vaccinia virus (hV01) and the PD-1 Inhibitor Tislelizumab in patients with advanced solid tumors.",[59],"Advanced Solid Tumors","2025-09-18",{"date":62,"type":37},"2025-09-22",{"date":64,"type":37},"2025-06-23",{"date":66,"type":21},"2028-06",{"name":43,"class":44},""]