[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CNBG-Virogin Biotech (Shanghai) Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":132},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,62,86,109],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100573453","phase-2-clinical-study-of-vg161-in-advanced-intrahepatic-cholangiocarcinoma-100573453",false,"NCT06746480","Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma","A Single-Arm, Multicenter, Open-Label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* 1\\. Subjects must fully understand and give informed consent to this study before the trial, and voluntarily sign a written informed consent form.\n\n  2\\. aged 18 to 75 years (inclusive), male or female. 3. patients with histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.\n\n  4\\. According to the Guidelines for the Diagnosis and Treatment of Biliary Malignant Tumors (CSCO), patients must have previously received at least systemic first-line therapy for advanced intrahepatic cholangiocarcinoma and failed, or cannot tolerate treatment. Patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy were counted as having failed first-line treatment if disease progression occurred during chemotherapy or within 6 months after stopping chemotherapy; 5. According to RECIST 1.1 criteria, one or more CT examinations are determined to be measurable and meet the requirements for the volume administered for the first injection, tumor lesions and\u002For metastases (the injected lesions should preferably be the main tumor burden lesions) that can be injected under ultrasound or CT guidance, and the baseline longest diameter of the injected lesions (lymph node lesions are short diameters) is \\> 1.5 cm.\n\n  6\\. Herpes simplex virus type I (HSV-1) antibody test results (HSV-1 IgG or HSV-1 IgM) are positive.\n\n  7\\. ECOG performance score 0-1. 8. Expected survival time of more than 3 months. 9.Adequate organ function:\n  1. Blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 109\u002FL, PLT ≥ 75 × 109\u002FL, Hb ≥ 85 g\u002FL;\n  2. Liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN;\n  3. Child-Pugh A-B;\n  4. Renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml\u002Fmin (calculated according to Cockcroft-Gault formula);\n  5. Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN; 10.Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.\n\n     Exclusion Criteria:\n* 1\\. received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).\n\n  2\\. Patients who have received transcatheter arterial chemoembolization (TACE) within 4 weeks before the first use of the study drug.\n\n  3\\. Received other clinical trial drugs that are not approved for marketing within 4 weeks before the first use of the study drug.\n\n  4\\. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.\n\n  5\\. Have received a vaccine within 4 weeks prior to the first dose of study drug.\n\n  6\\. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).\n\n  7\\. The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities that are judged by the investigator to have no safety risk); 8. Patients with central nervous system metastasis, spinal cord metastasis and\u002For spinal cord compression.\n\n  9\\. in the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.\n\n  10\\. other active uncontrolled infections. 11. History of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.\n\n  12\\. Patients with active chronic hepatitis B or active hepatitis C. (Except hepatitis B virus carriers, hepatitis B virus stable after drug treatment \\[HBV-DNA negative or \\\u003C 500 IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA negative\\]) 13. History of serious cardiovascular disease:\n  1. Ventricular arrhythmia requiring clinical intervention;\n  2. QTc interval \\> 480 ms;\n  3. Acute coronary syndrome, congestive heart failure, stroke or other Grade III and above cardiovascular events within 6 months before the first use of study drugs;\n  4. New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) \\\u003C 40%;\n  5. Uncontrolled hypertension after treatment (judged by the investigator); 14. Patients with active, or have had and have the possibility of relapse of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); except for clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, type I diabetes treated with stable doses of insulin, vitiligo or recovered childhood asthma\u002Fallergy, without any intervention in adults.\n\n  15\\. Having received immunotherapy and have experienced immune-related adverse events (irAEs) such as immune-related pneumonia and myocarditis, which may affect the safety of the investigational drug as judged by the investigator.\n\n  16\\. Known alcohol or drug dependence. 17. Patients with mental disorders or poor compliance. 18. Pregnant or lactating women. 19. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.","ALL","18 Years","75 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","VG161 is a recombinant human-IL12\u002F15\u002FPDL1B oncolytic HSV-1 Injectable. This trial is a single-agent, single-arm, multicenter, open-label design clinical trial for advanced intrahepatic cholangiocarcinoma who have failed standard therapy. To evaluate the efficacy of VG161 administered by ultrasound or CT-guided intratumoral injection in patients with advanced intrahepatic cholangiocarcinoma, with the primary outcome measure being objective response rate (ORR).",[27],"Advanced Intrahepatic Cholangiocarcinoma",[29],"Advanced intrahepatic cholangiocarcinoma","RECRUITING","2024-12-19",{"date":33,"type":34},"2024-12-24","ACTUAL",{"date":36,"type":34},"2022-03-19",{"date":38,"type":21},"2025-12-01",{"name":40,"class":41},"CNBG-Virogin Biotech (Shanghai) Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":42},"100525805","phase-2-clinical-study-of-vg161-in-the-treatment-of-advanced-bone-and-soft-tissue-sarcoma-100525805","NCT06126510","Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma","A Single-arm, Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.\n* Age 18 to 75 years old (inclusive), gender is not limited.\n* Patients with advanced bone and soft tissue sarcoma confirmed by histopathological or cytology, who are unresectable by surgery and have failed at least one standard treatment (among them, patients with Ewing sarcoma need to be patients without standard treatment).\n* According to RECIST 1.1, it is determined that at least one CT examination shows measurable and meets the volume requirement for the first injection, superficial lesions are preferred, and tumor lesions that can be injected under ultrasound guidance can also be selected (the injected lesions are preferably major tumor burden lesions), and the longest diameter of the injected lesion at baseline (short diameter for lymph node lesions) \\> 1.5cm.\n* Those who have a positive HSV-1 IgG or HSV-1 IgM antibody test result (HSV-1 IgM).\n* ECOG physical status score of 0-1.\n* Estimated survival time of more than 3 months.\n* Have adequate organ function:\n\n  1. Blood routine (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥1.5×109\u002FL, PLT≥75×109\u002FL, Hb≥85g\u002FL, lymphocyte count≥1.5×109\u002FL (for lymphocyte count 0.8×109\u002FL to 1.5×109\u002FL at the discretion of the investigator);\n  2. Liver function: TBIL ≤1.5×ULN, ALT≤3×ULN, AST≤3×ULN (ALT≤5×ULN and AST≤5×ULN are acceptable for patients with liver metastases);\n  3. Renal function: Cr≤1.5×ULN, and creatinine clearance ≥45ml\u002Fmin (calculated according to Cockcroft-Gault formula);\n  4. Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.\n* Eligible subjects (males and females) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) for the duration of the trial and for at least 3 months after the last dose; Female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n* Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).\n* Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.\n* Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.\n* Patients who have received systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressants within 14 days before the first use of study drugs; Exceptions are the following: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids (≤10 mg prednisone equivalent) for prophylactic treatment (e.g., prevention of contrast media allergy).\n* Have received vaccination within 4 weeks before the first use of study drugs.\n* The adverse reactions of previous anti-tumor treatments have not returned to CTCAE 5.0 grade ≤1 (except for toxicities such as hair loss that the researcher has judged to have no safety risks).\n* Patients with central nervous system metastasis or meningeal metastasis are not suitable for inclusion according to the investigator's judgment.\n* With spinal cord compression, the researcher determines that the patient is not suitable for enrollment.\n* In the period of recurrent infection of herpes simplex virus, with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, genital herpes, etc.\n* Other uncontrolled active infections.\n* Have a history of immunodeficiency, including positive HIV antibody test and Treponema pallidum antibody test.\n* Patients with active chronic hepatitis B or active hepatitis C (except hepatitis B virus carriers, stable hepatitis B after drug treatment \\[negative HBV-DNA test or \\\u003C50IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA Tested negative\\]).\n* Have a history of severe cardiovascular disease:\n\n  1. Ventricular arrhythmias requiring clinical intervention;\n  2. QTc interval\\>480ms;\n  3. Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months before using the study drug for the first time;\n  4. New York Heart Association (NYHA) cardiac function class ≥ class II or left ventricular ejection fraction (LVEF) \\\u003C40%;\n  5. Uncontrolled hypertension (systolic blood pressure ≥140mmHg, or diastolic blood pressure ≥90mmHg after treatment).\n* Patients with active or past autoimmune diseases that may relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (including but not limited to these diseases or syndromes, etc.); but does not include patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; Type I diabetes on insulin; patients with vitiligo or childhood asthma\u002Fallergies that have resolved and do not require any intervention in adulthood.\n* Have received immunotherapy and experienced immune-related adverse events (irAEs) such as immune-related pneumonia, myocarditis, etc., which may affect the safety of the trial medication as judged by the researcher.\n* Known dependence on alcohol or drugs.\n* People with mental disorders or poor compliance.\n* Pregnant or lactating women.\n* Patients with obvious symptoms and unstable pleural effusion, peritoneal effusion or pericardial effusion (those with stable clinical symptoms after treatment of pleural effusion, ascites or pericardial effusion can be included).\n* The researcher believes that the subject has other serious systemic diseases or other reasons and is not suitable to participate in this clinical study.",{"count":51,"type":21},40,[24],"This study plans to use 1.0×108PFU\u002Fday per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.",[55],"Sarcoma",{"date":33,"type":34},{"date":58,"type":34},"2023-07-18",{"date":60,"type":21},"2026-01-17",{"name":40,"class":41},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":42},"100424405","phase-1-clinical-study-of-vg161-in-subjects-with-advanced-primary-liver-cancer-100424405","NCT04806464","Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer","A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics Characteristics and Preliminary Effectiveness of VG161 in Subjects with Advanced Primary Liver Cancer","1. According to 'The Diagnostic and Therapeutic Criteria for Primary Liver Cancer' (NMPA, 2019 Edition), subject with advanced primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, combined hepatocellular which is refractory\u002Frelapsed after and\u002For intolerant of standard therapies or for which no standard therapy exists. For the second stage of Simon\\'s two-stage in part 2, only patients with advanced primary hepatocellular carcinoma will be enrolled.\n2. There are tumor lesions intrahepatic and \u002F or extrahepatic metastases that can be injected under B ultrasound and meet the volume requirements of the current dose group, and the longest diameter of injectable tumor lesion \\>1.5cm（or the shortest diameter of lymph node lesions）\n3. Eastern Cooperative Oncology Group (ECOG) scores 0 or 1.\n4. Life expectancy is at least 3 months.\n5. Required organ function:\n\n1\\) Hematology blood (no blood transfusion or colony stimulating factor treatment within 14 days): absolute neutrophil count (ANC)≥1.5×10\\^9L, platelets (PLT)≥75×10\\^9L, hemoglobin (Hb)≥85g\u002FL; 2) Liver function: Total Serum bilirubin (TBIL)≤1.5×ULN (the upper limit of the reference range), Alanine aminotransferase (ALT)≤5×ULN, aspartate aminotransferase (AST)≤5×ULN; 3)Child-Pugh A-B level; 4) Renal function: Serum creatinine≤1.5×ULN, and creatinine clearance≥45 ml\u002Fmin (calculated per Cockcroft-Gault formula); 5) Coagulation function: activated partial thromboplastin time (APTT)≤1.5×ULN, prothrombin time(PT) ≤1.5×ULN, international standardized ratio (INR)≤1.5×ULN.\n\n6\\. Subjects who are HBV-DNA negative; or HBV-DNA positive are required to receive treatment in accordance with the 'Guidelines for the prevention and treatment of chronic hepatitis B' (2019 Edition) or clinical practice.\n\n7.Subjects of childbearing potential (male and female) must agree to use a reliable contraceptive method (hormone or barrier method or abstinence) during the study and for at least 90 days following the last dose; females of childbearing potential must have a negative blood pregnancy test within 7 days of study enrollment.\n\n8.Signed written informed consent.\n\nExclusion Criteria:\n\n1. Subject in prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation. Oral fluorouracil analogues and small molecule targeted drugs were 2 weeks prior to the first dose of study drug or within 5 half-lives of the drug (whichever was longer).\n2. Transcatheter arterial chemoembolization(TACE) within 4 weeks of study treatment initiation\n3. Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation.\n4. Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks of study treatment initiation.\n5. Patients who received systemic treatment with either corticosteroids ( \\>10 mg\u002F daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.\n6. Subjects with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy (except for toxicity that the investigator assessed to be no safety risk, such as alopecia.).\n7. Subjects with Central Nervous System (CNS) metastasis or meningeal metastasis .\n8. Seronegative for Herpes Simplex Virus (HSV) (HSV-1IgG and HSV-1IgM).\n9. Subjects with the relapse of HSV infection and relevant clinical manifestations, such as lip herpes, herpes keratitis, herpes dermatitis, and genital herpes.\n10. Subjects with other uncontrolled active infections.\n11. Known history of immunodeficiency and test positive of human immunodeficiency virus (HIV).\n12. History of severe cardiovascular disease:\n\n1)Ventricular arrhythmias requiring clinical intervention; 2)QTc interval \\>480 ms; 3)Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of III grade or above within 6 months; 4)The cardiac function grade≥II or left ventricular ejection fraction (LVEF) \\<50% per the New York Heart Association (NYA); 5)Uncontrolled hypertension.\n\n13\\. Subjects with active or past autoimmune diseases that are likely to recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); acceptable for patients with clinically stable autoimmune thyroiditis.\n\n14\\. Previous immunotherapy with an immune-related adverse event (irAE) such as immune-related pneumonia, myocarditis, etc., which, in the judgement of the investigator, may affect the safety of the investigational drug. 15. known to have alcohol or drug dependence. 16. Persons with mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Subjects with any significant unrelated systemic illness that to the investigator's opinion would compromise the subject's eligibility to participate the study.",{"count":70,"type":21},44,[72],"PHASE1","VG161 is a recombinant human-IL12\u002F15\u002FPDL1B oncolytic HSV-1 Injectable. This phase I study will be conducted in HSV-seropositive subjects with advanced primary liver cancer that are refractory to conventional therapies. This is an open label study and it's divided into two parts.\n\nPart 1: This part is ascending dose design to determine the safety and tolerability of VG161 and find recommended dose of VG161.\n\nPart 2: This part is extended dose design to determine the effectiveness of VG161.",[75],"Primary Liver Cancer",[77],"Liver Cancer","2024-09-10",{"date":80,"type":34},"2024-09-19",{"date":82,"type":34},"2021-03-16",{"date":84,"type":21},"2024-12-31",{"name":40,"class":41},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100525612","phase-1-clinical-study-of-vg161-combined-with-camrelizumab-in-patients-with-advanced-primary-hepatocellular-carcinoma-100525612","NCT06124001","Clinical Study of VG161 Combined With Camrelizumab in Patients With Advanced Primary Hepatocellular Carcinoma","An Open-label Phase Ib\u002FIIa Clinical Trial of VG161 Combined With Camrelizumab in the Treatment of Advanced Primary Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.\n* Age 18 to 75 (inclusive), gender is not limited.\n* Patients with advanced primary hepatocellular carcinoma confirmed by histopathology or cytology.\n* According to the CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition), patients who have received at least previous first-line treatment regimens that have failed treatment (disease progression or inability to tolerate treatment) must have been treated.\n* According to RECIST 1.1, it is determined that at least one CT examination shows that it is measurable and meets the requirements of the volume of injection administration (or the volume of first injection administration in phase IIa) that can be injected under ultrasound guidance (preferably the main tumor burden lesion) under ultrasound guidance, and the longest baseline diameter of the injection lesion (short diameter of lymph node lesions) is \\>1.5 cm (of which the portal vein lymph node is short, the diameter needs to be \\> 20 mm).\n* Those with positive herpes simplex virus antibody test results (HSV-1 IgG or HSV-1 IgM).\n* ECOG physical status score 0-1.\n* Estimated survival time of more than 3 months.\n* Have adequate organ function:\n\n  1. Routine blood (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥ 1.5×109\u002FL, PLT≥75×109\u002FL, Hb≥85g\u002FL, lymphocyte count ≥1.5×109\u002FL (for lymphocyte count 0.8×109\u002FL to 1.5×109\u002FL is determined by the investigator whether to enroll);\n  2. Liver function: TBIL≤1.5×ULN, ALT≤5×ULN, AST≤5×ULN;\n  3. Child-Pugh A or better B (≤ 7);\n  4. Renal function: Cr≤1.5×ULN, and creatinine clearance ≥ 45ml\u002Fmin (calculated according to Cockcroft-Gault formula);\n  5. Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.\n* Eligible subjects of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier or abstinence) during the trial and at least 90 days after the last dose (VG161 or carrelizumab, whichever occurs later); Female patients of childbearing age must have a negative blood pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n* Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma or mixed hepatocellular carcinoma.\n* Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).\n* Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.\n* Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.\n* Patients who have received systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressants within 14 days before the first use of study drugs;Exceptions are the following: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids (≤10 mg prednisone equivalent) for prophylactic treatment (e.g., prevention of contrast media allergy).\n* Have received vaccination within 4 weeks before the first use of study drugs.\n* Known severe allergic reaction to any monoclonal antibody.\n* The adverse reactions of previous anti-tumor treatments have not returned to CTCAE 5.0 grade ≤1 (except for toxicities such as hair loss that the researcher has judged to have no safety risks).\n* Liver tumor burden is greater than 50% of the total liver volume, or those who have received liver transplantation in the past.\n* Patients with central nervous system metastasis, spinal cord metastasis and\u002For spinal cord compression are not suitable for inclusion according to the investigator's judgment.\n* In the period of recurrent infection of herpes simplex virus, with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, genital herpes, etc.\n* Other uncontrolled active infections.\n* Have a history of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.\n* Patients with active chronic hepatitis B or active hepatitis C (except hepatitis B virus carriers, stable hepatitis B after drug treatment \\[negative HBV-DNA test or \\\u003C50IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA Tested negative\\]).\n* Have a history of serious cardiovascular and cerebrovascular diseases:\n\n  1. Ventricular arrhythmias requiring clinical intervention;\n  2. QTc interval\\>480ms;\n  3. Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months;\n  4. New York Heart Association (NYHA) cardiac function class ≥ class II or left ventricular ejection fraction (LVEF) \\\u003C40%;\n  5. Uncontrolled hypertension (systolic blood pressure ≥140mmHg, or diastolic blood pressure ≥90mmHg after treatment).\n* Patients with active or past autoimmune diseases that may relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (including but not limited to these diseases or syndromes, etc.); but does not include patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; Type I diabetes on insulin; patients with vitiligo or childhood asthma\u002Fallergies that have resolved and do not require any intervention in adulthood.\n* Have received immunotherapy and experienced immune-related adverse events (irAEs) such as immune-related pneumonia, myocarditis, etc., which may affect the safety of the trial medication as judged by the researcher.\n* Known alcohol or drug dependence.\n* People with mental disorders or poor compliance.\n* Pregnant or lactating women.\n* Patients with obvious symptoms and unstable pleural effusion, peritoneal effusion or pericardial effusion (those with stable clinical symptoms after treatment of pleural effusion, ascites or pericardial effusion can be included).\n* The researcher believes that the subject has other serious systemic diseases or other reasons and is not suitable to participate in this clinical study.",{"count":94,"type":21},36,[72,24],"VG161 is a recombinant human-IL12\u002F15\u002FPDL1B oncolytic HSV-1 injection.This study will be conducted in combination with camrelizumab in patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. This is an open-label study divided into two parts.\n\nPart 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.\n\nPart 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.",[98],"Primary Hepatocellular Carcinoma",[98],"NOT_YET_RECRUITING","2023-11-13",{"date":103,"type":34},"2023-11-15",{"date":105,"type":21},"2023-11-30",{"date":107,"type":21},"2026-06-30",{"name":40,"class":41},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":42},"100516776","phase-1-clinical-study-of-vg161-combined-with-nivolumab-injection-in-patients-with-advanced-metastatic-gastric-cancer-100516776","NCT06008925","Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer","A Dose Ascending, Open Phase Ib\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of VG161 Combined With Nivolumab Injection in Subjects With Metastatic Gastric Cancer","Inclusion Criteria:\n\n\\- (Subjects must meet all of the following inclusion criteria to enter the trial)\n\n1. Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.\n2. aged 18 to 75 years (inclusive), male or female.\n3. Patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology.\n4. According to the Guidelines for the Diagnosis and Treatment of Gastric Cancer (CSCO, version 2021), patients must have previously failed two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies), or patients who cannot continue treatment due to severe adverse reactions as judged by the investigator.\n5. Be able to provide paraffin blocks and\u002For tissue sections of previously archived pathological tissues, or willing to undergo tumor tissue biopsy before administration.\n6. The presence of at least one measurable CT scan according to RECIST 1.1 and meeting the requirements for an acceptable injection dose volume (or the first injection dose volume in Phase IIa) in the current dose group, tumor metastases that can be injected under ultrasound guidance (injected lesions are best major tumor burden lesions), and the baseline longest diameter of the injected lesion (lymph node lesions are short diameters) \\> 1.5 cm.\n7. Positive test result for herpes simplex virus I antibodies (HSV-1 IgG or HSV-1 IgM).\n8. ECOG performance status score 0-1.\n9. Expected survival time of more than 3 months.\n10. adequate organ function: 1) blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 10\\^9\u002FL, PLT ≥ 100 × 10\\^9\u002FL, Hb ≥ 85 g\u002FL, lymphocyte count ≥ 1.5 × 10\\^9\u002FL (for lymphocyte count 0.8 × 10\\^9\u002FL to 1.5 × 10\\^9\u002FL, the investigator judged whether to enroll); 2) liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN; 3) renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml\u002Fmin (calculated according to Cockcroft-Gault formula); 4) coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN.\n11. eligible subjects of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose (VG161 or nivolumab, calculated at the later of the day).\n12. Female patients of childbearing age must have a negative blood pregnancy test within 1 day prior to enrollment.\n\nExclusion Criteria:\n\n\\- (Any of the following criteria must be excluded)\n\n1. received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).\n2. received other unmarketed clinical trial treatment within 4 weeks before the first dose of study drug.\n3. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.\n4. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).\n5. Vaccination within 4 weeks prior to the first dose of study drug.\n6. Adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities judged by the investigator as having no safety risk).\n7. Patients with central nervous system metastasis, spinal cord metastasis and\u002For spinal cord compression.\n8. patients with active diverticulitis or symptomatic gastrointestinal ulcers;\n9. in the herpes simplex virus recurrence infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpes keratitis herpeticum, genital herpes, etc., or there are herpes infection-related complications (herpes keratitis, encephalitis, nerve injury, etc.), and intermittent or long-term use of anti-herpes drugs (e.g., acyclovir) treatment, except intermittent local use.\n10. other active uncontrolled infections.\n11. History of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.\n12. Patients with active chronic hepatitis B or active hepatitis C (except hepatitis B virus carriers, stable hepatitis B after drug treatment \\[HBV-DNA test negative or \\\u003C 50 IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA test negative\\]);\n13. history of serious cardiovascular disease: 1) ventricular arrhythmia requiring clinical intervention; 2) QTc interval \\> 480 ms; 3) Acute coronary syndrome, congestive heart failure, stroke or other Grade III or higher cardiovascular events within 6 months; 4) New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) \\\u003C 40%; 5) uncontrolled hypertension after treatment (as judged by the investigator).\n14. Patients with active, or have had and have had autoimmune diseases that may recur (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes, etc.); but excluding patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type I diabetes using stable doses of insulin; vitiligo or recovered childhood asthma\u002Fallergy, and patients who do not require any intervention in adulthood.\n15. Having received immunotherapy and have experienced immune-related adverse events (irAEs) such as immune-related pneumonia and myocarditis, which may affect the safety of the investigational drug as judged by the investigator.\n16. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.\n17. Known alcohol or drug dependence.\n18. Mental disorders or poor compliance.\n19. Pregnant or lactating women.\n20. subjects with pleural effusion or pericardial effusion or ascites requiring clinical intervention.\n21. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.",{"count":117,"type":21},43,[72,24],"VG161 is a recombinant human-IL12\u002F15\u002FPDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies). This is an open-label study divided into two parts.\n\nPart 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.\n\nPart 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.",[121],"Metastatic Gastric Cancer",[123],"Gastric cancer","2023-08-23",{"date":126,"type":34},"2023-08-24",{"date":128,"type":34},"2022-11-17",{"date":130,"type":21},"2026-06",{"name":40,"class":41},""]