[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GONGCHU Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":36,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100555147","phase-1-a-phase-i-clinical-study-of-intratumoral-injection-oncolytic-vaccinia-virus-gc001-in-patient-with-advanced-solid-tumors-100555147",false,"NCT06508307","A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors","A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Advanced Solid Tumors.","Inclusion Criteria:\n\nTo be eligible for participation in this study, individuals must meet the following criteria:\n\n1. Fully comprehend the purpose, nature, methods, and potential adverse effects of the trial, volunteer as a participant, and provide informed consent by signing the form prior to undergoing any procedures.\n2. Be male or female patients aged 18 to 75 years (including those with borderline age values).\n3. Patients with advanced solid tumors, including but not limited to: colorectal cancer, lung cancer, ovarian cancer, cervical cancer, etc., that have been histologically or cytologically diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).\n4. Possess at least one extracranial measurable lesion (as determined by a CT scan or MRI conducted no more than 4 weeks before signing the informed consent form) that is suitable for intratumoral injection based on RECIST v1.1 criteria.\n5. Have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1.\n6. Be expected to survive for at least 3 months.\n7. Within 7 days prior to receiving the first dose of treatment, patients must meet the following organ function and bone marrow reserve:\n\n   1. Hematology: platelets (PLT) ≥ 80 × 109\u002FL, neutrophil count (ANC) ≥ 1.5 × 109\u002FL, and hemoglobin ≥ 9 g\u002FdL (without having received adjuvants like EPO, G-CSF, or GM-CSF in the 14 days leading up to the first dose, and not having received a blood transfusion for at least 7 days);\n   2. Coagulation function: INR ≤ 1.2, APTT ≤ 1.2 × ULN (upper limit of normal), PT ≤ 1.2 × ULN;\n   3. Hepatic function: total bilirubin ≤ 1.5\n   4. × ULN (patients with Gilbert syndrome may be enrolled with a total bilirubin ≤ 3 × ULN), AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in the presence of hepatic metastases);\n   5. Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (according to the Cockcroft-Gault formula, see Appendix 2 for details);\n   6. Cardiac function: QT interval (QTcF) ≤ 470 ms in female and ≤ 450 ms in male.\n8. Ability to effectively communicate with the investigator and comprehend and adhere to the requirements of the study.\n\nExclusion Criteria:\n\n1. Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival \\> 90%), such as adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.\n2. Females of childbearing age who have a positive pregnancy test or are lactating.\n3. Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.\n4. Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.\n5. Patients who have previously received lysosomal virus, stem cell, or gene therapy products.\n6. Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for those who did not receive the test drug).\n7. Those who have undergone antitumor therapy, including radiation therapy (except palliative radiotherapy), chemotherapy, biotherapy, endocrine therapy, and immunotherapy within 28 days prior to the first administration of the drug; Individuals using small molecule targeted agents with antitumor effects within 14 days prior to the first administration of the drug or within 5 times the half-life of the drug (whichever is longer); Individuals using herbal medicines with antitumor effects within 14 days prior to the first administration of the drug.\n8. Individuals who have undergone surgery or interventional therapy (excluding tumor biopsy, puncture, etc.), or have unhealed wounds, ulcers, or fractures within 28 days prior to the first dose.\n9. Individuals who have been treated with systemic corticosteroids (at a dose equivalent to \\>10 mg prednisone\u002Fday) or other immunosuppressive medications within 28 days prior to the first dose, or who are currently taking antiviral medications (such as ribavirin, rifampin, imatinib, etc.), enrollment is permitted under the following cases:\n\n   1. short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergic diseases is permitted;\n   2. the use of topical topical or inhaled glucocorticoids is permitted;\n   3. patients with hepatitis B who are stable while receiving antiviral medications.\n10. Patients with clinically symptomatic CNS metastases or poorly controlled CNS metastases despite treatment (patients who have been stable for more than 4 weeks by MRI\u002FCT without requiring steroidal medications or other CNS-targeted treatments for at least 4 weeks) may be eligible for enrollment.\n11. Individuals with clinically significant or rapidly accumulating ascites, pericardial and\u002For pleural effusions.\n12. A history of severe cardiovascular disease, including but not limited to:\n\n    1. evere cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring medical intervention, II-III degree atrioventricular block, etc;\n    2. According to the standards of the New York Heart Association (NYHA), individuals with grade III-IV heart failure;\n    3. Recent cardiovascular events such as acute coronary syndrome, congestive heart failure, aortic dissection, stroke, cerebrovascular malformation, or other Grade 3 or higher events within the past 6 months prior to the first administration;\n    4. Uncontrolled hypertension despite standard antihypertensive therapy, with blood pressure persistently above systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg.\n13. Recent Grade 3 or greater bleeding event within 6 months prior to the first use of study drug, or who have current \\> Grade 2 bleeding, or hemangioma\u002Fvascular malformation, or tumor stroke, tumor invasion of a blood vessel, or active peptic ulcer, or esophageal varices judged by the investigator to be at significant risk for bleeding.\n14. Those with a history of severe hemoptysis。\n15. Adverse effects from prior antineoplastic therapy that have not recovered to a CTCAE v5.0 grade rating of ≤ 1 (excluding non-risky toxicities like alopecia).\n16. Patients with uncontrolled or severe diseases, including but not limited to persistent or active infections requiring antibiotic therapy.\n17. Subjects with active or prior history of autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) or at high risk (e.g., patients who have undergone organ transplantation requiring immunosuppressive therapy) are not eligible for enrollment. However, enrollment is permitted for subjects with:\n\n    1. type 1 diabetes mellitus that is stabilized on a fixed dose of insulin;\n    2. autoimmune hypothyroidism or Hashimoto's thyroiditis that requires only hormone replacement therapy.\n18. Individuals with a history of exfoliative skin conditions requiring systemic therapy (e.g., eczema or atopic dermatitis) are also excluded。\n19. Persons who are positive for human immunodeficiency virus (HIV) antibodies.\n20. Persons who have active hepatitis B (HBV)\u002Fhepatitis C (HCV) infection are not eligible for enrollment. However, subjects with a previous history of hepatitis C but negative HCV RNA at screening may be enrolled, and those who are HBsAg positive but have HBV DNA \\\u003C500 IU\u002Fml or below the lower limit of detection at the study center may also be enrolled. Subjects with primary liver cancer and HBV DNA \\\u003C1000 IU\u002Fml may be enrolled as well.\n21. Male and female patients who refuse to use an appropriate method of contraception, (such as the simultaneous use of spermicides, barrier contraceptives, and\u002For intrauterine contraceptives, as outlined in Appendix 1) throughout the study period and during the safety follow-up period are excluded.\n22. Patients with documented psychiatric illnesses or disorders that may impact adherence to the trial protocol.\n23. Patients with malignant tumors that may require antitumor therapy other than the investigational drug GC001.\n24. Patients who, as determined by the investigator, are unsuitable for participation in the study, including those with tumors surrounding major vascular structures such as the carotid arteries, tumors adjacent to critical neurovascular structures, or airways, or tumors in locations that present a high risk of adverse events or are unsuitable for intratumoral injections.","ALL","18 Years","75 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration.",[27,28,29,30,31,32,33,34,35],"Sarcoma","Cervical Cancer","Colon Cancer","Lung Cancer","Ovarian Cancer","Pancreatic Cancer","Hepatocellular Carcinoma","Breast Cancer","Gastric Cancer",[37],"GC001、Oncolytic virus 、WR","RECRUITING","2025-08-20",{"date":41,"type":42},"2025-08-21","ACTUAL",{"date":44,"type":42},"2023-04-26",{"date":46,"type":21},"2026-06",{"name":48,"class":49},"GONGCHU Biotechnology Co., Ltd","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":50},"100566813","phase-1-a-phase-i-clinical-study-of-intratumoral-injection-gc001-in-patient-with-recurrent-or-progressive-gliomas-100566813","NCT06660056","A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas","A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of Oncolytic Vaccinia Virus GC001, Pharmacodynamics, Immunogenicity, and Antitumor Activity of the Virus in Patient With Recurrent or Progressive Gliomas","Inclusion Criteria:\n\nTo be eligible for participation in this study, individuals must meet the following criteria:\n\n1. Subjects must be able to comprehend and voluntarily sign written informed consent, which includes requirements related to study sample collection.\n2. Able to communicate with researchers; Understand and comply with the requirements of the study; Voluntary and able to complete study procedures and follow-up examinations.\n3. Be male or female patients aged 18 (including those with borderline age values).\n4. Patients with recurrent or progressive high-grade gliomas (WHO grade III-IV) that have been histopathologically or molecularly diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).\n5. At least 1 intracranial measurable lesion according to RANO criteria (well-defined enhancing lesion detected on MRI, diameter \\>10 mm).\n6. Patient's willingness to undergo surgical maneuvers related to placement of the Ommaya capsule.\n7. Karnofsky functional status ≥ 60.\n8. Be expected to survive for at least 3 months.\n9. No serious hematologic (no adjuncts such as EPO, G-CSF, or GM-CSF within 14 days prior to the first dose and no blood transfusions for at least 7 days), hepatic, or renal function abnormalities consistent with the following laboratory test results:\n\nsystems Laboratory test values routine blood test Absolute neutrophil count（ANC） ≥1.5×109\u002FL blood platelet（PLT） ≥100×109\u002FL hemoglobin（HGB） ≥90g\u002FL gallbladder serum creatinine（Cr） ≤1.5×Upper limit of normal range（ULN） creatinine clearance（Ccr）（To be calculated only if creatinine \\> 1.5 x ULN） ≥50mL\u002Fmin（Based on the Cockcroft-Gault formula） liver total bilirubin（TBIL） ≤1.5×ULN glutamic pyruvic transaminase（ALT） aspartate transaminase（AST） ≤2.5×ULN Alkaline phosphatase（ALP） ≤2.5×ULN coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN Partially activated thromboplastin time（APTT） ≤1.5×ULN 10.Male or female subjects of childbearing potential use effective contraception during treatment and for 6 months after dosing.\n\nExclusion Criteria:\n\n1. Inability to perform an MRI for any reason.\n2. focal point under the curtain.\n3. Prior history of encephalitis, multiple sclerosis, or other central nervous system infection (unless resolved).\n4. Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival \\> 90%), such as adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.\n5. Females of childbearing age who have a positive pregnancy test or are lactating.\n6. Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.\n7. Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.\n8. Patients who have previously received lysosomal virus, stem cell, or gene therapy products.\n9. Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for those who did not receive the test drug).\n10. Those who have undergone antitumor therapy, including radiation therapy (except palliative radiotherapy), chemotherapy, biotherapy, endocrine therapy, and immunotherapy within 28 days prior to the first administration of the drug.\n11. Individuals who have undergone surgery or interventional therapy (excluding tumor biopsy, puncture, Ommaya capsule etc.).\n12. Individuals who have been treated with systemic corticosteroids (at a dose equivalent to \\>10 mg dexamethasone \u002Fday) or other immunosuppressive medications within 28 days prior to the first dose, or who are currently taking antiviral medications (Mainly sensitive to poxviruses), enrollment is permitted under the following cases:\n\n    1. short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergic diseases is permitted;\n    2. the use of topical topical or inhaled glucocorticoids is permitted;.\n13. A history of severe cardiovascular disease, including but not limited to:\n\n    1. A history of severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree II-III AV block requiring clinical intervention;\n    2. Acute coronary syndrome, congestive heart failure, aortic coarctation, stroke, or other grade or greater cardiovascular event within 6 months prior to the first dose;\n    3. New York Heart Association (NYHA) \\> Class II heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%; heart rate-corrected baseline QTcF intervals \\>450msec (men) and \\>470msec (women) using the Fridericia formula; any factor that increases the risk of QTc prolongation or the risk of cardiac arrhythmias, such as heart failure, hypokalemia , congenital long QT syndrome, family history of long QT syndrome, or use of any concomitant medication known to prolong the QT interval；\n    4. Clinically uncontrolled hypertension (blood pressure uncontrolled at \\\u003C 160 mmHg systolic and \\\u003C 100 mmHg diastolic after standard antihypertensive treatment).\n14. Recent Grade 3 or greater bleeding event within 6 months prior to the first use of study drug, or who have current \\> Grade 2 bleeding, or hemangioma\u002Fvascular malformation, or tumor stroke, tumor invasion of a blood vessel, or active peptic ulcer, or esophageal varices judged by the investigator to be at significant risk for bleeding.\n15. Those with a history of severe hemoptysis.\n16. Patients with uncontrolled or severe diseases, including but not limited to persistent or active infections requiring antibiotic therapy.\n17. .Subjects with active or prior history of autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) or at high risk (e.g., patients who have undergone organ transplantation requiring immunosuppressive therapy) are not eligible for enrollment. However, enrollment is permitted for subjects with:\n\n    1. type 1 diabetes mellitus that is stabilized on a fixed dose of insulin;\n    2. autoimmune hypothyroidism or Hashimoto's thyroiditis that requires only hormone replacement therapy；\n    3. Individuals with a history of exfoliative skin conditions requiring systemic therapy (e.g., eczema or atopic dermatitis) are also excluded.\n18. Persons who are positive for human immunodeficiency virus (HIV) antibodies.\n19. Persons who have active hepatitis B (HBV)\u002Fhepatitis C (HCV) infection are not eligible for enrollment. However, subjects with a previous history of hepatitis C but negative HCV RNA at screening may be enrolled, and those who are HBsAg positive but have HBV DNA \\\u003C500 IU\u002Fml or below the lower limit of detection at the study center may also be enrolled. Subjects with primary liver cancer and HBV DNA \\\u003C1000 IU\u002Fml may be enrolled as well.\n20. Patients with documented psychiatric illnesses or disorders that may impact adherence to the trial protocol.\n21. Patients with malignant tumors that may require antitumor therapy other than the investigational drug GC001.\n22. Patients who, as determined by the investigator, are unsuitable for participation in the study.\n\n    \\-",{"count":59,"type":21},35,[24],"A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Recurrent or Progressive Gliomas .",[63],"High-grade Gliomas",[65,66,67,68],"Oncolytic virus","GC001","WR","high-grade gliomas","2025-03-11",{"date":71,"type":42},"2025-03-13",{"date":73,"type":42},"2024-10-08",{"date":75,"type":21},"2026-08-08",{"name":48,"class":49},""]