[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jie Yuan，MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100658302","a-prospective-real-world-observational-study-of-intratumoral-oncolytic-virus-injection-combined-with-immune-checkpoint-inhibitors-for-metastatic-tumors-colorectal-cancer-gastric-cancer-and-hepatocellular-carcinoma-100658302",false,"NCT07850882","A Prospective Real-World Observational Study of Intratumoral Oncolytic Virus Injection Combined With Immune Checkpoint Inhibitors for Metastatic Tumors (Colorectal Cancer, Gastric Cancer, and Hepatocellular Carcinoma)","Inclusion Criteria:\n\n* Patients aged 18-75 years.\n* Pathologically confirmed solid tumors, including superficial metastatic lesions and intra-abdominal or intrathoracic tumors, that are amenable to intratumoral injection with a longest diameter ≥1.0 cm.\n* For superficial metastatic lesions that have not received local radiotherapy, ablation, or surgical resection; if such treatments have been performed, at least 4 weeks must have elapsed since completion and the lesion must show documented progression.\n* Prior systemic therapy must have been completed at least 4 weeks or 5 half-lives ago, and the patient must have recovered from previous treatment-related toxicities.\n* Adequate cardiopulmonary, hepatic, and renal function to tolerate Oncorine® (H101) intratumoral injection.\n* The patient and their family members are willing to participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n* Peripheral blood lymphocyte count \\\u003C1.0×10⁹\u002FL；\n* Target superficial or body cavity tumors located adjacent to major blood vessels or nerves, with a high risk of puncture or injection; or lesions with active infection or ulceration；\n* Known severe hypersensitivity to Oncorine® (H101) or any of its components；\n* Active intra-abdominal infection or uncontrolled ascites；\n* Currently receiving systemic glucocorticoids or other potent immunosuppressive agents；\n* Planned receipt of other antitumor therapies during the study period (except supportive care)；\n* Concurrent other malignancy or a history of prior malignancy；\n* Tumors complicated by rupture with hemorrhage, massive gastrointestinal bleeding, intestinal obstruction, or other conditions requiring emergency surgery；\n* American Society of Anesthesiologists (ASA) classification ≥ IV and\u002For Eastern Cooperative Oncology Group (ECOG) performance status score \\>2；\n* Active autoimmune disease, or history of autoimmune disease requiring systemic therapy; uncontrolled severe infections (e.g., HIV, active hepatitis B with HBV-DNA above the lower limit of detection, active hepatitis C); severe cardiovascular or cerebrovascular disease; history of organ transplantation; active bleeding or high bleeding risk；\n* History of severe psychiatric illness；\n* Pregnant or breastfeeding women；\n* Uncontrolled active infection；\n* Other clinical or laboratory conditions that, in the opinion of the nvestigator, render the patient unsuitable for participation in this trial.","ALL","18 Years","75 Years",{"count":19,"type":20},30,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this single-arm, open-label, prospective clinical trial is to evaluate the safety, feasibility, and preliminary antitumor activity of intratumoral oncolytic virus (H101, recombinant human type 5 adenovirus) combined with immune checkpoint inhibitors (ICIs), and to explore the dynamic remodeling of the tumor immune microenvironment and potential predictive biomarkers, in patients with advanced metastatic colorectal cancer, gastric cancer, or hepatocellular carcinoma who have failed multiple prior lines of therapy.\n\nThe main questions it aims to answer are:\n\nWhat are the incidence of treatment-related adverse events and serious adverse events, and the completion rate of the combination therapy (safety and feasibility)? What is the objective response rate and local control rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (preliminary antitumor activity)? How does the combination therapy reshape the tumor immune microenvironment in terms of immune cell infiltration, subset proportions, functional status, and signaling pathways, and which differentially expressed genes or immune cell subtypes are associated with clinical response? This is a single-arm study; there is no comparator group.\n\nParticipants will:\n\nReceive intratumoral H101 injection once per cycle (dose stratified by lesion size), followed 5-7 days later by intravenous ICI \\[Anti-Programmed Cell Death Protein 1 Antibody (anti-PD-1) with or without Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Antibody (anti-CTLA-4)\\], repeated every 2-3 weeks for a total of 4 cycles.\n\nProvide paired tumor biopsy samples and peripheral blood specimens at baseline and after 4 cycles for single-cell RNA sequencing and biomarker analyses.\n\nUndergo routine clinical assessments, imaging for tumor response evaluation, and safety monitoring with adverse event grading per Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).",[25,26,27],"Colorectal Cancer (CRC)","Gastric Cancer (GC)","Hepatocellular Carcinoma (HCC)",[29,30,31,32,33,34],"Oncolytic virus","H101","Immune checkpoint inhibitors","Intratumoral injection","Metastatic cancer","Abscopal response","RECRUITING","2026-09-27",{"date":38,"type":39},"2026-09-30","ACTUAL",{"date":41,"type":20},"2026-09-01",{"date":43,"type":20},"2028-02-29",{"name":45,"class":46},"Jie Yuan，MD","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":54,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":69,"locationsCount":47},"100658295","a-real-world-observational-study-of-intratumoral-h101-oncolytic-adenovirus-combined-with-immune-checkpoint-inhibitors-for-advanced-metastatic-breast-cancer-100658295","NCT07850869","A Real-World Observational Study of Intratumoral H101 Oncolytic Adenovirus Combined With Immune Checkpoint Inhibitors for Advanced Metastatic Breast Cancer","Inclusion Criteria:\n\n* Age 18 to 75 years, both genders;\n* Pathologically confirmed breast cancer (Stage IV)；\n* Disease progression after at least one line of standard systemic therapy；\n* ECOG performance status 0-2；\n* Intolerant to or refusal of standard chemotherapy；\n* At least one radiologically measurable lesion per RECIST 1.1 criteria；\n* At least one lesion amenable to puncture\u002Finjection (i.e., accessible for intratumoral injection)；\n* Estimated life expectancy ≥3 months；\n* Adequate major organ function as defined by the following laboratory values:Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL,Platelet count (PLT) ≥100×10⁹\u002FL,Hemoglobin (Hb) ≥90 g\u002FL,Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN),Serum creatinine (Cr) ≤1.5× ULN；\n* Signed informed consent form；\n* Agreement to provide tumor tissue samples and peripheral blood samples before and after treatment for research purposes.。\n\nExclusion Criteria:\n\n* Known allergy to H101 formulation, PD-1 inhibitors, or any of their excipients ;\n* Lymphocyte count \\\u003C0.5×10⁹\u002FL;\n* Severe infection, active infection (particularly HBV, HCV, HIV), or severely immunocompromised status;\n* Presence of lesions that cannot be safely punctured\u002Finjected;\n* Prior treatment with PD-1\u002FPD-L1 inhibitors with grade ≥3 immune-related adverse events that have not resolved;\n* Concurrent active malignancy other than breast cancer (except for those cured for \\>5 years with no evidence of recurrence);\n* Uncontrolled brain metastases;\n* Pregnant or breastfeeding wome;\n* Psychiatric disorders, cognitive impairment, or poor compliance that may interfere with study participation and completion;\n* Severe cardiac, hepatic, or renal failure;\n* Long-term immunosuppressive therapy;\n* Uncontrolled active autoimmune disease.",{"count":55,"type":20},15,"This prospective, single-center, open-label, real-world observational study plans to enroll 10-15 patients with advanced (Stage IV) breast cancer who have failed multiple prior therapies \\[aged 18-75, Eastern Cooperative Oncology Group Performance Status Clinical Classification（ECOG） 0-2, with measurable and injectable lesions\\]. It aims to preliminarily evaluate the antitumor activity, safety, and immune-microenvironment modulation of intratumoral H101（Recombinant Human Adenovirus Type 5 Injection） oncolytic virus combined with immune checkpoint inhibitors (ICIs) in real-world practice. The regimen is determined by physicians based on clinical status and multidisciplinary input, but follows a standardized framework: 2- to 3-week cycles; H101 injected on day 1 (dose stratified by lesion size), with ICI infusion started 7±2 days later, for 4 planned cycles. Paired tumor biopsies (when feasible) and peripheral blood are collected at baseline and after 4 cycles for single-cell RNA sequencing and immune profiling, focusing on changes in T lymphocyte (T), Natural Killer cell (NK), dendritic, and macrophage subsets and correlating with clinical outcomes. Primary endpoints include adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0（CTCAE v5.0）), objective response and local control rates (Response Evaluation Criteria in Solid Tumors Version 1.1（RECIST 1.1）), 4-cycle completion, and toxicity-related discontinuation. Secondary endpoints include disease control rate, progression-free survival (Kaplan-Meier), and dynamic immune changes. First radiological assessment occurs at 6-8 weeks post-treatment, then every 3 months until progression, loss to follow-up, or 1 year. If re-biopsy is unsafe, only peripheral blood may be collected without protocol violation. Comprehensive follow-up, data confidentiality, and missing-data handling are in place to ensure scientific validity and participant protection.",[58],"Breast Cancer (Locally Advanced or Metastatic)",[60,61,62,63,64],"H101 oncolytic virus","immune checkpoint inhibitors","advanced metastatic breast cancer","tumor immune microenvironment","intratumoral injection",{"date":38,"type":39},{"date":67,"type":20},"2026-09-09",{"date":43,"type":20},{"name":45,"class":46},""]