[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612936":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":26,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":26,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":26},{"fullName":5,"class":6},"Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","This arm includes all participants who receive the investigational autologous immune cell therapy (either DC-CIK or NK cells), either alone or in combination with chemotherapy. It consolidates the following original arms:\n\nPhase I - DC-CIK Therapy Arm Intervention Name: Autologous DC-CIK Cells\n\nPhase I - NK Therapy Arm Intervention Name: Autologous NK Cells\n\nPhase II - DC-CIK + Chemotherapy Arm Intervention Name: Autologous DC-CIK Cells+Standard Chemotherapy\n\nPhase II - NK + Chemotherapy Arm Intervention Name:Autologous NK Cells+Standard Chemotherapy",[13,14],"Biological: Autologous immune Cells","Drug: Standard chemotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","This arm includes all participants who receive standard chemotherapy alone, without any investigational cell therapy. It consolidates the following original arms:\n\nPhase II - Chemotherapy Control Arm (HLA-A Positive)\n\nPhase II - Chemotherapy Control Arm (HLA-A Negative)",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Autologous immune Cells","1. Autologous DC-CIK Cells：Dendritic Cells (DC) and Cytokine-Induced Killer (CIK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). DC cells (\\>5x10⁶ cells) are administered via subcutaneous injection. CIK cells (\\>5x10⁹ cells) are administered via intravenous infusion.\n2. Autologous NK Cells：Natural Killer (NK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). NK cells (≥3x10⁹ cells) are administered via intravenous infusion.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Standard chemotherapy","Investigator's choice of standard chemotherapy regimen(s) appropriate for the participant's specific type of advanced solid tumor (lung, liver, colorectal, or breast cancer), administered according to local clinical practice.",[16,9],[33],{"name":34,"affiliation":5,"role":35},"Wei Minjie, Doctor","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Chen Lin, Doctor","CONTACT","+86 024-88456888","jiaoxue@lnmdtc.com",{"type":43,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[45],{"name":46,"class":47},"Liaoning Cancer Hospital & Institute","OTHER","100612936","phase-1-immune-cell-therapy-for-advanced-solid-tumors-100612936",false,"NCT07260058","Immune Cell Therapy for Advanced Solid Tumors","Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. The participant must voluntarily participate in the study and provide written informed consent。\n2. Age ≥ 18 years, male or female.\n3. Histologically and\u002For cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer.\n4. ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2.\n5. Life expectancy ≥ 3 months.\n6. Has not received any other cellular immunotherapy within 3 months prior to enrollment.\n7. Has at least one measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) Version 1.1.\n8. Adequate organ function, defined as follows:\n\nHematology:\n\nWhite Blood Cell (WBC) count \\> 3.5 × 10⁹\u002FL Lymphocyte count \\> 0.9 × 10⁹\u002FL Monocyte count \\> 0.16 × 10⁹\u002FL Absolute Neutrophil Count (ANC) \\> 1.5 × 10⁹\u002FL Platelet (PLT) count \\> 75 × 10⁹\u002FL Hemoglobin (HB) \\> 75 g\u002FL Blood Biochemistry： Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)\n\nCoagulation:\n\nProthrombin Time (PT) and International Normalized Ratio (INR) ≤ 1.5 × ULN\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Prior receipt of any salvage chemotherapy, implanted intraperitoneal chemotherapy, targeted therapy, or biological immunotherapy (except: patients whose disease progressed more than 6 months after completing adjuvant, neoadjuvant, or radiosensitizing chemotherapy, or more than 1 month after intraperitoneal chemoperfusion\u002Fwash, are eligible, provided chemotherapy-related toxicities have recovered to Grade 1 or below, excluding alopecia).\n2. Major surgical procedure within 4 weeks prior to enrollment, with incomplete recovery from side effects.\n3. History of any active malignancy within 5 years, except for the specific cancer under investigation in this trial and cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and prostate carcinoma in situ.\n4. Presence of more than a small amount of pericardial effusion, or uncontrolled pleural or peritoneal effusion, defined as: detectable by physical examination at screening, or requiring therapeutic paracentesis during the screening period.\n5. Inability to tolerate peripheral blood collection due to various reasons (e.g., severe coronary heart disease, inability to establish peripheral venous access).\n6. Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \\> NYHA (New York Heart Association) Class III, or severe arrhythmia.\n7. Active infection, unexplained fever ≥ 38.5°C within 7 days prior to medication, or baseline white blood cell count \\> 15×10⁹\u002FL; OR any severe acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (except for active hepatitis).\n8. Any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Patients with childhood asthma that has completely resolved in adulthood without any intervention are eligible; Asthma requiring bronchodilator medical intervention is excluded). Patients are eligible if: they have a history of autoimmune-related hypothyroidism and are on stable thyroid hormone replacement therapy; or have type I diabetes controlled by insulin therapy.\n9. History of drug allergy.\n10. Pregnant or lactating women; OR women of childbearing potential or men with pregnant partners who are unwilling to use adequate contraception during the planned trial period (from the screening visit until 120 days after the last study treatment).\n11. History of organ transplantation.\n12. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.","ALL","18 Years",{"count":58,"type":59},48,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE1","PHASE2","The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.",[66,67,68,69,70],"Lung Cancer (Locally Advanced or Metastatic)","Liver Cancer (Locally Advanced or Metastatic)","Colorectal Cancer (Locally Advanced or Metastatic)","Breast Cancer (Locally Advanced or Metastatic)","Advanced Solid Tumors",[70,72,73,74,75,76,77,78,79],"Metastatic Lung Cancer","Metastatic Liver Cancer","Metastatic Colorectal Cancer","Metastatic Breast Cancer","Autologous Immune Cell Therapy","Dendritic Cell Vaccine","CIK Cells","NK Cells","NOT_YET_RECRUITING","2025-11-20",{"date":83,"type":84},"2025-12-02","ACTUAL",{"date":86,"type":59},"2025-12-01",{"date":88,"type":59},"2027-12-31",{"name":5,"class":6}]