[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"personalized-cancer-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:personalized-cancer-treatment":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100636426","establishment-of-a-prospective-clinical-cohort-of-small-cell-lung-cancer-patients-receiving-radiotherapy-involved-comprehensive-treatment-100636426",false,"NCT07565532","Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment","Inclusion Criteria:\n\nInclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):\n\n1\\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically and radiologically confirmed, previously untreated limited-stage SCLC (according to the Veterans Administration Lung Study Group staging system).\n\n3\\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. At least one documented efficacy assessment. 7. At least one measurable lesion as confirmed by the investigator according to RECIST (iRECIST 2017) criteria.\n\n8\\. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):\n\n1. Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 90 × 10⁹\u002FL.\n2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g\u002FL.\n3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).\n\n9\\. Pulmonary function test showing FEV₁ \\> 0.75 L. 10. No evidence of severe interstitial lung disease confirmed by CT or PET\u002FCT prior to treatment.\n\n11\\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level.\n\nInclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):\n\n1\\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically confirmed SCLC with complete staging workup showing extensive-stage disease (according to the Veterans Administration Lung Study Group staging system).\n\n3\\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. At least one documented efficacy assessment. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2. 7. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):\n\n1. Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 90 × 10⁹\u002FL.\n2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g\u002FL.\n3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).\n\n8\\. No severe concurrent medical illness. 9. Forced expiratory volume in one second (FEV₁) \\> 0.75 L. 10. For patients with prior radiotherapy to the primary lesion, the current radiotherapy target is limited to metastatic lesions.\n\n11\\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. 13. For patients with limited-stage SCLC who previously received curative-intent treatment, upon recurrence or metastasis, if complete staging workup is available and this is their first use of immunotherapy, they may still be considered for inclusion in the extensive-stage cohort.\n\nExclusion Criteria:\n\nExclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):\n\n1. Histologically confirmed non-small cell lung cancer (NSCLC).\n2. No efficacy assessment record, or missing efficacy assessment data.\n3. Presence of other primary malignancies; history of allogeneic organ transplantation.\n4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose.\n5. History of substance abuse (e.g., drug addiction), long-term alcoholism, or AIDS or HIV carrier.\n6. Active autoimmune disease, or history of autoimmune disease with potential for relapse.\n7. Current systemic corticosteroid therapy (e.g., equivalent to \\>10 mg prednisone daily) or use of any other form of immunosuppressive therapy within 14 days prior to the first dose.\n8. Prior treatment with any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints), including but not limited to PD-1, PD-L1, CTLA-4, TIM-3, and LAG-3.\n9. Interstitial lung disease (ILD) or history of ILD requiring corticosteroid therapy.\n10. History of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), idiopathic pneumonia, or evidence of active pneumonitis on screening chest CT.\n11. Receipt of live vaccine within 28 days prior to the first dose of study drug.\n12. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), and immunosuppressive therapy.\n13. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).\n14. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.\n15. Evidence of inherited bleeding diathesis or coagulation disorders.\n16. Prior history of malignancy (excluding skin cancer, or in situ breast cancer, oral cancer, or cervical cancer with life expectancy \\>3 years).\n\nExclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):\n\n1. Pulmonary carcinoid or non-small cell lung cancer, unless transformed SCLC is ruled out.\n2. No efficacy assessment record, or missing efficacy assessment data.\n3. History of severe anaphylactic\u002Fallergic reaction to humanized antibodies or fusion proteins.\n4. Acute exacerbation of chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring hospitalization.\n5. Active or prior autoimmune disease (within the past 2 years) or history of primary immunodeficiency.\n6. Progression after immunotherapy; prior or concurrent diagnosis of any other malignancy, excluding non-melanoma skin cancer or carcinoma in situ of the cervix.\n7. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), or immunosuppressive therapy.\n8. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).\n9. Current or prior history of autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, and rheumatoid arthritis.\n10. History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonia; or evidence of active pneumonitis on chest CT scan. Patients with a history of radiation pneumonitis (fibrosis) within the radiation field may be enrolled.\n11. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.","ALL","18 Years",{"count":18,"type":19},500,"ESTIMATED","2 Years","OBSERVATIONAL","By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.",[24,25,26,27],"Small Cell Lung Cancer ( SCLC )","Radiotherapy","Immunotherapy","Personalized Cancer Treatment",[29,25,26,27],"Small Cell Lung Cancer (SCLC)","RECRUITING","2026-04-27",{"date":33,"type":34},"2026-05-04","ACTUAL",{"date":36,"type":34},"2026-04-01",{"date":38,"type":19},"2030-03-31",{"name":40,"class":41},"Shanghai Chest Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100533929","clinical-study-of-individualized-treatment-of-relapsed-or-drug-resistant-advanced-gynecological-tumors-guided-by-ptc-model-100533929","NCT06232213","Clinical Study of Individualized Treatment of Relapsed or Drug-resistant Advanced Gynecological Tumors Guided by PTC Model","The PTC Microtumor Model is Used to Guide the Feasibility Study of Treatment for Patients With Drug-resistant or Relapsed Advanced Ovarian Epithelial Cancer or Endometrial Cancer","Inclusion Criteria:\n\n1. Age ≥18 years, ≤80 years\n2. Recurrent\u002Fdrug-resistant gynecological tumors include: ① patients with advanced high-grade ovarian serous cancer whose tumor is uncontrolled or recurrent within 6 months after receiving platinum-based chemotherapy; ② Advanced ovarian high-grade serous cancer patients with platinum resistance at first treatment; ③ Patients with advanced or recurrent endometrial adenocarcinoma.\n3. Life expectancy \\> 6 months;\n4. Malignant tumors that are not being treated by other systems or are in an active phase;\n5. Have at least one measurable target lesion according to RECIST1.1 criteria;\n6. Specimen requirements: fresh specimens with sufficient cell culture, including tissue samples and abdominal effusion;\n7. Physical strength score: ECOG 0-2;\n8. Major organ functions must meet clinical treatment requirements:\n\n   * Blood routine: neutrophil (ANC) ≥1.5x109\u002FL; Platelet count (PLT) ≥90x109\u002FL; Hemoglobin (Hb) ≥90g\u002FL; ② Blood biochemistry: total bilirubin (TBIL) ≤1.5x upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5xULN; Urea nitrogen (BUN) and creatinine (Cr) ≤1.5 x ULN\n\n(3) Heart color ultrasound: left ventricular ejection fraction (LVEF) ≥55%;\n\n④ 12-lead ECG: Fridericia method corrected QT period (QTcF) \\\u003C 470 msec. (9) Consent to abstinence from sex or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment for female patients who are not menopausal or have not been surgically sterilized; (10) Patients participating in the study (or their legal representatives) understand and voluntarily sign informed consent, have good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients who are unable to provide sufficient fresh samples;\n2. pregnant and lactating women, female patients with fertility and positive pregnancy tests, or patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period;\n3. The patient has uncontrollable co-morbidity, including but not limited to: symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, diabetes uncontrolled blood sugar, arrhythmia and mental illness;\n4. Other circumstances in which the investigator determines that participation in the study is not appropriate.","FEMALE","80 Years",{"count":53,"type":19},40,"The clinical treatment of patients with resistant\u002Frelapsed\u002Fadvanced gynecological malignancies is very difficult, and the difficulty lies in the selection of effective drugs. This study was a cohort study of recurrent\u002Fdrug-resistant advanced ovarian high-grade serous carcinoma and advanced\u002Frecurrent endometrial adenocarcinoma treated in our hospital. A total of 20 cases were included in the proposed study group, including 12 cases of high-grade serous ovarian carcinoma and 8 cases of endometrial adenocarcinoma. Twenty patients who did not use PTC model to guide treatment at the same period were selected as controls. To compare the consistency of in vitro drug sensitivity detection results of PTC microtumor with clinical therapeutic effect, and to explore the feasibility of using PTC microtumor model to guide the treatment of patients with drug-resistant\u002Frecurrent advanced ovarian epithelial cancer or endometrial cancer. The clinical therapeutic effects of the study group and the control group were compared, and the rates of CR, PR, SD, PFS, OS and TTP were evaluated by RECIST1.1 standard. PTC models based on different clinical samples (tissue and ascites) were compared to analyze the consistency of in vitro drug sensitivity detection results and the relationship with clinical efficacy.",[27],"2024-01-22",{"date":58,"type":34},"2024-01-30",{"date":60,"type":34},"2023-09-01",{"date":62,"type":19},"2026-09-30",{"name":64,"class":41},"Hua Li"]