[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"concurrent-chemoradiotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:concurrent-chemoradiotherapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,76,103],{"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":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100599589","phase-2-combination-of-concurrent-chemoradiotherapy-with-surufatinib-and-tislelizumab-in-patients-with-locally-advanced-non-small-cell-lung-cancer-100599589",false,"NCT07086456","Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer","Evaluating the Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Prospective, Single-Arm Phase II Clinical Trial","Inclusion Criteria:\n\n* A written and dated informed consent form must be obtained prior to the initiation of any study-specific procedures.\n* Male or female patients aged 18 to 75 years.\n* Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer (NSCLC) (Stage IIIA-IIIC).\n* Tumor sample requirement: Adequate archival, unstained tumor tissue samples must be provided for analysis.\n* Expected life expectancy of ≥12 weeks.\n* World Health Organization (WHO) performance status (PS) score of 0 or 1.\n* Postmenopausal women, or negative urine or serum pregnancy test (with a minimum sensitivity of 25 IU\u002FL or equivalent for HCG) within 14 days prior to receiving study medication.\n* Female participants must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use effective contraception during the study treatment period and for 6 months after the last dose of study drug.\n* Male participants who are sexually active with WOCBP must agree to use effective contraception during the study treatment period and for 6 months after the last dose of study drug.\n* Male participants with azoospermia are exempt from contraceptive requirements. WOCBP who are not heterosexually active are also exempt from contraceptive use but must still undergo pregnancy testing as specified above.\n* Adequate organ and bone marrow function as defined by the following criteria: Forced expiratory volume in 1 second (FEV1) ≥ 800 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 9.0 g\u002FdL; Serum creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; Cockcroft and Gault, 1976); Total serum bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN\n\nExclusion Criteria:\n\n* Participation in another clinical study, unless it is an observational (non-interventional) study.\n* Histological diagnosis of combined small cell and non-small cell lung cancer.\n* Presence of EGFR or ALK driver gene mutations.\n* Any condition that may affect oral medication administration (e.g., dysphagia, chronic diarrhea, bowel obstruction).\n* Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).\n* Average QT interval corrected for heart rate (QTc) ≥ 470 ms, calculated using Bazett's formula from three ECG cycles.\n* Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, clinically significant arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, or patients who are HBsAg-positive with HBV DNA \\> 500 IU\u002FmL, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection. Also excluded are individuals with psychiatric or social conditions that may interfere with study compliance or the ability to provide written informed consent.\n* History of another primary malignancy within 5 years prior to study treatment initiation, except for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.\n* Pregnant or breastfeeding women; or women and men of reproductive potential who are not using effective contraception.\n* Use of immunosuppressive medications within 28 days prior to the first dose of tislelizumab, excluding intranasal corticosteroids at physiological doses and systemic corticosteroids at a dose equivalent to ≤10 mg\u002Fday of prednisone.\n* History of autoimmune disease or active autoimmune disease within the past 2 years.\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* History of primary immunodeficiency.\n* History of organ transplantation requiring immunosuppressive therapy.\n* Receipt of a live attenuated vaccine within 30 days prior to study initiation or within 30 days after receiving tislelizumab.\n* Any condition that, in the investigator's judgment, may interfere with the assessment of efficacy or safety of the study treatment.","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of surufatinib and tislelizumab in combination with concurrent chemoradiotherapy, followed by consolidation therapy with tislelizumab plus surufatinib, in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).",[27,28,29,30,31],"Surufatinib","Tislelizumab","Concurrent Chemoradiotherapy","Consolidation Therapy","Non-small Cell Lung Cancer",[33,34,35,36,37],"surufatinib","tislelizumab","concurrent chemoradiotherapy","consolidation therapy","non-small cell lung cancer","RECRUITING","2025-07-24",{"date":41,"type":42},"2025-07-25","ACTUAL",{"date":44,"type":21},"2025-07-20",{"date":46,"type":21},"2029-07-19",{"name":48,"class":49},"Sun Yat-sen University","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":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100572548","phase-3-neoadjuvant-immunotherapy-plus-chemotherapy-followed-by-concurrent-chemoradiotherapy-and-consolidative-immunotherapy-for-locally-advanced-non-small-cell-lung-cancer-100572548","NCT06734702","Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer","Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy Compared With Concurrent Chemoradiotherapy and Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study","Inclusion Criteria:\n\n* Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant.\n* Age Range: Male or female patients aged 18 to 75 years.\n* Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis.\n* Previous Treatment: Patients must not have received prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.\n* Tumor Sample Requirement: Tumor tissue samples must be provided, and they should be sufficient for analysis. The samples must be unstained and archived.\n* Life Expectancy: Patients must have an expected survival of at least 12 weeks.\n* Performance Status (PS): The patient's WHO Performance Status (PS) must be 0 or 1.\n* Pregnancy Testing: Postmenopausal women, or women who have had a negative urine or serum pregnancy test within 14 days before the study medication (HCG sensitivity ≥ 25 IU\u002FL or equivalent).\n* Breastfeeding: Women must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment period and for 5 months after the last dose of the investigational drug (i.e., 30 days \\[ovulation cycle\\] + approximately 5 half-lives of the study drug).\n* Men who have sexual relations with WOCBP must agree to use contraception during the study treatment period and for 7 months after the last dose of the investigational drug (i.e., 90 days \\[sperm renewal cycle\\] + approximately 5 half-lives of the study drug).\n* Males with no sperm production are exempt from contraception requirements. WOCBP who are not sexually active are exempt from contraception but must still undergo pregnancy testing as outlined above.\n* Organ and Bone Marrow Function: The following laboratory parameters must be met:\n\nForced expiratory volume in 1 second (FEV1) ≥ 800 mL Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 9.0 g\u002FdL Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 50 mL\u002Fmin Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) AST and ALT ≤ 2.5 × ULN\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria should not be enrolled in the study:\n* Concurrent participation in another clinical trial, except for observational (non-interventional) studies.\n* Histological subtype of mixed small-cell and non-small-cell lung cancer. Use of immunosuppressive drugs within 28 days before treatment, except for intranasal or inhaled corticosteroids at physiological doses or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent.\n* Prior treatment with anti-PD-1 or anti-PD-L1 antibodies.\n* Major surgery within 4 weeks prior to enrollment (excluding procedures for vascular access).\n* History or active autoimmune diseases within the past two years.\n* Active or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* History of primary immunodeficiency.\n* History of organ transplantation requiring immunosuppressive therapy.\n* Average corrected QT interval (QTc) ≥470 ms calculated from three ECG cycles using the Bazett formula.\n* Uncontrolled comorbidities, including but not limited to: Persistent or active infections. Symptomatic congestive heart failure. Poorly controlled hypertension. Unstable angina. Cardiac arrhythmias. Active peptic ulcer disease or gastritis. Active bleeding disorders. Hepatitis C or HIV infection. HBsAg-positive patients with HBV DNA \\>500 IU\u002FmL. Mental or social conditions that may limit adherence to study requirements or compromise the ability to provide informed consent.\n* Known history of tuberculosis.\n* Receipt of a live attenuated vaccine within 30 days before study initiation or planned during the study period.\n* History of another primary malignancy within the past 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or in situ cervical cancer.\n* Pregnancy, breastfeeding, or not using effective contraception (for men and women of reproductive potential).\n\nPatients in the experimental group should not proceed to concurrent chemoradiotherapy if any of the following criteria are met:\n\n* Presence of distant metastases.\n* Locoregional progression making definitive concurrent chemoradiotherapy unfeasible due to normal tissue dose constraints (assessed by the radiation oncologist).\n* WHO performance status score of 2-4.\n* Impaired organ or bone marrow function, including:\n\nForced expiratory volume in 1 second (FEV1) \\\u003C800 mL. Absolute neutrophil count (ANC) \\\u003C1.5 × 10⁹\u002FL. Platelets \\\u003C100 × 10⁹\u002FL. Hemoglobin \\\u003C9.0 g\u002FdL. Creatinine clearance (Cockcroft-Gault formula) \\\u003C50 mL\u002Fmin. Serum bilirubin \\>1.5 × upper limit of normal (ULN). AST and ALT \\>2.5 × ULN.\n\n\\- Patient withdrawal from the study.\n\nPatients should not proceed to consolidation immunotherapy if any of the following criteria are met:\n\n* Disease progression during concurrent chemoradiotherapy.\n* Use of immunosuppressive drugs within 28 days before the first dose of tislelizumab, except for physiological doses of intranasal or inhaled corticosteroids or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent. Use of corticosteroids to manage chemoradiotherapy-related toxicity is permitted.\n* Persistent unresolved CTCAE grade \\>2 toxicities from prior chemoradiotherapy.\n* Grade ≥2 pneumonitis resulting from prior chemoradiotherapy.\n* Any prior grade ≥3 immune-related adverse event (irAE) or unresolved irAE \\> grade 1.",{"count":59,"type":21},497,[61],"PHASE3","Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC), leading to a 5-year survival rate of over 40%. The optimal timing of radiotherapy combined with immunotherapy still requires further exploration. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy, compared with concurrent chemoradiotherapy and consolidative immunotherapy in LANSCLC patients.",[64,29,65,66],"Neoadjuvant Therapy","Immunotherapy","Locally Advanced Non-Small Cell Lung Cancer",[68,29,65,66],"Neoadjuvant therapy","2025-07-19",{"date":39,"type":42},{"date":72,"type":42},"2024-11-30",{"date":74,"type":21},"2028-11-29",{"name":48,"class":49},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100538249","phase-2-neoadjuvant-chemoimmunotherapy-versus-concurrent-chemoradiotherapy-for-lacc-100538249","NCT06288373","Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC","Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Locally advanced (2018 FIGO staged IB3, IIA2 and IIB（tumor size\\> 4cm) ) cervical cancer，staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);\n2. At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;\n3. Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma (common type), and adenosquamous carcinoma;\n4. Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;\n5. Patient age ≥18 years and ≤70 years;\n6. ECOG score ≤1;\n7. Laboratory tests: WBC (white blood cell count) ≥ 3.5×109\u002FL, NEU (neutrophil count) ≥ 1.5×109\u002FL, PLT (platelet count) ≥ 100×109\u002FL, total bilirubin ≤ 1.5 times the upper limit of normal, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 1.5 times the upper limit of normal, serum creatinine (BUN) ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration equation, or the Modification of Diet in Renal Disease equation);\n8. Be willing to follow up and good compliance;\n9. Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program；\n10. Agree to use effective contraception measures during the trial period and for 5 months after the last dose of pembrolizumab or 6 months after chemotherapy (whichever is longer).\n\nExclusion Criteria:\n\n1. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;\n2. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;\n3. Has a history of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), and hepatitis C (HCV antibody positive, and HCV-RNA above the lower limit of detection of the assay);\n4. Receipt of immunosuppressive medications or systemic corticosteroid therapy for immunosuppression (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to study dosing;\n5. Diagnosed with another primary malignancy within 5 years prior to the first use of the investigational drug;\n6. Received other investigational drugs\u002Ftreatments or participated in another clinical trial within 4 weeks prior to randomization. Participation in observational and non-interventional clinical trials is allowed;\n7. Pregnant or breastfeeding female patients;\n8. Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe\u002Funstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or individuals with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR \\>2. 0, PT\\>16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and development of an active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;\n9. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;\n10. Patients with a prior allogeneic bone marrow or solid organ transplant;\n11. Drug and\u002For alcohol abuse;\n12. Patients who, in the opinion of the investigator, are unlikely to comply with the procedures, restrictions, and requirements of the study may not be enrolled in the study.","FEMALE","70 Years",{"count":86,"type":21},440,[24,61],"It is a prospective, open-label, randomized, controlled phase II\u002FIII clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \\>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.",[90,91,29,92],"Cervical Cancer","Locally Advanced Cervical Cancer","Neoadjuvant Chemoimmunotherapy","2024-10-26",{"date":95,"type":42},"2024-10-30",{"date":97,"type":42},"2024-04-22",{"date":99,"type":21},"2031-03-01",{"name":101,"class":49},"Tongji Hospital",12,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":18,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":50},"100546150","phase-1-concurrent-chemoradiotherapy-followed-by-pd-1-inhibitor-in-advanced-cervical-cancer-100546150","NCT06391190","Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer","A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel\u002FCisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Age between 18 and 75;\n2. Untreated patients with pathologically proven locally advanced cervical cancer;\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n4. Adequate hematological, renal and hepatic functions:\n\n   4.1 Hemoglobin \\> 8.0 g\u002Fdl 4.2 Neutrophils \\> 2000 cells\u002Fμl; Leukocytes \\> 4 × 109\u002FL 4.3 Platelets \\> 100 × 109\u002FLg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT\u002FAST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL\n5. Life expectancy \\> 6 months\n6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;\n7. No obvious active bleeding;\n8. Written informed consent must be available before study registration.\n\nExclusion Criteria:\n\n1. Recurrent or distant metastatic disease;\n2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;\n3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;\n4. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;\n5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;\n6. Previous organ transplantation or HIV patients;\n7. Allergic to macromolecular proteins \u002Fmonoclonal antibodies, or to any test drug component;\n8. Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\\> 2000IU\u002Fml or 104 copies\u002Fml; hepatitis C virus (HCV) RNA\\> 103 copies\u002Fml.",{"count":111,"type":21},20,[113,24],"PHASE1","To explore the safety and efficacy of Albumin-Bound Paclitaxel\u002FPlatinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer",[116,29,65],"Locally Advanced Cervical Carcinoma","2024-04-25",{"date":119,"type":42},"2024-04-30",{"date":121,"type":42},"2022-01-01",{"date":123,"type":21},"2026-12-30",{"name":125,"class":49},"RenJi Hospital"]