[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-checkpoint-inhibitors-icis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-checkpoint-inhibitors-icis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,38,54,82,107,138,170,191],{"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":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100644128","real-world-study-on-the-efficacy-safety-and-prognostic-factors-of-immune-checkpoint-inhibitors-combined-with-radiotherapy-in-patients-with-malignant-tumors-a-prospective-non-interventional-clinical-study-100644128",false,"NCT07665736","Real-world Study on the Efficacy, Safety, and Prognostic Factors of Immune Checkpoint Inhibitors Combined With Radiotherapy in Patients With Malignant Tumors: A Prospective Non-interventional Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically or cytologically confirmed malignant tumor;\n3. Planned to receive immunotherapy combined with radiotherapy as the basis of treatment;\n4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);\n5. Adequate organ function (reference may be made to laboratory test indicators, such as routine blood tests, liver and kidney function);\n6. Voluntarily participate in this study, sign the informed consent form, and agree to comply with follow-up.\n\nExclusion Criteria:\n\n1. Patients with severe cognitive impairment, mental illness, or other conditions that, in the judgment of the investigator, preclude them from cooperating with participation in this study;\n2. Active, uncontrolled serious infection, or known human immunodeficiency virus (HIV) infection;\n3. Pregnant or breastfeeding women;\n4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","OBSERVATIONAL","Currently, chemotherapy, targeted therapy, immunotherapy, and radiotherapy are the core treatment modalities for malignant tumors, with technologies advancing rapidly. Radiotherapy can induce massive tumor cell death in a short period and expose abundant tumor-specific antigens, turning the irradiated tumor into an endogenous tumor vaccine and even causing regression or disappearance of non-irradiated tumors (the abscopal effect) . Preclinical studies have shown that stereotactic body radiotherapy (SBRT) combined with PD-1\u002FPD-L1 inhibitors can activate systemic immunity, sensitize tumor-specific T cells to enter the bloodstream, and enable their homing to distant tumors, thereby inhibiting the growth of non-irradiated tumors . However, conclusions from rigorous randomized controlled trials have limitations when applied to the complex and heterogeneous patient populations in real-world settings. Real-world research is increasingly valued globally to complement traditional clinical trial evidence. This project prospectively collects data from patients receiving immunotherapy combined with radiotherapy in real-world clinical practice, which is of great value for evaluating long-term efficacy, safety, and impact on quality of life, and can provide high-level evidence for optimizing clinical practice and informing healthcare decisions.",[23,24],"Radiotherapy","Immune Checkpoint Inhibitors (ICIs)","NOT_YET_RECRUITING","2026-06-19",{"date":28,"type":29},"2026-06-24","ACTUAL",{"date":31,"type":19},"2026-06-30",{"date":33,"type":19},"2029-06-15",{"name":35,"class":36},"Sichuan University","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":46,"conditions":47,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":50,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":53,"locationsCount":37},"100644182","analysis-of-efficacy-and-outcomes-of-immunotherapy-for-malignant-tumors-a-prospective-non-interventional-clinical-study-100644182","NCT07665697","Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically or cytologically confirmed malignant tumor;\n3. Planned to receive immune checkpoint inhibitor (e.g., PD-1\u002FPD-L1 inhibitor)-based therapy (monotherapy or in combination with chemotherapy\u002Ftargeted therapy\u002Fradiotherapy, etc.);\n4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);\n5. Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);\n6. Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.\n\nExclusion Criteria:\n\n1. Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);\n2. Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;\n3. Pregnant or breastfeeding women;\n4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).",{"count":45,"type":19},500,"The population receiving immunotherapy is heterogeneous. Multiple factors, including combination treatment modalities, influence the immune response, and survival outcomes also vary among individuals receiving immunotherapy. The aim of this study is to develop and validate a clinical prediction model that can predict survival outcomes of immunotherapy for malignant tumors, and to assess the calibration and discrimination of this model in a prospective independent cohort.",[48,49,24],"Neoplasms","Drug Therapy",{"date":28,"type":29},{"date":31,"type":19},{"date":33,"type":19},{"name":35,"class":36},{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100637502","phase-1-exploratory-study-on-the-efficacy-and-safety-of-nebulized-huc-msc-derived-exosomes-for-non-acute-cip-100637502","NCT07599111","Exploratory Study on the Efficacy and Safety of Nebulized hUC-MSC-Derived Exosomes for Non-Acute CIP","Exploratory Study on the Efficacy and Safety of Nebulized Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Non-Acute Immune Checkpoint Inhibitor-Related Pneumonitis","Inclusion Criteria:\n\n* Informed consent: Signed written informed consent.\n* Age and diagnosis: Aged 18-75 years with histologically confirmed malignant tumor.\n* Treatment history: Received at least one cycle of immune checkpoint inhibitor therapy and developed immune checkpoint inhibitor-related pneumonitis.\n* Confirmed Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP) by clinical evaluation (diagnosis and grading in accordance with the NCCN Guidelines for Management of Immunotherapy-Related Toxicities Version 1.2025), having received standard glucocorticoid therapy for ≥4 weeks, with glucocorticoids either discontinued or tapered to a prednisone-equivalent dose of \\\u003C20 mg\u002Fday.\n* Recent HRCT imaging: Persistent residual CIP-related lesions in both lungs, including ground-glass opacity, consolidation, reticular opacity, traction bronchiectasis, and\u002For honeycombing, involving a large extent of the lung fields; no significant resolution or improvement of these residual lesions on repeated HRCT within the past 4 weeks.\n* General condition: ECOG PS score 0-1, with stable control of the primary tumor for ≥6 months.\n* Contraception: Fertile subjects agree to use effective contraception during the study period and for 360 days after the last dose.\n\nExclusion Criteria:\n\n* Concomitant medication: Current use of antifibrotic agents such as pirfenidone and nintedanib.\n* Operational limitation: Inability to cooperate with pulmonary function testing or nebulized inhalation.\n* History of other pulmonary diseases: Presence of unresolved interstitial lung disease or pulmonary fibrosis induced by targeted therapy, radiotherapy, or other causes.\n* Severe comorbidities: Including severe cardiac, hepatic, or renal insufficiency, or severe hematological abnormalities.\n* Specific medical history: Severe neuromuscular disease, history of organ transplantation, active epilepsy, primary or severe acquired\u002Fsecondary immunodeficiency.\n* Other factors: Severe allergic constitution, psychiatric disorders, use of other investigational products within 28 days, or any other condition deemed inappropriate by the investigator.","75 Years",{"count":63,"type":19},40,"INTERVENTIONAL",[66,67],"PHASE1","PHASE2","Study Objectives The primary objective of Phase II is to evaluate the percentage of lesion resolution on high-resolution computed tomography (HRCT) as assessed by independent blinded reviewers. Secondary objectives include evaluating effects on pulmonary function, exercise capacity, dyspnea, quality of life, and oxygenation, as well as comprehensively assessing safety and tolerability. Phase I focuses on determining safety, dose-limiting toxicities (DLT), and recommended Phase II dose.\n\nStudy Population\n\nThe target population is patients with non-acute CIP aged 18-75 years with histologically confirmed malignancy. Key inclusion criteria include:\n\nAt least one cycle of immune checkpoint inhibitor (ICI) therapy and development of Grade 3-4 CIP per NCCN Guidelines V1.2025 Standard glucocorticoid treatment for ≥4 weeks, with current dose \\\u003C20 mg\u002Fday prednisone equivalent or discontinued Persistent residual CIP lesions on HRCT without significant improvement in the past 4 weeks ECOG PS 0-1 and stable primary tumor for ≥6 months Effective contraception during the study and for 360 days after last dosing\n\nKey exclusion criteria include:\n\nConcomitant use of pirfenidone, nintedanib, or other antifibrotic agents Inability to perform pulmonary function tests or tolerate nebulization Unresolved interstitial lung disease from radiotherapy or targeted therapy Severe cardiac, hepatic, renal, or hematological dysfunction Organ transplantation, severe immunodeficiency, active epilepsy, or severe allergic status Other investigational drug use within 28 days Study Design and Sample Size Phase I: 9-18 subjects, open-label, dose-escalation design to evaluate DLT and safety Phase II: 40 subjects, randomized, double-blind, placebo-controlled design Study Endpoints Phase I Primary Endpoints Incidence of DLT Incidence of adverse events (AE) and serious adverse events (SAE) Phase II Primary Endpoint Percentage of HRCT lesion resolution at Weeks 4, 12, and 24, assessed by independent blinded reviewers Secondary Endpoints Pulmonary function: FVC%, TLC, RV, FRC, DLCO Functional and symptomatic measures: 6MWD, mMRC dyspnea score, SGRQ, LCQ Oxygenation: PaO₂, A-aDO₂, oxygenation index Exploratory Endpoints Dynamic changes in serum biomarkers: KL-6, cytokines (IL-1β, IL-6, IL-10), immune cell subsets (Tregs, Th1\u002FTh17) Safety Assessments Monitoring of AEs\u002FSAEs graded by CTCAE v5.0 and causality assessment Physical examination, vital signs, SpO₂, 12-lead ECG Laboratory tests: CBC, biochemistry, coagulation, urinalysis, CRP, ESR Study Termination Rules Overall Study Termination Successful completion after all 40 subjects finish 24-week follow-up and database lock Occurrence of unexpected serious or unacceptable safety risks Demonstration of overwhelming efficacy or futility Sponsor termination due to slow enrollment, funding, or major protocol deviations Regulatory or ethics committee requirements Individual Subject Discontinuation Development of DLT or severe hypersensitivity Rapid CIP progression (e.g., \\>50% radiological worsening) Tumor progression or clinical deterioration Withdrawal of informed consent Poor compliance unresponsive to intervention Loss to follow-up or death Investigator judgment of inappropriateness for continued participation Study Timeline Preparation and initiation: January 2026 - May 2026 Phase I\u002FII enrollment: June 2026 - May 2027 Treatment and follow-up (overlapping with enrollment): through June 2028 Database lock and statistical analysis: July 2028 - August 2028 Study closeout: August 2028 - December 2028",[70,24,71,72],"Pneumonitis, Interstitial","Mesenchymal Stem Cells","Exosomes","2026-05-13",{"date":75,"type":29},"2026-05-20",{"date":77,"type":19},"2026-04",{"date":79,"type":19},"2028-10",{"name":81,"class":36},"Zhou Chengzhi",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":88,"targetDuration":90,"studyType":20,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100589152","development-and-application-of-a-thrombosis-risk-prediction-model-in-lung-cancer-patients-treated-with-immune-checkpoint-inhibitors-100589152","NCT06950697","Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Age ≥18 years\n* Histopathologically confirmed lung cancer diagnosis at enrollment\n* Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Presence of two or more primary cancers\n* Missing data for key variables\n* Inability to comply with follow-up requirements\n* Presence of VTE\u002FATE at the time of ICI initiation",{"count":89,"type":19},2400,"30 Months","The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are:\n\n1. What is the real-world incidence of VTE\u002FATE in lung cancer patients receiving immune checkpoint inhibitors?\n2. What are the risk factors and biomarkers for VTE\u002FATE in lung cancer patients receiving immune checkpoint inhibitors?\n3. What is the impact of VTE\u002FATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors?\n\nResearchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE\u002FATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.",[93,94,95,24],"Lung Cancer","Venous Thromboembolism","Arterial Thromboembolism","RECRUITING","2026-04-26",{"date":99,"type":29},"2026-04-30",{"date":101,"type":29},"2019-01-01",{"date":103,"type":19},"2027-12-01",{"name":105,"class":36},"Beijing Chao Yang Hospital",5,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":61,"enrollmentInfo":114,"targetDuration":4,"studyType":64,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100589225","phase-2-ctdna-mrd-guided-escalation-of-ivonescimab-and-docetaxel-in-advanced-nsclc-with-long-term-responses-to-first-line-immunotherapy-cr1stal-adaptive-100589225","NCT06951646","ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)","ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy: a Randomized, Open-label, Phase II Trial (CR1STAL-Adaptive)","Inclusion Criteria:\n\n1. Sign written informed consent prior to any study-related procedures, be willing and able to complete the visits, treatment regimen, and laboratory tests specified in the schedule, and comply with other requirements of the study;\n2. Aged ≥18 and ≤75 years old;\n3. ECOG PS score 0-1;\n4. Expected survival time ≥ 12 weeks;\n5. Patients with stage IIIB-IIIC and IV non-small cell lung cancer confirmed by histology or cytology that cannot be treated locally (TNM lung cancer staging of the 9th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification);\n6. There must be no EGFR gene-sensitive mutation, ALK gene fusion or ROS1 gene fusion in non-squamous carcinoma\n7. Immunotherapy combined with platinum-containing doublet chemotherapy as a first-line standard treatment regimen;\n8. Non-PD with PFS at screening enrollment is 11 to 15 months;\n9. According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), it is recommended to have at least one measurable lesion, but patients without measurable lesions can still be included in the group (primary tumor recurrence or new metastatic lesions are considered PD).\n\nParticipants with brain metastases who are asymptomatic or whose symptoms are stable after local treatment are allowed to enroll, as long as the participants meet the following conditions:\n\n1. There are measurable lesions outside the central nervous system\n2. No central nervous system symptoms or no worsening of symptoms for at least 2 weeks\n3. No need for glucocorticoid treatment, or glucocorticoid treatment was discontinued within 7 days before the first dose, or the glucocorticoid dosage was stable and reduced to less than 10mg\u002Fday prednisone (or equivalent dose) within 7 days before the first dose.\n\n10\\. Meet the following laboratory indicators (within 14 days before the first treatment):\n\n1. Routine blood test: absolute neutrophil count ≥1.5×109\u002FL; platelet count ≥100×109\u002FL; hemoglobin content ≥9.0 g\u002FdL (no blood transfusion or erythropoietin-dependent administration within 7 days).\n2. Liver function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); for patients with liver metastasis or confirmed\u002Fsuspected Gilbert's syndrome, TBIL ≤3×ULN; in the absence of liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. For patients with liver metastasis, ALT or AST ≤5×ULN.\n3. Renal function: serum creatinine (Cr) ≤ 1.5 times ULN or Cr clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula), and urine routine test results show urine protein (UPRO) \\\u003C2+ or 24-hour urine protein quantification \\\u003C1g.\n4. Coagulation function: international normalized ratio (INR) ≤ 1.5 times ULN or partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; if the study participants are receiving anticoagulant therapy, as long as PT is within the range of the anticoagulant drug;\n5. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% 11. For female study participants of childbearing age, a urine or serum pregnancy test with a negative result should be performed within 3 days before the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as women who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; if there is a risk of pregnancy, all study participants (whether male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).\n\n12\\. If an intact male study participant has sexual intercourse with a female partner of reproductive potential, the study participant must use effective contraception from screening until day 120 after the last dose. Whether to discontinue contraception after this time point should be discussed with the investigator.\n\nExclusion Criteria:\n\n1. Concurrent participation in another interventional clinical study or receipt of another investigational drug, unless participating in an observational clinical study；\n2. Systemic therapy with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thiopeptides, interferons, interleukins, except those used locally for the control of hydrothorax or ascites) within 2 weeks prior to the first dose；\n3. No measurable lesions as defined by RECIST 1.1 due to prior radical treatment (e.g., surgery or radiotherapy)\n4. Subjects who have received systemic antiangiogenic therapy;\n5. Subjects who are enrolled in another clinical study at the same time, unless it is a non-interventional clinical study or the follow-up period of an interventional study (defined as the time between the first dose of this study and the last dose of the previous clinical study being more than 4 weeks or more than 5 half-lives of other study drugs, whichever is shorter);\n6. During the screening period, imaging shows that the tumor surrounds important blood vessels or there is significant necrosis or cavity, and the investigator determines that entering the study will cause a risk of bleeding;\n7. Imaging findings during the screening period show that the tumor invades important peripheral organs and blood vessels (such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or there is a risk of developing esophagotracheal fistula or esophagopleural fistula;\n8. Active autoimmune diseases requiring systemic treatment (such as treatment with disease-modifying drugs, corticosteroids, and immunosuppressants) within 2 years before the first dose (excluding irAEs caused by the use of PD-1\u002FL1 inhibitors). Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;\n9. A history of major diseases within 1 year before the first dose, specifically:\n\n   * Unstable angina, myocardial infarction, congestive heart failure (NYHA classification ≥ Class 2) or vascular diseases (such as aortic aneurysm with a risk of rupture) that require hospitalization within 12 months before the first dose, or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial ischemia, etc.);\n   * Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh class B or more severe cirrhosis\n   * Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy;\n   * Hyperglycemia that cannot be controlled after treatment (fasting blood glucose \\> 10 mmol\u002FL);\n   * A history of esophageal and gastric varices, with severe ulcers and unresolved wounds, abdominal fistulas, intraabdominal abscesses, or acute gastrointestinal bleeding within 6 months before the first dose;\n   * Any arterial thromboembolic events, venous thromboembolic events of grade 3 orabove as specified in NCI CTCAE 5.0, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy that occurred within 6 months before the first dose;\n   * Acute exacerbation of chronic obstructive pulmonary disease that occurred within 4 weeks before the first dose;\n   * Active or prior history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);\n10. A history of gastrointestinal perforation and\u002For fistula, a history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), or extensive bowel resection (partial colon resection or extensive small bowel resection, with chronic diarrhea) within 6 months before the first dose;\n11. Those who have received chest radiotherapy \\>30 Gy within 6 months before the first dose, non-chest radiotherapy \\>30 Gy within 4 weeks before the first dose, and palliative radiotherapy ≤ 30 Gy within 2 weeks before the first dose, and who have not recoveredfrom the toxicity and\u002For complications of these interventions to NCI-CTC AE ≤ grade 1 (excluding alopecia and fatigue). Palliative radiotherapy to control symptoms is allowed, but it must be completed at least 2 weeks before the first dose, and no additional radiotherapy is scheduled for the same lesion;\n12. Those who have received live or live attenuated vaccines within 4 weeks before the first dose, or plan to receive live or live attenuated vaccines during the study period. The use of inactivated vaccines is allowed;\n13. Severe infections within 4 weeks before the first dose, including but not limited to complications requiring hospitalization such as sepsis, or severe pneumonia; active infections that have received systemic anti-infective treatment within 2 weeks before the first dose (excluding antiviral treatment for hepatitis B or C);\n14. Those with a history of severe bleeding tendencies or coagulation disorders; those with clinically significant bleeding symptoms within 4 weeks before the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or vomiting up ≥ 1 teaspoon of blood or small blood clots, or only coughing up blood without sputum; those with blood in the sputum are allowed to be enrolled), nasal bleeding (excluding epistaxis and bloody nasal discharge); those who have received continuous antiplatelet or anticoagulant therapy (except for preventive use of anticoagulants, such as the use of anticoagulants to maintain venous patency) within 14 days before the first dose;\n15. Those who have undergone major surgery or experienced severe trauma within 4 weeks before the first dose, or have a major surgery planned within 4 weeks after the first dose (as determined by the investigator);\n16. Presence of clinically uncontrolled pleural effusion or ascites (subjects may be recruited who do not require drainage of the effusion or who do not have a significant increase in the effusion after 3 days of cessation of drainage)\n17. Previous history of non-infectious pneumonia requiring systemic glucocorticoid treatment or current interstitial lung disease;\n18. Those with a history of immunodeficiency; those with positive HIV antibody tests;\n19. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n20. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA \\> 1000 copies\u002FmL (200 IU\u002FmL) or above the lower limit of detection, whichever is higher), for subjects with hepatitis B who are required to receive anti-hepatitis B virus treatment during the study treatment period; subjects with active hepatitis C subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n21. Known presence of active pulmonary tuberculosis (TB);\n22. Known active syphilis infection;\n23. Known allergy to any component of any study drug; a known history of severe hypersensitivity to other monoclonal antibodies\n24. Those with a history of immunodeficienc; those who are currently receiving long-term systemic corticosteroids or other immunosuppressants;\n25. A known history of mental illness, drug abuse, alcohol or drug addiction;\n26. The toxicity of previous anti-tumor therapy has not been relieved, which is defined as the toxicity has not returned to grade 1 or below specified in NCI CTCAE 5.0, or the level specified in the inclusion\u002Fexclusion criteria, except for alopecia and fatigue;\n27. Known symptomatic CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may be enrolled in the trial if they are clinically stable (no evidence of imaging progression for at least 4 weeks prior to the first dose of the experimental treatment, no evidence of new brain metastases or increase in size of pre-existing brain metastases as confirmed by repeat imaging) and do not require steroid therapy for at least 14 days prior to the first dose of the experimental treatment. This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable.\n28. History of other primary malignancies within 5 years, except：\n\n    * malignancies that have been in complete remission for at least 2 years prior to enrolment and for which no other treatment was required during the study period.\n    * adequately treated non-melanoma skin cancer or malignant nevus with no evidence of disease recurrence.\n    * adequately treated carcinoma in situ without evidence of disease recurrence\n29. Subjects who are pregnant or breastfeeding or plan to breastfeed during the study;\n30. Other acute or chronic illnesses, psychiatric disorders, or abnormal laboratory test values that could increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results and, in the investigator's judgment, render the patient ineligible for participation in the study.\n31. Uncontrolled metabolic disorders, or local or systemic diseases due to non-malignant tumors, or diseases or symptoms secondary to the tumor, which may lead to higher medical risk and\u002For uncertainty in survival assessment, or diseases that the investigator considers unsuitable for enrollment;",{"count":115,"type":19},70,[67],"The CR1STAL-Adaptive study is a randomized, open-label, phase II multicenter interventional trial designed to evaluate the safety and efficacy of Ivonescimab (PD-1\u002FVEGF bispecific antibody) combined with docetaxel versus standard treatment in patients with advanced NSCLC who have achieved long-term benefit from first-line immune checkpoint inhibitors (ICIs), but are ctDNA-MRD positive. Building upon insights from previous CR1STAL study (NCT05198154), the CR1STAL-Adaptive study supports the development of precision-guided, adaptive treatment strategies to delay progression and improve outcomes in NSCLC patients with a long-term response to immunotherapy. It represents a step forward in integrating dynamic molecular monitoring with individualized intervention strategies in the era of immunotherapy.",[119,24],"Non Small Cell Lung Cancer",[121,24,122,123,124,125,126,127],"Non Small Cell Lung Cancer (NSCLC)","Circulating-tumor DNA (ctDNA)","Minimal Residual Disease (MRD)","Ivonescimab (AK112)","Adaptive Therapy","Bispecific Antibody","Escalation","2026-03-06",{"date":130,"type":29},"2026-03-09",{"date":132,"type":19},"2026-03-10",{"date":134,"type":19},"2030-06-01",{"name":136,"class":36},"Second Xiangya Hospital of Central South University",20,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":146,"targetDuration":148,"studyType":20,"phases":4,"briefSummary":149,"conditions":150,"keywords":155,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":106},"100603787","the-impact-of-emotional-stress-on-immunotherapy-outcomes-in-liver-cancer-patients-a-multi-cohort-study-100603787","NCT07141056","The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study","Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study","SOLACE","Cohort 1 (SOLACE-1):\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Able to complete psychological questionnaires\n* Child-Pugh liver function class A\n* ECOG performance status ≤ 1\n* Signed informed consent\n* Expected survival \\> 3 months\n* Diagnosed with unresectable HCC by pathology or imaging\n* BCLC stage B or C\n* Has at least one measurable lesion (mRECIST)\n* About to receive first-line ICI treatment\n\nExclusion Criteria:\n\n* Currently taking antidepressant or anti-anxiety medications\n* Previous diagnosis of psychiatric disorders\n* Concurrent malignancy\n* Unable to complete psychological assessments\n* Previous systemic anti-tumor therapy\n* Symptomatic brain metastases\n* Child-Pugh score \\> 7\n\nCohort 2 (SOLACE-2):\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Able to complete psychological questionnaires\n* Child-Pugh liver function class A\n* ECOG performance status ≤ 1\n* Signed informed consent\n* Expected survival \\> 3 months\n* Pathologically confirmed HCC after curative surgery\n* Pathological stage II or III (AJCC 8th edition)\n* Will start adjuvant ICI therapy within 4-6 weeks after surgery\n* Expected survival \\> 12 months\n\nExclusion Criteria:\n\n* Currently taking antidepressant or anti-anxiety medications\n* Previous diagnosis of psychiatric disorders\n* Concurrent malignancy\n* Unable to complete psychological assessments\n* Residual lesions after surgery\n* Child-Pugh score B or C\n\nCohort 3 (SOLACE-3):\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Able to complete psychological questionnaires\n* Child-Pugh liver function class A\n* ECOG performance status ≤ 1\n* Signed informed consent\n* Expected survival \\> 3 months\n* Diagnosed with resectable HCC by pathology or imaging\n* Has at least one measurable lesion (RECIST 1.1)\n* About to receive neoadjuvant ICI treatment\n* Expected survival \\> 12 months\n\nExclusion Criteria:\n\n* Currently taking antidepressant or anti-anxiety medications\n* Previous diagnosis of psychiatric disorders\n* Severe cardiac, pulmonary, or renal dysfunction\n* Concurrent malignancy\n* Unable to complete psychological assessments\n* Previous systemic anti-tumor therapy\n* Symptomatic brain metastases\n* Child-Pugh score B or C",{"count":147,"type":19},700,"36 Months","The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.",[151,152,24,153,154],"HCC - Hepatocellular Carcinoma","Psychological Distress","Cancer, Treatment-Related","Unresectable Hepatocellular Carcinoma",[156,157,158,159,160],"Observational Study","Hepatocellular Carcinoma (HCC)","Emotional Distress","Immune Checkpoint Inhibitors","Cancer Immunotherapy","2025-08-18",{"date":163,"type":29},"2025-08-26",{"date":165,"type":29},"2025-01-01",{"date":167,"type":19},"2027-12-31",{"name":169,"class":36},"Guilin Medical University, China",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100578688","immune-checkpoint-inhibitors-icis-retreatment-in-second-line-treatment-of-advanced-gastric-cancer-a-retrospective-real-world-study-100578688","NCT06814548","Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study","Inclusion Criteria:\n\n* Histologically confirmed metastatic or advanced GC\u002FGEJC;\n* Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting;\n* Receiving at least 2 cycles of ICI-based second-line therapy;\n* ECOG PS 0 or 1;\n* Radiographic response was also assessed during treatment and survival.\n\nExclusion Criteria:\n\n* patients had other malignancies within the past 5 years;\n* lack of survival and clinical efficacy data;\n* combined radiotherapy regimens in the second-line treatment.",{"count":18,"type":19},"This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.",[179,24,180,181],"Gastric Cancer, Gastroesophageal Junction Cancer","Second-line","Retreatment","2025-02-03",{"date":184,"type":29},"2025-02-07",{"date":186,"type":19},"2025-02-10",{"date":188,"type":19},"2025-05-31",{"name":190,"class":36},"Yongxu Jia",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":64,"phases":201,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":37},"100567976","phase-2-neoantigen-vaccines-in-esophageal-squamous-cell-carcinoma-100567976","NCT06675201","Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma","Neoantigen Vaccines in Combination with Immune Checkpoint Inhibitors for Maintenance Therapy Following Definitive Treatment of Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: an Open-Label, Randomized, Phase II Study","Inclusion Criteria:\n\nA. Age 18-80 years\n\nB. Locally advanced unresectable ESCC patients after radical treatment (radical chemoradiotherapy or chemoradiation); including:\n\n* Cervical esophageal segment, T4, supraclavicular lymph node metastasis, or inability\u002Frefusal to undergo surgery due to personal reasons (refer to hospital below); ② Failure of neoadjuvant or conversion therapy; ③ Postoperative local recurrence, unresectable (target lesion present). C. No evidence of tumor recurrence or metastasis 2-3 weeks after radical treatment D. Ability to provide fresh tumor tissue samples (baseline) E. Normal major organ function F. Performance status (PS) score ≤ 1 G. Patients of childbearing potential must use contraception H. Voluntary participation with signed informed consent\n\nExclusion Criteria:\n\nA. History of fistula caused by primary tumor invasion B. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation C. Poor nutritional status D. Immune-related adverse events during prior radical treatment, such as Grade ≥3 pneumonitis, myocarditis, etc.\n\nE. Signs and symptoms of interstitial diseases F. Presence of any severe and\u002For uncontrolled medical conditions G. Presence of concurrent malignancies H. Presence of other autoimmune diseases, or prolonged use of immunosuppressants or steroids I. Difficulty in patient communication or inability to comply with long-term follow-up J. Other conditions deemed unsuitable by the investigator","80 Years",{"count":200,"type":19},165,[67],"The aim of this clinical trial is to evaluate the efficacy and safety of consolidation therapy with a neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) following radical chemoradiotherapy or chemoradiation-immunotherapy in patients with locally advanced, unresectable ESCC. The primary endpoint of the study is the OS rate. Secondary endpoints include OS, PFS, adverse events, CR rate, and quality of life (QoL) of patients. Exploratory endpoints involve the assessment of biomarkers such as TMB, PD-L1, and ctDNA.\n\nThe key questions this study aims to answer are:\n\n-Can the combination of (ICIs and NeoDC-Vac as maintenance therapy improve OS and QoL in patients with locally advanced, unresectable ESCC following radical treatment? Can this novel approach provide an effective treatment option for these patients?\n\nParticipant Procedures:\n\n1. Endoscopic examination at West China Hospital. Baseline fresh tumor tissue collection for NGS in neoantigen vaccine group.\n2. Screening assessments, informed consent, and random assignment to experimental or control group.\n\n   Experimental Group\\*\\*: Neoantigen-loaded vaccine + standard ICIs as maintenance therapy.\n\n   Control Group\\*\\*: Standard ICIs as maintenance. One cycle per month for one year.\n3. Tumor tissue NGS, ctDNA analysis, TIME evaluation, T cell response profiling. All costs covered by research funding.\n4. After completing the full treatment regimen, participants will be monitored with regular follow-up visits by healthcare professionals to assess ongoing health outcomes and safety.",[204,205,24],"Esophageal Squamous Cell Carcinoma (ESCC)","Neoantigen-loaded Dendritic Cell Vaccine",[204,207,208],"neoantigen tumor vaccine","immunotherapy","2024-11-03",{"date":211,"type":29},"2024-11-05",{"date":213,"type":29},"2024-10-01",{"date":215,"type":19},"2027-10-01",{"name":35,"class":36}]