[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-cancers":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,63,97,124,157,187,215,238,262,287,313,339,364,386,407,427,466,506],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":41,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100644985","clonal-hematopoiesis-chemotherapy-and-radiation-effects-study-100644985",false,"NCT07675967","Clonal Hematopoiesis Chemotherapy and Radiation Effects Study","CH CARE","Inclusion Criteria:\n\n* Participants to be included in this study include the following:\n* Adults age \\>18 years\n* Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers)\n* Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer).\n* Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.\n\nExclusion Criteria:\n\n* Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure\n* Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer)\n* Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study participation.","ALL","18 Years",{"count":19,"type":20},5000,"ESTIMATED","OBSERVATIONAL","The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers.\n\nThe study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs).\n\nUltimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Lung Cancer (Diagnosis)","Osteochondroma","Spitz Nevus","Solid Cancers","Breast Cancer","Gastric (Stomach) Cancer","Colorectal (Colon or Rectal) Cancer","Sarcoma","Ovarian Adenocarcinoma","Uterine Adenocarcinoma","Endometrial Adenocarcinoma","Esophageal Adenocarcinoma","Head and Neck Cancer","Therapy-Related Acute Myeloid Leukemia","Therapy-Related MDS","Clonal Hematopoiesis of Indeterminate Potential (CHIP)","Clonal Cytopenia of Undetermined Significance",[42,43,44,45,46,47,48,49],"Adult cancer survivors","Precursor Lesions","clonal hematopoiesis","chemotherapy","radiation","therapy-related myeloid neoplasms","CCUS","clonal hematopoiesis of indeterminate potential","RECRUITING","2026-06-29",{"date":53,"type":54},"2026-06-30","ACTUAL",{"date":56,"type":54},"2025-04-04",{"date":58,"type":20},"2035-03-31",{"name":60,"class":61},"Dana-Farber Cancer Institute","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":62},"100641488","the-effect-of-using-weighted-blanket-on-anxiety-stress-depression-and-comfort-level-among-patients-with-cancer-undergoing-intravenous-anticancer-therapy-and-its-feasibility-of-use-by-nurses-compared-to-routine-care-100641488","NCT07653035","The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care","The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care; a Randomized Controlled Study (CALM-WB)","CALM-WB","Inclusion Criteria: for patients\n\n* Newly diagnosed cancer patients aged 18 years and older.\n* Receiving first-line intravenous anticancer therapy (chemotherapy or immunotherapy or a combination of both) in the daycare unit (adjuvant, neoadjuvant, or palliative).\n* Weighting at least 55 kg during obtaining the informed consent. (At least 54 kg before the intervention).\n* Able to complete study assessments.\n* Speaks Arabic or English.\n* Signs Informed consent.\n\nExclusion Criteria for patients:\n\n* Prior psychological treatment or psychotherapy (confirmed psychological diagnosis, history of psychotropic medications and previous psychotherapy).\n* Currently hospitalized in inpatient units.\n* Patients on daily anticancer infusions.\n* Positive fall risk assessment.\n* Open wounds and recent surgeries\u002F stoma.\n* Enrolled in any other device study or clinical trial during data collection.\n* History of:\n\n  * Diabetes mellitus\n  * Respiratory disorders,\n  * Claustrophobia (Miller et al 2003) Because of the possibility for altered sensory perception,\n  * Patients who had a diagnosis of peripheral neuropathy or fibromyalgia (Vinson et al. 2020)\n  * Cognitive impairment\n\nEligibility criteria for the nurse's population:\n\nDay Care Unit nurses will be recruited by convenient sampling and feedback will be sought per patient per visit. The reason to this is because the same nurses maybe caring for multiple patients using the WBs and each patient will provide a different experience for the nurses caring for those patients. Only nurses who agree to complete the study questionnaire will be included.",{"count":72,"type":20},152,"INTERVENTIONAL",[75],"NA","Protocol Title: Protocol Title: The Effect of using Weighted Blanket on anxiety, stress, depression and comfort level among Patients with cancer undergoing intravenous (IV) anticancer therapy and its feasibility of use by nurses compared to routine care; a Randomized controlled study.\n\nStudy Tools: VAS-A, ESAS-R, DASS-21 and comfort level scale will be used to study the patients' population. A survey will be used to assess the feasibility of using the weighted blankets on patients receiving IV anticancer therapy.\n\nMethodology: Consented patients will be stratified per gender then randomized to either ARM1: The interventional arm, Weighted blanket, or ARM2: The control arm, Standard of care. (Regular blanket). The weighted blanket will be administered in the two cycles of IV anticancer therapy for the interventional arm, exploring the temporal trajectory of anxiety, depression, and psychological distress, and investigating the potential of a weighted blanket intervention to mitigate these symptoms. The tools will be administered according to the study protocol. Day Care Unit nurses will be assessed on how feasible they think the blankets are for patients. Expected Outcome: WB is expected to reduce the anxiety in patients undergoing IV anticancer therapy and reduce the nurses' burden when caring for those patients.",[27,78,79],"Anxiety Depression","Stress",[81,82,83,84,85,86,87],"blankets","cancer","anxiety","depression","comfort","intravenous infusion","non-pharmacological intervention","2026-06-14",{"date":90,"type":54},"2026-06-17",{"date":92,"type":54},"2025-12-25",{"date":94,"type":20},"2027-07",{"name":96,"class":61},"Sultan Qaboos Comprehensive Cancer Center",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":73,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100325235","monitoring-of-immunological-mechanisms-and-biomarkers-underlying-efficacy-and-toxicity-of-cancer-immunotherapy-100325235","NCT03514368","Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy","MINER","Inclusion Criteria:\n\n1. Age ≥18 years at the time of study entry.\n2. Patient with histologically documented metastatic and\u002For unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).\n3. Patient for which a treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination has been decided.\n4. Archived tumor specimen available or feasible for pre-treatment tumor biopsy.\n5. Current treatment with ICB not yet started.\n6. Evaluable disease (measurable as per RECIST 1.1. or not).\n7. ECOG Performance status 0-2.\n8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n9. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Patient pregnant, or breast-feeding.\n2. Uveal melanoma\n3. Any condition contraindicated with tumor \u002Fblood sampling procedures required by the protocol.\n4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.\n6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n7. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":105,"type":20},770,[75],"This is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and\u002For metastatic) solid cancers.\n\nThe study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.\n\nPatients with any of the following tumor types may be enrolled in the trial:\n\n* Non-Small Cell Lung Cancer (NSCLC),\n* Head and neck cancer,\n* Melanoma,\n* Bladder cancer,\n* Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.\n\nFor each included patient, tumor biopsy specimens and blood samples will be collected at different time points.\n\nAll included patients will be followed-up until progression. After this date, survival data will be collected.",[27],[110,111,112,113],"Immune checkpoint modulation","Tumor antigens","Adaptive immune responses","Tumor molecular signature","2026-06-12",{"date":116,"type":54},"2026-06-16",{"date":118,"type":54},"2018-05-28",{"date":120,"type":20},"2029-11",{"name":122,"class":61},"Institut Claudius Regaud",3,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":73,"phases":133,"briefSummary":134,"conditions":135,"keywords":143,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":156},"100605812","xdrive-for-florida-based-cancer-patients-100605812","NCT07167381","xDRIVE for Florida-based Cancer Patients","xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed\u002F Refractory Cancers","Inclusion Criteria:\n\n* Patients with recurrent\u002Frefractory cancer patients up to age 18 (willing to sign assent if ages 7 - 17 years)\n* -OR- Patients with recurrent\u002Frefractory cancer ≥18 years of age.\n* Patients who have received at least one prior line of standard of care therapy.\n* Patients able to provide treatment and outcome information from previous line(s) of therapy.\n* Patients with sufficient health status to undergo cancer therapy, e.g., Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2 for adult patients.\n* Patients who are scheduled for or have recently undergone a tumor biopsy, excision, or resection.\n* Patients willing to have a blood draw or buccal swab performed for matched normal material for comparison during tumor DNA profiling.\n\nExclusion Criteria:\n\n* Patients who do not have malignant tissue available and accessible, patients where the amount of excised malignant tissue is insufficient material for ex vivo drug testing and\u002For genetic profiling, defined as \\\u003C0.3g for resections or core\u002Ffine-needle biopsies not containing malignant tissue by pathology review, or insufficient malignant tissue in peripheral blood or bone marrow aspirate samples.\n* Patients with insufficient health indicators to undergo therapeutic intervention.",{"count":132,"type":20},210,[75],"Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).",[136,137,138,139,140,141,142,27],"Cancer","Neoplams","Refractory","Recurrence","Leukaemia","Lymphoma","Solid Tumor Malignancies",[144,145],"Functional Precision Medicine","Artificial Intelligence","2026-05-17",{"date":148,"type":54},"2026-05-19",{"date":150,"type":54},"2025-11-01",{"date":152,"type":20},"2027-04-01",{"name":154,"class":155},"First Ascent Biomedical Inc.","INDUSTRY",2,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":73,"phases":167,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":123},"100597473","phase-2-spatially-fractionated-radiotherapy-combined-with-immunotherapy-for-advanced-solid-tumors-100597473","NCT07058948","Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors","A Phase II Prospective, Open-Label, Single-Arm Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With Immunotherapy in Patients With Advanced Solid Tumors","SFRT-IM-P2","\\*\\*Inclusion Criteria:\\*\\*\n\n1. Signed informed consent.\n2. Histologically or cytologically confirmed malignant solid tumor.\n3. Advanced solid tumor unsuitable for surgery as determined by a multidisciplinary tumor board or consulting physicians.\n4. No available standard therapy or inability to tolerate it, with imaging and clinical assessment showing stable disease (SD) or progressive disease (PD).\n5. Age ≥18 years on the day of signing informed consent.\n6. No prior radiotherapy to the proposed site, or last radiotherapy ≥6 months ago.\n7. KPS score ≥70.\n8. At least one measurable lesion per RECIST 1.1. Previously irradiated lesions qualify only if significant progression post - radiotherapy.\n9. Life expectancy \\>3 months.\n10. Adequate organ and bone marrow function:\n\n    * Marrow: ANC ≥1.5×10⁹\u002FL, platelets ≥80×10⁹\u002FL, hemoglobin ≥9 g\u002FdL;\n    * Liver: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT\u002FAST ≤1.5× ULN;\n    * Kidney: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 ml\u002Fmin, blood urea nitrogen ≤200 mg\u002FL;\n    * Coagulation: INR ≤1.5× ULN, PTT ≤1.5× ULN.\n11. Recovery from prior therapy - related adverse events (≤Grade 1 or baseline).\n12. Willingness to use appropriate contraception.\n13. No radiotherapy contraindications as judged by the radiation oncologist.\n14. Agreement to receive both immunotherapy and radiotherapy.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n1. Active central nervous system (CNS) metastases, carcinomatous meningitis, or spinal cord compression.\n2. Severe comorbidities such as myocardial infarction within 6 months, severe arrhythmias, or psychosis that may affect treatment completion or result in a life expectancy of \\\u003C3 months.\n3. Evidence of interstitial lung disease or active\u002Fnon - infectious pneumonia (e.g., drug - induced, radiation - induced) requiring steroid treatment.\n4. History of pulmonary fibrosis, pulmonary artery hypertension, or severe irreversible airway obstruction.\n5. Presence of peripheral neuropathy.\n6. Severe organ dysfunction (e.g., hepatic, cardiopulmonary failure) that is likely to make radiotherapy intolerable.\n7. Known allergy to study drugs or excipients, or a history of severe allergic reaction to any PD - 1 monoclonal antibody.\n8. Serious infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; or receipt of oral or intravenous antibiotics within 2 weeks prior to study treatment. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or chronic obstructive pulmonary disease exacerbations) are eligible.\n9. Known or suspected active autoimmune disease (e.g., uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis). Exceptions: patients with vitiligo, cured childhood asthma; patients with well - controlled type 1 diabetes on insulin.\n10. History of allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant.\n11. Pregnant or breastfeeding women.\n12. Any other condition that the investigator deems a valid reason for disqualification based on the protocol.",{"count":166,"type":20},30,[168],"PHASE2","Lattice radiation therapy (LRT) is a spatially fractionated radiotherapy technique that creates alternating high - and low - dose areas within a tumor to enhance local control and reduce toxicity to surrounding tissues. This study aims to evaluate the effectiveness and safety of combining LRT with immunotherapy in patients with advanced or metastatic solid tumors, through a Phase II clinical trial. Patients will receive specific - dose irradiation using a medical linear accelerator. Within the GTV of the largest tumor, spheres (0.5 - 3 cm in diameter) will be created as high - dose targets (LRT targets), spaced 2.0 - 5.0 cm apart. The LRT targets must be drawn within the GTV, avoiding blood vessels, with a margin of at least 1 cm from the GTV margin, and a volume ratio of 1% - 10% of the GTV. For a single lesion, the D95 of the GTV will be ≥1 Gy\u002Ffraction, and the D95 of the LRT target will be 8 - 12 Gy\u002Ffraction, with minimal possible single - fraction doses to organs at risk. All other irradiated metastases will receive low - dose radiotherapy (100 - 300 cGy × 5 fractions), except for brain and bone metastases, which will be treated with palliative radiotherapy as per clinical routine. Immunotherapy will be administered during or within one week after radiotherapy.",[27,171,172,173],"Radiotherapy","Immune Checkpoint Inhibitor","Lung Cancer",[175,176,177],"spatially fractionated radiotherapy","solid cancers","immune checkpoint inhibitor","2026-04-27",{"date":180,"type":54},"2026-04-29",{"date":182,"type":54},"2025-07-01",{"date":184,"type":20},"2027-07-01",{"name":186,"class":61},"Tianjin Medical University Cancer Institute and Hospital",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":73,"phases":196,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":62},"100469706","phase-1-a-clinical-study-of-cea-targeted-car-t-in-the-treatment-of-cea-positive-advanced-malignant-solid-tumors-100469706","NCT05396300","A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors","A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer;\n3. After receiving at least second-line standard treatment and failing (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;\n4. Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); If over 3 months, the patient's serum CEA should exceed 10ug\u002FL.\n5. At least one assessable lesion according to RECIST 1.1 criteria;\n6. ECOG score 0-2 points;\n7. No serious mental disorder;\n8. Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:\n\n   1. Blood routine: white blood cells\\>2.0×109\u002FL, neutrophils\\>0.8×109\u002FL, lymphocytes cells\\>0.5×109\u002FL, platelets\\>50×109\u002FL, hemoglobin\\>90g\u002FL;\n   2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;\n   3. Renal function: serum creatinine≤2.0×ULN;\n   4. Liver function: ALT and AST ≤3.0×ULN (for those with liver tumor infiltration, it can be relaxed to≤5.0×ULN);\n   5. Total bilirubin≤2.0×ULN;\n   6. Oxygen saturation \\> 92% in non-oxygen state.\n9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;\n10. Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);\n11. The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.\n\nExclusion Criteria:\n\n1. CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion;\n2. Participated in other clinical studies within 1 month before screening;\n3. vaccinated with live attenuated vaccine within 4 weeks before screening;\n4. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);\n5. Active infection or uncontrollable infection requiring systemic treatment;\n6. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;\n7. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;\n8. Suffering from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;\n   3. Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (caused by vasovagal except those caused by neurosis or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n9. Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;\n10. Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin;\n11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;\n12. Women who are pregnant or breastfeeding;\n13. Other investigators deem it unsuitable to participate in the study.",{"count":195,"type":20},110,[197],"PHASE1","This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.",[200,27,201],"Colorectal Cancer","Gastric Cancer",[203,204,205],"CAR-T","CEA","CEA-positive advanced malignant solid tumors","2026-04-22",{"date":208,"type":54},"2026-04-28",{"date":210,"type":54},"2022-05-25",{"date":212,"type":20},"2027-12-30",{"name":214,"class":61},"Weijia Fang, MD",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":73,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":4},"100632219","phase-1-jy016-injection-in-patients-with-advanced-solid-tumors-expressing-egfr-100632219","NCT07510841","JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR","A Phase I\u002FII Clinical Study on the Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years and ≤ 75 years;\n* 2\\. Tumor diagnosis and previous anti-tumor treatment: Phase I dose escalation stage: Subjects with advanced solid tumors with EGFR expression (immunohistochemistry 1+, 2+ or 3+) who have undergone standard treatment failure, or lack effective treatment options, or are unable to tolerate standard treatment, diagnosed by histological or cytological methods; Phase II expansion stage: Several tumor types with confirmed EGFR expression (initially determined as immunohistochemistry 1+, 2+ or 3+, and can be adjusted based on the exploratory results of EGFR expression in the dose escalation stage) confirmed by the central laboratory.\n* 3\\. ECOG physical condition score is 0-1 point;\n* 4\\. Expected survival exceeds 12 weeks;\n* 5\\. The bone marrow reserve and organ function levels must meet the following requirements 4 weeks before the first administration:(1) Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; platelet count ≥ 100 × 109\u002FL; hemoglobin ≥ 90 g\u002FL; (no blood transfusion or hematopoietic stimulating factor treatment within 14 days before the first administration);(2) Liver and kidney function: serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN; creatinine clearance rate ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula) or serum creatinine ≤ 1.5 × ULN;(3) Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal; international normalized ratio (INR) ≤ 1.5 × ULN;(4) Cardiac function: cardiac ultrasound examination, left ventricular ejection fraction ≥ 50%; QT interval (QTcF) ≤ 450 milliseconds.\n* 6\\. At least one measurable lesion defined by RECIST v1.1 must exist at the baseline period;\n* 7\\. Reproductive-capable subjects (male and female) must agree to use reliable contraceptive methods (hormonal or barrier methods or abstinence) with their partners during the trial period and for at least 3 months after the last administration; for pregnant women of childbearing age, a negative blood pregnancy test must be obtained within 14 days before the first use of the trial drug.\n* 8.I have fully understood this study and voluntarily signed the informed consent form, willing and able to follow the research procedures.\n\nExclusion Criteria:\n\n* 1\\. The time interval between the last anti-tumor treatment and the first administration: for cytotoxic drugs and small molecule targeted drugs, ≤ 3 weeks; for large molecule monoclonal antibodies, ≤ 4 weeks; for radiotherapy (except for local radiotherapy for relieving pain) ≤ 4 weeks; for traditional Chinese medicine with anti-tumor indications approved by NMPA, ≤ 2 weeks;\n* 2\\. Known to be allergic to injectable JY016 or any of its excipient components; or having a history of allergy to drugs containing monoclonal components; other drug-induced liver toxicity or allergy history; or having a specific allergic reaction history (asthma, rubella, eczematous dermatitis); the subjects who have undergone previous anti-tumor treatment with central nervous system metastasis cancer, cancerous meningitis, or other central nervous system diseases or abnormalities;\n* 3\\. Have received targeted CD3 drug treatment before;\n* 4\\. Known to have central nervous system metastatic cancer, cancerous meningitis, or other central nervous system diseases or abnormalities;\n* 5\\. Human immunodeficiency virus (HIV) antibody positive, syphilis antibody positive or having other acquired or congenital immune deficiency diseases; active hepatitis C, antibody positive and HCV RNA test positive; active hepatitis B, for HBsAg positive, HBV DNA needs to be detected, and HBV DNA is higher than the upper limit of the normal value;\n* 6\\. Have received any anti-tumor treatment that was effective through T-cell recruitment therapy before, including but not limited to CAR-T and other in vitro cell therapies, CD3+ monoclonal antibodies, CD3+ dual antibodies, etc.;\n* 7\\. Have had a subject who experienced cytokine release syndrome (CRS) after any treatment;\n* 8\\. Have had anti-tumor treatment-related toxicity that has not been relieved to grade 1 or below (CTCAE v5.0) (excluding alopecia, pigmentation, and other toxicities determined by the investigator not affecting the safety of the study drug);\n* 9\\. Have other malignant tumors (excluding skin basal cell carcinoma and carcinoma in situ that underwent radical treatment and no disease recurrence within 5 years before screening);\n* 10\\. Have used other clinical trial test drugs within 4 weeks before the first administration of the test drug;\n* 11\\. Have used live virus vaccines within 4 weeks before the first administration of the test drug or during the expected study period, and within 4 weeks after the expected cessation of the study treatment;\n* 12\\. Have had active or requiring treatment bacterial, viral or fungal infections within 4 weeks before the first administration of the test drug;\n* 13\\. History of active tuberculosis;\n* 14\\. Have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n* 15\\. Have active autoimmune diseases (including but not limited to immune-related myocarditis, immune-related pneumonia, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, multiple sclerosis, vasculitis or glomerulonephritis, etc.) within 1 year of receiving systemic treatment;\n* 16\\. Have undergone major organ surgery (excluding biopsy and minimally invasive surgeries that have recovered well) or had significant trauma within 4 weeks before the first administration of the test drug, or need to undergo elective surgery during the study period;\n* 17\\. Have had severe non-healing wounds\u002Fulcers\u002Ffractures within 4 weeks before the first administration of the test drug;\n* 18\\. Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: 1) Severe cardiac rhythm or conduction abnormalities; 2) Congestive heart failure (NYHA classification ≥ III); 3) Acute coronary syndrome, aortic dissection, stroke or other grade 3 or above cardiovascular events within 6 months before the first administration;\n* 19\\. Uncontrolled third space effusion (pleural effusion, pericardial effusion or abdominal effusion, etc.);\n* 20\\. Known to have a history of drug abuse;\n* 21\\. Pregnant or lactating women;\n* 22.The investigator believes that the subject has other systemic diseases or other reasons that make them unsuitable to participate in this clinical study.","75 Years",{"count":224,"type":20},228,[197,168],"This study is a single-arm, open-label, multi-center Phase I\u002FII clinical trial, consisting of Part A: the Phase I dose escalation stage, and Part B: the Phase II expansion stage. The objective of the Phase I dose escalation stage is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of JY016 injection in patients with advanced solid tumors expressing EGFR (immunohistochemistry 1+, 2+, or 3+). In the Phase II stage, the efficacy of JY016 in pancreatic cancer, non-small cell lung cancer, esophageal cancer, colorectal cancer, and squamous cell carcinoma of the head and neck with EGFR expression will be further evaluated.",[27],"NOT_YET_RECRUITING","2026-03-31",{"date":231,"type":54},"2026-04-06",{"date":233,"type":20},"2026-04-30",{"date":235,"type":20},"2029-05-31",{"name":237,"class":61},"Biotech Pharmaceutical Co., Ltd.",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":73,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":62},"100629822","phase-1-an-antibody-armored-dendritic-cell-in-patients-with-solid-tumors-100629822","NCT07479667","An Antibody-armored Dendritic Cell in Patients With Solid Tumors","An Exploratory, Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Antibody-armored Dendritic Cell Injection Following a Single Administration in Patients With Solid Tumors","dendritic cell","Inclusion Criteria:\n\n* Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;\n* ECOG performance status score of 0 to 1;\n* Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;\n* Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;\n* Positive expression for at least one of TERT, P53, KRAS and Survivin;\n* Sufficient venous access with no contraindications to peripheral blood mononuclear cell collection;\n* Adequate organ and bone marrow function:\n* a) Platelet count ≥ 90×10⁹\u002FL;\n* b) Hemoglobin ≥ 90 g\u002FL (no blood transfusion or erythropoietin dependence within 7 days);\n* c) Mononuclear cell count ≥ 1.0×10⁹\u002FL;\n* d) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN);\n* e) Serum creatinine ≤ 1.5 × upper limit of normal (ULN);\n* f) Aminotransferases (AST, ALT) ≤ 2.5 × upper limit of normal (ULN);\n* g) Total bilirubin ≤ 2 × upper limit of normal (ULN);\n* h) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as assessed by echocardiography within 1 month prior to enrollment;\n* Able to understand the study requirements and considerations and provide informed consent to participate in the clinical study in accordance with the study requirements\n* Subjects agree to use effective contraceptive measures for at least 6 months following dendritic cell (DC) injection.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding;\n* Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies\u002FmL; or hepatitis C virus (HCV) RNA copy number above the LLOD;\n* Prior treatment with any dendritic cell (DC) or other immune cell therapy;\n* History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;\n* Uncontrolled active infection;\n* Subjects with active autoimmune disease receiving relevant treatment; subjects with organ transplantation who are still on immunosuppressive agents; or subjects requiring long-term use of immunosuppressive agents (\\> 15 mg\u002Fday prednisone or equivalent glucocorticoid dose) and who have used them within 4 weeks prior to screening;\n* Presence of central nervous system (CNS) metastases and clinically significant CNS diseases;\n* Received systemic anti-tumor therapy within 4 weeks prior to screening;\n* Presence of residual lesions or unremoved foci on screening examinations (post-adjuvant chemotherapy \u002F post-surgery), with imaging indicating local recurrence or confirmed distant metastasis;\n* History of other active malignancies within 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);\n* Clinically significant major cardiovascular diseases including:\n* a) Symptomatic congestive heart failure\n* b) Unstable angina pectoris\n* c) Severe arrhythmia requiring pharmacotherapy\n* d) Uncontrolled hypertension\n* e) Myocardial infarction or ventricular arrhythmia within 6 months prior to screening;\n* Any other conditions deemed by the investigator to render the subject ineligible for participation in the clinical study","80 Years",{"count":248,"type":20},8,[197],"This study is a single-arm, open-label, single-administration dose-escalation study.",[27,252],"Adjuvant Therapy","2026-03-15",{"date":255,"type":54},"2026-03-18",{"date":257,"type":54},"2026-02-05",{"date":259,"type":20},"2029-06-30",{"name":261,"class":155},"Shanghai Cell Therapy Group Co.,Ltd",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":73,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":62},"100607727","predicting-reactions-and-effects-of-drugs-immunotherapy-and-complications-through-oncosafety-predicto-clinical-study-100607727","NCT07192315","Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)","PREDICTO","Inclusion Criteria:\n\n* Adult patient (≥18 years old)\n* Patient presenting an histologically or cytologically confirmed solid tumour malignancy\n* Patient scheduled to receive his\u002Fher first infusion of immunotherapy with anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3, alone or in combination, as part of standard care, in all validated solid oncology indications.\n* Patient must have at least one measurable lesion according to RECIST 1.1 criteria\n* Patient treated at AP-HM in one of the CEPCM-affiliated departments.\n* Patient able to comply with study procedures and follow-up schedule\n* Patient who has been informed about the study and signed the consent form\n* Patient who is a beneficiary or entitled beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Patient previously treated with ICIs\n* Patient whose treatment plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI\n* Patient included in a trial with an experimental molecule\n* Patient has an active autoimmune disease or any other pathology requiring systemic corticosteroid therapy at more than 10 mg prednisone equivalent per day or any other immunosuppressive drug\n* Patients with a history of organ transplantation, hematopathy or hematopoietic stem cell transplantation\n* Patient with history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patient in emergency situations, persons deprived of their liberty by judicial or administrative decision, adults subject to legal protection measures, or persons who are unable to give their consent, or pregnant or breastfeeding.",{"count":270,"type":20},160,[75],"Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (iRAE) that can be life-threatening. About 20% of patients treated with an ICI monotherapy, and up to 60% of patients treated with a combination of ICIs, experienced a severe iRAE. Most side effects are reversible if managed early, but can affect survival and quality of life, leading to treatment interruptions or hospitalization. Some of these irAEs, particularly those affecting hormonal functions, may be irreversible and persist even after treatment discontinuation.\n\nThe development of predictive biomarkers of such toxicities is an unmet medical need. The variety of mechanisms involved in iRAE, and the lack of effective animal models, could probably explain why the topic remains largely unexplored. To date, some biomarkers predictive of the occurrence of iRAE, irrespective of the type of organ affected, have been identified by state-of-the-art techniques on small cohorts prior to treatment initiation, but none is individually robust enough to be used in daily practice.\n\nWe hypothesize that a signature derived from the integrative analysis of various biological parameters (immunomonitoring, auto-immunity features, viral monitoring, microbiota monitoring, fragmentome analysis, pharmacokinetics, radiomics and genetics), available in routine hospital practice, could answer this question, and thus enable the development of specific prevention strategies\n\nThe objectives are :\n\nPrimary objective:\n\nIdentify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected.\n\nSecondary objectives:\n\n* Identify a predictive signature for severe iRAE including baseline and T1 data, irrespective of the type of organ affected.\n* Identify a baseline predictive signature for organ-specific severe iRAE.\n* Identify a predictive signature for organ-specific severe iRAE including baseline and T1 data.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in monotherapy.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in combination.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for each specific immunotherapy received.\n* Compare the predictive signatures between responders and non-responders according to RECIST 1.1 in order not to overlook the influence of clinical response on the variability observed.\n* Describe the results obtained for each biological parameter between severe irAEs and non-severe irAEs patients.\n* Describe patient-reported outcomes and quality of life parameters.",[142,27],[275,276,277],"immuno-induced adverse events","Immune checkpoint inhibitor","baseline predictive signature","2026-03-11",{"date":280,"type":54},"2026-03-13",{"date":282,"type":20},"2026-04",{"date":284,"type":20},"2028-01",{"name":286,"class":61},"Assistance Publique Hopitaux De Marseille",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":73,"phases":296,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":123},"100625788","monitoring-of-immunological-mechanisms-and-biomarkers-underlying-efficacy-of-immunotherapy-in-patients-with-early-stage-cancer-100625788","NCT07427186","Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer","MINER2","* Inclusion Criteria:\n\n  1. Age ≥18 years at the time of study entry.\n  2. Patient with histologically documented early stage solid malignant tumor (NSCLC, head and neck cancer, melanoma (except uveal melanoma), bladder cancer or any other early stage solid tumor when I-O agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).\n  3. Patient for whom a neo-adjuvant treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination with chemotherapy or other therapies has been decided.\n  4. Availability of an archived tumor specimen (block FFPE) sampled prior to the start of the treatment.\n  5. Treatment with ICB not yet started.\n  6. ECOG Performance status 0-2.\n  7. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n  8. Patient affiliated to a Social Health Insurance in France.\n* Exclusion Criteria:\n\n  1. Patient pregnant, or breast-feeding.\n  2. Uveal melanoma\n  3. Any condition contraindicated with tumor \u002Fblood sampling procedures required by the protocol.\n  4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n  5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.\n  6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n  7. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":295,"type":20},600,[75],"This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). Patients with any of the following tumor types may be enrolled in the trial:\n\nNon-Small Cell Lung Cancer (NSCLC), Head and neck cancer, Melanoma, Bladder cancer, Other tumor types when Immuno-Oncology agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).\n\nFor each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study.\n\nAll included patients will be followed up for 5 years after baseline.",[27],[300,301,302,303,304],"Immunotherapy","tumor microenvironment","adaptive immune responses","Immune checkpoint blockade","tumor antigens","2026-02-23",{"date":307,"type":54},"2026-02-25",{"date":309,"type":20},"2026-04-15",{"date":311,"type":20},"2041-04-15",{"name":122,"class":61},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":73,"phases":322,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":337,"locationsCount":123},"100621518","phase-1-an-phase-ibii-clinical-trial-of-tcc1727-combination-therapy-in-advanced-solid-tumors-100621518","NCT07371663","An Phase Ib\u002FII Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors","An Open-Label, Multicenter Phase Ib\u002FII Clinical Trial of TCC1727 in Combination With Benmelstobart\u002FOlaparib\u002FTopotecan for Advanced Solid Tumors","Inclusion Criteria:\n\n* -Voluntarily participate in this study and sign the informed consent form.\n* At the time of signing the informed consent, subjects must be ≥18 years of age (inclusive).\n* Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows:\n\n  * Phase Ib :Subjects with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II.\n  * Phase II Study:Based on different combination therapy groups, subjects with the following specific tumor types (different population cohorts):\n\nTCC1727 combined with Benmelstobart Group:\n\nThe study will enroll subjects with advanced solid tumors lacking standard therapies, including but not limited to non-small cell lung cancer (NSCLC), endometrial cancer, and other advanced solid tumors (e.g., colorectal cancer, urothelial carcinoma, gastric cancer, and gastroesophageal junction cancer):\n\nCohort 1 (NSCLC):Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who are eligible for second- or third-line therapy. Patients must have received prior therapy with an anti-PD-(L)1-containing regimen (either as monotherapy or in combination) and a platinum-based doublet regimen for locally advanced or metastatic NSCLC.\n\nSubgroup 1: ATM mutation. Subgroup 2: ATM wild-type, with or without other DDR functional defects.\n\nCohort 2 (Endometrial Cancer):Patients with histopathologically confirmed recurrent or metastatic advanced endometrial cancer who have received at least one prior platinum-based chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (sequential or concurrent therapy allowed; sequential therapy refers to platinum-based chemotherapy followed by immune checkpoint inhibitor maintenance therapy).\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nCohort 3 (Other Advanced Solid Tumors):Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard therapy, are intolerant to standard therapy, have no standard therapy available, or for whom standard therapy is currently unsuitable.\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nTCC1727 combined with Olaparib Tablets Group:\n\nThe study will enroll subjects with histopathologically confirmed recurrent ovarian cancer:\n\nCohort 4 (Ovarian Cancer):Subjects with histopathologically confirmed recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer:\n\nSubgroup 1: Subjects who have experienced disease progression after prior Olaparib Tablets therapy (maintenance or subsequent therapy). Subjects must not have received further treatment after progression on Olaparib Tablets.\n\nSubgroup 2: Subjects who have not received Olaparib Tablets and have primary platinum-resistant\u002Frefractory disease (recurrence within 6 months of last platinum-based therapy). Subjects must have received ≤3 prior lines of therapy since developing platinum resistance.\n\nTCC1727 combined with Topotecan Hydrochloride for Injection Group:\n\nThe study will enroll subjects with histopathologically or cytologically confirmed small cell lung cancer (SCLC):\n\nCohort 5 (SCLC):Subjects who have progressed after platinum-based chemotherapy combined with PD-(L)1 therapy, or subjects with extensive-stage SCLC who have relapsed or progressed within ≤6 months after first-line therapy.\n\n* At least one measurable lesion (per RECIST v1.1; lesions previously treated with local therapy may be considered target lesions if they show clear progression per RECIST v1.1).\n* Subjects must provide sufficient tumor tissue samples, including but not limited to fresh specimens (preferred) or formalin-fixed, paraffin-embedded (FFPE) tumor tissue obtained within approximately 24 months prior to randomization, unstained FFPE slides, or core needle biopsy tissue for biomarker testing.\n* ECOG performance status score of 0-1 within 7 days prior to the first dose of study drug.\n* Expected survival ≥12 weeks.\n* Ability to swallow tablets whole and maintain this method of administration.\n* Organ function within the following ranges within 7 days prior to the first dose of study drug (no blood component or growth factor therapy within 14 days prior to the first dose):\n\n  1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n  2. White blood cell count (WBC) ≥3.0 × 10⁹\u002FL;\n  3. Platelet count ≥100 × 10⁹\u002FL;\n  4. Hemoglobin (Hb) ≥90 g\u002FL;\n  5. Serum albumin ≥30 g\u002FL;\n  6. Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  7. ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  8. Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if bone metastases are present);\n  9. Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCL) ≥60 mL\u002Fmin (Cockcroft-Gault formula);\n  10. APTT ≤1.5 × ULN and INR or PT ≤1.5 × ULN (for subjects not receiving anticoagulation therapy);\n  11. QTc \\\u003C450 ms (male) or \\\u003C470 ms (female), LVEF ≥50%.\n* For non-sterilized or fertile female subjects, medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study and for 6 months after the last dose. Non-sterilized female subjects must have a negative serum HCG test within 72 hours before the first dose and must not be breastfeeding. Male subjects with fertile partners must use effective contraception during the study and for 3 months after the last dose.\n\nExclusion Criteria:\n\n* Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled CNS metastases. Exceptions: Subjects with completely resected and\u002For irradiated CNS metastases that are stable or improved for ≥4 weeks before screening (no evidence of brain edema and no need for corticosteroids or anticonvulsants). Asymptomatic brain metastases \\\u003C1 cm in diameter without surrounding edema are also allowed.\n* Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed \\\u003C4 weeks before the first dose (exceptions: small-molecule anti-tumor therapy completed \\>5 half-lives or \\>10 days before the first dose, whichever is longer; palliative radiotherapy completed \\>2 weeks before the first dose).\n* Use of strong CYP3A4 inhibitors or inducers within 14 days before the first dose (e.g., rifampin, rifapentine, St. John's wort, carbamazepine, phenytoin, barbiturates, ketoconazole, itraconazole, clarithromycin, voriconazole, atazanavir, ritonavir, saquinavir, grapefruit juice).\n* Any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) from prior anti-tumor therapy (except alopecia, pigmentation, or laboratory abnormalities meeting inclusion criteria).\n* Inability to swallow tablets, gastrointestinal dysfunction, or any condition that may affect drug absorption (per investigator's judgment).\n* Uncontrolled severe diseases, including:\n\n  1. Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);\n  2. Clinically significant cardiovascular disease within 6 months before the first dose (e.g., myocardial infarction, severe\u002Funstable angina, stroke, ≥Grade 2 congestive heart failure \\[NYHA classification\\]);\n  3. Arrhythmia (≥Grade 2 per CTCAE v5.0, including QTcF ≥450 ms \\[male\\] or ≥470 ms \\[female\\]);\n  4. Unexplained fever ≥38.5°C within 14 days before the first dose or active infection requiring systemic therapy;\n  5. Active viral hepatitis (HBV DNA ≥500 IU\u002FmL for HBsAg-positive and\u002For anti-HBc-positive subjects; HCV RNA-positive for anti-HCV-positive subjects; antiviral therapy required for eligible HBV\u002FHCV-positive subjects);\n  6. Active syphilis;\n  7. Active tuberculosis;\n  8. Immunodeficiency (e.g., HIV-positive, congenital\u002Facquired immunodeficiency, organ transplant history);\n  9. Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL).\n* Uncontrolled pleural effusion, pericardial effusion, ascites, or recurrent ascites requiring drainage within 28 days before the first dose.\n* Significant bleeding symptoms or tendency within 3 months before the first dose.\n* Chronic systemic corticosteroid therapy (\\>10 mg prednisone equivalent daily) or immunosuppressive therapy within 14 days before the first dose.\n* Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., immunomodulators, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement for adrenal\u002Fpituitary insufficiency) is allowed. (Applies only to Ib Phase and Phase II TCC1727 + Benmelstobart groups.)\n* History of severe allergic reactions to study drugs or their excipients.\n* Other malignancies within 3 years before screening (except cured basal cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma).\n* Prior ≥Grade 3 immune-mediated adverse events (imAEs) or permanent discontinuation due to imAEs during anti-PD-(L)1 therapy.\n* Prior treatment with TCC1727, other ATR inhibitors, or cell cycle checkpoint inhibitors (e.g., ATM inhibitors, WEE1 inhibitors, CHK1\u002FCHK2 inhibitors).\n* Other severe physical\u002Fmental illnesses or factors that may increase study risk or interfere with results, or any condition deemed unsuitable by the investigator.\n\nAdditional exclusions:\n\n* Phase II Cohort 1 (NSCLC):Exclude subjects with known EGFR, ALK, ROS1, BRAF, MET, RET, or RAS mutations; exclude mixed NSCLC\u002FSCLC histology.\n* Phase II Cohort 2 (Endometrial Cancer):Exclude uterine carcinosarcoma, endometrial leiomyosarcoma, or endometrial stromal sarcoma.\n* Phase II Cohort 3 (Other Solid Tumors):Exclude KRAS\u002FNRAS\u002FBRAF mutations or MSI-H status.\n* Phase II Cohort 4 (Ovarian Cancer) \\& Ib Phase TCC1727 + Olaparib Tablets: Exclude prior myelodysplastic syndrome or acute myeloid leukemia.",{"count":321,"type":20},266,[197,168],"This is a Phase Ib\u002FII clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart \u002Folaparib \u002Ftopotecanfor patients with advanced solid tumors.\n\nThe Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart \u002Folaparib\u002Ftopotecanin selected advanced solid tumor indications.\n\nThe study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.",[27,325,29,326,327],"NSCLC (Advanced Non-small Cell Lung Cancer)","Endometrial Cancer","Malignant Melanoma",[329,330],"Ataxia Telangiectasia and Rad3-related protein inhibitor","Advanced solid tumor","2026-01-19",{"date":333,"type":54},"2026-01-28",{"date":335,"type":54},"2025-12-03",{"date":259,"type":20},{"name":338,"class":155},"Beijing Tide Pharmaceutical Co., Ltd",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":73,"phases":348,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":62},"100606034","phase-2-phase-ii-trial-of-tunlametinib-in-patients-with-nras-mutant-non-melanoma-refractory-solid-tumors-100606034","NCT07170293","Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors","An Exploratory, Prospective, Single Arm, Open Label, Single Center, Basket, Phase II Clinical Study of Tunlametinib (HL-085) in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors","Exclusion Criteria:\n\n1. Have had other malignant tumors in the past 2 years (excluding tumors with low malignancy such as basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc. that have undergone radical treatment) or have been diagnosed with melanoma;\n2. Moderate or greater amounts of pleural effusion, pericardial effusion, and peritoneal effusion that cannot be controlled by researchers (including but not limited to those that require repeated drainage and have clinical symptoms);\n3. Prior to initial administration of anti-tumor therapy: Within 4 weeks or 5 drug half lives (whichever is shorter) prior to administration, anti-tumor drugs (including cytotoxic therapy, targeted therapy, antibody therapy, immunotherapy, etc.) were administered; Received nitrosourea or mitomycin C treatment within 6 weeks prior to administration; Received palliative radiotherapy within 2 weeks prior to administration; Received other anti-tumor treatments such as radical radiotherapy and electric field therapy within 4 weeks before administration; Received traditional Chinese medicine treatment for anti-tumor indications within 2 weeks before administration;\n4. Toxic reactions of previous anti-tumor treatments that have not yet improved to CTCAE ≤ 1 (excluding hair loss, skin toxicity, or other toxicity that researchers consider to be of no safety risk);\n5. Any situation that affects the ingestion of drugs and seriously affects the absorption or pharmacokinetic parameters of the investigational drug, including but not limited to active gastrointestinal ulcers, long-term gastroesophageal reflux disease (GERD), etc;\n6. Severe or uncontrollable heart diseases that require treatment, including any of the following conditions (including but not limited to): ECG QT interval prolongation corrected according to the Fridericia formula, male QTcF\\>450milliseconds or female QTcF\\>470milliseconds; Various clinically significant arrhythmias, including but not limited to second degree type II conduction block, third degree conduction block, etc; Cardiac ultrasound indicates a left ventricular ejection fraction (LVEF) of less than 50%; Within 6 months before the first medication, there is myocardial infarction, unstable angina, NYHA class III or IV heart failure; An arterial\u002Fvenous thrombosis event occurred within 6 months prior to the first medication, and the risk was deemed uncontrollable, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Or known familial and\u002For acquired thrombophilia tendencies, such as genetic or acquired defects in anticoagulant proteins, coagulation factors, fibrinolytic proteins, etc; 8 Severe or uncontrolled diabetes (fasting blood glucose ≥ 10mmol\u002FL under the standardized blood pressure reduction program), hypertension (poorly controlled under the standardized blood pressure reduction program, systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg), epilepsy, chronic obstructive pulmonary disease, interstitial pneumonia, pulmonary fibrosis, Parkinson's disease, active bleeding, systemic active infection;\n\n9\\. Any unstable systemic disease (such as severe liver, kidney, or metabolic diseases such as cirrhosis, renal failure, and uremia); Within 14 days or 5 half lives prior to the first administration, have used CYP3A4 potent and moderate inhibitors and inducers, CYP3A4, CYP2C9, and CYP2C8 sensitive substrates, OATP1B1, OATP1B3, OAT1, OAT3, P-gp, and BCRP substrates (see Appendix 8 for details); 11. Cognitive impairment, history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence, or drug abuse; Received autologous or allogeneic organ or stem cell transplantation surgery within 3 months prior to the first use of medication; Having undergone major surgery or severe trauma within 4 weeks prior to the first use of medication (excluding biopsy due to sample collection); 13. History of immunodeficiency, including HIV antibody positivity or other acquired or congenital immunodeficiency diseases; 14. There are serious eye diseases (excluding cataracts, etc.), and they have not yet recovered and improved to ≤ level 1; The following serological status reflecting active hepatitis B or hepatitis C infection exists: hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV DNA\\>1000 copies\u002FmL; hepatitis C virus antibody positive, and HCV RNA\\>the upper limit of normal value; 16 cases of active syphilis infection; 17 is known to be severely allergic to the active ingredients or any excipients of the investigational drug; Participated in other clinical trials within 4 weeks prior to the first administration of medication; 19. Patients with positive pregnancy test results or breastfeeding during the screening period; 20 researchers believe that it is not suitable to participate in this study. According to the researchers' assessment, the patient may have other factors that could affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug abuse, other serious illnesses (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that could affect the patient's safety.",{"count":347,"type":20},15,[168],"This study is a single cohort, open label exploratory clinical trial aimed at observing and evaluating the efficacy and safety of Tunlametinib (HL-085) in the treatment of refractory solid tumors with advanced metastatic non melanoma. It is expected that the ORR of Tunlametinib (HL-085) treatment can reach 20%. According to the literature results, the experimental group rate is 0.2 and the target value rate is 0.02. If the bilateral alpha is 0.05 and the beta is 0.2, the sample size is calculated as 12 cases in the experimental group. Considering a 20% dropout rate, a total of 15 cases are required.",[27],[352,353,354],"NRAS","Tunlametinib","MEK","2025-09-11",{"date":357,"type":54},"2025-09-12",{"date":359,"type":20},"2027-08-31",{"date":361,"type":20},"2027-09-30",{"name":363,"class":61},"Tianjin Medical University Second Hospital",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":73,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":4},"100595286","phase-1-a-study-to-evaluate-the-safety-and-tolerability-of-ep0089-100595286","NCT07030478","A Study to Evaluate the Safety and Tolerability of EP0089","A Phase I\u002FIIa Study to Evaluate the Safety and Tolerability of Monoclonal Antibody EP0089 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\nApplicable to all patients:\n\n1. Must be ≥18 years of age (≥19 in South Korea) with documented recurrent, metastatic or unresectable solid tumours for whom no standard therapy exists or standard therapy has failed\n2. ECOG performance status of 0 or 1 and life expectancy \\>3 months at screening\n3. Ability to understand and provide written informed consent\n4. Must be willing to comply with necessary contraceptive methods as required\n5. Willing and able to comply with the scheduled study treatment plan, laboratory tests, and other study procedures.\n6. Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.\n7. Additional cohort\u002Fdisease specific criteria apply\n8. Measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n1. Known active CNS metastases and\u002For leptomeningeal disease and\u002For carcinomatous meningitis.\n2. Recent major surgery\n3. Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose\n4. Current active, or history of, autoimmune disease that requires or required systemic treatment (ie, with disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to starting study treatment.\n5. Prior severe hypersensitivity reaction to mAbs\n6. Previous \\> Grade 2 peripheral neuropathy.\n7. Significant neurological condition eg stroke, transient ischaemic attack (in the last 12 months), epilepsy, head trauma, brain surgery or prior history of any significant psychiatric disorder\n\n9\\. Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment\n\n10\\. Receiving chronic systemic steroid therapy (\\> 10 mg \u002Fday of prednisone or equivalent) or any other form of immunosuppressive therapy ≤ 7 days prior the first dose of study drug. Topical or inhaled steroids are permitted.\n\n11\\. Any prior immune-mediated or immune-related adverse events related to treatment with immune-modulatory agents that caused permanent discontinuation of the agent, that were ≥ Grade 3 in severity or in the opinion of the Investigator would otherwise jeopardise patient safety in this study.\n\n12\\. One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)",{"count":372,"type":20},190,[197,168],"This is a first-in-human (FIH), first-in-class, Phase I\u002FIIa, open-label study designed to evaluate the safety and tolerability of EP0089 (study drug). Study drug will initially be given via intravenous (IV) infusion once every 2 weeks (Q2W), with one treatment cycle defined as 14 days. The study will enroll patients with advanced solid tumours for whom no standard therapy exists or for whom standard therapy has failed. An independent Safety Monitoring Committee (SMC) will review safety data at regular intervals to ensure participant safety and support dose escalation decisions.",[27,376],"Solid Tumours","2025-06-12",{"date":379,"type":54},"2025-06-22",{"date":381,"type":20},"2025-09",{"date":383,"type":20},"2029-06",{"name":385,"class":155},"Ellipses Pharma",{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100592907","real-life-performance-evaluation-of-the-liflow-x-ray-platform-100592907","NCT06999538","Real-life Performance Evaluation of the LiFlow X-ray Platform","LiFE","Inclusion Criteria:\n\n* TAP (thoraco-abdomino-pelvic) scans\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Examination of imperfect quality due to movement or breathing,\n* Inability to inject contrast medium or incomplete injection\n* refusal to use data",{"count":394,"type":20},400,"The thoraco-abdomino-pelvic (TAP) scanner is crucial for assessing and monitoring solid cancers. However, advancements in scanner technology have led to a significant increase in data volume, from 100 images per exam 20 years ago to 2,000 today. The rising number of cancer cases and treatments requiring closer monitoring further strain the workload, prolonging interpretation time and causing delays in therapeutic management and adjustments. The limited number of radiologists contributes to this saturation, increasing the risk of missing metastatic lesions, especially in the lungs, liver, bones, peritoneum, and lymph nodes. The RECIST 1.1 criteria, introduced 15 years ago for standardized follow-up, are useful but time-consuming to implement, resulting in only a small fraction of oncology CT reports using them.",[27],"2025-05-22",{"date":399,"type":54},"2025-05-31",{"date":401,"type":20},"2025-09-01",{"date":403,"type":20},"2026-09-01",{"name":405,"class":406},"University Hospital, Angers","OTHER_GOV",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":413,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":425,"locationsCount":4},"100588312","application-of-the-sg8-scale-in-real-world-geriatric-oncology-patients-100588312","NCT06939764","Application of the sG8 Scale in Real-World Geriatric Oncology Patients","Inclusion Criteria:\n\n1. Patients aged 65 years or older.\n2. Patients with confirmed malignant tumors based on definitive pathological data.\n3. Patients who are assessed by clinicians to have indications for systemic anti-tumor therapy.\n4. Patients with a survival time greater than 12 weeks.\n\nExclusion Criteria:\n\n1. Patients who do not meet the above inclusion criteria or are considered unsuitable for this study by the investigator due to other circumstances.\n2. Patients who are unwilling to cooperate in completing the sG8 scale assessment.\n3. Patients who do not understand the content of this study or are unwilling to participate.","65 Years",{"count":415,"type":20},346,"This study is a multicenter, prospective, observational study. The study included patients aged 65 and older with solid tumors requiring systemic anti-tumor therapy. All patients underwent screening using the sG8 scale before the start of treatment, followed by routine treatment based on a plan developed through clinician decision-making. The study did not intervene in any way with the patients' diagnosis and treatment, and relevant clinical data during the treatment process were recorded accurately for follow-up patients. Study data were obtained from the electronic medical record databases and hospital information systems of multiple centers, including Sichuan Cancer Hospital. Patient clinicopathological features, pathological diagnoses, clinical stages, previous treatment histories, as well as anti-tumor treatment regimens after patient enrollment, drug dosages per cycle, treatment start times, incidence and grades of adverse events (AEs), and tumor response were extracted and collected from the medical records. All data were entered, managed, quality-controlled, exported, and analyzed through a real-world data management platform (RWDMP).",[27,418],"Geriatric Assessment","2025-04-15",{"date":421,"type":54},"2025-04-23",{"date":423,"type":20},"2025-05-16",{"date":233,"type":20},{"name":426,"class":61},"Sichuan Cancer Hospital and Research Institute",{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":73,"phases":436,"briefSummary":437,"conditions":438,"keywords":447,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":156},"100583992","phase-1-a-phase-i-study-of-lxp1788-injection-with-advanced-solid-tumors-100583992","NCT06883539","A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.","A Phase I Open-label Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LXP1788 Injection in Patients with Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Written (signed) Informed Consent.\n2. Male or female ≥ 18 years old.\n3. Life expectancy \\> 8 weeks.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available.\n6. Measurable disease per RECIST 1.1.\n7. Willing to have a tumor biopsy or having tissue sample from a previous biopsy available in the tissue bank for analysis that had been collected in the past 3 years.\n\nExclusion Criteria:\n\n1. Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (\\\u003C 6 months before enrollment), COPD with frequent exacerbations, uncontrolled hypertension (systemic blood pressure \\>= 160 mmHg and\u002For diastolic blood pressure \\>= 100 mmHg with or without anti-hypertensive medication), recent CVA (\\\u003C 6 months before enrollment), or active infection which requires treatment withintravenous antibiotics.\n2. Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of steroids to control their CNS disease.\n\n   Asymptomatic patients with metastatic brain disease who have been on a stable dose of steroids for less than 14 days prior to screening.\n3. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n   Bone marrow:\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL\n   * Platelet count \\\u003C 100 x 10\\^9\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Having had a blood transfusion within 2 weeks of screening date is also not allowed.\n\n   Hepatic:\n   * Total bilirubin \\> 1.5 x ULN\n   * AST and ALT \\> 3 x ULN if no liver metastases\n   * AST and ALT \\> 5 x ULN in the presence of liver metastases\n\n   Renal:\n\n   ⚫ Estimated creatinine clearance (CrCL) \\\u003C 60 mL\u002Fmin per the Cockcroft and Gault formula\n4. Known history of human immunodeficiency virus (HIV)-1 or -2 infection.\n5. Psychiatric disorders that would compromise the patient's compliance or ability to give consent.\n6. Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.\n7. Toxicities from any prior therapy, surgery, or radiotherapy that did not resolve to grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, with the exception of alopecia, skin hyperpigmentation or hypopigmentation.\n8. Underlying medical conditions that, in the investigator's opinion, will make the administration of LXP1788 Injection hazardous or obscure the interpretation of toxicities or adverse events.\n9. Exposure to any other investigational or commercial anti-cancer agents or curative therapies within 28 days or 5 half-lives (whichever is shorter), before the first dose of LXP1788 Injection. Exposure to radiation therapy for non-curative purposes or pain control may be permitted under the judgement of the investigator.\n10. Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions, or requirements.\n11. Pregnancy or breast feeding.\n12. Women or men of childbearing potential not willing to use effective means of contraception.\n13. Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).\n14. History of allergic reactions to any component of LXP1788 Injection.",{"count":435,"type":20},24,[197],"A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor.\n\nPatients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected.\n\nThe main questions it aims to answer are:\n\n1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection\n2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection",[439,27,440,441,442,443,444,445,446],"Solid Tumor Malignancies, Cancer","Solid Tumor Cancer","Solid Tumor, Unspecified, Adult","Solid Tumour","Solid Tumors Refractory to Standard Therapy","HCC - Hepatocellular Carcinoma","RCC, Renal Cell Cancer","Pancreas Cancer",[448,449,450,451,452,82,453,454,455,456],"Phase 1","LXP1788","LAUNXP","DBPR114-101","solid tumor","Hepatocellular carcinoma","Pancrease Cancer","Renal Cell Carcinoma","Tyrosine kinase inhibitor","2025-03-12",{"date":459,"type":54},"2025-03-19",{"date":461,"type":54},"2024-12-31",{"date":463,"type":20},"2028-06-30",{"name":465,"class":155},"LaunXP Biomedical Co., Ltd.",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":73,"phases":475,"briefSummary":476,"conditions":477,"keywords":484,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":156},"100563329","phase-1-a-parg-inhibitor-dat-2645-monotherapy-in-patients-with-advancedmetastatic-solid-tumors-harboring-brca12-loss-of-function-alterations-andor-other-defects-in-the-ddr-pathway-100563329","NCT06614751","A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DDR Pathway","A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of DAT-2645 in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DNA Damage Repair Pathway","Inclusion Criteria:\n\n* Signed informed consent prior to initiation of any procedures in this study.\n* At least 18 years of age (inclusive).\n* Evidence of an DDR deficiency status in tumor tissue determined by validated testing method.\n* Patients with advanced or metastatic solid tumor who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain\u002Funwilling to receive standard therapy. Regardless of PARP inhibitors were used or not in previous treatment.\n* At least one measurable lesion by RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0\\~2.\n* Life expectancy at least 3 months.\n* Adequate hematologic and non-hematologic function during the screening.\n* Women of childbearing potential must have a negative result of serum pregnancy test at screening.\n* Women of childbearing potential or male patients whose spouse have childbearing potential must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients who received systemic chemotherapy, small-molecule targeted drugs within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* Patients who received biological anti-tumor drugs (including immunotherapy, target therapy, antibody-drug conjugate \\[ADC\\]) within 4 weeks prior to the first dose of the study drug.\n* Patients who have undergone major surgery within 4 weeks prior to the first dose of study drug.\n* Patients who have received radiotherapy within 4 weeks prior to the first dose of study drug (palliative radiotherapy for non-target lesions could be acceptable if it was performed before 14 days prior to the first dose of study drug).\n* Any previous treatment with a PARG inhibitor.\n* Patients with active CNS metastases (patients with asymptomatic CNS metastases which are imaging stable and not require steroid treatment within 28 days prior to the first dose of study drug, and previous treated breast cancer brain metastasis, can only be enrolled in the Part 2 study).\n* Patients who have second primary malignant tumors within the past 3 years prior to screening, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.\n* Patients with clinically significant cardiovascular or cerebrovascular diseases.\n* Active uncontrolled infections requiring intravenous antibiotics or hospitalization.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of DAT-2645 and no history of bowel obstruction within 6 months prior to enrollment.\n* Known pulmonary interstitial disease or pulmonary interstitial fibrosis.\n* Patients known hypersensitivity to any component or excipient of DAT-2645.\n* Any unresolved toxicities from any prior therapy with severity great than CTCAE Grade 1 prior to start of DAT-2645, except for alopecia and pigmentation and Grade 2 of peripheral sensory neuropathy.\n* Participated in other clinical trials (except for screening failure) within 4 weeks prior to the first dose of the study drug in this study.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (active HBV infection is defined as positive hepatitis B surface antigen \\[HbsAg\\], or HBV DNA exceeding the lower limit of detection; active HCV infection is defined as positive anti-HCV antibody, and HCV RNA exceeding the lower limit of detection).\n* Known human immunodeficiency virus (HIV) infection (patients with adequate CD4+ T cell counts and without history of acquired immune deficiency syndrome \\[AIDS\\]-defining opportunistic infections could be enrolled after consultation with sponsor).\n* Women who are pregnant or breastfeeding.\n* History or evidence of any other clinically significant condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would be a risk to patient safety or interfere with the study evaluation, procedures or completion.",{"count":474,"type":20},112,[197],"The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced\u002Fmetastatic solid tumors harboring BRCA1\u002F2 loss of function alterations and\u002For other defects in the DNA damage repair (DDR) pathway.",[27,478,479,28,480,200,481,326,201,482,483],"BRCA Mutation","HRD Cancer","Prostate Cancer","Pancreatic Cancer","Advanced Cancer","Metastatic Solid Tumors",[485,486,487,488,489,490,491,492,493,494,495,496],"PARGi","DAT-2645","PARPi","Advanced solid tumors","Metastatic solid tumors","HRD gene alteration","Homologous recombination","BRCA","BRCA1\u002F2","PALB2","RAD51C","RAD51D","2024-09-26",{"date":499,"type":54},"2024-09-27",{"date":501,"type":20},"2024-11-01",{"date":503,"type":20},"2027-06-01",{"name":505,"class":155},"Danatlas Pharmaceuticals Co., Ltd",{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":515,"conditions":516,"keywords":517,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":62},"100456785","68ga-psma-617-petct-for-psma-expressing-tumor-a-pragmatic-study-100456785","NCT05228106","68Ga-PSMA-617 PET\u002FCT for PSMA-expressing Tumor: a Pragmatic Study","Pragmatic Study on the Use of 68Ga-PSMA-617 PET\u002FCT Imaging as a Standard of Care to Influence Clinical Management of Tumors Overexpressing PSMA.","Inclusion Criteria:\n\n1. Clinical requisition for a 68Ga-PSMA-617 PET\u002FCT signed by a referring doctor;\n2. Patients with suspected, proven or prior tumor expressing PSMA;\n3. Informed consent by patient.\n\nExclusion Criteria:\n\n1. Patient refusal to participate;\n2. Prior severe anaphylactic reaction to 68Ga-PSMA-617 .",{"count":514,"type":20},1000,"This project aims to monitor the innocuity\u002Fsafety profile of cyclotron-produced \\[68Ga\\]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for \\[68Ga\\]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA.\n\nThis study also aims to instigate the use of \\[68Ga\\]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.",[27],[518,519,520,521],"[68Ga]-PSMA-617","PET imaging","Pragmatic study","PSMA-expressing cancers","2024-02-05",{"date":524,"type":54},"2024-02-07",{"date":526,"type":54},"2022-01-21",{"date":528,"type":20},"2027-01-31",{"name":530,"class":61},"Centre de recherche du Centre hospitalier universitaire de Sherbrooke"]