[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Cancer Center, China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":145},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,72,100,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100603040","phase-1-study-of-iparomlimab-and-tuvonralimab-plus-chemotherapy-in-malignant-mesothelioma-100603040",false,"NCT07131345","Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma","A Single-Arm, Multicenter, Open-Label Phase Ib\u002FII Clinical Study Exploring the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy for the Treatment of Malignant Mesothelioma","Inclusion Criteria:\n\n* Subjects must provide informed consent prior to initiating any study-specific procedures.\n* Male or female subjects aged ≥18 and ≤75 years.\n* Histologically\u002Fcytologically confirmed malignant mesothelioma (MM), including malignant pleural mesothelioma (PM) and malignant peritoneal mesothelioma (PeM).\n* Subjects with MM unsuitable for radical resection and\u002For radiotherapy per AJCC 8th Edition.\n* Subjects who received neoadjuvant\u002Fadjuvant chemotherapy for radical surgery completed \\>6 months prior to current recurrent disease diagnosis, not counted in subsequent treatment lines.\n* Prior systemic anti-tumor therapy requirements:\n\n  * Safety run-in phase: ≥1 prior anti-tumor therapy line (maximum 3 lines)\n  * Phase II first-line cohort: No prior systemic anti-tumor therapy\n  * Phase II second-line cohort: Only 1 prior systemic anti-tumor therapy line\n* ECOG performance status 0-2.\n* Investigator-assessed life expectancy \\>3 months.\n* Adequate hematological parameters.\n\nExclusion Criteria:\n\n* Prior CTLA-4 inhibitors prohibited; prior PD-1\u002FPD-L1 allowed unless discontinued for immune toxicity\n* Immunomodulators within 14 days (e.g., thymosin, interleukin-2, interferon)\n* Significant cardiovascular history within 6 months","ALL","18 Years","75 Years",{"count":20,"type":21},55,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This clinical trial aims to investigate the effectiveness and safety of a new treatment combination-Iparomlimab and Tuvonralimab (QL1706, a dual-function antibody targeting PD-1 and CTLA-4) combined with chemotherapy-for patients with malignant mesothelioma (MM). MM is a rare and aggressive cancer often linked to asbestos exposure. Current treatments have limited success, and this study seeks to explore a potentially more effective and safer option.\n\nStudy Design:\n\nPhase Ib (Safety Phase): 6 patients will receive the combination therapy to assess safety. If no major safety issues arise, the study will proceed to Phase II.\n\nPhase II (Efficacy Phase): 49 patients will be enrolled to evaluate treatment effectiveness. The study includes two groups for first-line treatment and second-line treatment.",[28,29],"Malignant Mesothelioma","Mesothelioma",[28,31,32],"iparomlimab and tuvonralimab","immunotherapy","NOT_YET_RECRUITING","2025-08-19",{"date":36,"type":37},"2025-08-20","ACTUAL",{"date":39,"type":21},"2025-09-01",{"date":41,"type":21},"2027-07-01",{"name":43,"class":44},"National Cancer Center, China","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100569429","real-world-observational-study-of-targeted-therapy-in-patients-with-advanced-ros1-positive-nsclc-100569429","NCT06694129","Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC","Inclusion Criteria:\n\n* 1\\) Histologically or cytologically confirmed non-small cell lung cancer;\n* 2\\) TNM stage of the ninth edition is IIIB, IIIC, or IV;\n* 3\\) ROS1 fusion positive confirmed by one of the following qualified results: next-generation sequencing technology, fluorescence in situ hybridization, reverse transcription polymerase chain reaction;\n* 4\\) No prior systemic chemotherapy, radiation therapy, or surgery;\n* 5\\) Aged 18 years or older;\n* 6\\) ECOG PS score of 0-1.\n\nExclusion Criteria:\n\n* 1\\) any prior history of NSCLC and\u002For any prior treatment for NSCLC;\n* 2\\) prior systemic chemotherapy or radiation therapy or surgical treatment;\n* 3\\) the presence of a second primary tumor;\n* 4\\) hypersensitivity to ROS1-TKI or intolerance to it.","86 Years",{"count":53,"type":21},40,"3 Years","OBSERVATIONAL","The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.",[58,59,60,61],"Non-Small Cell Lung Cancer","ROS1 Gene Rearrangement","Resistance","Targeted Therapy",[58,59,63],"Targeted therapy","2024-11-16",{"date":66,"type":37},"2024-11-19",{"date":68,"type":21},"2024-12-01",{"date":70,"type":21},"2027-12-01",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100543984","phase-1-a-study-with-bpi-1178-and-osimertinib-in-advanced-non-small-cell-lung-cancer-patients-with-egfr-mutations-100543984","NCT06362980","A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations","An Open-label, Single-arm, Investigator-initiated Phase I Clinical Study Evaluating BPI-1178 Capsules in Combination With Osimertinib Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations","EGFR","Inclusion Criteria:\n\nParticipants must meet all of the following inclusion criteria to be eligible for this study:\n\n1. Signed written informed consent and ability to comply with the scheduled visits and study procedures outlined in the protocol.\n2. Age ≥ 18 years, any gender.\n3. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (mainly adenocarcinoma) not suitable for curative surgery or radiation therapy.\n4. ECOG Performance Status (ECOG PS) score of 0-1. Expected survival of at least 12 weeks.\n5. Prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) targeted therapy, with radiological evidence of disease progression. The last treatment before enrollment must show radiological evidence of disease progression, intolerance to chemotherapy toxicity, or the patient being ineligible for standard treatment or unable to tolerate the current treatment regimen.\n6. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria that has not been previously irradiated.\n7. Tissue, plasma, or cytological samples collected after disease progression confirmed by imaging following treatment with a third-generation EGFR TKI, demonstrating an EGFR-positive gene mutation sensitive to EGFR TKI treatment (including exon 19 deletion, 21 L858R mutation, etc.), with or without T790M mutation.\n8. Adequate organ and bone marrow function, with clinical laboratory test results meeting the following criteria:\n\n   * Hematology: Neutrophils ≥ 1.5 × 10\\^9\u002FL; Platelets ≥ 100 × 10\\^9\u002FL; Hemoglobin (Hgb) ≥ 100 g\u002FL;\n   * Liver function: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (≤3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN;\n   * Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCr, Cockcroft-Gault formula) ≥ 50 mL\u002Fmin; Semi-quantitative urine testing (e.g., urine dipstick) result showing urine protein \\\u003C 2+; patients with urine protein ≥ 2+ at baseline should undergo a 24-hour urine collection, and the protein content in the urine within 24 hours should be \\\u003C 1g;\n   * Coagulation function: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) both ≤ 1.5 × ULN;\n   * Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * At rest, male QTcF \\\u003C 450 msec or female QTcF \\\u003C 470 msec.\n9. Ability to swallow oral medications.\n10. Reproductive-age female patients must agree to use effective contraception throughout the study period until 60 days after discontinuing BPI-1178 and osimertinib. Female patients must have a negative pregnancy test result before the start of treatment or prove the absence of pregnancy possibility. Male patients must agree to use effective contraception throughout the study period until 120 days after discontinuing BPI-1178 and osimertinib.\n11. Apart from stable Grade 2 peripheral neuropathy (CTCAE v5.0) and alopecia, any treatment-related clinical toxicity before enrollment must have recovered to baseline or Grade 1.\n12. All patients must have sufficient mental capacity to understand the nature, significance of the study, and risks associated with the study.\n\nExclusion Criteria:\n\nSubjects with any of the following cannot be included in this study:\n\n1. History of prior or current use of anti-tumor drugs targeting CDK4\u002F6.\n2. Individuals with allergies or a history of severe allergic reactions.\n3. Tissue, plasma, or cytological samples collected after radiological confirmation of disease progression, with testing confirming the presence of specific therapeutic targets such as anaplastic lymphoma kinase (ALK), BRAF V600E, or retinoblastoma (Rb) protein loss.\n4. Received the last dose of anti-tumor treatment (chemotherapy, targeted therapy, investigational drugs, immunotherapy, tumor embolization, herbal medicine for anti-tumor purposes, etc.) within the 2 weeks preceding the start of study drug administration.\n5. Presence of third-space effusion (such as significant pleural or abdominal fluid) that cannot be controlled by drainage or other methods.\n6. Long-term use of steroids is required.\n7. Unresolved hypokalemia and hypomagnesemia at the time of enrollment.\n8. Meets any of the following criteria: Various clinically significant arrhythmias and conduction abnormalities, such as atrial fibrillation, complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \\> 250 msec; various factors that may increase the risk of QT interval prolongation or arrhythmia events, such as symptomatic heart failure - New York Heart Association (NYHA) class II-IV, congenital long QT syndrome, Brugada syndrome, history of QT interval prolongation (male \\> 470 ms, female \\> 480 ms) or torsades de pointes (TdP), family history of long QT syndrome or unexplained sudden death before the age of 40, various concomitant medications that may prolong QT interval; within the 6 months before starting the study drug, had the following diseases, including unstable angina, myocardial infarction, cerebrovascular accident, pulmonary embolism, etc., or underwent cardiac revascularization surgery.\n9. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease.\n10. Known active infections, such as hepatitis B (HBsAg positive and hepatitis B virus (HBV) DNA copy number ≥ 200 IU\u002Fml), hepatitis C, and human immunodeficiency virus (HIV) infection.\n11. Cannot be included if there has been a relapse or concurrent malignancy in the past 5 years. Cervical cancer treated with curative intent, non-melanoma skin cancer, superficial bladder tumors (non-invasive tumors), or cancer with no recurrence for 3 years after curative treatment can be considered for inclusion.\n12. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n13. Various factors judged by the investigator to potentially affect the intake and absorption of BPI-1178 or osimertinib, including gastrointestinal factors (such as uncontrolled inflammatory gastrointestinal diseases, history of abdominal fistula or gastrointestinal perforation within 6 months, extensive small intestine resection requiring enteral or parenteral supplementation, inability to swallow, chronic diarrhea, intestinal obstruction, etc.).\n14. Spinal cord compression, leptomeningeal metastases, or symptomatic brain metastases cannot be included. Asymptomatic patients with brain metastases may be allowed to participate under the following conditions: Asymptomatic brain metastases discovered during screening, determined by the investigator not to require steroids and\u002For local treatment; asymptomatic brain metastases treated with local therapy (such as radiation) with the patient discontinuing steroids and\u002For antiepileptic treatment for at least 7 days before the first administration of BPI-1178 in combination with osimertinib.\n15. Major surgery (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures within the 4 weeks preceding the start of study drug administration.\n16. Local radiation therapy for symptom relief within 1 week before the first administration of the study drug; bone marrow radiation therapy or extensive radiation therapy exceeding 30% within 4 weeks before the first administration of the study drug.\n17. Presence of factors, according to the investigator's judgment, that may interfere with patient participation in the trial or the assessment of study results, such as substance abuse, alcohol addiction, medical, psychiatric illness, and social disorders, or any factors that the investigator deems the patient unsuitable for receiving the study drug (such as severe hypertension, diabetes, thyroid disease, severe infection, portal hypertension, cirrhosis, etc.). Patients who were unwilling or unable to comply with the requirements of this study protocol will be excluded.",{"count":81,"type":21},20,[24],"BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.",[85],"NSCLC",[85,87,88,89],"EGFR Gene Mutation","BPI-1178","Osimertinib","RECRUITING","2024-07-09",{"date":93,"type":37},"2024-07-10",{"date":95,"type":37},"2024-05-22",{"date":97,"type":21},"2026-04-01",{"name":43,"class":44},1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100547971","phase-2-surufatinib-combined-with-tislelizumab-in-advanced-lung-cancer-with-neuroendocrine-differentiation-100547971","NCT06414915","Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation","A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation","Inclusion Criteria:\n\n* Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));\n* Have at least one measurable lesion according to RECIST v1.1;\n* ECOG performance status: 0-1;\n* Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;\n* Urine protein \\\u003C ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;\n* Expected survival time \\> 3 months;\n\nExclusion Criteria:\n\n* Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);\n* Prior anti-VEGF\u002FVEGFR-targeted therapy or anti-PD (L)1 antibody;\n* Have uncontrolled hypertension, defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mm Hg, while under anti-hypertension treatment;\n* Patients with active ulcer, intestinal perforation and intestinal obstruction;\n* With active bleeding or bleeding tendency;\n* Severe history of cardiovascular and cerebrovascular diseases;\n* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.",{"count":108,"type":21},29,[25],"Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.",[85],[85,113,114,115],"neuroendocrine differentiation","Surufatinib","Tislelizumab","2024-05-10",{"date":118,"type":37},"2024-05-16",{"date":120,"type":21},"2024-06-01",{"date":122,"type":21},"2027-06-01",{"name":43,"class":44},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":99},"100537551","lateral-pelvic-lymph-node-dissection-for-rectal-neuroendocrine-neoplasms-undergoing-laparoscopic-total-mesenteric-excision-100537551","NCT06279299","Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision","Inclusion Criteria:\n\n1. Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);\n2. Meets any one of the following conditions:\n\n   * Preoperative imaging examinations reveal that the maximum diameter of the tumor is greater than 2cm.\n   * Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and the clinical staging is T2 or higher.\n   * Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and is categorized as Grade 3 differentiation.\n   * Recurrence after local excision under endoscopy.\n3. Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;\n4. Written informed consent;\n\nExclusion Criteria:\n\n1. Complete intestinal obstruction;\n2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);\n3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation；\n4. Pregnancy or breastfeeding;\n5. Alcohol abuse or drug addiction;\n6. Concurrent uncontrolled medical condition;",{"count":131,"type":21},30,[133],"NA","The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.",[136],"Rectal Neuroendocrine Neoplasm","2024-02-26",{"date":139,"type":37},"2024-02-28",{"date":141,"type":37},"2022-08-01",{"date":143,"type":21},"2028-08-01",{"name":43,"class":44},""]