[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"first-line\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:first-line":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100547247","phase-2-naliri-xeloxak104-for-first-line-treatment-of-advanced-pdac-100547247",false,"NCT06405490","NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC","Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study","Inclusion Criteria:\n\n1. Age ≥18, male or female;\n2. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);\n3. Has not received prior systemic treatment for their locally advanced or metastatic PDAC;\n4. Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);\n5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;\n6. Has a life expectancy of at least 3 months;\n7. Has adequate organ function;\n8. If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;\n9. If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.\n\nExclusion Criteria:\n\n1. Untreated active CNS metastasis or leptomeningeal metastasis.\n2. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;\n3. Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;\n4. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and\u002For if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;\n5. Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;\n6. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \\\u003C 10 mg prednisone daily, inhaled steroids and topical use of steroids);\n7. Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);\n8. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;\n9. History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；\n10. Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody\u002Fdrug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；\n11. Is pregnant or breastfeeding;\n12. Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.",[26,27,28,29,30,31,32,33],"Nanoliposomal Irinotecan","Cadonilimab","Oxaliplatin","Capecitabine","First-Line","Advanced Cancer","Pancreatic Adenocarcinoma","Drug Use",[32,26,27,35,36],"First-Line Treatment","Advanced Pancreatic Adenocarcinoma","RECRUITING","2024-12-19",{"date":40,"type":41},"2024-12-24","ACTUAL",{"date":43,"type":41},"2024-04-17",{"date":45,"type":20},"2026-12-30",{"name":47,"class":48},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":49},"100563817","phase-2-anlotinib-plus-benmelstobart-and-ag-in-first-line-treatment-of-advanced-metastatic-pancreatic-cancer-alter-pa-001-100563817","NCT06621095","Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001)","Anlotinib Plus Benmelstobart and AG Versus AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial (ALTER-PA-001)","Inclusion Criteria:\n\n* 18-75 years old (including 18 and 75 years old);\n* Histologically or cytologically confirmed diagnosis of metastatic pancreatic cancer;\n* No prior systemic therapy for metastatic pancreatic cancer (allowable circumstances for inclusion include recurrence more than 6 months after neoadjuvant (chemo)radiotherapy plus radical surgery, or recurrence more than 6 months after the completion of adjuvant (chemo)radiotherapy or radical concurrent chemoradiotherapy);\n* At least one measurable lesion according to RECIST v1.1 criteria (any previous radiotherapy-treated lesion that has not progressed cannot be selected as the target lesion);\n* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;\n* Life expectancy ≥ 3 months;\n* Adequate organ and bone marrow function, meeting the following criteria (within 7 days before enrollment):\n\n  1. Hematology:\n\n     Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL Platelet count (PLT) ≥ 90 x 10\\^9\u002FL Hemoglobin (HB) ≥ 90 g\u002FL\n  2. Biochemistry:\n\n     Without liver metastasis: Serum total bilirubin (TBIL) ≤ 1.5x the upper limit of normal (ULN); with liver metastasis: TBIL ≤ 2.5 x ULN.\n\n     Without liver metastasis: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN; with liver metastasis: ALT and AST ≤ 5 x ULN.\n\n     Serum creatinine ≤ 1.5 x ULN and creatinine clearance rate ≥ 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n  3. Adequate coagulation function, defined as an international normalized ratio (INR) or a partial thromboplastin time (APTT) ≤ 1.5 x ULN.\n* Women of childbearing age need to take effective contraceptive measures.\n\nExclusion Criteria:\n\n* Previously received treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or immune checkpoint inhibitors;\n* Received other systemic antitumor treatments within 4 weeks prior to enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy, biological immunotherapy, targeted therapy, photodynamic therapy, and traditional Chinese medicine with clear antitumor indications;\n* Have other untreated or concurrent malignancies (excluding cervical carcinoma in situ, well-controlled basal cell or squamous cell carcinoma of the skin, or malignancy that has been treated and has shown no signs or evidence of recurrence for more than 3 years, and patients who do not require systemic therapy at the time of signing informed consent);\n* Presence of central nervous system (CNS) metastases or brain metastases before enrollment;\n* Underwent any surgery (excluding biopsy), invasive treatment or operation without complete healing of surgical incisions within 4 weeks before enrollment (excluding venous catheter placement and puncture drainage);\n* Received radiotherapy within 4 weeks before enrollment (allowable if at least 2 weeks have passed since palliative radiotherapy for bone lesions was completed before starting study medication);\n* Previously received any organ transplantation;\n* Clinically symptomatic ascites, pleural effusion, or pericardial effusion requiring puncture or drainage, or received drainage of effusions within 14 days before the first dose;\n* International normalized ratio (INR) \\> 1.5 or partial thromboplastin time (APTT) \\> 1.5 x ULN;\n* Clinically significant electrolyte abnormalities as determined by the investigator;\n* Presence of active gastrointestinal diseases like active gastric and duodenal ulcers, ulcerative colitis, or unremoved tumors with active bleeding, or other conditions judged by the investigator to possibly cause gastrointestinal bleeding or perforation;\n* Evidence or history of significant bleeding tendency or episodes within 3 months before enrollment (bleeding \\>30 mL, hematemesis, melena, or hematochezia), hemoptysis (\\> 5 mL of fresh blood within 4 weeks), or thromboembolic events such as stroke and\u002For transient ischemic attack within 12 months;\n* Any severe and\u002For uncontrollable disease, including:\n\n  1. History or presence of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severely impaired lung function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.\n  2. Clinically significant history of liver diseases, including active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA \\> 1 x 10\\^4 copies\u002FmL or \\> 2000 IU\u002FmL; Hepatitis C reference: HCV antibody positive with HCV RNA \\> 1 x 10\\^3 copies\u002FmL), or other hepatitis, clinically significant moderate to severe hepatic cirrhosis; Note: Participants with eligible Hepatitis B or C must receive continuous antiviral treatment to prevent viral reactivation.\n  3. Human immunodeficiency virus (HIV) antibody positivity.\n  4. Uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg not controlled by medications);\n  5. Poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to acute myocardial infarction, malignant arrhythmias (including QTc \\> 450 ms for males and \\> 470 ms for females), ≥ Grade II congestive heart failure (New York Heart Association (NYHA) classification), or clinically significant abnormal myocardial enzyme levels as determined by the investigator;\n  6. Active or uncontrollable severe infections (≥ NCI-CTC AE Grade 2 infections);\n  7. Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n  8. Proteinuria ≥ ++ on urinalysis and confirmed 24-hour urinary protein \\> 1.0 g;\n  9. History or presence of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, or autoimmune neuropathies (e.g., Guillain-Barre syndrome). Exceptions include stable hypothyroidism requiring hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic treatment;\n* Pregnant or breastfeeding women;\n* Known history of allergy to investigational drug components;\n* Participation in other clinical trials and treatment with investigational drugs within 4 weeks before enrollment;\n* Any disease or condition that affects drug absorption or the inability of participants to take oral medications;\n* Any other conditions judged by the investigator to be unsuitable for enrollment, including diseases, metabolic disorders, abnormal physical examination, laboratory result abnormalities, or any other conditions affecting the study.","75 Years",{"count":59,"type":20},104,[23],"This study is designed to explore the efficacy and safety of anlotinib combined with benmelstobart and AG (nab-paclitaxel and gemcitabine) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in metastatic pancreatic cancer.",[63,64,65],"Pancreatic Cancer","First-line","Metastatic Pancreatic Cancer",[65,64,67,68,69],"Immunotherapy","Angiogenesis inhibitors","Anlotinib","NOT_YET_RECRUITING","2024-09-27",{"date":73,"type":41},"2024-10-01",{"date":75,"type":20},"2024-10-30",{"date":77,"type":20},"2026-12-31",{"name":79,"class":48},"RenJi Hospital",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":49},"100513809","phase-2-xelox-bev-tislelizumab-for-first-line-treatment-of-msspmmr-ras-mutated-mcrc-100513809","NCT05970302","XELOX +Bev +Tislelizumab for First-line Treatment of MSS\u002FpMMR RAS-mutated mCRC","XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS\u002FpMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.","Inclusion Criteria:\n\n1. Histologically confirmed initially unresectable MSS\u002FpMMR-type RAS-mutant metastatic colorectal adenocarcinoma;\n2. ECOG score of 0 or 1;\n3. Ability to swallow oral medications;\n4. Have at least one measurable lesion (according to RECIST v1.1 standard);\n5. No anti-tumor treatment has been received after recurrence and metastasis;\n6. Neoadjuvant or adjuvant chemotherapy containing fluorouracil drugs is allowed before or after radical resection of colorectal cancer, but the treatment needs to be completed for ≥ 6 months; if oxaliplatin is used in neoadjuvant or adjuvant chemotherapy, it includes The oxaliplatin regimen needs to be completed for ≥12 months;\n7. Adequate organ function: On the premise of no component blood transfusion within 14 days: white blood cells ≥ 3.5\\*10\\^9\u002FL and neutrophils ≥ 1.5\\*10\\^9\u002FL, hemoglobin ≥ 90g\u002FL, platelets ≥ 100\\* 10\\^9\u002FL; serum bilirubin ≤ 1.5 times the normal value, alanine aminotransferase (ALT) ≤ 2.5 times the normal value, aspartate aminotransferase (AST) ≤ 2.5 times the normal value; Urinary protein \\\u003C2+. Or urine protein 2+ but 24-hour urine protein quantity ≤ 1 g; serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml\u002Fmin; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);\n8. Expected survival period ≥ 3 months;\n9. Patients fully understand this research, voluntarily participate in this clinical trial and sign an informed consent;\n10. Women with reproductive potential (\\\u003C 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.\n\nExclusion Criteria:\n\n1. Previously received bevacizumab or anti-CTLA4, anti-PD-1\u002FPD-L1 therapeutic antibodies or pathway-targeted drugs;\n2. Received radiotherapy within 4 weeks before the evaluation;\n3. Symptomatic peripheral neuropathy \\> grade 2 (CTCAE5.0 standard);\n4. Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;\n5. HIV-positive and other immunodeficiency diseases;\n6. Active hepatitis B or hepatitis C (except for those who have been infected or cured before, that is, HBsAg negative and hepatitis B core antigen anti-HBc antibody positive; except for hepatitis C patients whose HCV RNA is negative by PCR);\n7. Existing autoimmune diseases or other diseases that require immunosuppressant treatment, except for type 1 diabetes; except for hypothyroidism that only requires hormone replacement therapy; skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia areata); inhaled or topical steroids or equivalent steroids in excess of 10 mg prednisone per day, except for inactive autoimmune disease on adrenal replacement therapy;\n8. Received systemic hormone therapy or treatment with a daily dose of more than 10 mg prednisone equivalent dose or other forms of immunosuppressive treatment within 7 days, but inhaled or topical steroids or daily application of more than 10 mg prednisone, etc. Except for inactive autoimmune diseases treated with adrenal replacement therapy with potent steroids;\n9. Have a history of organ transplantation;\n10. Uncontrolled central nervous system (CNC) metastasis (symptomatic or metastatic sites are midbrain, pons, medulla or spinal cord) or other central nervous system diseases;\n11. Those who have undergone major surgery, open biopsy or obvious traumatic trauma within 1 month, or who may need major surgery during the study period; those who have undergone open biopsy or obvious traumatic trauma, or may need major surgery during the study period;\n12. Combined with other malignant tumors other than intestinal cancer (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 1 year, and there is no clinical and imaging evidence of recurrence or progression except);\n13. Combined active and refractory infection;\n14. Cardiovascular diseases with clinical significance, such as cardiovascular accident (CVA) (≤ 6 months before treatment), myocardial infarction (≤ 6 months before treatment), unstable angina, chronic heart failure of NYHA ≥ 2 (CHF), uncontrolled arrhythmia; uncontrolled hypertension; thromboembolic or bleeding events within 6 months before treatment;\n15. Evidence of causing coagulation disease;\n16. With dysphagia, active peptic ulcer, complete or incomplete intestinal obstruction, active gastrointestinal bleeding, perforation, malabsorption syndrome or uncontrollable gastrointestinal inflammatory disease (such as Crohn's disease or ulcerative colon inflammation);\n17. Severe unhealed wounds\u002Fulcers or severe fractures;\n18. Any serious acute or chronic medical condition that may affect the patient's participation in the study or interfere with the interpretation of the study results;\n19. There are mental illnesses, serious social and psychological illnesses, or researchers believe that there are factors that may affect research compliance;\n20. Pregnant or lactating women;\n21. No therapeutic anticoagulant or antiplatelet drugs or NSAIDs (aspirin ≤ 325 mg\u002Fday allowed);\n22. Severe allergic reaction to the test drug;\n23. Reluctance to use alternative therapies such as (but not limited to) bisphosphonates if receiving RANKL inhibitors (eg, denosumab).",{"count":88,"type":20},52,[23],"The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS\u002FpMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a \"hot tumor\" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.",[92,93,28,29,94,95,96,30],"Tislelizumab","Bevacizumab","MSS\u002FpMMR","Metastatic Colorectal Cancer (mCRC)","RAS-mutated",[98,99],"Single-arm","Phase II","2023-07-21",{"date":102,"type":41},"2023-08-01",{"date":104,"type":41},"2023-07-07",{"date":106,"type":20},"2026-07",{"name":47,"class":48}]