[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Junjie Hang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100596036","phase-1-a-phase-ibii-clinical-study-of-regorafenib-combined-with-toripalimab-and-albumin-bound-paclitaxel-for-the-third-line-treatment-of-advanced-pancreatic-cancer-100596036",false,"NCT07040228","A Phase Ib\u002FII Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer","Inclusion Criteria:\n\n1. The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);\n2. Age ≥ 18 years old and ≤ 80 years old;\n3. Patients with unresectable\u002Fmetastatic pancreatic cancer confirmed by histopathology;\n4. Imaging confirmation of tumor progression after previous first-line and second-line standard treatment;\n5. According to RECIST 1.1 criteria, patients must have at least one measurable target lesion;\n6. Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;\n7. Expected survival time ≥ 2 months;\n8. Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9\u002FL, platelets ≥ 100 × 10 \\^ 9\u002FL, and hemoglobin ≥ 90 g\u002FL (No blood transfusion or blood products within 14 days prior to laboratory examination.\n\n   Not treated with granulocyte colony-stimulating factor or other hematopoietic stimulating factors);\n9. Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver metastases); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver metastasis);\n10. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result must be negative, And willing to use appropriate contraception methods during the trial period and 6 months after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. Have hypersensitivity reactions to any research drug or its components;\n2. Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);\n3. Heart function and disease meet one of the following conditions:\n\n   1. Long QTc syndrome or QTc interval\\>480 ms;\n   2. Complete left bundle branch block, grade II or III atrioventricular block;\n   3. Severe and uncontrolled arrhythmias requiring medication treatment;\n   4. New York College of Cardiology classification ≥ III;\n   5. Heart ejection fraction (LVEF) below 50%;\n   6. History of myocardial infarction, unstable angina, and severe unstable ventricular arrhythmia within 6 months prior to recruitment or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or there may be electrocardiographic evidence of acute ischemic or active conduction system abnormalities.\n4. Active infection of hepatitis B and C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies\u002FmL; Hepatitis C virus RNA exceeding 1x103 copies\u002FmL).Asymptomatic chronic carriers of hepatitis B or hepatitis C excluded;\n5. Human immunodeficiency virus (HIV) infection (HIV antibody positive);\n6. Imaging confirms intestinal obstruction;\n7. Previously or currently suffering from other malignant tumors simultaneously (Except for non melanoma basal cell carcinoma and breast\u002Fcervical carcinoma in situ that have been effectively controlled and other malignant tumors that have been effectively controlled without treatment in the past five years);\n8. Pregnant and lactating women, as well as reproductive age patients who are unwilling to take contraceptive measures;\n9. Patients who require treatment for merging with other malignant tumors;\n10. History of pulmonary hemorrhage\u002Fhemoptysis ≥ grade 2 (defined as at least 2.5mL of bright red blood) within one month prior to the first administration;\n11. Within 6 months prior to the first administration, there are arterial embolism, severe bleeding (excluding bleeding caused by surgery), and a tendency for severe bleeding;\n12. Merge symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression syndrome;\n13. Have used other clinical trial drugs within one month before the first administration;\n14. The researchers have determined that patients who are not suitable to participate in this study.","ALL","18 Years","80 Years",{"count":19,"type":20},23,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this clinical trial is to explore the efficacy and safety of Regorafenib combined with Toripalimab and Paclitaxel-albumin in patients as the third line treatment for patients with unresectable or metastatic pancreatic cancer.The main question it aims to answer is:\n\nPhase Ib: Evaluate the maximum tolerated dose (MTD) of regorafenib and\u002For phase II clinical recommendations Dose (RP2D).\n\nPhase II: Evaluation of the efficacy and safety of Regorafenib Combined with Terriptylimab and Albumin Paclitaxel for Late Third Line Treatment for pancreatic cancer patients.\n\nParticipants will:\n\nPhase Ib: Selected patients will receive treatment with Regorafenib at main dose levels of 40, 80, and 120mg\u002Fd (po d1-14 Q3W), Toripalimab(240mg, ivgtt, d1, Q3W), and Paclitaxel-albumi(125mg\u002Fm2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.\n\nPhase II: Regorafenib: Based on the results of the completed Phase I study, determine the dosage for Phase II (po d1-14 Q3W). Toripalimab (240mg, ivgtt, d1, Q3W) and Paclitaxel-albumi (125mg\u002Fm2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.",[27],"Pancreatic Cancer Metastatic",[29,30,31,32,33],"Efficacy","Safety","Advanced pancreatic cancer","Regorafenib","Toripalimab","RECRUITING","2026-05-15",{"date":37,"type":38},"2026-05-18","ACTUAL",{"date":40,"type":38},"2025-05-26",{"date":42,"type":20},"2027-05-30",{"name":44,"class":45},"Junjie Hang","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100560508","irinotecan-liposome-in-combination-with-capecitabine-100560508","NCT06578052","Irinotecan Liposome in Combination With Capecitabine","Irinotecan Liposome in Combination With Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer: Phase II Clinical Study","Inclusion Criteria:\n\n1. patients were fully aware of the study, participated voluntarily and signed the informed consent form (ICF);\n2. aged ≥18 years and ≤80 years;\n3. patients with histopathologically confirmed unresectable\u002Fmetastatic pancreatic cancer;\n4. imaging-confirmed tumor progression after prior treatment with a standard first-line regimen;\n5. patients with at least one measurable target lesion according to RECIST 1.1 criteria;\n6. Eastern Cooperative Oncology Group (ECOG) physical status score: 0-2;\n7. expected survival time ≥ 3 months;\n8. absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL, platelets ≥ 100 x 10\\^9\u002FL and hemoglobin ≥ 90 g\u002FL (not transfused with blood, blood products, or corrected with granulocyte colony-stimulating factor or other hematopoietic-stimulating factor in the 14 days prior to the laboratory test);\n9. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value.\n\nLiver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver metastases); total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver metastases); 10. Women of childbearing potential must have had a negative pregnancy test (serum) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 6 months after the last administration of the test drug.\n\n\\-\n\nExclusion Criteria:\n\n1. hypersensitivity to any of the study drugs or their components;\n2. concomitant serious uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe renal impairment; (e.g., progressive infections, uncontrollable hypertension, diabetes mellitus, etc.);\n3. cardiac function and disease consistent with one of the following conditions\n\n   1. Long QTc syndrome or QTc interval \\>480 ms;\n   2. Complete left bundle branch block, degree II or degree III atrioventricular block;\n   3. Severe, uncontrolled arrhythmia requiring pharmacologic therapy;\n   4. New York Society of Cardiology classification ≥ grade III;\n   5. Cardiac ejection fraction (LVEF) less than 50%;\n   6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormality within 6 months prior to recruitment.\n4. active hepatitis B or C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA greater than 1x103 copies\u002FmL; hepatitis C virus RNA greater than 1x103 copies\u002FmL), except for asymptomatic chronic hepatitis B or hepatitis C carriers;\n5. human immunodeficiency virus (HIV) infection (HIV-positive);\n6. imaging confirmation of intestinal obstruction;\n7. previous or current concurrent other malignancies (except effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast\u002Fcervix, and other malignancies that have been effectively controlled without treatment within the past five years);\n8. pregnant and lactating women and patients of childbearing age who do not wish to use contraception;\n9. patients with other malignant tumors requiring treatment;\n10. patients who, in the judgment of the investigator, are not suitable for participation in this study.\n11. history of pulmonary hemorrhage\u002Fcoughing up ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose of drug;\n12. a predisposition to arterial embolism, severe hemorrhage (other than bleeding due to surgery), and severe bleeding within 6 months prior to first dose;\n13. a combination of symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression\n14. use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to receiving study drug therapy\n15. who have used other clinical trial medications within 1 month prior to the first dose;\n16. pregnant or lactating female patients, subjects of childbearing age who refuse to accept contraception; -",{"count":55,"type":20},20,[57],"NA","Pancreatic cancer is a group of malignant tumors mainly originated from pancreatic ductal epithelium and follicular cells, with high degree of malignancy, insidious onset, difficult early diagnosis, rapid progression, short survival time, and one of the malignant tumors with the worst prognosis, which is known as the \"king of cancers\". In recent years, the incidence rate of pancreatic cancer has been increasing both at home and abroad. At present, the palliative treatment of advanced pancreatic cancer is still mainly based on chemotherapy, such as FOLFIRINOX regimen. And after standard first-line treatment, most of the patients have problems such as poor physical status, no standard treatment options and limited options available.\n\nCapecitabine is a selective fluorouracil methionine salt antitumor drug, belongs to the pyrimidine class of antimetabolites, and is the precursor drug of 5-fluorouracil. Its first-line monotherapy for pancreatic cancer is 24% effective, and it is directly recommended by NCCN 2024 V2.0 as a second-line treatment for patients with pancreatic cancer who have failed gemcitabine therapy.The 2024 CSCO Guidelines for Pancreatic Cancer recommend the use of 5-fluorouracil (5-FU)-like regimens as a second-line treatment for patients who have been treated with a gemcitabine-based regimen as first-line treatment. In a clinical study exploring capecitabine in gemcitabine-treated patients with metastatic or unresectable locally advanced pancreatic cancer, 42 patients received oral capecitabine 1,250 mg\u002Fm2 twice daily (2,500 mg\u002Fm2\u002Fd) as intermittent therapy in 3-week cycles consisting of 2 weeks of dosing followed by 1 week of withdrawal. A total of 4 remissions were achieved in 42 evaluable patients, for an overall remission rate of 9.5%.\n\nIrinotecan Hydrochloride Liposome Injection, the first domestic generic product developed by Shiyao Group, was launched in China in September 2023 with an approved indication for use in combination with 5-FU and calcium folinate (LV) in patients with metastatic pancreatic cancer that has progressed after treatment with gemcitabine. Liposomal irinotecan hydrochloride has been studied in a number of indications including biliary tract cancer, colorectal cancer, glioma, gastric cancer, small cell lung cancer, cervical cancer, breast cancer, head and neck cancer, esophageal cancer, and neuroendocrine cancer. In the bioequivalence trial of Shiyi Group's irinotecan hydrochloride liposome injection, the ORR rate reached 12.9%, the median PFS was 6.24 months, and the median OS was 10.38 months; indicating similar efficacy and a similar safety profile. A randomized, open-label, phase 3 NAPOLI 3 study and the first phase 3 trial comparing two combination chemotherapy regimens in the first-line treatment of patients with pancreatic ductal carcinoma head-to-head was designed to compare the efficacy and safety differences between the NALIRIFOX regimen (irinotecan liposomal, fluorouracil, and calcium folinic acid in combination with oxaliplatin) versus the doublet regimen (gemcitabine + albumin-conjugated paclitaxel) in the first-line treatment of metastatic pancreatic ductal carcinoma efficacy and safety differences in the treatment of metastatic pancreatic ductal cancer. The results showed that the median OS in the NALIRIFOX treatment group was 11.1 months, while the median OS in the dual combination treatment group was 9.2 months (HR=0.83; 95% CI 0.70-0.99; p=0.036).\n\nBased on the above literature research, combined with the efficacy and safety advantages of irinotecan liposome chemotherapy combination regimen in patients with metastatic pancreatic cancer, we propose to carry out a phase II clinical study of irinotecan liposome combined with capecitabine in the second-line treatment of advanced pancreatic cancer. The aim is to explore the efficacy and safety of irinotecan liposomal chemotherapy combined with capecitabine in second-line unresectable or metastatic pancreatic cancer patients, and to explore more effective clinical options for patients with pancreatic cancer that has progressed after previous treatment.",[60],"Pancreatic Cancer","2025-02-12",{"date":63,"type":38},"2025-02-14",{"date":65,"type":38},"2024-08-28",{"date":67,"type":20},"2027-12-31",{"name":44,"class":45},""]