[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,70,99,124,147,175,210,238],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100585873","phase-2-scrtmfolfox6pd-1-antibody-and-targeted-therapy-for-high-risk-pmmrmss-rectal-cancercrit-100585873",false,"NCT06908031","SCRT+mFOLFOX6+PD-1 Antibody and Targeted Therapy for High-Risk pMMR\u002FMSS Rectal Cancer(CRIT)","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Prospective, Multicenter Phase II Study(CRIT)","CRIT","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   1. White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n   2. Hemoglobin (HGB) ≥80 g\u002FL;\n   3. Platelets (PLT) ≥100×10\\^9\u002FL;\n   4. Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range;\n   5. Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range;\n   6. Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":21,"type":22},49,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","To explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS\u002FBRAF Wild-Type)\u002Fbevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.",[28,29,30],"Rectal Adenocarcinoma","High-Risk Cancer","MSS",[32,33,34],"Short-Course Radiotherapy","Targeting Therapy","Immunotherapy","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2025-04-02",{"date":43,"type":22},"2027-04-01",{"name":45,"class":46},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100635185","phase-3-scrt--chemo-targeted-immuno-neoadjuvant-therapy-for-high-risk-pmmrmss-rc-100635185","NCT07549399","SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR\u002FMSS RC","Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS\u002FBRAF Wild-Type)\u002FBevacizumab (for RAS\u002FBRAF Mutant) in High-Risk pMMR\u002FMSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial","CRITⅡ","Inclusion Criteria:\n\n1. Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.\n2. Age 18-75 years.\n3. Histologically or cytologically confirmed pMMR\u002FMSS rectal adenocarcinoma; all other histological types are excluded.\n4. Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.\n5. Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).\n6. No evidence of distant metastasis before treatment.\n7. No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n8. ECOG performance status of 0-1.\n9. Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):\n\n   * White blood cells (WBC) ≥3.0×10\\^9\u002FL or absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n\n     * Hemoglobin (HGB) ≥80 g\u002FL; ③Platelets (PLT) ≥100×10\\^9\u002FL; ④Liver transaminases (AST\u002FALT) \\\u003C3.0 times the upper limit of the normal range; ⑤Total bilirubin (TBIL) \\\u003C1.5 times the upper limit of the normal range; ⑥Creatinine (CREAT) \\\u003C1.5 times the upper limit of the normal range.\n10. No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n2. Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;\n3. A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;\n4. Severe electrolyte abnormalities;\n5. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;\n6. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;\n7. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;\n8. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);\n9. Presence of severe ECG abnormalities or active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n10. Patients with active infections (infections causing fever above 38°C);\n11. Patients with uncontrolled hypercalcemia, hypertension, or diabetes;\n12. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n13. Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;\n14. Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n15. Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);\n16. Any unstable medical condition that may affect patient safety and compliance with the study;\n17. Patients deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":57,"type":22},204,[59],"PHASE3","To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS\u002FBRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR\u002FMSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.",[28,29,30],[32,33,34],"2026-06-29",{"date":38,"type":39},{"date":66,"type":39},"2026-05-20",{"date":68,"type":22},"2029-04-30",{"name":45,"class":46},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":47},"100440278","phase-1-mutant-kras--targeted-long-peptide-vaccine-for-patients-at-high-risk-of-developing-pancreatic-cancer-100440278","NCT05013216","Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer","Inclusion Criteria:\n\nCohort A: Must fall into one of the three categories defined as high risk of developing pancreatic cancer and are undergoing pancreatic surveillance AND 2) have documented radiographic evidence of a pancreatic abnormality such as a pancreatic cyst.\n\n* High Risk Group 1 (familial pancreatic cancer relatives):\n\n  * \\>\u002F=55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and\n  * Come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and\n  * Have a first-degree relationship with at least one of the relatives with pancreatic cancer.\n  * If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened.\n* High Risk Group 2 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \\~10% or higher):\n\n  * \\>\u002F=40 years old and the Patient is a carrier of FAMMM (p16\u002FCDKN2A) mutation regardless of family pancreas cancer history.\n\nOR\n\n* \\>\u002F= 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and the Patient is a carrier of a known BRCA2, ATM, PALB2 mutation.\n* Persons with known genetic mutation should have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory.\n\n  o High Risk Group 3 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \\~5%):\n* \\>\u002F= 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and\n* The patient is a carrier of a known, BRCA1, or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation, and there is \\> 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.\n* Persons with known genetic mutation should have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory.\n* Cohort A: Patients must have a pancreatic imaging abnormality that is being followed by pancreatic imaging surveillance (EUS and\u002For MRI and \u002For CT), such as a pancreatic cyst consistent with an IPMN or parenchymal abnormalities consistent with PanIN.\n\n  * Cohort B: Patients must have clinical, radiographic, or histologic evidence of pancreatic cystic neoplasm with high-risk features warranting surgical resection per the discretion of the treating hepatobiliary surgeon.\n  * Cohort B: Patients must have cystic fluid testing that demonstrates the presence of one of the six KRAS mutations included in the study vaccine.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.\n* Ability to understand and willingness to sign a written informed consent document.\n* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.\n* Men must use acceptable form of birth control while on study.\n\nExclusion Criteria:\n\n* If expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Within 4 weeks prior to first dose of study drug.\n\n  o Any systemic or topical corticosteroids at immunosuppressive agents.\n* Within 4 weeks prior to first dose of study drug.\n\n  * Any investigational device.\n  * Has received a live vaccine.\n  * Received any allergen hyposensitization therapy.\n  * Any major surgery.\n* Infection with HIV or hepatitis B or C.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements monoclonal antibody.\n* Has a diagnosis of immunodeficiency.\n* Any other sound medical, psychiatric, and\u002For social reason as determined by the Investigator.\n* Unwilling or unable to follow the study schedule for any reason.\n* Are pregnant or breastfeeding.",true,"40 Years",{"count":79,"type":22},37,[81],"PHASE1","This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant for patients who have been identified to be at risk of developing pancreatic cancer.",[84,85],"High Risk Cancer","Pancreatic Cancer",[87,88,89,34,90],"KRAS Peptide Vaccine","Neoantigen Vaccines","Cancer Vaccines","Pancreatic Ductal Adenocarcinoma (PDAC)","2026-06-26",{"date":36,"type":39},{"date":94,"type":39},"2022-04-11",{"date":96,"type":22},"2031-05-01",{"name":98,"class":46},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100537378","phase-3-maintenance-therapy-with-toripalimab-and-capecitabine-versus-capecitabine-alone-in-high-risk-nasopharyngeal-carcinoma-100537378","NCT06277050","Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma","Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)","Inclusion Criteria:\n\n1. Pathologically confirmed nasopharyngeal carcinoma;\n2. High-risk nasopharyngeal cancer meets one of three points: a. TanyN3M0; b. High-grade rENE, coalescent nodal or invasion of surrounding structures (muscle, skin, nerves, etc.); c. Detectable EBV DNA after 2 cycles of induction chemotherapy.\n\n3.18-70 years old, both genders; 4. ECOG≤1; 5. Received 2-3 cycles of induction chemotherapy and concurrent chemoradiotherapy (intensity-modulated radiotherapy); 6. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet count ≥ 75×109\u002FL; Hemoglobin ≥ 9 g\u002FdL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml\u002Fmin (Cockcroft-Gault formula); serum albumin ≥28 g\u002FL.\n\n7\\. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative; 8. Written informed consent;\n\nExclusion Criteria:\n\n1. Recurrent or distant metastatic nasopharyngeal carcinoma.\n2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.\n3. Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC\n4. Has received prior therapy with an anti-PD-1 mab.\n5. Active autoimmune diseases or history of autoimmune diseases that may relapse.\n\n   Note: Patients with the following diseases are not excluded and may proceed to further screening:\n   1. Controlled Type I diabetes\n   2. Hypothyroidism (provided it is managed with hormone replacement therapy only)\n   3. Controlled celiac disease\n   4. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of external triggering factors.\n6. Any condition that required systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the start of the study。\n\n   Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:\n   1. Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)\n   2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption\n   3. Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)。\n7. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.\n8. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.\n\n   1. Severe infections within 4 weeks before the start of the study, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n   2. Received therapeutic oral or intravenous antibiotics within 2 weeks before start of the study.\n9. A known history of HIV infection\n10. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is \\>1000 IU\u002FmL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C1000 IU\u002FmL), and cured hepatitis C patients can be enrolled.\n11. Any major surgical procedure requiring general anaesthesia ≤28 days before start of study。\n12. Prior allogeneic stem cell transplantation or organ transplantation.\n13. Any of the following cardiovascular risk factors:\n\n    1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤28 days before start of study\n    2. Pulmonary embolism ≤28 days before start of study\n    3. Any history of acute myocardial infarction ≤6 months before start of study\n    4. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤6 months before start of study\n    5. Any event of ventricular arrhythmia ≥Grade 2 in severity ≤6 months before start of study\n    6. Any history of cerebrovascular accident ≤6 months before start of study\n    7. Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite anti-hypertension medications ≤28 days before start of study\n    8. Any episode of syncope or seizure ≤28 days before start of study.\n14. A history of severe hypersensitivity reactions to toripalimab, capecitabine and\u002For any of its excipients.\n15. Has received any herbal medicine used to control cancer within 14 days of the start of study\n16. Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)\n17. Concurrent participation in another therapeutic clinical study\n18. Emotional disturbance or mental illness\n19. Refusal or inability to sign informed consent","70 Years",{"count":108,"type":22},264,[59],"N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.\n\nThe purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).",[112,29,113],"Nasopharyngeal Carcinoma","Maintenance Therapy","2026-05-13",{"date":116,"type":39},"2026-05-15",{"date":118,"type":39},"2024-03-07",{"date":120,"type":22},"2031-02-20",{"name":122,"class":46},"Jiangxi Provincial Cancer Hospital",3,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":76,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":47},"100435199","prevent-cancer--greenville-100435199","NCT04947098","Prevent Cancer- Greenville","Prevent Cancer-Greenville: A Center for Cancer Prevention and Wellness Research Project","CCPW","Inclusion Criteria:\n\n* 18 years or older",{"count":133,"type":22},1000,"OBSERVATIONAL","Prevent Cancer-Greenville was created to provide individuals with the opportunity to have their risk of developing cancer studied. Some individuals may be at a higher risk due to their personal lifestyle, family history and\u002For exposures. If subjects are found to be at high risk for developing a disease, they will be sent to a healthcare provider for further care.",[137,29],"Cancer","2026-02-11",{"date":140,"type":39},"2026-02-17",{"date":142,"type":39},"2018-11-08",{"date":144,"type":22},"2029-11-08",{"name":146,"class":46},"Prisma Health-Upstate",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100477538","phase-2-study-of-neoadjuvant-parp-inhibition-followed-by-radical-prostatectomy-in-patients-with-unfavorable-intermediate-risk-or-high-risk-prostate-cancer-with-select-hrr-gene-alterations-100477538","NCT05498272","Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations","A Phase 2 Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations (NePtune)","NePtune","Inclusion Criteria:\n\nSubject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent and HIPAA authorization for release of personal health information prior to registration.\n* Age ≥ 18 years at the time of consent.\n* T stage 1-3 prostatic adenocarcinoma per AJCC staging manual Ed8.\n* Histologically confirmed adenocarcinoma of the prostate without histological variants comprising \\>50% of the sample. Patients with intraductal carcinoma are eligible.\n* Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within 7 months from registration. Less than 3 core biopsies are allowed if the patient has \\>1 cm or T3 disease on magnetic resonance imaging (MRI).\n* Localized unfavorable intermediate or high-risk prostate cancer patients. Patients must have at least one of the following features:\n\n  * Gleason ≥ 4+3 (grade group 3, 4, 5) OR\n  * PSA \\> 20 ng\u002FdL OR\n  * T3 disease NOTE: Patients with intraductal carcinoma are eligible independent of Gleason score, PSA and T stage.\n* Must have evidence of germline or somatic BRCA1\u002F2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA, BRIP1, CHEK2, ATM, and CDK12 gene alteration via standard of care CLIA based assay detection. Testing will be confirmed centrally but results of central testing not required for enrollment.\n* No evidence of metastatic disease as determined by radionuclide bone scan and CT\u002FMRI. Lymph nodes must be less than 20 mm in the short (transverse) axis.\n* Participants must be candidates for RP and considered surgically resectable by urologic evaluation.\n* ECOG Performance Status of 0-1 within 28 days prior to registration.\n* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.\n\n  * White blood cell count ≥ 3,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Hemoglobin ≥ 10 g\u002FdL with no transfusion support in the past 28 days\n  * Platelets ≥ 100,000\u002FmcL\n  * Aspartate aminotransferase, alanine aminotransferase ≤ 2.5×ULN, and total bilirubin ≤ 1.5 x Institutional upper limit of normal\n  * Calculated creatinine clearance ≥ 51 mL\u002Fmin based on Cockcroft-Gault formula or 24 hour urine. NOTE: See the protocol for Cockcroft-Gault formula or 24 hour urine.\n* Life expectancy≥ 16 weeks.\n* Subjects must use a condom plus spermicide beginning prior to treatment Cycle 1 Day 1, during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. See protocol for additional details.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n* Active infection requiring systemic therapy.\n* Prior treatments not allowed: hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, apalutamide and others), CYP17 inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others), estrogens and radiation therapy. Prior bicalutamide is allowed if taken for \\\u003C 4 weeks prior to registration and there is a washout period of 2 weeks prior to the initiation of study treatment. LHRH agonist\u002Fantagonist therapy is allowed if begun within 4 weeks of registration. Prior 5-alpha reductase inhibitors are allowed but require a washout period of 2 weeks to initiation of study treatment.\n* Prior treatment with a PARP inhibitor.\n* Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:\n\n  * tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice).\n  * Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at screening. Testing is not required unless there was a prior known positive hepatitis B or C test or hepatitis is suspected at screening. Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Known to have tested positive for human immunodeficiency virus (HIV) unless currently on effective anti-retroviral therapy with an undetectable viral load within 6 months.\n* Severe hepatic impairment (Child-Pugh Class C).\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily. Physiologic replacement is permitted. Topical, intra-articular steroids or inhaled corticosteroids are permitted.\n* Active cardiac disease, defined as:\n\n  * Myocardial infarction within 6 months of study treatment.\n  * Uncontrolled angina within 3 months of study treatment.\n  * Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless an echocardiogram performed within 3 months of the screening visit results in a left ventricular ejection fraction that is ≥ 45%.\n  * History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)\n  * Other clinically significant cardiovascular disease within 6 months of registration.\n* Uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n* Individuals with a history of another malignancy are not eligible if the cancer is under active treatment or the cancer can be seen on radiology scans.\n* Major surgery within 4 weeks from start of treatment. Subjects must have recovered from any effects as the surgery as assessed by investigator discretion.\n* Treatment with any investigational drug within 28 days prior to registration.\n* Persistent toxicities Grade \\> 2 caused by previous cancer therapy (per Common Terminology Criteria for Adverse Event (CTCAE)).\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorders that prohibits obtaining informed consent.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.\n* Concomitant use of known strong CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks.\n* Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to the protocol).\n* Patients with a known hypersensitivity to olaparib or any of the excipients of the product.","MALE",{"count":157,"type":22},32,[25],"Phase 2 open-label, single-arm clinical trial evaluating the efficacy and safety of neoadjuvant olaparib + LHRH agonist administered for 6 months prior to radical prostatectomy (RP) in men with unfavorable intermediate-risk or high-risk localized prostate cancer. All patients must have confirmed germline or somatic select HRR alterations. Germline and somatic mutation testing will be performed as part of commercially available CLIA assays and will be validated on a uniform platform centrally all patients retrospectively.\n\nEligible patients will receive treatment with olaparib + LHRH agonist. Following 6 months of therapy, patients will undergo RP with mandatory lymph node dissection. The lymph node dissection template will be at the discretion of the treating urologist. RP specimens will undergo pathology blinded independent central review. Following RP, patients will be followed for testosterone recovery and PSA progression.",[161,162,163,164,29],"Prostate Cancer","BRCA1 Mutation","BRCA2 Mutation","Prostatic Adenocarcinoma","2026-01-22",{"date":167,"type":39},"2026-01-23",{"date":169,"type":39},"2023-02-01",{"date":171,"type":22},"2026-12",{"name":173,"class":46},"Rana McKay, MD",6,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":76,"sex":17,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100482089","taiwan-real-world-ldct-screening-behavior-and-outcome-research-for-high-risk-subjects-based-on-health-promotion-administration-100482089","NCT05557487","Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration","Taiwan Real-world Low-dose Computed Tomography Screening behavIor and Outcome Research for High Risk Subjects Based on Health Promotion Administration-part A: Questionnaire Survey -Part B: LDCT Screening Outcome and Management","TRIO","Inclusion Criteria:\n\nGroup 1: Previous heavy smokers Age 50 to 80 years, meet both criteria in the followings.\n\n1. Cigarette smoking of at least 20 pack-years\n2. With successful smoking cessation history (stopping smoking for more than 6 months), but less than 15 years\n\nGroup 2: First-degree relatives of lung cancer patients\n\n1. aged more than 50 years\n2. age less than 50 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family\n\nGroup 3: With other high-risk occupational or environmental factors Age 50 to 80 years, meet one or more of the following criteria.\n\n1. air-pollution exposed occupations (such as traffic policemen, and street cleaners….) for at least 10 years\n2. cooking index ≥ 110, defined as 2\u002F7 \\* days cooking by pan frying, stir-frying, or deep frying in one week \\* years cooking.\n3. cooking without using ventilation for more than 20 years\n4. history of pulmonary tuberculosis and complete anti-tuberculosis treatment with intervals more than 5 years before this study\n\nExclusion Criteria:\n\n1. previous history of lung cancer\n2. another malignancy except for cervical carcinoma in situ or non-melanomatous carcinoma of the skin within 5 years\n3. an inability to tolerate transthoracic procedures or thoracotomy\n4. chest CT examination was performed within 18 months\n5. hemoptysis of unknown etiology within one month\n6. body weight loss of more than 6 kg within one year without an evident cause\n7. a known pregnancy\n8. Not capable of understanding or responding to the written questionnaire even through the help from the study team","20 Years","80 Years",{"count":186,"type":22},6618,"Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Compared to lung cancer in smokers, lung cancer in never-smokers is associated with East Asian ethnicity, female sex, and adenocarcinoma histology. This unique risk group is likely to have distinct molecular drivers, especially EGFR, ALK, and ROS1 mutations.In National Taiwan Cancer Registry data, more than half (53%) of all newly diagnosed lung cancer patients and 93% of female patients are lifelong never-smokers. This scenario is common in East Asia. It is essential to develop a different strategy for screening lung cancer patients with other high-risk profiles. Several risk factors have been identified in never-smoking lung cancer and one of the most important factor is a lung cancer family history (LCFH) in a first-degree relative. Other high-risk occupational or environmental factors include air-pollution exposed occupations (such as traffic policeman and street cleaners) for at least 10 years, cooking index ≥ 110, defined as 2\u002F7 \\* days cooking by pan frying, stir frying, or deep frying in one week \\* years cooking, cooking without using ventilation, passive smoke exposure, and history of pulmonary tuberculosis or chronic obstructive pulmonary disorders.\n\nAs described above, three high risk groups are interested in this study, the previous heavy smokers (group 1); those who has family history (group 2) and those who have high risk occupation or environment factors (group 3). From the published researches, we assume the detection rate to be 1.1% for group 1 based on NLST results16, 2.6% for group 2 (395 out of 12,011 subjects in TALENT), and we assume the detection Group 3 to be 1% after consulting board-certified senior specialists in this field.\n\nThis is a prospective, multi-center, single arm study in Taiwan of subjects who are eligible to receive LDCT screening based on recommendation of Health Promotion Administration of Taiwan.\n\nThe primary objective of TRIO part A is the LDCT screening acceptance rate of high lung cancer risk subjects.\n\nThe primary objective of TRIO part B is the exact lung cancer detection rates in these three groups.\n\nOther secondary objectives are also included.",[189,29,190,191,192],"Lung Cancer","Smoking","Pollution; Exposure","Family Relations",[194,195,196,197,198,190,199],"Lung cancer","Low-dose computed tomography","Real world data","Lung cancer family history","Air pollution","Lung cancer risk questionnaire","2025-09-03",{"date":202,"type":39},"2025-09-10",{"date":204,"type":39},"2022-12-15",{"date":206,"type":22},"2028-12-31",{"name":208,"class":46},"Gee-Chen Chang",7,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":47},"100541262","anal-cancer-andor-precancer-screening-performance-analysis-of-the-bd-onclarity-hpv-assay-on-anal-specimens-100541262","NCT06327568","Anal Cancer and\u002For Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens","Anal Cancer and\u002For Precancer Screening: Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens","Inclusion Criteria:\n\n* Subjects older than 18 years old\n* Subjects with histological-confirmed high-grade anal intraepithelial neoplasia (AIN2+) or anal invasive cancer\n* Subjects with histological-confirmed low-grade anal intraepithelial neoplasia (AIN1)\n* Subjects at high-risk for anal cancers, including:\n\n  1. Immunocompromised subjects (patients with HIV infection, or taking immunosuppressive drugs, or post-organ transplantation)\n  2. Men who have sex with men (MSM)\n  3. Women aged at least 40 years with a history of cervical intraepithelial neoplasia CIN2+ and\u002For vulvar cancer\n  4. Subjects affected by anal and\u002For peri-anal localizations of Crohn's disease\n* Subjects undergoing colorectal cancer screening\n* Signed written consent.\n\nExclusion Criteria:\n\n* Refuse to sign written consent.",{"count":218,"type":22},200,"Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors. Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors (AIN) (H-SIL) to invasive anal tumors.\n\nThe diagnosis of AIN is made by cytology or biopsy during routine examinations. To date, no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose.\n\nThe performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach.",[221,222,223,29],"Anal Intraepithelial Neoplasia 2","Anal Intraepithelial Neoplasia 1","Anal Cancer",[225,226,227,228],"anal cancer","Human papillomavirus (HPV) infection","PCR genotyping","AIN 2","2024-03-22",{"date":231,"type":39},"2024-03-26",{"date":233,"type":39},"2022-06-17",{"date":235,"type":22},"2029-06-17",{"name":237,"class":46},"European Institute of Oncology",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":253,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":47},"100519280","phase-2-adjuvant-therapy-for-high-risk-hepatocellular-carcinoma-post-liver-transplantation-100519280","NCT06041490","Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation","A Randomized, Controlled, Open-label, Multi-center Clinical Trial of Multi-kinase Inhibitor Combined With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma and High-risk Recurrence Factors After Liver Transplantation","Inclusion Criteria:\n\n1. Voluntary enrollment, accompanied by the signing of a written informed consent form, is a prerequisite for participation in this study. This ensures that participants enter the study based on their own decision and understanding of the research objectives, procedures, and potential risks.\n2. The study includes individuals aged between 18 and 75 years, inclusive, without any gender restrictions. This broad age range and gender inclusivity allow for a diverse representation of participants, facilitating a comprehensive understanding of the study outcomes across different demographic profiles.\n3. Prior to enrollment, participants must have undergone liver transplantation within the preceding 4 to 8 weeks. This specific time frame serves as an inclusion criterion to ensure that participants have recently undergone the surgical procedure, enabling researchers to investigate the effects of the transplantation within a relevant timeframe.\n4. Participants must have a confirmed pathological diagnosis of hepatocellular carcinoma (HCC) and meet at least one of the following criteria:\n\n   a) Pre-operative imaging or post-operative pathological confirmation of exceeding the Milan criteria.\n\n   b) Presence of major vascular invasion. c) Post-operative pathological confirmation of the presence of microvascular invasion (MVI).\n\n   d) Pre-operative imaging or post-operative pathological confirmation of the presence of satellite nodules.\n\n   e) Recurrence of HCC after liver resection and subsequent liver transplantation.\n5. Participants should have an anticipated life expectancy of more than 3 months.\n6. Participants should not have received systemic anti-tumor treatment prior to liver transplantation, with the exception of pre-operative transarterial chemoembolization (TACE), traditional Chinese medicine, and interferon treatment.\n7. Participants should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1, indicating good functional status.\n8. Participants' liver function, as assessed by the Child-Pugh score, should be classified as Grade A, indicating well-preserved liver function.\n9. HBsAg-positive patients should receive continuous antiviral therapy post-transplantation, using first-line antiviral drugs such as entecavir, tenofovir, or tenofovir alafenamide.\n10. Participants should have adequate hematological and organ function, based on the laboratory test results obtained within 14 days before the initiation of the study treatment, as follows:\n\n    Laboratory tests (unless otherwise specified, no blood transfusion or use of G-CSF within 14 days prior to screening):\n    1. Hemoglobin ≥ 90 g\u002FL.\n    2. White blood cell count ≥ 3.0 x 10\\^9\u002FL.\n    3. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL.\n    4. Platelet count ≥ 75 x 10\\^9\u002FL.\n\n       Biochemical tests (no use of albumin within 14 days prior to screening):\n    5. Serum albumin ≥ 28 g\u002FL.\n    6. Total bilirubin ≤ 2 times the upper limit of normal (ULN).\n    7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN.\n    8. Alkaline phosphatase (ALP) ≤ 5 times ULN.\n    9. Creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) \\> 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula):\n\n       \\- For females: CrCl = ((140 - age) x body weight (kg) x 0.85) \u002F (72 x serum creatinine \\[mg\u002FdL\\]).\n       * For males: CrCl = ((140 - age) x body weight (kg) x 1.00) \u002F (72 x serum creatinine \\[mg\u002FdL\\]).\n\n       Coagulation Function:\n    10. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times the Upper Limit of Normal (ULN) or PT prolongation ≤ 6 seconds.\n    11. Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN.\n11. Women of Childbearing Potential: Women who agree to abstain from heterosexual intercourse during the treatment period and for at least 6 months after the last dose of the study drug, or use a contraceptive method with a failure rate of less than 1% per year. For women who have experienced menstrual bleeding and have not reached a postmenopausal state (continuous absence of menstruation for ≥12 months without any other known cause) and have not undergone sterilization procedures (removal of ovaries and\u002For uterus), they are considered to be of childbearing potential.\n\n    1. Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormone-based contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n    2. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial, patients' preferred lifestyle, and daily activities. Periodic abstinence methods (such as calendar-based methods, ovulation period methods, symptothermal methods, or post-ovulation methods) and withdrawal are not acceptable contraceptive methods.\n12. Men: Men who agree to abstain from heterosexual intercourse or use contraception and also agree not to donate sperm, as defined below:\n\n    1. If the female partner is of childbearing potential, male patients must abstain from heterosexual intercourse during the treatment period and for 6 months after the last dose of the study drug or use a condom plus another contraceptive method to achieve a contraceptive failure rate of \\\u003C1% per year. During the same period, male patients must also agree not to donate sperm. If the female partner is already pregnant, male patients must abstain from heterosexual intercourse or use a condom for contraception during the treatment period and for 6 months after the last dose of the study drug to avoid potential effects on the fetus.\n    2. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial, patients' preferred lifestyle, and daily activities. Periodic abstinence methods (such as calendar-based methods, ovulation period methods, symptothermal methods, or post-ovulation methods) and withdrawal are not acceptable contraceptive methods.\n\nExclusion Criteria:\n\nAccording to the information provided, the following patients are not eligible for participation in this study.\n\n1. Patients with a previous histological\u002Fcytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other similar components.\n2. Patients with a history of malignancies other than hepatocellular carcinoma, unless they meet the following criteria:\n\n   1. Patients who have undergone potentially curative treatment and have no evidence of the disease within the past 5 years.\n   2. Patients who have successfully undergone resection of basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other in situ carcinomas; or patients who have been treated for superficial bladder cancer, have undergone surgical treatment, and have prostate-specific antigen (PSA) tumor markers within the normal range.\n3. Patients who are concurrently taking medications that may prolong the QTc interval and\u002For induce torsades de pointes (Tdp) or medications that affect drug metabolism.\n\n   Patients with a known or suspected history of allergies to sorafenib, lenvatinib, donafenib, or similar drugs.\n4. Patients with active bleeding or coagulation abnormalities, bleeding tendencies, or those undergoing thrombolysis, anticoagulant therapy, or antiplatelet therapy.\n5. Patients who have experienced thrombosis or thromboembolic events within the past 6 months, such as stroke and\u002For transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.\n\n7.Patients who have experienced esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months or any life-threatening bleeding event within the past 3 months. Patients with a history of gastrointestinal bleeding within the past 6 months or clear evidence of gastrointestinal bleeding tendencies, such as high-risk esophageal varices, locally active gastrointestinal ulcers, fecal occult blood ≥(++), are not eligible for inclusion. If fecal occult blood is (+), a gastroscopy examination is required. Evidence or history of bleeding mechanism disorders with ≥3 grade (CTC-AE 5.0) bleeding events, etc.\n\n8.Patients with clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction within the past 6 months, severe\u002Funstable angina or coronary artery bypass grafting, congestive heart failure (NYHA class \\>2), poorly controlled or requiring pacemaker therapy for arrhythmias, poorly controlled hypertension (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg) despite medication.\n\n9.Other significant clinical and laboratory abnormalities that the investigator deems to impact safety assessment, such as uncontrolled diabetes, chronic kidney disease, peripheral neuropathy of grade II or higher (CTCAE V5.0), thyroid dysfunction, etc.\n\n10.Active or poorly controlled severe infections, including:\n\n1. HIV-positive (HIV1\u002F2 antibody).\n2. Active hepatitis B (positive for HBsAg or HBV DNA\\>2000 IU\u002Fml and abnormal liver function).\n3. Active hepatitis C (positive for HCV antibody or HCV RNA≥103 copies\u002Fml and abnormal liver function).\n4. Active tuberculosis.\n5. Other uncontrolled active infections (CTCAE V5.0 \\>2 grade). 11.Patients who have not yet recovered from surgery, with unhealed wounds or severe postoperative complications.\n\n   12.Patients with substance abuse or any medical, psychological, or social conditions that may affect the study, patient compliance, or potentially endanger patient safety.\n\n   13.Patients who have received treatment with potent CYP3A4 inhibitors (such as clarithromycin, indinavir, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole, etc.) within 7 days prior to study participation or potent CYP3A4 inducers (such as phenytoin, phenobarbital, primidone, carbamazepine, rifampin, rifabutin, rifapentine, St. John's wort, etc.) within 12 days prior to study participation.\n\n   14.Recipients of multiorgan transplantation. 15.Development of distant metastasis within 1 month after transplantation. 16.Participation in another clinical trial within the past 30 days. 17.Incomplete treatment duration of less than 3 months. 18.The investigator's comprehensive judgment deems the patient unsuitable for participation in this study.",{"count":246,"type":22},88,[25],"1. Explore the impact of postoperative administration of multi-kinase inhibitors (including sorafenib, lenvatinib, and regorafenib) in conjunction with bevacizumab on post-transplant recurrence, overall survival, and drug safety in liver transplant recipients at high risk of recurrence in hepatocellular carcinoma.\n2. The primary objective of this study is to evaluate the efficacy of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the one-year recurrence-free survival rate (1-year RFS rate).\n3. The secondary objectives of this study are to assess the effectiveness and safety of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the following parameters: Recurrence-free survival (RFS) duration, Overall survival (OS), Two-year and three-year RFS rates, Graft survival, Quality of life evaluation (QoL), Incidence of adverse events and serious adverse events.",[250,251,252,29],"Liver Transplant; Complications","Hepatocarcinoma","Recurrent Osteosarcoma",[251,254,255,256,257,258],"Liver Transplant","Recurrence","High-Risk","multikinase inhibitor","bevacizumab","NOT_YET_RECRUITING","2023-09-11",{"date":262,"type":39},"2023-09-18",{"date":264,"type":22},"2023-09",{"date":266,"type":22},"2027-01",{"name":268,"class":46},"Peking Union Medical College Hospital"]