[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nab-paclitaxel\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nab-paclitaxel":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,68,96,117,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100599800","phase-2-tislelizumab-combined-with-anlotinib-and-nab-paclitaxel-in-iii-resectable-non-small-cell-lung-cancer--a-prospective-single-arm-phase-ii-study-100599800",false,"NCT07089199","Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study","TitAN","Inclusion Criteria:\n\n1. Age 18-75 years old, gender is not limited;\n2. Histologically confirmed Stage III non-small cell lung cancer (AJCC Stage 8th edition)\n3. The tumor is resectable after assessment by the attending surgeon\n4. EGFR\u002FALK mutation negative or unknown (unknown only for squamous non-small cell lung cancer)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. No previous treatment received\n7. At least 1 measurable lesion as defined by RECIST v1.1\n8. Be able to provide the Informed Consent Form (ICF), and be able to understand and agree to abide by the research requirements and assessment schedule\n9. Good organ function; • Patients have not received blood transfusion or growth factor support therapy ≤ 14 days prior to sample collection during the screening period and: Absolute neutral cell count (ANC) ≥1.5 x 109\u002FL Platelet ≥100 x 109\u002FL Hemoglobin ≥90 g\u002FL • Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) creatinine clearance ≥ 45 mL\u002Fmin Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert\\'s syndrome must have total bilirubin \\< 3 × ULN) AST and ALT≤ 2.5 x ULN Patients who did not receive anticoagulant therapy: International standardized ratio or activated partial thromboplastin time ≤ 1.5 × ULN\n10. Women of childbearing age must take a serum pregnancy test within 3 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must agree to use highly effective methods of contraception during the study period and for 120 days after the last dose of the study drug\n\nExclusion Criteria:\n\n1. A history of received treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.\n2. Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, but if patients with squamous non-small cell lung cancer, the EGFR mutation status and ALK mutation status are unknown, it is not required to conduct tests during screening\n3. There are multiple factors influencing patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction)\n4. Allergy to any study drug (Tislelizumab, Anlotinib, albumin-bound Paclitaxel) or excipients.\n5. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor invasion of important blood vessels during treatment is likely to cause fatal bleeding.\n6. Clinically significant hemoptysis (more than 50 ml per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above baseline, or suffering from vasculitis, etc.).\n7. Vaccination with attenuated live vaccines within 4 weeks before the first dose or planned vaccination during the study period.\n8. Patients who are expected to be unable to tolerate surgery, such as those with cardiopulmonary insufficiency.\n9. Occurrence of or concurrent other malignancies within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\].\n10. Patients with active viral hepatitis requiring treatment as determined by the investigator.\n11. Active autoimmune diseases requiring systemic treatment, or long-term use of high doses of steroids or other immunomodulators, which the investigator assesses as affecting the study treatment.\n12. Unhealed surgical incisions before the start of study treatment (small biopsy incisions can be included).\n13. Active hepatitis B\u002FC infection and human immunodeficiency virus (HIV) infection.\n14. Arterial or venous thrombotic events within 6 months (such as cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) or severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, uncontrolled arrhythmias; heart failure above grade III-IV according to NYHA standards, or left ventricular ejection fraction (LVEF) \\\u003C 50% as indicated by echocardiography.\n15. Interstitial lung disease, uncontrolled systemic medical history, including diabetes, hypertension, acute lung disease, etc.\n16. Active bleeding or coagulation dysfunction (INR \\> 2.0, PT \\> 16s), bleeding tendency or receiving thrombolytic, anticoagulant, antiplatelet therapy; any major surgery requiring general anesthesia within ≤ 28 days before the first dose.\n17. Underlying medical conditions or alcohol\u002Fdrug abuse that are unfavorable for the administration of study drugs, may affect the interpretation of results, or pose a high risk of treatment complications.","ALL","18 Years","75 Years",{"count":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.",[27,28,29,30],"NSCLC","Tislelizumab","Anlotinib","Nab-paclitaxel","RECRUITING","2026-06-11",{"date":34,"type":35},"2026-06-15","ACTUAL",{"date":37,"type":35},"2025-07-25",{"date":39,"type":21},"2028-07-10",{"name":41,"class":42},"Qilu Hospital of Shandong University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100610874","phase-2-nephron-sparing-treatment-of-tislelizumab--nab-paclitaxel-for-renal-pelvic-cancer-100610874","NCT07233252","Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer","Nephron-sparing Treatment Combining Tislelizumab and Nab-Paclitaxel for Renal Pelvic Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U03)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. Suitable and planned to undergo laser ablation of renal pelvic tumors via ureteroscopy;\n3. The tumor is located in the renal pelvis, diagnosed as upper tract urothelial carcinoma based on ureteroscopic biopsy, urinary cytology, or imaging examinations (CT, MRI, or PET-CT), without lymph node metastasis or distant metastasis, with a clinical stage of T1-2N0M0. Additionally, requiring maximum tumor diameter is less than 3 cm.\n4. Expected survival time of more than 12 weeks;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n6. Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.);\n7. The organ function levels must meet the following requirements:\n\n   Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin, with the affected-side GFR \\>10 ml\u002Fmin, excluding the presence of a non-functional kidney (low-level decreasing curve on dynamic renal ECT imaging) on the affected side.\n8. Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in ureter or bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.",{"count":52,"type":21},35,[24],"This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy of nephron-sparing treatment combining Tislelizumab and Nab-Paclitaxel for HER-2 expressing renal pelvic cancer (RPC) . Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo evaluation. Patients who achieve all of the following criteria of \"well response and tolerance\" will receive further maintenance treatment:\n\n(1)The patient achieves a complete response (CR) or partial response (PR) according to the RECIST 1.1 criteria, indicating that the tumor is well-controlled. (2) If the patient has residual lesions, it should be confirmed by the clinical physician that these lesions can be eliminated through laser ablation via ureteroscopy. (3)The patient has not experienced any treatment-related adverse events (TRAEs) that warrant discontinuation of therapy during systemic treatment. (4)The patient is willing to undergo further maintenance therapy. If the patient meets all the criteria above, ureteroscopic biopsy should be performed. If residual lesions are detected under the ureteroscope, endoscopic intervention (e.g., laser ablation, cryoablation) should be carried out simultaneously to eliminate these residual lesions. Patients who meet the above criteria will proceed with no less than 2 cycles of maintenance systemic therapy (Tislelizumab + Nab-Paclitaxel). Patients who do not meet the criteria will be excluded from the study and are recommended to undergo salvage radical nephroureterectomy (RNU) as soon as possible. One-year Nephron-Sparing Survival (1 year-NSS): Defined as the absence of surgical indications for nephrectomy due to progression or recurrence of upper urinary tract urothelial carcinoma, distant metastasis caused by the primary upper urinary tract tumor, or death from any cause within 1 year from the initiation of treatment. Treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[56,28,57,58,30],"Renal Pelvic Carcinoma","PD-1 Inhibitor","Kidney-sparing","2025-11-16",{"date":61,"type":35},"2025-11-18",{"date":63,"type":21},"2025-11-25",{"date":65,"type":21},"2030-12-30",{"name":67,"class":42},"Tianjin Medical University Second Hospital",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":43},"100374721","phase-2-nab-paclitaxel-plus-carboplatin-versus-nab-paclitaxel-plus-capecitabine-in-the-treatment-of-advanced-triple-negative-breast-cancer-100374721","NCT04159142","Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer","Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Females with age between 18 to 70 years old;\n2. Histologically confirmed triple negative breast cancer;\n3. No more than one-line prior treatment for locally advanced or metastatic breast cancer;\n4. Have at least one measurable lesion as per the RECIST criteria (version 1.1);\n5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;\n6. Patients with life expectancy of at least 3 months;\n7. Bone marrow function：neutrophils (≥1.5×10\\^9\u002FL), platelets (≥100×10\\^9\u002FL), hemoglobin (≥90 g\u002FL);\n8. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;\n9. Patients had good compliance with the planned treatment, understood the research process and written informed consent.\n\nExclusion Criteria:\n\n1. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;\n2. Brain metastasis;\n3. Recurrence or metastasis within 6 months after capecitabine withdrawal;\n4. Recurrence or metastasis within 6 months after platinum withdrawal;\n5. Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;\n6. Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;\n7. Patients who had Grade 2 or above Peripheral neuropathy;\n8. Patients with severe systemic infection or other serious diseases;\n9. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;\n10. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;\n11. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;\n12. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;\n13. The researchers considered the patients who were not suitable for enrollment.","FEMALE","70 Years",{"count":78,"type":21},414,[24],"This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \\\u003C1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.\n\nThe purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.",[82,30],"Triple Negative Breast Cancer",[30,84,85,82,86],"Carboplatin","Capecitabine","Maintenance therapy","2025-09-10",{"date":89,"type":35},"2025-09-11",{"date":91,"type":35},"2019-11-20",{"date":93,"type":21},"2028-09-20",{"name":95,"class":42},"Hebei Medical University Fourth Hospital",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":76,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":116,"locationsCount":43},"100373153","phase-2-nab-paclitaxel-plus-carboplatin-versus-nab-paclitaxel-plus-epirubicin-in-the-neoadjuvant-therapy-for-breast-cancer-100373153","NCT04138719","Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer","Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer","Inclusion Criteria:\n\n1. Females with age between 18 to 70 years old;\n2. Histologically confirmed primary invasive breast cancer;\n3. Histologically confirmed triple negative breast cancer;\n4. Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.\n5. Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.\n6. Have at least one measurable lesion as per the RECIST criteria (version 1.1);\n7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;\n8. LVEF≥55%；\n9. Bone marrow function：neutrophils (≥1.5×10\\^9\u002FL), platelets (≥100×10\\^9\u002FL), hemoglobin (≥90 g\u002FL);\n10. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;\n11. Patients had good compliance with the planned treatment, understood the research process and written informed consent.\n\nExclusion Criteria:\n\n1. Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;\n2. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;\n3. Patients with severe systemic infection or other serious diseases;\n4. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;\n5. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;\n6. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;\n7. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;\n8. The researchers considered the patients who were not suitable for enrollment.",{"count":104,"type":21},520,[24],"This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \\\u003C1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.\n\nNeoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery.\n\nThe purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application.\n\nThe total number of patients to be included in this study is 520 patients.",[108,109,30],"Breast Cancer","Triple-negative Breast Cancer",[109,30,84,111],"Epirubicin",{"date":89,"type":35},{"date":91,"type":35},{"date":115,"type":21},"2028-06-20",{"name":95,"class":42},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":136,"locationsCount":43},"100602638","phase-2-neoadjuvant-tislelizumab-in-combination-with-nab-paclitaxel-for-utuc-100602638","NCT07126119","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0); High risk disease confirmed in accordance with the EAU guidelines.\n3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \\>50% in the specimen from ureteroscopic biopsy;\n4. Suitable and planned to receive RNU.\n5. Expected survival time of more than 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n\n6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin.\n\n8.Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.",{"count":52,"type":21},[24],"This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[128,129,57,30],"Upper Tract Urothelial Carcinoma","Neoadjuvant Therapy","2025-08-15",{"date":132,"type":35},"2025-08-17",{"date":134,"type":35},"2025-07-05",{"date":65,"type":21},{"name":67,"class":42},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":153,"locationsCount":43},"100602594","phase-2-neoadjuvant-tislelizumab--nab-paclitaxel-followed-by-distal-ureterectomy-for-ureteral-cancer-100602594","NCT07125547","Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer","Neoadjuvant Tislelizumab Combined With Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U01)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. Ureteral cancer indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0).\n3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \\>50% in the specimen from ureteroscopic biopsy;\n4. Suitable and planned to receive distal ureterectomy (including distal ureterectomy + partial cystectomy + ipsilateral pelvic lymph node dissection + psoas hitch procedure + ureteral reimplantation into the bladder).\n5. Expected survival time of more than 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n\n6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin, with the affected-side GFR \\>10 ml\u002Fmin, excluding the presence of a non-functional kidney (low-level decreasing curve on dynamic renal ECT imaging) on the affected side.\n\n8.Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in the renal pelvis or bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.",{"count":52,"type":21},[24],"This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy and safety of neoadjuvant Tislelizumab combined with Nab-Paclitaxel followed by distal ureterectomy for patients with non-metastatic ureteral cancer (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo distal ureterectomy (DU). The assessment of efficacy is based on the histology of specimen from DU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[148,129,57,58,28,30],"Ureteral Cancer","2025-08-09",{"date":130,"type":35},{"date":134,"type":35},{"date":65,"type":21},{"name":67,"class":42}]