[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pd-1-inhibitor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pd-1-inhibitor":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,44,72,101,129,153,173,202,221,238,263,293,317,346,368,386],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100549259","phase-1-safety-and-efficacy-of-whole-brain-ldrticiintrathecal-chemotherapy-in-refractory-meningeal-metastasis-of-lung-cancer-100549259",false,"NCT06431685","Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer","Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer","Inclusion Criteria:\n\n1. ≥ 18 years old and ≤ 75 years old;\n2. Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.;\n3. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment;\n4. Efficacy of extracranial lesions SD;\n5. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy;\n6. Expected survival ≥3 months, PS score ≤3;\n7. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing;\n8. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases;\n9. One week before enrollment, bone marrow and liver and kidney function met the following criteria:\n\n   ① Hemoglobin ≥80 g\u002FL, neutrophils ≥1.5×10\\^9\u002FL and platelets ≥70×10\\^9\u002FL;\n\n   ② Renal function: Cr≤ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr)≥55 ml\u002Fmin; Liver function: total bilirubin ≤ULN × 1.5; ALT, AST≤ULN × 2.5; (In case of liver metastasis, total bilirubin should not be higher than 3 times the upper normal limit, and transaminase should not be higher than 5 times the upper normal limit);\n10. The fertile women agreed to use contraception during the study period and for 6 months after the study ended; Patients who tested negative for a serum or urine pregnancy test within 7 days prior to joining the study and were not breastfed; Men who agreed to use contraception during the study period and for 6 months after the study ended\n\nExclusion Criteria:\n\n1. Active autoimmune disease or history of autoimmune diseases;\n2. Congenital or acquired immunodeficiency;\n3. Uncontrolled cardiac clinical symptoms or diseases;\n4. Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes;\n5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n6. Other systemic malignancies within the last 5 years;\n7. Allergy to any test drug;\n8. Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator;\n9. Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures.","ALL","18 Years","75 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.",[27,28,29,30],"NSCLC","Low Dose Radiotherapy","PD-1 Inhibitor","Leptomeningeal Metastasis","RECRUITING","2026-05-04",{"date":34,"type":35},"2026-05-08","ACTUAL",{"date":37,"type":35},"2024-04-25",{"date":39,"type":21},"2026-12-31",{"name":41,"class":42},"Sichuan 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":55,"conditions":56,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100633845","phase-2-prospective-open-label-multi-cohort-study-of-becotatug-vedotin-with-tislelizumab-and-chemotherapy-in-esophageal-squamous-cell-carcinoma---phase-2-100633845","NCT07531979","Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemotherapy in Esophageal Squamous Cell Carcinoma - Phase 2","A Prospective, Open-label, Multicohort, Phase II Clinical Study of Becotatug Vedotin in Combination With Tislelizumab and Chemotherapy for Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Male or non-pregnant, non-lactating female.\n3. ECOG performance status of 0 or 1, with no deterioration within 7 days.\n4. Histologically confirmed locally advanced or metastatic esophageal squamous cell carcinoma.\n5. No prior systemic therapy for ESCC. Patients who have received neoadjuvant or adjuvant therapy must have experienced disease progression or recurrence more than 6 months after completion of that treatment.\n6. Patients with metastatic disease must have at least one measurable lesion per RECIST 1.1 criteria; patients with disease after neoadjuvant therapy must have an evaluable lesion.\n7. Adequate organ and bone marrow function, as demonstrated by the following laboratory values:\n\n   1. Hemoglobin (HGB) ≥ 90 g\u002FL.\n   2. Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL.\n   3. Platelet count (PLT) ≥ 80 × 10⁹\u002FL.\n   4. Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN).\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN.\n   6. Creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n   7. Urine protein \\\u003C (++) or 24-hour urinary protein \\\u003C 1.0 g.\n8. Normal coagulation function and no active bleeding:\n\n   1. International Normalized Ratio (INR) ≤ 1.5.\n   2. Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n9. For women of childbearing potential: negative pregnancy test (serum or urine) within 14 days prior to enrollment, and agreement to use adequate contraception during the study period and for 8 weeks after the last dose of study drug. For men: surgically sterile or agreement to use adequate contraception during the study period and for 8 weeks after the last dose of study drug.\n10. Expected survival ≥ 6 months.\n11. Patient voluntarily participates in the study and signs the informed consent form (ICF).\n12. Patient is expected to be compliant and able to undergo follow-up for efficacy and adverse events as required by the protocol.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria at screening will be excluded from the study:\n\n1. Prior treatment with any anti-EGFR monoclonal antibody, or with anti-PD-1\u002FPD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, CTLA-4 antibody, or any other drug\u002Fantibody targeting T-cell co-stimulation or checkpoint pathways.\n2. Administration of a live vaccine within 4 weeks prior to enrollment or anticipated during the study period.\n3. Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment.\n4. Prior allogeneic bone marrow transplantation or solid organ transplant.\n5. Uncontrolled hypertension at enrollment, defined as: systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg.\n6. Any disease or condition affecting drug absorption at enrollment.\n7. Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction within 6 months prior to enrollment; severe\u002Funstable angina or coronary artery bypass grafting; congestive heart failure \\> New York Heart Association (NYHA) Class 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) \\\u003C 50%.\n8. Active or uncontrolled severe infection (≥ CTCAE v5.0 Grade 2 infection).\n9. Known HIV infection. Known clinically significant liver disease, including viral hepatitis \\[known hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, i.e., HBV DNA positive (\\>1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL); known hepatitis C virus (HCV) infection with HCV RNA positive (\\>1×10³ copies\u002FmL)\\].\n10. Any other disease, clinically significant metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, reasonably suggests the presence of a disease or condition that contraindicates the use of the investigational drug (e.g., a condition associated with seizures requiring treatment), would affect the interpretation of study results, or would place the patient at high risk.\n11. Patients deemed by the investigator to be unsuitable for participation in this study.",{"count":52,"type":21},93,[54],"PHASE2","Esophageal squamous cell carcinoma (ESCC) is a common malignant tumor worldwide, with particularly high incidence in East Asian regions such as China, and is associated with poor patient prognosis. In recent years, immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1 antibodies) combined with chemotherapy have become the standard first-line treatment for advanced ESCC. Multiple randomized controlled trials have confirmed that this combination significantly improves patient survival compared to chemotherapy alone. However, a subset of patients still exhibit poor response or develop resistance to the immunotherapy-chemotherapy regimen, necessitating the exploration of novel combination strategies to further enhance efficacy.\n\nThe epidermal growth factor receptor (EGFR) is frequently overexpressed in ESCC and is associated with tumor proliferation, metastasis, and poor prognosis, making it an important therapeutic target. Antibody-drug conjugates (ADCs) targeting EGFR achieve precise tumor killing by conjugating an anti-EGFR antibody to a potent cytotoxic payload. Preclinical studies have demonstrated significant antitumor activity of EGFR ADCs in ESCC models. Mechanistically, anti-EGFR therapy and immune checkpoint inhibitor therapy may exert synergistic effects through several avenues: enhancing tumor antigen presentation, remodeling the tumor microenvironment, and modulating PD-L1 expression. Therefore, this triple combination strategy holds promise for overcoming the limitations of monotherapies and providing a new treatment option for patients with ESCC.",[57,58,59,60,61,29],"ESCC","Tislelizumab","Chemotherapy","Becotatug Vedotin","EGFR ADC","NOT_YET_RECRUITING","2026-04-13",{"date":65,"type":35},"2026-04-15",{"date":67,"type":21},"2026-04-01",{"date":69,"type":21},"2029-12-31",{"name":71,"class":42},"Tianjin Medical University Cancer Institute and Hospital",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100623250","phase-2-short-course-radiotherapy-with-tumor-draining-lymph-node-preservation-followed-by-pd-1-inhibitors-in-pmmrmss-stage-ii-iii-rectal-cancer-100623250","NCT07394192","Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR\u002FMSS Stage II-III Rectal Cancer","Exploratory Study on the Efficacy and Safety of Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR\u002FMSS Stage II-III Rectal Cancer","PKUCH- R11","Inclusion Criteria:\n\n* Age 18-75 years old, regardless of sex.\n\n  * Fibrocolonoscopy or digital rectal examination indicates that the distal border of the lesion is located 5-10 cm from the anal verge.\n\n    * Pathologically confirmed rectal adenocarcinoma.\n\n      * Imaging examinations (including pelvic MRI and chest-abdominal CT) confirm a clinical stage of II\u002FIII (cT3-T4aN0 or cT2-4aN+, MRF (-), with no distant metastasis) according to the AJCC Cancer Staging Manual, 8th Edition (2018) (for detailed TNM staging of rectal cancer).\n\n        * If N+, metastatic lymph nodes are confined to the mesorectal and superior rectal artery drainage regions, with no lateral pelvic lymph node metastasis.\n\n          ⑥ Confirmed by immunohistochemistry or molecular testing to be mismatch repair proficient (pMMR) or microsatellite stable (MSS).\n\n          ⑦ Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1 (see Appendix 2 for details).\n\n          ⑧ Meeting the following laboratory criteria: Hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5 × 10⁹\u002FL; Neutrophil count ≥ 1.5 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL; Creatinine ≤ 1.0 × upper limit of normal (ULN), blood urea nitrogen (BUN) ≤ 1.0 × ULN; Alanine aminotransferase (ALT) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) ≤ 1.5 × ULN; Alkaline phosphatase (ALP) ≤ 1.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Urine protein negative; normal coagulation time; normal thyroid function.\n\n          ⑨ Patients with primary rectal cancer must have undergone no surgical interventions (excluding palliative stoma formation), chemotherapy, or other antitumor treatments from the time of diagnosis to enrollment.\n\n          ⑩ The planned radiation field must have no history of prior radiotherapy.\n          * The patient voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up visits and data provision.\n\nExclusion Criteria:\n\n* Previous treatment with anti-PD-1\u002FL1, anti-CTLA-4 immunotherapies, or other investigational immunotherapeutic agents is excluded.\n\n  * Patients with severe autoimmune diseases are excluded, including active inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.\n\n    * Patients with symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonitis are excluded.\n\n      * Patients with clinical or imaging evidence of intestinal obstruction or perforation, or those deemed by the investigator to be at high risk of perforation or hemorrhage, are excluded.\n\n        * History of other malignancies, excluding curatively treated non-melanoma skin cancer and carcinoma in situ of the cervix, are excluded.\n\n          * Patients with severe cardiovascular or cerebrovascular diseases are excluded, including cerebrovascular accidents, transient ischemic attacks, myocardial infarction within 6 months prior to enrollment, or significant vascular diseases (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis). Also excluded are those with poorly controlled cardiac symptoms or conditions, such as unstable angina, heart failure of New York Heart Association (NYHA) Class II or higher, left ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography, or severe arrhythmias uncontrolled by medication.\n\n            * Physical examination findings, clinical laboratory abnormalities, or other uncontrolled conditions that, in the investigator's judgment, may interfere with the study results or increase the patient's risk of treatment complications are excluded.\n\n              * Lactating or pregnant women are excluded. ⑨ Patients with congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV) infection, or a history of organ transplantation or allogeneic stem cell transplantation, are excluded.\n\n                ⑩ Known active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis are excluded.\n\n                ⑪ Patients with concurrent use of other immunomodulators, chemotherapeutic agents, other investigational drugs, or requiring long-term corticosteroid therapy are excluded.\n\n                ⑫ Patients with psychiatric disorders, substance abuse, or social issues that may affect compliance, as determined upon physician review, are excluded.\n\n                ⑬ Patients with allergies or contraindications to the investigational drug(s) are excluded.",{"count":81,"type":21},44,[54],"This study aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients with stage II-III pMMR\u002FMSS locally advanced rectal cancer.",[85,86,29],"Rectal Cancer","Radiotherapy",[88,89,90,91,92],"short-course radiotherapy","tumor-draining lymph nodes","PD-1 inhibitors","pMMR\u002FMSS","locally advanced rectal cancer","2026-02-01",{"date":95,"type":35},"2026-02-06",{"date":93,"type":21},{"date":98,"type":21},"2031-12-31",{"name":100,"class":42},"Peking University Cancer Hospital & Institute",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":43},"100616961","phase-1-ldrt-combined-with-pucotenlimab-and-standard-therapy-for-advanced-pancreatic-cancer-a-single-arm-study-100616961","NCT07312422","LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study","An Open-label, Single-center, Single-arm Study to Evaluate the Efficacy and Safety of Low-dose Radiation Therapy Combined With Pultelimab and Standard Treatment in Patients With Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of gender;\n* ECOG score of 0 to 1;\n* Patients with histologically or cytologically confirmed pancreatic malignancy;\n* No prior treatment with PD-1 or PD-L1 inhibitors;\n* Presence of a radiotherapeutically eligible target lesion (excluding bone metastases);\n* Subjects voluntarily participate in the study and provide signed informed consent.\n\nExclusion Criteria:\n\n* Previous history of radiotherapy;\n* Uncontrolled chronic infectious or non-infectious diseases, including but not limited to: medication-refractory heart failure, poorly controlled hypertension, etc.;\n* Active or clinically uncontrolled severe infections;\n* History of psychoactive drug abuse that cannot be abstained from, or patients with psychiatric disorders;\n* Pregnant or lactating women, or patients of childbearing potential who are unwilling or unable to adopt effective contraceptive measures;\n* Other conditions deemed by the investigator as potentially affecting the conduct of the clinical study or the interpretation of study results.",{"count":20,"type":21},[24,54],"To investigate the activating effect of local lesion low-dose radiotherapy (2Gy) on the tumor immune microenvironment, and the efficacy, safety, and feasibility of its combination with pembrolizumab and standard therapy in patients with advanced pancreatic cancer. Concurrently, to preliminarily establish an efficacy prediction model for the early identification of patient populations who would benefit from the treatment, thereby providing a theoretical foundation for the implementation of precision medicine.",[112,113,29,114,115],"Pancreatic Cancer","PD-L1","LDRT","Proterizumab",[117,118,114,119],"pancreatic cancer","PD-1 inhibitor","immunotherapy","2026-01-22",{"date":122,"type":35},"2026-01-26",{"date":124,"type":35},"2025-09-30",{"date":126,"type":21},"2026-10-30",{"name":128,"class":42},"Zhejiang Provincial People's Hospital",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"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":137,"type":21},35,[54],"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.",[141,58,29,142,143],"Renal Pelvic Carcinoma","Kidney-sparing","Nab-paclitaxel","2025-11-16",{"date":146,"type":35},"2025-11-18",{"date":148,"type":21},"2025-11-25",{"date":150,"type":21},"2030-12-30",{"name":152,"class":42},"Tianjin Medical University Second Hospital",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":172,"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":137,"type":21},[54],"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.",[164,165,29,143],"Upper Tract Urothelial Carcinoma","Neoadjuvant Therapy","2025-08-15",{"date":168,"type":35},"2025-08-17",{"date":170,"type":35},"2025-07-05",{"date":150,"type":21},{"name":152,"class":42},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":180,"maxAge":18,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":190,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100603226","phase-1-application-of-pd-1-inhibitors-tenofovir-chidamide-and-lenalidomide-in-relapsedrefractory-ebv-associated-lymphoproliferative-disorders-100603226","NCT07133763","Application of PD-1 Inhibitors, Tenofovir, Chidamide, and Lenalidomide in Relapsed\u002FRefractory EBV-associated Lymphoproliferative Disorders.","A Multicenter, Single-Arm, Prospective Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of Relapsed or Refractory EBV-Associated Lymphoproliferative Disorders.","Inclusion Criteria:\n\n1. Histologically confirmed EBV-associated lymphoproliferative disorders, including EBV-positive B-cell LPD and EBV-positive T\u002FNK-cell LPD, with EBV-encoded RNA (EBER)+ by in situ hybridization, or EBV nuclear antigen (EBNA)+, or latent membrane protein (LMP1\u002F2)+ in the lesion tissue.\n2. Age ≤75 years with an ECOG performance status ≤2.\n3. At least one bidimensionally measurable lesion for evaluation: for nodal lesions, longest diameter ≥1.5 cm and shortest diameter ≥1.0 cm; for extranodal lesions, longest diameter ≥1.0 cm; or ≥20% monoclonal EBV-infected lymphocytes detected by flow cytometry.\n4. Expected survival of more than 3 months.\n5. Ability to comply with follow-up. Patients must be aware of the nature of their disease and voluntarily agree to participate in the study and follow-up.\n\nExclusion Criteria:\n\n1. Patients with impaired liver or kidney function, defined as serum direct bilirubin, indirect bilirubin, and\u002For ALT, AST, or serum creatinine levels \\>2 times the upper limit of normal, unless deemed lymphoma-related.\n2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL or platelets \\\u003C75×10⁹\u002FL, unless the hematologic abnormalities are considered due to bone marrow infiltration by lymphoma.\n3. Patients who have experienced grade ≥3 neurotoxicity within the past 2 weeks.\n4. Patients with chronic heart failure classified as NYHA Class III or IV, or with left ventricular ejection fraction \\\u003C50%, or with a history within the past 6 months of any of the following: acute coronary syndrome, acute heart failure (Class III or IV), or significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, or post-resuscitation sudden cardiac arrest).\n5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \\>1×10⁴ copies\u002Fml) or active hepatitis C infection.\n6. Patients diagnosed with malignancies other than lymphoma or currently undergoing treatment for other cancers, except:\n\n   ① Those who have received curative treatment and have been disease-free for ≥5 years prior to enrollment;\n\n   ② Patients with adequately treated, non-melanoma skin cancers such as basal cell carcinoma without evidence of disease;\n\n   ③ Patients with adequately treated carcinoma in situ of the cervix without evidence of disease.\n7. Patients with other hematologic diseases (e.g., hemophilia, myelofibrosis) considered unsuitable for the study by the investigator.\n8. Patients with severe active infections.\n9. Patients who underwent Grade 2 or higher surgery within 3 weeks before treatment initiation.\n10. Patients with a history of substance abuse, or medical, psychological, or social conditions that may interfere with study participation or evaluation, as judged by the investigator.\n11. Any other condition the investigator considers unsuitable for study enrollment.\n12. Known hypersensitivity to any component of the investigational drugs.","0 Years",{"count":182,"type":21},50,[24,54],"This study is a prospective, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in the treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disorders (LPDs). The primary endpoint is the overall response rate (ORR) at 3 months, including complete response (CR) and partial response (PR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), as well as safety and tolerability assessments. Eligible patients must have histologically confirmed EBV-positive B-cell or T\u002FNK-cell LPDs with measurable lesions. This combination regimen targets multiple mechanisms, including inhibition of EBV replication, activation of the immune system, and enhancement of antitumor effects, aiming to provide an innovative therapeutic strategy for this challenging disease.",[186,29,187,188,189],"EBV-Associated Lymphoproliferative Disorders","Tenofovir","Chidamide","Lenalidomide",[186,29,191,188,192],"tenofovir","lenalidomide","2025-08-14",{"date":195,"type":35},"2025-08-21",{"date":197,"type":21},"2025-09-01",{"date":199,"type":21},"2027-09-01",{"name":201,"class":42},"The Affiliated Hospital of Xuzhou Medical University",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":180,"maxAge":18,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":220,"locationsCount":4},"100603227","phase-1-application-of-pd-1-inhibitors-combined-with-tenofovir-chidamide-and-lenalidomide-in-the-treatment-of-ebv-associated-diseases-100603227","NCT07133776","Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.","A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases","Inclusion Criteria:\n\n1. Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;\n2. EBV DNA ≥ 10⁴ copies\u002FmL in whole blood or plasma;\n3. Age ≤ 75 years with ECOG performance status ≤ 2;\n4. Estimated life expectancy over 3 months;\n5. Patients must be able to undergo follow-up. They should understand the nature of their disease and voluntarily agree to participate in this study for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Patients with impaired liver or kidney function, specifically defined as serum direct bilirubin, indirect bilirubin, and\u002For ALT, AST, or serum creatinine \\>2 times the upper limit of normal (ULN), unless such abnormalities are attributed to lymphoma;\n2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL or platelets \\\u003C75×10⁹\u002FL;\n3. Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;\n4. Patients with chronic heart failure classified as NYHA class III or IV, or left ventricular ejection fraction (LVEF) \\\u003C50%, or those with a history of the following cardiac events within the past 6 months: acute coronary syndrome, acute heart failure (NYHA class III or IV), or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or resuscitated sudden cardiac arrest);\n5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \\>1×10⁴ copies\u002FmL) or hepatitis C infection;\n6. Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;\n7. Patients with severe concurrent infections;\n8. Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;\n9. Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;\n10. Patients deemed unsuitable for enrollment by the investigator;\n11. Patients with known hypersensitivity to components of the investigational drug.",{"count":210,"type":21},30,[24,54],"Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.",[214,29,187,188,189],"Epstein-Barr Virus (EBV) Infection",[216,29,191,188,192],"Epstein-Barr Virus (EBV) infection",{"date":195,"type":35},{"date":197,"type":21},{"date":199,"type":21},{"name":201,"class":42},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":237,"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":137,"type":21},[54],"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.",[232,165,29,142,58,143],"Ureteral Cancer","2025-08-09",{"date":166,"type":35},{"date":170,"type":35},{"date":150,"type":21},{"name":152,"class":42},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":260,"locationsCount":262},"100578480","phase-2-two-cycle-and-three-cycle-induction-therapy-with-modified-tpf-regimen-combined-and-camrelizumab-for-lanpc-100578480","NCT06811844","Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC","Comparison of Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for Locally Advanced Nasopharyngeal Carcinoma: A Prospective, Phase II, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n* Age: 18-65 years old;\n* Pathologically (including histology or cytology) confirmed nasopharyngeal carcinoma patients, with clinical staging T1-4N2-3M0 (according to the UICC\u002FAJCC TNM staging system, 8th edition);\n* No prior systemic treatment (surgery, radiotherapy, chemotherapy, etc.);\n* At least one measurable lesion on imaging (as per RECIST criteria version 1.1);\n* ECOG Performance Status (PS): 0-1;\n* Expected survival ≥3 months;\n* Male subjects and women of childbearing potential must use contraception from the first dose of study medication until 24 weeks after the last dose of study medication;\n* Normal major organ function, with basic normal results in hematology, biochemistry, and coagulation tests;\n* The investigator believes that the treatment will provide a survival benefit.\n\nExclusion Criteria:\n\n* Active, known, or suspected autoimmune disease;\n* Patients with hypertension that cannot be controlled to normal range despite antihypertensive medication (systolic BP \\>160 mmHg, diastolic BP \\>90 mmHg);\n* History of hereditary bleeding tendency or coagulation dysfunction. Any clinically significant bleeding symptoms within 12 weeks prior to screening, or cumulative bleeding over 50 ml in 24 hours;\n* Unwell-controlled cardiac clinical symptoms or diseases;\n* Interstitial lung disease, drug-induced pneumonia, steroid-treated radiation pneumonitis, active pneumonia with symptoms, or severe pulmonary dysfunction;\n* Active hepatitis B (HBV DNA ≥2000 IU\u002FmL or 10\\^4 copies\u002FmL), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection of the assay);\n* Allergy to any of the study drugs;\n* Pregnant or breastfeeding women;\n* Any other factors that, in the investigator's judgment, may cause premature termination of the study.","65 Years",{"count":247,"type":21},208,[54],"This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma.",[251,29,252,253,59],"Nasopharyngeal Neoplasms","Induction Therapy","Complete Response","2025-06-30",{"date":256,"type":35},"2025-07-01",{"date":258,"type":35},"2025-02-25",{"date":69,"type":21},{"name":261,"class":42},"The First Affiliated Hospital of Xiamen University",3,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":270,"maxAge":18,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":279,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100578302","phase-1-intrathecal-dual-checkpoint-inhibitor-pd-1-and-ctla-4-in-combination-with-pemetrexed-for-leptomeningeal-metastasis-100578302","NCT06809530","Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis","Intrathecal Administration of Dual Checkpoint Inhibitor in Combination With Pemetrexed in Patients With Leptomeningeal Metastasis: a Phase I\u002FII Study","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.\n2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n3. No history of severe nervous system disease; No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \\>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.\n4. Patients with poor compliance or other reasons that were unsuitable for this study.","21 Years",{"count":272,"type":21},34,[24,54],"This phase I\u002FII study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.",[30,276,29,277,278],"Pemetrexed","CTLA4","Solid Tumors",[280,281,282],"Leptomeningeal metastasis","dual checkpoint inhibitor","pemetrexed","2025-05-14",{"date":285,"type":35},"2025-05-18",{"date":287,"type":35},"2025-03-17",{"date":289,"type":21},"2026-07-01",{"name":291,"class":42},"Guangzhou Medical University",2,{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":43},"100583069","phase-1-fruquintinib-combined-with-pd-1-inhibitor-and-folfox-as-first-line-treatment-for-advanced-gastric-cancer-100583069","NCT06871527","Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer","Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* 18-75 years old (including 18 and 75 years old);\n* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;\n* Pathologically determined gastric or gastroesophageal junction adenocarcinoma;\n* Advanced patients with radiographic confirmation of inoperable complete resection;\n* No previous anti-tumor treatment for metastatic diseases;\n* At least one measurable lesion according to RECIST version 1.1;\n* Ability to take medications orally;\n* No active bleeding;\n* Adequate organ functions:\n\nAbsolute neutrophil count ≥2×109\u002FL; Platelet ≥100×109\u002FL; Hemoglobin ≥90g\u002FL; WBC≥4×109\u002FL Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；\n\n• Have fully understood the study and voluntarily signed the informed consent;\n\nExclusion Criteria:\n\n* Patients who had received any drug in the study protocol in the last year;\n* Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;\n* HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;\n* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;\n* Patients with massive pleural or peritoneal effusion requiring drainage;\n* Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;\n* Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n* Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;\n* Patients with autoimmune diseases;\n* Patients with grade 3 or higher bleeding within 4 weeks;\n* Patients with a history of allergy to any drug, similar drug or vehicle in this study;\n* Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;\n* Patients with nonhealed wounds, ulcers, or fractures;\n* Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;\n* Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;\n* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.",{"count":81,"type":21},[24,54],"This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.",[304,305,306,29,58,307],"Gastric (Stomach) Cancer","Gastric Adenocarcinoma","Fruquintinib","GEJ Adenocarcinoma","2025-03-11",{"date":310,"type":35},"2025-03-12",{"date":312,"type":21},"2025-03-01",{"date":314,"type":21},"2028-12-31",{"name":316,"class":42},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":324,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":327,"conditions":328,"keywords":332,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":43},"100541722","haic-combined-with-lenvatinib-and-pd-1-inhibitor-in-infiltrative-hepatocellular-carcinoma-100541722","NCT06333561","HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma","Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study","Inclusion Criteria:\n\n1. primary infiltrative HCC according to MRI or CT imaging characteristics.\n2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n3. Lenvatinib as initial treatment.\n4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.\n5. no history of other malignancies.\n6. no tumor thrombus in the atrium or vena cava.\n\nExclusion Criteria:\n\n1. HCC with tumor capsule.\n2. under 18 years or over 75 years.\n3. TACE as initial treatment.\n4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.\n5. incomplete tumor imaging data.\n6. lost to follow-up after treatment within three months.",{"count":325,"type":21},300,"OBSERVATIONAL","Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.",[329,330,29,331],"Hepatocellular Carcinoma","Lenvatinib","Hepatic Arterial Infusion Chemotherapy",[333,58,334,335,336,330],"Hepatic arterial infusion chemotherapy","Toripalimab","Sintilimab","Camrelizumab","2025-02-05",{"date":339,"type":35},"2025-02-06",{"date":341,"type":35},"2021-01-01",{"date":343,"type":21},"2025-12-30",{"name":345,"class":42},"Sun Yat-sen University",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":366,"locationsCount":262},"100516602","phase-2-neoadjuvant-therapy-for-stage-ii-iva-resectable-esophageal-squamous-cell-100516602","NCT06006650","Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell","Pembrolizumab Plus Albumin Paclitaxel or 5-fluorouracil and Cisplatin Versus 5-fluorouracil and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Prospective, Randomized Controlled Trial Study","Inclusion Criteria:\n\n1.Pathological diagnosis: esophageal squamous cell carcinoma. 2.18-75 years old; 3.Clinical stage II-IVa; 4.no prior antitumor therapy, such as immunotherapy or chemoradiotherapy; 5.ECOG PS score 0-1. 6.Organs function well:Hemoglobin ≥100g\u002FL, white blood cell count ≥4\\*10\\^9\u002FL or neutrophil count ≥2.5\\*10\\^9\u002FL, platelet count ≥100\\*10\\^9\u002FL, serum total bilirubin level ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal,Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, serum creatinine level below the upper limit of normal or creatinine clearance rate ≥60ml\u002Fmin, urea nitrogen ≤200mg\u002FL, urinary protein \\\u003C+, if urinary protein +, 24-hour total protein must be \\\u003C500mg, blood glucose:In patients with normal-range and\u002For diabetes under treatment but stable glycemic control, pulmonary function: baseline FEV1 of at least 2L;If the baseline FEV1 was \\\u003C2L, the predicted FEV1 after surgery was \\>800ml, and the cardiac function was: no myocardial infarction within 1 year;Unstable angina pectoris;Asymptomatic severe arrhythmias;The centerless function is incomplete; 7.Non-surgically sterilized women, or women of reproductive age, need to use a medically approved contraceptive method (such as an intrauterine device, birth control pill, or condom) during and for 3 months after the end of the study treatment period.Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 72 hours before study enrollment.And must be non-lactation period;For male patients with partners of women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last dose of treatment; 8.Sign an informed consent form.\n\nExclusion Criteria:\n\n1. Pathological findings suggest compound squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc.\n2. History of subtotal gastrectomy;\n3. accompanied by a second primary cancer;\n4. Tumor metabolic imaging prior to treatment suggested distant metastasis.\n5. people who have previously received chemoradiotherapy;\n6. preesophageal perforation signs\n7. pregnant women of reproductive age;\n8. Any active autoimmune disease or a history of autoimmune disease (such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.);\n9. People with the following active infectious diseases, including active tuberculosis, hepatitis, and known human immunodeficiency virus (HIV) infection;\n10. Someone who has a known or concomitant hemorrhagic disease or other uncontrollable disease that cannot be treated surgically;\n11. Physical examination or clinical trial findings that researchers believe could interfere with the outcome or put the patient at increased risk of treatment complications;\n12. A previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any clinically documented active interstitial lung disease, and the presence of idiopathic pulmonary fibrosis on CT scan at baseline;Uncontrolled massive pleural or pericardial effusion;\n13. unstable systemic diseases (active infection, moderately severe chronic obstructive pulmonary disease (copd), poorly controlled hypertension, unstable angina and congestive heart failure, 6 months occurrence of myocardial infarction, drug control severe mental disorders, liver, kidney or other metabolic disease, nerve mental disease such as Alzheimer 's disease);\n14. Gastrointestinal dysfunction, malabsorption syndrome, active gastrointestinal ulcers;\n15. Previously treated with anti-PD-1 or anti-PD-L1 antibodies;\n16. Receiving any investigational drug within 4 weeks before the first use of the investigational drug;\n17. Enroll in another clinical study at the same time, unless it's an observational (non-intervention) clinical study or an intervention clinical study follow-up;\n18. Subjects who require systematic treatment with corticosteroids (equivalent dose of prednisone \\> 10 mg per day) or other immunosuppressive agents within 2 weeks prior to the first use of the study drug, except for the use of corticosteroids for local esophageal inflammation and prevention of allergy, nausea, and vomiting.Other special circumstances, need to communicate with the sponsor.In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses \\> 10mg\u002F day in response to prednisone are permitted;\n19. People who have been vaccinated with anti-tumor vaccine or who have been vaccinated with live vaccine within 4 weeks prior to the first administration of the study drug;\n20. Major surgery or severe trauma within 4 weeks before the first use of the study drug;\n21. Congenital or acquired immunodeficiency disease or a history of organ transplantation;A history of allergies to monoclonal antibodies, albumin paclitaxel, 5-fluorouracil, cisplatin, and other platinum-based drugs",{"count":354,"type":21},114,[54],"The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.",[358,29,59,359],"Neoadjuvent","Esophageal Squamous Cell Carcinoma","2023-08-17",{"date":362,"type":35},"2023-08-23",{"date":364,"type":35},"2022-08-01",{"date":98,"type":21},{"name":367,"class":42},"Tang-Du Hospital",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":375,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":384,"locationsCount":43},"100469407","immune-indicator-model-for-predicting-efficacy-of-pd-1-monoclonal-antibody-100469407","NCT05392413","Immune Indicator Model for Predicting Efficacy of PD-1 Monoclonal Antibody","Construction and Application of Immune Indicator Model for Predicting Efficacy of PD-1 Monoclonal Antibody in the Treatment of Advanced Esophageal Cancer","Inclusion Criteria:\n\n* Patients with metastatic advanced esophageal squamous cell carcinoma (stage IV) confirmed by histology or cytology who are ready to receive PD-1 monoclonal antibody combined with TP chemotherapy regimen.\n* Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2.\n* Have measurable lesions.\n* Expected survival \\> 3 months.\n* Subjects who have received anti-tumor therapy in the past should be enrolled after the toxicity of the previous treatment has returned to the baseline level (except for residual hair loss effects) or CTCAE v4.03 scale score ≤ 1.\n* Female or male subjects of reproductive age and their partners should agree to use effective contraception from the time of signing the ICF until 6 months after the last dose of study drug.\n* Absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelets ≥100×109\u002FL, hemoglobin ≥9 g\u002FdL. Liver: Bilirubin ≤1.5 times the upper limit of normal, alkaline phosphatase (AP) , Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times the upper limit of normal (AP, AST, ALT ≤5 times the upper limit of normal are allowed if there is liver metastases) Renal: Calculated creatinine clearance ≥45 mL\u002Fmin.\n\nExclusion Criteria:\n\n* Have active, or have had an autoimmune disease that is likely to recur (eg, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or at risk (e.g., organ transplant recipients requiring immunosuppressive therapy).\n* Subjects who need to receive glucocorticoid (prednisone \\> 10 mg\u002Fday or equivalent dose of other similar drugs) or other immunosuppressive therapy due to certain conditions within 14 days prior to study drug administration.\n* Major surgery, or radical radiation therapy, or palliative radiation therapy within the previous 14 days, or radiopharmaceuticals (strontium, samarium, etc.) within 56 days before starting study treatment.\n* Received systemic anti-tumor therapy, including immunotherapy, biological therapy (tumor vaccines, cytokines, or growth factors to control cancer), etc. 14 days before starting study treatment.\n* Have suffered from interstitial lung disease, chemical pneumonia, hypersensitivity pneumonitis, connective tissue disease pneumonia, pulmonary fibrosis, acute lung disease, etc. (except for local interstitial pneumonia induced by radiotherapy), or uncontrolled systemic disease, including diabetes and hypertension.\n* Patients with human immunodeficiency virus (HIV) infection.\n* patients with active pulmonary tuberculosis.\n* Any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug.\n* People who have received a solid organ transplant.\n* Patients who have received any antibody\u002Fdrug (including anti-programmed death-1 (PD-1), PD-L1, etc.) targeting T-cell co-regulatory proteins (immune checkpoints).",{"count":376,"type":21},200,"200 patients with advanced esophageal cancer who received PD-1 monoclonal antibody treatment would be enrolled in this study. Changes in peripheral blood immune cells before and after treatment would be recorded and used for machine learning to establish a prediction model for the efficacy of PD-1 monoclonal antibody treatment.",[359,29],"2022-07-05",{"date":381,"type":35},"2022-07-06",{"date":364,"type":21},{"date":39,"type":21},{"name":385,"class":42},"Nanfang Hospital, Southern Medical University",{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":43},"100461556","phase-2-radiotherapy-combined-with-pd-1-monoclonal-antibody-and-capecitabine-in-the-treatment-of-nasopharyngeal-carcinoma-100461556","NCT05290194","Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma","Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial","Inclusion Criteria:\n\n1. The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;\n2. The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the efficacy reached more than stable disease;\n3. Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;\n4. ECOG PS score 0-2 points;\n5. Aged 18-70 years old;\n6. Major organ function met the following criteria (14 do not allow the use of any blood components and cell growth factor):\n\n   1. Neutrophil ANC ≥ 2.0 × 10\\^9\u002FL; platelet count PLT ≥ 100 × 10\\^9\u002FL; hemoglobin HB ≥ 90 g\u002FL;\n   2. Serum albumin ≥ 28 g\u002FL;\n   3. Alanine aminotransferase ALT, aspartate aminotransferase AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;\n   4. Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL\u002Fmin;\n   5. INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN;\n7. Life expectancy ≥ 12 weeks;\n8. The subject who voluntarily joins the study, sign informed consent, and coordinates with follow-up.\n\nExclusion Criteria:\n\n1. Recurrent and metastatic nasopharyngeal carcinoma after initial treatment;\n2. Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments;\n3. Central nervous system metastastic (confirmed or suspected);\n4. Allergy to PD-1 monoclonal antibody or other PD-1 monoantibody; intolerance or allergy to capecitabine; suffering any disease or extrinsic factors affecting oral drugs;\n5. Uncontrolled cardiac clinical symptoms or diseases, such as: ① heart failure of NYHA Grade II or higher ; ② unstable angina pectoris; ③ suffering myocardial infarction within 1 year; ④ patients with supraventricular or arrhythmia requiring clinical intervention;\n6. Severe infection (CTCAE 5.0 ≥ 2) 4 weeks before the first use of study drugs, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization; baseline chest imaging examination suggests the presence of active pulmonary inflammation; symptoms and signs of infection or the need for oral or intravenous antibiotics (excluding the prophylactic use of antibiotics) 2 weeks before the first use of the study drug;\n7. History of other malignancies within 5 years or at the time,but except for cured cutaneous basal cell carcinoma and cervical carcinoma in situ, breast carcinoma in situ, superficial bladder tumors (Ta, Tis and T1) and papillary thyroid cancer as well as other cancers treated more than 3 years before the start of the study;\n8. Any of the following conditions is met:\n\n   1. Received any investigational drug before the first use of the study drug;\n   2. Participated in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or interventional clinical study at the follow-up time;\n   3. Required systemic treatments with corticosteroids (the dose higher than the equivalent dose of 10 mg prednisone per day) or other immunosuppressive agents 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticotropic hormone replacement at doses greater than 10 mg daily in prednisone efficacy dose are allowed;\n   4. Received anti-tumor vaccines or vaccinated live vaccines 4 weeks before the first dose of study drug;\n   5. Underwent excessive surgery or severe trauma 4 weeks before the first use of study drug;\n9. Patients had active autoimmune diseases and a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes) in the past 2 years; patients who did not require any intervention after adulthood are allowed;\n10. History of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;\n11. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection 1 year ago but without regular treatment;\n12. Patients with active hepatitis (HBV ≥ 2000 IU\u002Fml or HBV DNA ≥ 10000\u002Fml), or hepatitis C (hepatitis C antibody positive, and HCV-RNA ≥ 1000\u002Fml);\n13. Patients with coagulation abnormalities (PT \\> 16s, APTT \\> 43s, TT \\> 21s, Fbg \\\u003C 2 g\u002FL), bleeding tendency or receiving thrombolytic or anticoagulant therapy; or patients with previous severe bleeding (bleeding \\> 30ml within 3 months), hemoptysis (bleeding \\> 5ml within 4 weeks) within 12 months due to thromboembolic events (including stroke events and\u002For transient ischemic attack);\n14. Uncontrolled hypertension (systolic blood pressure \\> 140 mmHg, or diastolic blood pressure \\> 90 mmHg); coronary heart disease, arrhythmia ≥ grade II (including QTc prolongation, male \\> 450 ms, female \\> 470 ms) and heart failure;\n15. Urine protein ≥ + +, or 24 hour urine protein ≥ 1.0 g;\n16. Current diarrhea-related diseases (e.g., ulcerative colitis, Crohn's disease, chronic diarrhea, etc.);\n17. Known history of psychotropic drug abuse, alcoholism and drug abuse; or current history of antiepileptic drug use;\n18. Pregnant or lactating;\n19. Patients considered unsuitable for inclusion by the investigator as assessed by the investigator.","70 Years",{"count":395,"type":21},28,[54],"This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.",[86,29,399,400],"Capecitabine","Nasopharyngeal Carcinoma","2022-04-13",{"date":403,"type":35},"2022-04-14",{"date":405,"type":35},"2022-03-28",{"date":407,"type":21},"2027-01-01",{"name":409,"class":42},"Fifth Affiliated Hospital, Sun Yat-Sen University"]