[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shandong Cancer Hospital and Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":632},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,47,73,95,120,147,172,196,215,239,264,286,312,347,374,397,423,443,471,491,514,540,565,584,609],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100639757","phase-2-efficacy-of-stereotactic-body-radiotherapy-sbrt-combined-with-maintenance-therapy-compared-to-maintenance-therapy-alone-in-advanced-pancreatic-cancer-100639757",false,"NCT07600268","Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer","Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer: A Multi-center, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n* Age 18 to 70 years old.\n* Histologically or cytologically confirmed diagnosis of pancreatic - adenocarcinoma.\n* No prior radiation therapy for pancreatic cancer.\n* At least one measurable lesion of the primary pancreatic tumor as per RECIST 1.1 criteria, eligible for SBRT.\n* Completion of first-line chemotherapy with stable disease (SD) or partial response (PR) after ≥4 months of treatment.\n* ECOG performance status of 0-2.\n* Expected survival of ≥3 months.\n* Adequate organ function within 14 days prior to enrollment:\n* Hemoglobin (Hb) ≥ 90 g\u002FL\n* Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL\n* Platelets (PLT) ≥ 75×10⁹\u002FL\n* Total bilirubin ≤ 1.5× ULN or direct bilirubin ≤ ULN\n* ALT\u002FAST ≤ 2.5× ULN\n* ALP ≤ 2.5× ULN\n* Serum creatinine ≤ 1.5× ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin\n* Urine protein \\\u003C 2+ (if ≥2+ on dipstick, 24-hour urine protein must be \\\u003C 2g)\n* No use of systemic corticosteroids in the last 7 days prior to enrollment (physiological corticosteroid replacement is allowed).\n* Women of childbearing potential and men must use effective contraception during the study and for 12 months following treatment completion.\n* Voluntary participation with signed informed consent.\n* Ability to comply with the study schedule.\n\nExclusion Criteria:\n\n* Currently participating in any interventional clinical trial or having received other investigational drugs or devices within 4 weeks prior to enrollment.\n* Peritoneal metastasis.\n* Known active central nervous system (CNS) metastasis and\u002For carcinomatous meningitis.\n* Receiving systemic corticosteroid treatment within 7 days prior to enrollment (except for physiological doses).\n* Active, untreated hepatitis B (HBsAg positive and detectable HBV-DNA) or active hepatitis C infection (HCV antibody positive and detectable HCV RNA).\n* Pregnant or breastfeeding women.\n* Any severe or uncontrolled systemic disease, including:\n* QTc interval ≥ 480 ms\n* Unstable angina\n* NYHA class III-IV congestive heart failure\n* Arterial thromboembolism (MI, unstable angina, stroke, TIA) within 6 months prior to enrollment\n* Uncontrolled hypertension (systolic BP ≥ 150 mmHg, diastolic BP ≥ 90 mmHg)\n* Active pulmonary tuberculosis, severe infections, or other uncontrolled diseases\n* Active gastrointestinal perforation, fistula, or bowel obstruction.\n* Inadequately controlled diabetes (fasting blood glucose \\> 10 mmol\u002FL).\n* History of mental illness preventing compliance with treatment.\n* Active bleeding or significant coagulation abnormalities within the last 30 days.\n* Previous gastrointestinal perforation or other serious gastrointestinal conditions in the past 6 months.\n* Participation in other trials that may interfere with this study.","ALL","18 Years","70 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase II, multicenter, randomized controlled trial to assess the efficacy of Stereotactic Body Radiotherapy (SBRT) in combination with maintenance therapy in patients with advanced pancreatic cancer. The aim is to compare the efficacy of SBRT combined with maintenance therapy versus maintenance therapy alone. The primary outcome is the overall survival (OS) of patients, with secondary endpoints including progression-free survival (PFS), response rates, and quality of life assessments. The study will involve patients with unresectable pancreatic adenocarcinoma who are receiving chemotherapy and have stable disease. The hypothesis is that SBRT, by improving local control, can enhance the benefit of ongoing maintenance therapy and lead to better overall survival outcomes in this patient group.",[28],"Pancreatic Cancer Non-resectable",[30,31,32,33],"Pancreatic cancer","Stereotactic Body Radiotherapy","maintenance therapy","chemotherapy","RECRUITING","2026-05-19",{"date":37,"type":38},"2026-05-20","ACTUAL",{"date":40,"type":38},"2025-08-14",{"date":42,"type":22},"2028-08-14",{"name":44,"class":45},"Shandong Cancer Hospital and Institute","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"100637348","concordance-between-large-language-model-and-multidisciplinary-team-recommendations-in-rectal-cancer-100637348","NCT07595107","Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer","A Prospective Single-Center Observational Study Evaluating Concordance Between Large Language Model-Generated Recommendations and Multidisciplinary Team Recommendations in Rectal Cancer","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Pathologically confirmed rectal adenocarcinoma.\n3. Scheduled for routine rectal cancer multidisciplinary team discussion at the study center.\n4. Availability of complete or substantially complete standardized decision-making information before multidisciplinary team discussion, including clinical, pathological, and key imaging information.\n5. Availability of a structured pelvic magnetic resonance imaging report meeting the requirements of the institutional rectal cancer multidisciplinary team, including at least tumor location, clinical T stage, clinical N stage, circumferential resection margin or mesorectal fascia status, extramural vascular invasion status, and lateral lymph node status.\n6. Presence of a defined clinical treatment decision question.\n7. Clinical data can be sufficiently de-identified for research use.\n\nExclusion Criteria:\n\n1. Severely incomplete clinical information preventing preparation of a standardized case summary.\n2. Non-rectal primary tumor.\n3. Routine follow-up cases without a defined treatment decision question.\n4. Absence of a structured pelvic magnetic resonance imaging report meeting the requirements of the institutional rectal cancer multidisciplinary team, or missing pelvic magnetic resonance imaging elements that preclude key rectal cancer decision-making.\n5. Cases containing sensitive information considered unsuitable for large language model input by the study team.\n6. Cases in which a definitive treatment decision has already been made before the multidisciplinary team discussion and the meeting serves only as a formal review.",{"count":55,"type":22},180,"OBSERVATIONAL","This prospective single-center observational study will evaluate the concordance between recommendations generated by a locally deployed large language model and standardized multidisciplinary team recommendations for patients with rectal cancer.\n\nConsecutive adult patients with pathologically confirmed rectal adenocarcinoma who are scheduled for routine rectal cancer multidisciplinary team discussion will be enrolled. For each case, investigators will prepare a standardized de-identified clinical summary before the multidisciplinary team meeting. The same summary will be used for large language model generation and routine multidisciplinary team discussion.\n\nThe large language model recommendation will not be disclosed to the clinical team and will not influence actual patient management. Concordance between the large language model recommendation and the multidisciplinary team reference recommendation will be assessed using predefined structured rules and blinded expert review.",[59],"Rectal Cancer",[61,62,59,63,64],"Large Language Model","Multidisciplinary Team","Clinical Decision Support","Artificial Intelligence","NOT_YET_RECRUITING","2026-05-16",{"date":35,"type":38},{"date":69,"type":22},"2026-06-01",{"date":71,"type":22},"2027-12-01",{"name":44,"class":45},{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":46},"100594974","phase-2-iparomlimabtuvonralimab-integrating-with-total-neoadjuvant-therapy-for-pmmrmss-locally-advanced-rectal-cancer-it-tnt-100594974","NCT07026422","Iparomlimab\u002FTuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR\u002FMSS Locally Advanced Rectal Cancer (IT-TNT)","Iparomlimab\u002FTuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR\u002FMSS Locally Advanced Rectal Cancer (IT-TNT): A Single-arm, Exploratory, Phase II Trial","Inclusion Criteria:\n\n1. Age 18-75 years old, male and female\n2. Histologically confirmed pMMR\u002FMSS rectal adenocarcinoma, defined by MRI as clinical stage II (T3-4, N-) or stage III (any T, N+)\n3. Tumor within 12 cm of the anal verge with at least one of the following high-risk factors: cT4, cN2, extramural vascular invasion \\[EMVI+\\], mesorectal fascia involved \\[MRF+\\], lateral lymph node \\[LN+\\], tumor deposit, or low rectal cancer (≤5 cm from the anal verge)\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n5. No evidence of distant metastases based on chest and abdominal CT or whole body PET-CT examinations\n6. No other rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, neuroendocrine carcinoma, etc.) or synchronous colon cancer\n7. Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.\n\nExclusion Criteria:\n\n1. dMMR or MSI-H patients\n2. Myelosuppression without obvious causes\n3. Locally advanced rectal cancer without high-risk factors\n4. Prior or concurrent other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix)\n5. Severe allergic reaction to other monoclonal antibodies\n6. Uncontrolled cardiac clinical symptoms or disease\n7. Active autoimmune disease or immunodefciencies, known history of organ transplantation or systematic use of immunosuppressive agents\n8. Abnormal coagulation (INR\\>1.5 or PT\\>16s), bleeding tendency or on thrombolytic or anticoagulant therapy\n9. Known history and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, or severely impaired lung function\n10. Known history of prior antitumor therapy, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T-cell related therapy, etc.\n11. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1-2 antibody-positive), active syphilis infection, active tuberculosis infection, or active hepatitis B virus or hepatitis C virus infection at screening","75 Years",{"count":82,"type":22},54,[25],"In colorectal cancer (CRC), ICIs show strong therapeutic associations with microsatellite instability-high (MSI-H) status, while patients with proficient mismatch repair\u002Fmicrosatellite stable (pMMR\u002FMSS) tumors exhibit poor responses. Dual immunotherapy may represent a promising strategy for MSS populations. The Dutch NICHE trial reported a 27% pathological response rate (4\u002F15) in MSS CRC patients with clinical stage I-III disease treated with neoadjuvant ipilimumab plus nivolumab. In advanced or metastatic CRC, a study by Jin Li et al. demonstrated that iparomlimab\u002Ftuvonralimab combined with bevacizumab and the XELOX regimen achieved an objective response rate of 70.6% (95% CI: 56.2%-82.5%).\n\nRadiotherapy may synergize with ICIs through multiple immunomodulatory mechanisms. For pMMR\u002FMSS LARC, combining CRT with ICIs holds promise to overcome the \"immune-cold\" tumor microenvironment and improve therapeutic efficacy. In this clinical trial, the investigators aim to evaluate the efficacy and safety of integrating immunotherapy with CRT as a novel total neoadjuvant therapy for pMMR\u002FMSS rectal cancer.",[86],"Rectal Malignant Neoplasms","2026-05-15",{"date":89,"type":38},"2026-05-18",{"date":91,"type":38},"2025-04-30",{"date":93,"type":22},"2028-05-30",{"name":44,"class":45},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":46},"100597712","phase-2-bits-to-hcc-study-haiciparomlimabtuvonralimab--bevacizumab--sbrt-for-bclc-c-hcc-with-pvtt-andor-oligometastases-100597712","NCT07062055","BITS-TO-HCC Study: HAIC+Iparomlimab\u002FTuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and\u002For Oligometastases","Bevacizumab Plus Iparomlimab\u002FTuvonralimab With Hepatic Artery Infusion Chemotherapy Followed by Stereotactic Body Radiotherapy in Patients With BCLC Stage C Hepatocellular Carcinoma With Thrombus and\u002For Extrahepatic Oligometastases (BITS-TO-HCC): Study Protocol of a Prospective, Single- Center, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Male or female patients aged between 18 and 70 years.\n2. Unresectable HCC, BCLC Stage C according to the BCLC strategy-2025 update, with staging established via biopsy pathology and\u002For clinical diagnosis.\n3. Child-Pugh class A without clinically significant hepatic decompensation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n4. Metastatic burden and SBRT eligibility\n\n   * Extrahepatic oligometastatic disease defined as ≤3 involved organs with ≤5 total metastatic lesions\n   * All intended intrahepatic and\u002For extrahepatic SBRT targets must satisfy protocol-specified target-coverage, liver reserve, and organ-at-risk (OAR) constraints within a composite 5-fraction plan\n5. Prognosis \\& measurable disease\n\n   * Life expectancy ≥3 months\n   * ≥1 measurable lesion (per RECIST 1.1):\n   * Tumor: ≥10 mm (CT long axis)\n   * Lymph node: ≥15 mm (CT short axis)\n6. Prior therapy\n\n   * Prior locoregional therapy permitted：radiofrequency ablation (RFA), TACE, or HAIC, provided that:\n   * Documented radiographic progression or intolerance after the prior therapy\n   * Washout ≥28 days\n   * Treatment-related toxicities recovered to ≤Grade 1 (alopecia and peripheral neuropathy ≤Grade 2 allowed)\n7. Laboratory and virologic requirements\n\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤5 × upper limit of normal (ULN); total bilirubin ≤3 × ULN; serum albumin ≥28 g\u002FL\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin\n   * Urine dipstick protein \\\u003C2+; if baseline dipstick proteinuria is ≥2+, 24-hour urinary protein must be \\\u003C1 g\n   * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n\nExclusion Criteria:\n\n1. Histopathological exclusions\n\n   * Mixed HCC subtypes: Fibrolamellar HCC or sarcomatoid HCC or cholangiocarcinoma components\n2. Curative local therapy candidacy\n\n   * Current candidacy for resection, liver transplant, or RFA\n3. RT infeasibility\n\n   * Prior radioembolization\n   * Single liver tumor ≥15 cm or total intrahepatic tumor diameter ≥20 cm\n   * more than 5 discrete intrahepatic parenchymal foci are present\n   * direct tumor extension into the stomach, duodenum, small bowel, or large bowel\n   * measurable common or main-branch biliary duct involvement\n   * Prior liver radiotherapy that would result in excessive overlap with the planned treatment fields\n4. Prior systemic therapies\n\n   * Received targeted-immunotherapy for HCC (e.g., PD-(L)1 inhibitors + tyrosine kinase inhibitors (TKIs))\n   * Prior immunotherapy: anti-PD-(L)1\u002FCTLA-4 or chimeric antigen receptor T-cell therapy\n5. Hemorrhage\u002Fportal hypertension and hepatic decompensation risk\n\n   * Variceal bleeding within 6 months.\n   * Untreated or high-risk esophagogastric varices (e.g., grade ≥2 on endoscopy within 3 months) or other clinical evidence of portal hypertension with high bleeding risk per investigator.\n   * Moderate or severe ascites\n   * History of or active hepatic encephalopathy\n   * History of hemoptysis (≥2.5 mL of bright red blood per episode) within 28 days before study treatment\n   * Evidence of bleeding diathesis or significant coagulopathy\n   * Current or recent (within 10 days before study treatment) use of aspirin (≥325 mg\u002Fday), dipyridamole, ticlopidine, clopidogrel, cilostazol, or therapeutic-dose oral\u002Fparenteral anticoagulants or thrombolytic agents\n6. Allergy to any component of iparomlimab\u002Ftuvonralimab or bevacizumab\n7. Comorbidities\n\n   * Active autoimmune disease or a history of autoimmune or inflammatory disease that may relapse; exceptions include hypothyroidism controlled with hormone replacement only, controlled celiac disease, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia)\n   * Any condition requiring systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medication within 14 days before study treatment\n   * Active or uncontrolled infection, including tuberculosis, or known HIV infection\n   * Prior allogeneic stem cell transplantation or organ transplantation\n   * Inadequately controlled hypertension, defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure \\>90 mmHg despite optimal medical management, or a history of hypertensive crisis or hypertensive encephalopathy\n   * History within 6 months before study treatment of myocardial infarction, unstable angina, symptomatic heart failure (New York Heart Association class ≥II), cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events\n   * Major surgical procedure within 28 days before study treatment, or serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture\n   * History within 6 months before study treatment of gastrointestinal perforation, abdominal or tracheoesophageal fistula, or intra-abdominal abscess",{"count":82,"type":22},[25],"This single-center, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining hepatic artery infusion chemotherapy (HAIC, for up to 4 cycles) with iparomlimab\u002Ftuvonralimab plus bevacizumab followed by stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and local control rate (LCR), as well as maintaining quality of life (QoL). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.",[106,107,108,109,110,111],"Hepatocellular Carcinoma","Portal Vein Tumor Thrombus","Oligometastases","Radiotherapy","Immunotherapy","Hepatic Artery Infusion Chemotherapy","2026-05-04",{"date":114,"type":38},"2026-05-08",{"date":116,"type":38},"2025-07-25",{"date":118,"type":22},"2029-07-25",{"name":44,"class":45},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":46},"100614067","phase-2-sbrt-plus-systemic-therapy-vs-systemic-therapy-alone-in-bclc-c-hepatocellular-carcinoma-100614067","NCT07274774","SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma","Systemic Therapy Combined With Stereotactic Body Radiotherapy Versus Systemic Therapy Alone in BCLC Stage C Hepatocellular Carcinoma (SCRATCH): A Prospective, Multicenter, Phase II, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 18-70 years.\n2. Histologically or clinically diagnosed HCC per national guidelines.\n3. BCLC stage C (CNLC IIIA\u002FIIIB), including PVTT and\u002For extrahepatic metastases amenable to protocol procedures.\n4. Child-Pugh class A or B (score ≤7).\n5. At least one measurable lesion per RECIST 1.1 (criteria specified).\n6. ECOG ≤2.\n7. Expected survival ≥6 months.\n8. Adequate organ function per protocol thresholds.\n9. For experimental arm candidates: active lesion count (when PET-CT used) ≤10.\n10. If prior initial systemic therapy given: intrahepatic disease stable ≥3 months.\n11. Effective contraception from consent through 1 year after treatment end.\n12. Ability to understand and sign consent.\n\nExclusion Criteria:\n\n1. Second primary malignancy (exceptions apply).\n2. Tumor thrombus\u002Fmetastases judged not amenable to radiotherapy.\n3. Prior systemic anticancer therapy for current HCC (prior local therapy permitted per rules).\n4. Severe organ dysfunction precluding treatment.\n5. Uncontrolled comorbidities (e.g., uncontrolled diabetes, active peptic ulcer, severe cardiopulmonary disease).\n6. Active uncontrolled infection or active autoimmune disease requiring systemic therapy.\n7. Significant neurologic dysfunction.\n8. Pregnant or breastfeeding women; no effective contraception.\n9. Known hypersensitivity to planned drugs.\n10. Any other condition making participation unsuitable per investigator.",true,{"count":129,"type":22},184,[25],"This prospective, multicenter, phase II randomized controlled trial compares the efficacy and safety of SBRT combined with systemic therapy versus systemic therapy alone in BCLC stage C hepatocellular carcinoma (HCC). The primary objective is to compare overall survival (OS) between the two arms. Secondary objectives include progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and incidence and severity of adverse events (AEs). Eligible patients will be randomized 2:1 to an experimental arm (SBRT + systemic therapy) or control arm (systemic therapy alone). Key inclusion criteria include BCLC C disease, Child-Pugh A-B liver function, ECOG ≤2, measurable disease per RECIST 1.1, and stable intrahepatic disease after initial systemic therapy for ≥3 months when applicable. The trial will also include predefined safety monitoring, QoL assessments (EORTC QLQ-C30 and QLQ-HCC18), and exploratory biomarker analyses.",[106,133],"BCLC Stage C Hepatocellular Carcinoma",[135,136,137,138],"hepatocellular carcinoma","BCLC stage C","metastasis","radiotheraphy","2026-04-27",{"date":141,"type":38},"2026-04-28",{"date":143,"type":38},"2025-11-30",{"date":145,"type":22},"2028-11-10",{"name":44,"class":45},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":46},"100591425","spatially-fractionated-radiotherapy-versus-conventional-radiotherapy-in-the-treatment-of-soft-tissue-sarcoma-100591425","NCT06980259","Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma","Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma:A Multicenter，Prospective, Phase II, Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. Age 18-70 years, irrespective of gender. 2. Pathologically or clinically confirmed diagnosis of soft tissue sarcoma. 3. Minimum tumor diameter ≥5 cm. 4. Receiving systemic treatment as per multidisciplinary team (MDT) recommendations.\n\n  5\\. Measurable lesion (per RECIST 1.1\u002FChoi criteria: longest diameter \\>1.5 cm, or \\>1 cm with two measurable perpendicular diameters).\n\n  6\\. ECOG performance status ≤2. 7. Expected survival ≥3 months. 8. Normal liver, kidney, lung, and cardiac function, with tolerance for treatment.\n\n  9\\. Patients of childbearing potential agree to use reliable contraception during treatment and for one year thereafter.\n\n  10\\. Voluntary provision of signed informed consent.\n\nExclusion Criteria:\n\n* (1) Patients with a second primary malignancy. (2) Diagnosis of aggressive fibromatosis or rhabdomyosarcoma. (3) Prior radiotherapy to the target lesion. (4) Tumor unsuitable for radiotherapy. (5) Severe liver, kidney, lung, or cardiac dysfunction, precluding tolerance to systemic therapy or radiotherapy.\n\n  (6) Other severe medical conditions that may impact the study (e.g., uncontrolled diabetes, gastric ulcers, or other serious cardiopulmonary diseases).\n\n  (7) Severe or uncontrolled infections, or active autoimmune diseases. (8) Clinically evident central nervous system dysfunction. (9) Pregnant or lactating women, or women of childbearing potential not using contraception.\n\n  (10) Other conditions deemed unsuitable for participation by the investigator.",{"count":155,"type":22},106,[157],"NA","This study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0), and quality of life (QoL, assessed by EORTC QLQ-C30). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.\n\nThis study is a multicenter, prospective, randomized controlled phase II clinical trial designed to evaluate the efficacy and safety of Spatially Fractionated Radiation Therapy (SFRT) compared to Conventional Radiation Therapy (CRT) in the treatment of soft tissue sarcoma (STS, minimum tumor diameter ≥5 cm). A total of 106 patients were enrolled and randomized in a 1:1 ratio. The primary endpoint is the objective response rate (ORR) of the target lesion at 3, 6, 9, and 12 months post-radiotherapy, assessed using RECIST 1.1 and Choi criteria. Secondary endpoints include the 1-year local control rate (LC) of the target lesion, progression-free survival (PFS), safety (per CTCAE v5.0). CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions. SFRT comprises CRT at 3.0 Gy per fraction for 15-20 fractions, augmented by weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions, aiming to enhance tumor control and potentially stimulate immune responses.",[160],"Soft Tissue Sarcoma (STS)",[162,163,164,165],"Soft Tissue Sarcoma","Spatially Fractionated Radiotherapy","Objective Response Rate","Conventional Radiotherapy",{"date":141,"type":38},{"date":168,"type":38},"2025-05-20",{"date":170,"type":22},"2028-05-20",{"name":44,"class":45},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":46},"100580985","phase-1-adapted-guided-stereotactic-body-radiotherapy-combined-with-chemotherapy-and-enhancement-of-novel-drug-ivonescimab-for-pancreatic-cancer-ascend-100580985","NCT06844422","Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)","Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND) -A Single-Arm Phase Ib\u002FII Trial","Inclusion Criteria:\n\n1. Pathologically or cytologically confirmed unresectable LAPC, as defined by the 8th edition of the American Joint Committee on Cancer (AJCC);\n2. Age between 18 and 80 years;\n3. At least one measurable pancreatic cancer lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Life expectancy of at least 3 months;\n6. Adequate hematological, renal, and hepatic function, as defined by the following criteria (within 14 days prior to enrollment): (1) Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.0 × 10\\^9\u002FL; Platelet count (PLT) ≥ 75 × 10\\^9\u002FL; (2) No significant organ dysfunction, with the following criteria: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN if total bilirubin \\> 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN, or ≤ 2.5 × ULN for the liver fraction if ALP \\> 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (using the MDRD formula) ≥ 40 mL\u002Fmin if serum creatinine is \\> 1.5 × ULN; Urine protein \\\u003C 2+, or if ≥ 2+ on dipstick, 24-hour urine protein must be \\\u003C 2 g or the urine protein-to-creatinine ratio (UPC) must be \\\u003C 2; International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;\n7. Ability to provide tissue and blood samples for translational research;\n8. Ability to comprehend study details and provide written informed consent.\n\nExclusion Criteria:\n\n1. History of any malignant tumors within the past 5 years, except for cured localized tumors;\n2. Uncontrolled infections (e.g., active tuberculosis or hepatitis), uncontrolled systemic diseases, poorly controlled hypertension or diabetes, or severe comorbidities within the past six months, including myocardial infarction, cerebral embolism, or significant arrhythmias;\n3. Previous treatment with drugs targeting other stimulatory or co-inhibitory T-cell receptors;\n4. Prior radiotherapy within 2 weeks before enrollment;\n5. Known allergy to Ivonescimab or its excipients;\n6. Pregnancy or lactation;\n7. Current or planned use of strong CYP3A4\u002F5 or CYP1A2 inducers or strong CYP3A4\u002F5 inhibitors;\n8. Requirement for oral vitamin K antagonists for anticoagulation. Low-dose warfarin (≤ 2 mg\u002Fday) and other low-dose anticoagulants for maintaining central venous access or preventing deep vein thrombosis are permitted. Low-molecular-weight heparin is also permitted;\n9. Conditions affecting oral medication administration, such as a history of gastrointestinal perforation or fistula within the past 6 months, history of intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.",{"count":180,"type":22},37,[182,25],"PHASE1","This study aims to evaluate the safety and efficacy of Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, in combination with stereotactic body radiotherapy (SBRT) and chemotherapy for treating locally advanced pancreatic cancer (LAPC). The Phase Ib portion is a dose-escalation study to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended Phase II dose (RP2D) of Ivonescimab. The Phase II portion will assess the median progression-free survival (mPFS) of patients receiving Ivonescimab with SBRT (25-50Gy\u002F5F) and modified FOLFIRINOX chemotherapy. The study aims to provide critical insights into treatment options for LAPC and inform future therapeutic strategies.",[185],"Pancreatic Cancer",[187,188,189,185],"Adapted Guided Stereotactic Body Radiotherapy","Chemotherapy","Ivonescimab",{"date":141,"type":38},{"date":192,"type":38},"2025-02-08",{"date":194,"type":22},"2028-02-18",{"name":44,"class":45},{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":46},"100581421","phase-3-neoadjuvant-radiotherapy-for-rectal-adenocarcinoma-with-capecitabine-versus-tas-102-neo-react-a-multi-center-randomized-phase-iii-trial-100581421","NCT06850090","Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial","Inclusion Criteria:\n\n1. Patients aged between 18 and 75 years of either sex.\n2. Histologically confirmed rectal adenocarcinoma with the following conditions:\n\n   1. Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.\n   2. The tumor is located within 12 cm from the anal margin, with at least one high-risk factors (ie, extramural vascular invasion \\[EMVI+\\], mesorectal fascia involved \\[MRF+\\], cT4, cN2, lateral lymph nodes, tumor deposit, or tumor located in the lower rectum \\[≤5 cm from the anal verge\\]).\n3. No other types of rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer.\n4. Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Estimated life expectancy \\> 6 months.\n\nExclusion Criteria:\n\n1. Patients of dMMR or MSI-H status.\n2. Unexplained myelosuppression.\n3. Evidence of distant metastasis and inguinal lymph node metastasis based on comprehensive chest and abdominal CT or whole-body PET-CT scans. Retroperitoneal lymph nodes above the iliac vessel bifurcation are considered distant metastasis.\n4. Active autoimmune disease or history of autoimmune disease.\n5. Uncontrolled cardiac symptoms or diseases.\n6. History of other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.",{"count":203,"type":22},210,[205],"PHASE3","Neoadjuvant fluoropyrimidine-based chemoradiotherapy followed by total mesorectal excision (TME) is the standard of care for locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates are low. Trifluridine\u002Ftipiracil (TAS-102) is a new oral anti-tumor oral formulation of nucleoside analogue, trifluridine (FTD), and a thymidine phosphorylase inhibitor, tipiracil (TPI). Previous studies have shown that TAS-102 has shown clinically relevant activity after fluoropyrimidine failure in colorectal cancer and may thus be of increased efficacy compared with current standard capecitabine chemoradiation. Also, a phase 2 trials conducted by our team have demonstrated that neoaduvant TAS-102 concurrent with long-course radiotherapy could lead to a high pCR rate of 32% with acceptable toxicity for LARC patients. Herein, we will conduct this multicenter, randomized controlled, phase III trial to explore the safety and efficacy benefit of TAS-102 concurrent with long-course radiotherapy for LARC.",[59,208],"Rectal Cancer Patients",{"date":141,"type":38},{"date":211,"type":38},"2025-07-30",{"date":213,"type":22},"2028-06",{"name":44,"class":45},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":46},"100575907","phase-2-delayed-systemic-therapy-following-destructive-local-treatment-of-pulmonary-oligometastases-after-no-evidence-of-disease-ned-in-colorectal-cancer-100575907","NCT06778382","Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.","Deferred Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After NED in Colorectal Cancer： A Phase II, Single-Arm Clinical Trail.","Inclusion Criteria:\n\n* Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions:\n\n  1. The patient has achieved No Evidence of Disease (NED) after undergoing EMR, surgery, radiofrequency ablation, or radiotherapy.\n  2. NED has been maintained for ≥ 6 months.\n  3. The patient has not received chemotherapy, or has only received postoperative adjuvant chemotherapy or first-line systemic therapy.\n  4. Oligometastatic lung lesions (defined as 5 or fewer lesions) detected after ≥ 6 months of NED maintenance, eligible for destructive therapy.\n  5. No prior radiotherapy to the lungs.\n* RECIST 1.1 criteria: The patient must have measurable lesions, defined as at least one nodal lesion with a longest diameter \\> 1.5 cm, or at least one nodal lesion \\> 1 cm with an accurately measurable pendulous diameter.\n* ECOG performance status: ≤ 2 (Eastern Cooperative Oncology Group general condition score).\n* The patient's expected survival must be ≥ 3 months.\n* Adequate hematologic function: Absolute neutrophil count ≥ 1.6 x 10⁹\u002FL, with no growth factor support for at least 7 days prior to testing.\n* Normal organ function: The patient must be able to tolerate at least one of the local destructive treatments, as assessed by the corresponding department's physician, based on normal hepatic, renal, pulmonary, and cardiac function.\n* Reproductive age: Female patients of childbearing potential must agree to use a reliable method of contraception with their partner from the time of informed consent until 1 year after treatment completion.\n* The patient must have voluntarily provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n* First diagnosis of advanced colorectal cancer with metastatic disease.\n* Multiple lung metastases (\\> 5 lesions), liver metastasis, bone metastasis, or lymph node metastasis.\n* Lung metastases that are not amenable to radiotherapy, as determined by the investigator.\n* Previously received second-line or higher systemic treatment.\n* Liver or kidney dysfunction: Alanine aminotransferase (ALT) \\> 3 times the upper limit of normal; Aspartate aminotransferase (AST) \\> 3 times the upper limit of normal; Total bilirubin (TBIL) \\> 2 times the upper limit of normal; Serum creatinine \\> 1.5 times the upper limit of normal.\n* Elevated tumor marker: CEA ≥ 50 ng\u002FmL.\n* Serious medical conditions that may interfere with the study (e.g., uncontrolled diabetes, gastric ulcers, severe cardiopulmonary diseases), at the discretion of the researchers.\n* Severe or uncontrolled infections.\n* Active autoimmune disease.\n* Clinically significant central nervous system dysfunction.\n* Recent major surgery (excluding lymph node biopsy) within the last 30 days.\n* Pregnant or breastfeeding women of childbearing age who are not using contraception.\n* Drug allergy to study treatments.\n* Other reasons, as determined by the researchers, that make the patient unsuitable for participation.",{"count":223,"type":22},22,[25],"Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is one of the primary treatment options for CRC; however, postoperative recurrence remains a significant clinical challenge for both the medical community and patients. Postoperative chemotherapy, as an important adjuvant therapy, is widely used in CRC patients aiming to reduce the risk of recurrence. Despite extensive research on the efficacy of postoperative chemotherapy in CRC, the mechanisms of postoperative recurrence, predictive factors, and strategies to enhance chemotherapy effectiveness remain unclear. For colorectal cancer patients who have achieved NED (No Evidence of Disease), the decision to either reinitiate or change the systemic chemotherapy regimen for newly developed pulmonary oligometastases remains controversial. Local treatment options for diagnosing oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic treatment should be added after local treatment in patients who have achieved NED remains uncertain , and this issue requires urgent resolution.",[227],"Colorectal Neoplasms Malignant",[227,229,230,231,232],"No evidence of disease","Lung metastases","Oligometastasis","Time without systemic therapy",{"date":141,"type":38},{"date":235,"type":38},"2024-06-24",{"date":237,"type":22},"2026-11-01",{"name":44,"class":45},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":254,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":46},"100543493","phase-2-fruquintinib-combined-with-sintilimab--radiotherapy-for-third-line-treatment-of-colorectal-cancer-with-liver-metastases-100543493","NCT06356584","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases","Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial","Inclusion Criteria:\n\n* ECOG PS 0-2\n* Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)\n* MSS\u002FpMMR subtype\n* Previously received standard first- and second-line systemic anti-tumor therapy\n* At least one measurable lesion as defined by RECIST 1.1 criteria\n* Access to tumor samples for biomarker assessment\n* Expected survival of ≥3 months\n* Normal function of major organ systems (within 14 days before enrollment)\n* No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.\n* Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.\n\nExclusion Criteria:\n\n* Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.\n* Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.\n* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.\n* Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).\n* Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy.\n* Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved.\n* Received liver radiotherapy within the past 2 weeks before enrollment.\n* Known presence of central nervous system metastases and\u002For carcinomatous meningitis.\n* Received systemic corticosteroid therapy within 7 days before enrollment.",{"count":247,"type":22},62,[25],"Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.",[251,110,109,252,253],"Colorectal Cancer","Targeted Therapy","Liver Metastasis",[255,110,109,256,257],"Colorectal cancer","Targeted therapy","Liver metastasis",{"date":141,"type":38},{"date":260,"type":38},"2024-04-01",{"date":262,"type":22},"2026-10-01",{"name":44,"class":45},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":46},"100519958","phase-2-sintilimab-combined-with-chemotherapy-and-radiotherapy-in-patients-with-inoperable-pancreatic-cancer-100519958","NCT06050317","Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer","Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial","Inclusion Criteria:\n\n* ECOG PS 0-1\n* Pathological tissue-confirmed unresectable locally advanced pancreatic cancer\n* Pancreatic cancer patients who have not received systemic anti-tumor therapy\n* Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards\n* A life expectancy of \\> 3 months\n* Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.0 ×109 cells\u002FL, platelets ≥ 75×109 cells\u002FL, hemoglobin ≥ 9.0 g\u002Fdl\n* AST\\\u003C2.5 × ULN(Upper Limit of Normal), ALT\\\u003C2.5 × ULN,creatinine ≤1.5xULN, total bilirubin \\\u003C ≤1.5 X ULN.\n\nExclusion Criteria:\n\n* Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment\n* Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment\n* Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors\n* Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment\n* Abnormal results of blood routine examinations and liver and kidney and coagulation tests\n* Abnormal function of major organs (14 days before enrollment)\n* Women who are pregnant\n* Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.",{"count":7,"type":22},[25],"Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.",[275],"Pancreas Cancer",[277,188,278,30],"Immunothrapy","Radiothrapy",{"date":280,"type":38},"2026-05-01",{"date":282,"type":38},"2023-08-18",{"date":284,"type":22},"2026-08-18",{"name":44,"class":45},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":309,"leadSponsor":311,"locationsCount":46},"100624351","nano-megestrol-acetate-for-cancer-cachexia-in-advanced-pancreatic-cancer-100624351","NCT07408505","Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer","Efficacy and Safety of Nano-Megestrol Acetate in the Treatment of Anorexia-Cachexia Syndrome in Patients With Advanced Pancreatic Cancer: A Randomized, Controlled, Prospective Study","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible for enrollment:\n\n  1\\. Pancreatic cancer-specific inclusion criteria:\n  1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma according to the TNM staging system of the International Association of Pancreatology and the 8th edition of the American Joint Committee on Cancer (AJCC);\n  2. No prior systemic antitumor therapy for recurrent or metastatic disease;\n  3. Prior adjuvant or neoadjuvant chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy for non-metastatic disease is allowed, provided that at least 6 months have elapsed since completion of the last treatment without disease recurrence;\n  4. At least one measurable lesion according to RECIST version 1.1 (previously irradiated lesions may be considered measurable only if there is clear evidence of disease progression after radiotherapy).\n\n  2\\. Fulfillment of Fearon criteria for cachexia or pre-cachexia:\n\n  (1) Cachexia stage according to Fearon criteria: fulfillment of any of the following criteria in combination with decreased appetite (FAACT-A\u002FCS 12 score ≤ 37) or systemic inflammation (CRP \\> 5 mg\u002FL):\n\n  ① Unintentional weight loss \\> 5% within the past 6 months;\n  * Body weight loss \\> 2% in patients with a BMI \\\u003C 18.5 kg\u002Fm². (2) Pre-cachexia stage according to Fearon criteria: all of the following three conditions must be met:\n\n    ① Unintentional weight loss ≤ 5% within the past 6 months;\n  * Systemic inflammation (CRP \\> 5 mg\u002FL);\n\n    ③ Decreased appetite (FAACT-A\u002FCS 12 score ≤ 37). 3. General inclusion criteria:\n    1. Good compliance and provision of written informed consent;\n    2. Age 18-75 years, regardless of sex;\n    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n    4. Expected survival greater than 4 months;\n    5. Adequate organ function, defined as follows:\n\n       • Hematologic function: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL, platelet count ≥ 100 × 10⁹\u002FL;\n\n       • Hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's syndrome may be enrolled if serum bilirubin ≤ 3 × ULN), AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases), and alkaline phosphatase ≤ 3 × ULN (≤ 5 × ULN in the presence of liver or bone metastases); serum albumin ≥ 3 g\u002FdL;\n\n       • Coagulation function: international normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;\n\n       • Renal function: creatinine clearance ≥ 60 mL\u002Fmin as calculated by the Cockcroft-Gault formula;\n       * Urinary protein: urine protein ≤ 1+ on dipstick or 24-hour urine protein \\\u003C 1.0 g;\n       * Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%.\n    6. Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to first dosing (if a urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required and shall prevail). Women of childbearing potential who engage in sexual activity with non-sterilized male partners must use an acceptable method of contraception from screening and agree to continue contraception for 120 days after the last dose of study medication; decisions regarding discontinuation of contraception after this time point should be discussed with the investigator. Male patients who engage in sexual activity with women of childbearing potential must use effective contraception from screening until 120 days after the last dose of study medication; decisions regarding discontinuation of contraception after this time point should be discussed with the investigator.\n\n       Exclusion Criteria:\n* Patients meeting any of the following criteria will be excluded from this study:\n\n  1\\. Cancer-specific exclusion criteria:\n  1. Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) during screening or based on prior imaging assessments. Patients with previously treated brain or leptomeningeal metastases may be eligible if the disease has been stable for ≥ 2 months and systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) has been discontinued for \\> 4 weeks prior to randomization.\n  2. Uncontrolled tumor-related pain;\n\n  (1) History of thromboembolic disease, ascites, or lower extremity edema within the past 6 months; (3) History of malignancy other than pancreatic cancer within 5 years prior to randomization, except for malignancies with negligible risk of metastasis or death (e.g., expected 5-year overall survival \\> 90%) and considered curable after appropriate treatment, such as adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative surgery, and ductal carcinoma in situ treated with curative surgery; (4) Unresolved toxicity from prior anticancer therapy, defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia) or failure to recover to levels specified in the inclusion\u002Fexclusion criteria; (5) Patients with peritoneal metastases will be excluded. 2. General medical exclusion criteria:\n  1. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;\n  2. Patients with hepatitis B or hepatitis C:\n\n     ① Patients with a history of hepatitis B virus (HBV) infection must undergo HBV deoxyribonucleic acid (DNA) testing; only patients with negative HBV DNA (HBV DNA \\\u003C 1000 copies\u002FmL or \\\u003C 200 IU\u002FmL or below the upper limit of normal) are eligible for participation in this study;\n\n     ② Among patients who are positive for hepatitis C virus (HCV) antibodies, only those with negative HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) testing are eligible to participate in this study;\n  3. Patients with a positive test result for human immunodeficiency virus (HIV);\n  4. Major surgery (excluding diagnostic procedures) within 28 days prior to randomization, or anticipated major surgery during the study period;\n  5. Significant cardiovascular disease, such as heart disease defined as New York Heart Association class II or higher, myocardial infarction within 3 months prior to randomization, unstable arrhythmia, unstable angina, cerebrovascular accident, or transient ischemic attack. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \\\u003C 50% must be receiving optimal stable therapy as determined by the treating physician; consultation with a cardiologist may be obtained if necessary;\n  6. Severe infection occurring within 4 weeks prior to first dosing, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).\n\n  3\\. Drug-related exclusion criteria:\n  1. Conditions affecting gastrointestinal absorption, including dysphagia, malabsorption, or uncontrolled vomiting; difficulty in food intake or requirement for tube feeding or parenteral nutrition; anorexia nervosa; anorexia caused by psychiatric disorders or pain-related inability to eat;\n  2. Current or planned use of other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone use during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants;\n  3. Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus; or current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite treatment with oral antihypertensive agents;\n  4. History within 6 months prior to first dosing of esophageal or gastric varices, severe ulcer disease, gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding;\n  5. Known hypersensitivity to any component of the study drug;\n  6. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.",{"count":294,"type":22},56,[157],"Cancer anorexia-cachexia syndrome is a common and severe complication in patients with advanced cancer, with a particularly high prevalence in pancreatic cancer. It is associated with systemic inflammation, metabolic disturbances, and dysregulation of central appetite control, leading to reduced quality of life, poor tolerance to anticancer therapy, and shortened survival. Anticancer treatments, including chemotherapy and immunotherapy, may further exacerbate the development and progression of cachexia.\n\nMegestrol acetate is recommended as a first-line treatment for cancer-related anorexia-cachexia syndrome by multiple international and national guidelines, based on its proven effects on appetite stimulation, weight gain, and quality of life improvement. The nanocrystalline formulation of megestrol acetate significantly enhances bioavailability and achieves effective plasma concentrations even in the fasting state, making it particularly suitable for patients with cancer cachexia.\n\nThis randomized, controlled, prospective study aims to evaluate the efficacy and safety of nanocrystalline megestrol acetate in patients with advanced pancreatic cancer complicated by cancer anorexia-cachexia syndrome. The study will assess improvements in appetite, body weight, nutritional status, and quality of life, and explore the clinical value of early anti-cachexia intervention in the era of immuno-chemotherapy, providing evidence to optimize comprehensive treatment strategies for advanced pancreatic cancer.",[298,299],"Advanced Pancreatic Ductal Adenocarcinoma","Cancer Anorexia-Cachexia Syndrome",[301,302,303,304,305],"Pancreatic ductal adenocarcinoma","Cancer anorexia-cachexia syndrome","Nanocrystalline megestrol acetate","Body weight and body composition","Appetite improvement","2026-04-23",{"date":139,"type":38},{"date":69,"type":22},{"date":310,"type":22},"2028-02-20",{"name":44,"class":45},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":319,"minAge":18,"maxAge":320,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":46},"100557009","phase-2-cadonilimab-with-chemoradiation-for-recurrent-and-oligometastatic-endometrial-carcinoma-100557009","NCT06532539","Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma","A Phase II, Single-arm, Multicenter Clinical Trial of Definitive Treatment With Cadonilimab, Paclitaxel, Cisplatin and Radiation for the Treatment of Locally Recurrent and Oligometastatic Endometrial Carcinoma","Inclusion Criteria:\n\n1. A written informed consent form must be signed before the implementation of any trial-related procedures.\n2. Female, aged 18 years or older and 80 years or younger.\n3. ECOG PS 0-1.\n4. Newly diagnosed with histologically or cytologically confirmed primary endometrioid adenocarcinoma, serous carcinoma, clear cell adenocarcinoma, undifferentiated carcinoma, mixed cell adenocarcinoma, mesonephric adenocarcinoma, mucinous carcinoma, intestinal-type mesonephric-like adenocarcinoma, and carcinosarcoma, meeting the clinical diagnostic criteria for endometrial cancer.\n5. Patients with locally recurrent or oligometastatic endometrial cancer after initial treatment. The number of recurrent and metastatic lesions is ≤5. Screening criteria for oligometastasis: lymph node metastases in the same region count as one metastatic lesion; liver metastases are limited to one; lung metastases are limited to three.\n6. At least one site suitable for radiotherapy (including the primary lesion), measurable, and meeting the RECIST v1.1 criteria for evaluable lesions.\n7. Tumor samples available for biomarker assessment.\n8. Expected survival time ≥6 months.\n9. Normal major organ function (within 7 days before enrollment), meeting the following criteria:\n\n(1) Hematology standards (without blood transfusion or hematopoietic growth factor treatment within 14 days before enrollment):\n\n1. Hemoglobin (HB) ≥80 g\u002FL;\n2. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n3. Platelet count (PLT) ≥50×10\\^9\u002FL; (2) No functional or organic diseases, meeting the following criteria:\n\na) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total serum bilirubin ≤1.5×ULN, alkaline phosphatase (ALP) ≤3×ULN, serum albumin ≥30 g\u002FL; b) Serum creatinine (Cr) ≤1.5×ULN; if serum creatinine is \\>1.5×ULN, creatinine clearance (CrCl) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); c) Prothrombin time (PT) prolongation ≤6 seconds, activated partial thromboplastin time (APTT) ≤1.5×ULN; d) Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, FT3 and FT4 levels should be considered; if FT3 and FT4 levels are normal, enrollment is allowed); f) Left ventricular ejection fraction (LVEF) \\>50%. 11. Before starting the first treatment, all reversible toxic reactions from previous anti-tumor treatments must have resolved to ≤ grade 1 (based on CTCAE v5.0), excluding any grade of alopecia and pigmentation, ≤ grade 2 peripheral sensory neuropathy, and other abnormalities considered by the investigator and\u002For sponsor to pose a benefit-risk balance favoring the subject receiving the study treatment.\n\n12\\. Non-surgically sterilized or childbearing potential female patients must use medically recognized contraception (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Non-surgically sterilized childbearing potential female patients must have a negative serum or urine HCG test within 7 days before enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Subjects with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved and does not require any intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible).\n2. Subjects currently using immunosuppressive agents or systemic, or absorbable local corticosteroid therapy to achieve immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) and continuing use within 2 weeks prior to enrollment.\n3. Known history of grade 3 or 4 immune-related adverse events associated with previous anti-tumor immunotherapy.\n4. Poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past six months; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\>450 ms (males); QTc \\>470 ms (females).\n5. Coagulation dysfunction (INR \\>1.5 or PT \\>16 s), bleeding tendency, or receiving thrombolytic or anticoagulant therapy.\n6. Subjects who have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy within 4 weeks (or 5 drug half-lives, whichever is longer) prior to the first dose of the study drug; subjects with adverse events from previous treatments (excluding alopecia) that have not recovered to ≤CTCAE grade 1.\n7. Subjects with clinically uncontrolled third-space effusion requiring puncture drainage or other local treatment prior to the first dose of the investigational drug.\n8. Subjects with significant hemoptysis within 2 months before randomization, or hemoptysis of at least half a teaspoon (2.5 ml) per day.\n9. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism).\n10. Subjects with active infection or unexplained fever \\>38.5°C during the screening period or prior to the first dose.\n11. Subjects with a history of or current evidence of lung fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function.\n12. Subjects with congenital or acquired immune deficiencies (e.g., HIV infection) or active hepatitis (hepatitis B reference: HBV DNA exceeding the upper limit of normal; hepatitis C reference: HCV viral load or RNA exceeding the upper limit of normal).\n13. Subjects who have used other investigational drugs or similar therapeutic agents within 4 weeks prior to the first dose or who have received radiotherapy or other local treatments within 2 weeks prior to the first dose and have not recovered from the adverse effects of such treatments.\n14. Subjects with a history of or concurrent other malignancies (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).\n15. Subjects who may receive other systemic anti-tumor therapies during the study period.\n16. Subjects who have received or are expected to receive live vaccines within 4 weeks prior to the first dose or during the study period.\n17. Subjects with other factors that may lead to forced termination of the study as judged by the investigator, such as severe diseases (including mental disorders) requiring combined treatment, severe laboratory abnormalities, and family or social factors that may affect the safety of the subject or the collection of data and samples.","FEMALE","80 Years",{"count":5,"type":22},[25],"The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are:\n\n1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?\n2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?\n\nParticipants will:\n\n* Receive cadonilimab, paclitaxel, cisplatin, and radiation therapy according to a specified protocol.\n* Visit the clinic for regular checkups and tests throughout the treatment period.\n* Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.\n* Provide hematologic and tissue samples to explore biomarkers.\n\nThis study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma, as well as identify biomarkers to better guide treatment strategies.",[325,326,327],"Endometrial Neoplasms","Neoplasm Recurrence, Local","Neoplasm Metastasis",[110,329,330,331,332,333,334,335,336,337,338],"Cadonilimab","Paclitaxel","Cisplatin","Radiation Therapy","Combined Modality Therapy","Clinical Trials, Phase II as Topic","Progression-Free Survival","Biomarkers, Tumor","Treatment Outcome","Safety","2026-04-21",{"date":341,"type":38},"2026-04-24",{"date":343,"type":38},"2024-06-13",{"date":345,"type":22},"2026-09",{"name":44,"class":45},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":319,"minAge":18,"maxAge":19,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":46},"100577781","phase-2-posaconazole-plus-pd-1-inhibitors-and-chemotherapy-vs-pd-1-inhibitors-and-chemotherapy-in-neoadjuvant-therapy-for-triple-negative-breast-cancer-100577781","NCT06802757","Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer","A Phase II, Randomised, Open-label, Multicentre Study of Posaconazole Plus PD-1 Inhibitors and Chemotherapy Versus PD-1 Inhibitors and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer","PRISM-TNBC","Inclusion Criteria:\n\n1. Female, aged ≥ 18 and ≤ 70 years old;\n2. first-confirmed TNBC;\n3. cT1cN1-3M0 or cT2-4N0-3M0;\n4. ECOG score 0-1 points.\n\nExclusion Criteria:\n\n1. Stage I or IV;\n2. History of previous breast cancer;\n3. Patients with a history of other tumors who have received systemic therapy or local radiotherapy;\n4. No immune system disease or connective tissue disease;\n5. No history of hormone therapy;\n6. Pregnant\u002Flactating.",{"count":356,"type":22},72,[25],"Triple-negative breast cancer (TNBC) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. Neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk TNBC. The Keynote-522 study demonstrated that the application of pembrolizumab has raised the pathological Complete Response (pCR) rate in TNBC to over 60%, but nearly 40% of patients still do not achieve pCR. How to further improve the pCR rate in TNBC patients has become a hot topic of current research.\n\nPosaconazole is an antibiotic used to prevent invasive Aspergillus and Candida infections and to treat oropharyngeal candidiasis. Our preclinical studies have found that posaconazole can inhibit immune cell-mediated steroidogenesis to restrict TNBC tumor progression. The investigators design and begin a a prospective randomized controlled clinical study to explore the effectiveness of posaconazole in the neoadjuvant treatment of TNBC.",[360],"Breast Cancer",[362,363,364,365],"Triple-Negative Breast Cancer","Pathological Complete Response","Neoadjuvant Therapy","Posaconazole","2026-02-23",{"date":368,"type":38},"2026-02-25",{"date":370,"type":38},"2025-05-01",{"date":372,"type":22},"2028-02-01",{"name":44,"class":45},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":319,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":46},"100621865","the-prognostic-impact-of-her2-expression-in-non-metastatic-her2-positive-breast-cancer-treated-with-dual-her2-targeted-therapy-100621865","NCT07376174","The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy","A Multicenter Retrospective Cohort Study Protocol on the Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Pathologically confirmed primary breast cancer, clinical stage I-III (AJCC 8th Edition).\n3. HER2-positive status confirmed by FISH testing (per ASCO\u002FCAP guidelines) with available HER2\u002FCEP17 ratio.\n4. Received at least one dose of dual-target therapy (trastuzumab combined with pertuzumab) in the adjuvant or neoadjuvant setting.\n5. Underwent curative-intent surgery (mastectomy or breast-conserving surgery).\n\nExclusion Criteria:\n\n1. Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis.\n2. Previous anti-HER2 targeted therapy prior to dual-target treatment.\n3. Missing key clinical data (e.g., HER2 FISH results, treatment regimen, surgery date).\n4. Carcinoma in situ or occult breast cancer, non-primary breast cancer, or concurrent other malignancies.\n5. Loss to follow-up or follow-up duration \\\u003C3 months (unless recurrence or death occurred within this period).",{"count":382,"type":22},300,"Previous studies suggest that among patients receiving trastuzumab monotherapy, a HER2\u002FCEP17 ratio \\>7.0 (ultra-high expression) is associated with poorer disease-free survival (DFS). Dual-target therapy (trastuzumab + pertuzumab) has become the standard treatment for high-risk HER2-positive breast cancer; however, whether it can predict outcomes in patients with ultra-high HER2 expression remains unsupported by clinical data. To analyze the clinicopathological characteristics and prognostic relationship between the HER2 ultra-high expression group and the normal expression group in non-metastatic HER2-positive breast cancer patients who received dual-target therapy.",[360,385],"HER2\u002FCEP17 Ratio",[387,388],"HER2\u002FCEP17 ratio","Breast cancer","2026-01-21",{"date":391,"type":38},"2026-01-29",{"date":393,"type":38},"2026-01-10",{"date":395,"type":22},"2026-06-20",{"name":44,"class":45},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":46},"100618565","phase-3-compare-radiotherapy-plus-nimotuzumab-versus-radiotherapy-alone-in-platinum-ineligible-patients-with-locoregionally-advanced-head-and-neck-squamous-cell-carcinoma-100618565","NCT07333274","Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma","An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)","Inclusion Criteria:\n\n* Eligible subjects must meet all of the following:\n\n  * Age ≥18 years.\n  * Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).\n  * Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \\[T3-4 N0-3 M0, or T1-2 N2-3 M0\\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).\n  * Suitable for definitive radiotherapy with curative intent.\n  * At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:\n* Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;\n* ECOG Performance Status \\>2 (if this criterion is met, the ECOG criterion listed below may be waived);\n* Renal dysfunction: creatinine clearance (CrCl) \\\u003C50 mL\u002Fmin (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);\n* Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);\n* Peripheral neuropathy \\> Grade 1;\n* Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.\n\n  * Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV\u002Fp16 testing if feasible (no need to retest if previously tested).\n  * ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).\n  * At least one measurable lesion per RECIST 1.1.\n  * Expected survival ≥6 months.\n  * Adequate hematologic function: WBC ≥4×10\\^9\u002FL; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n  * Adequate renal function: serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault):\n* Female CrCl = (140 - age) × weight (kg) × 0.85 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n* Male CrCl = (140 - age) × weight (kg) × 1.00 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n\n  * Adequate liver function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.\n  * Voluntary participation: signed written informed consent and ability to comply with visits and procedures.\n\nExclusion Criteria:\n\n* Any of the following excludes enrollment:\n\n  * Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.\n  * Participation in another interventional clinical trial within 30 days prior to screening.\n  * History of other malignancy (except cured basal cell carcinoma of the skin).\n  * History of primary immunodeficiency.\n  * Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).\n  * Known HIV infection, or active viral hepatitis or active tuberculosis.\n  * Major surgery within 90 days before first study treatment, or planned surgery during the study.\n  * Known allergy to nimotuzumab or its excipients.\n  * Deemed unsuitable to participate by the investigator.\n  * Unwilling or unable to sign informed consent.\n  * Receipt of a live vaccine within 30 days before first dose.",{"count":405,"type":22},335,[205],"This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),",[409,410],"Head & Neck Squamous Cell Carcinoma","Head & Neck Cancer",[412,109,413,414],"Nimotuzumab","locoregionally advanced head and neck squamous cell carcinoma","LA-HNSCC","2025-12-30",{"date":417,"type":38},"2026-01-12",{"date":419,"type":22},"2026-01-05",{"date":421,"type":22},"2030-01-05",{"name":44,"class":45},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":4},"100607376","identification-of-her2-positive-breast-cancer-molecular-characterization-and-subtypes-100607376","NCT07187752","Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes","A Prospective and Multicenter Clinical Study to Identify the Molecular Characterization and Subtypes in Patients With HER2-positive Breast Cancer Receiving Neoadjuvant Trastuzumab and Pertuzumab.","Inclusion Criteria:\n\n1. Age 18 - 75 years;\n2. Eastern Cooperative Oncology Group (ECOG) score status 0-1.\n3. Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\\>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0);\n4. HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization;\n5. Known estrogen receptor (ER) and progesterone receptor (PgR) status.\n6. Has adequate bone marrow, renal, hepatic and blood clotting functions.\n7. Left ventricular ejection fraction (LVEF) ≥50 percent (%).\n8. Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 7 months. Negative serum or urine pregnancy test within 7 days before study enrollment.\n9. Willing to provide tissue for research purposes.\n10. Volunteer to participate in this study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients with stage IV metastatic breast cancer.\n2. Bilateral invasive breast cancer;\n3. Patients with breast cancer who have previously received anti-tumor therapy.\n4. Occurred or present with other malignant tumors within 5 years. Patients with the following two conditions can be enrolled: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\\];\n5. Subjects had participated in clinical trials of other antineoplastic drugs within 4 weeks before the group;\n6. Has uncontrolled or significant cardiovascular disease.\n7. Allergy to any investigational drug or any ingredient or excipient in the drug;\n8. Female subjects who are pregnant, lactating or plan to become pregnant during the study.\n9. Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.",{"count":431,"type":22},1039,[157],"This study will evaluate the safety and efficacy of neoadjuvant trastuzumab, pertuzumab and chemotherapy chosen by the investigators and identify the molecular characterization and subtypes in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.",[360],"2025-09-16",{"date":437,"type":38},"2025-09-23",{"date":439,"type":22},"2025-09-30",{"date":441,"type":22},"2027-06-30",{"name":44,"class":45},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":458,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":46},"100580735","phase-3-continuation-of-first-line-therapy-with-radiotherapy-versus-early-switch-to-second-line-therapy-in-oligoprogressive-hcc-100580735","NCT06841172","Continuation of First-line Therapy With Radiotherapy Versus Early Switch to Second-line Therapy in Oligoprogressive HCC","Continuation of First-line Therapy With Radiotherapy for Oligoprogression Versus Early Switch to Second-line Therapy in Oligoprogressive Hepatocellular Carcinoma (CROSS): a Multi-center, Randomized, Controlled, Open-label, Phase Ⅲ Trial","Inclusion Criteria:\n\n* 1\\. Histological or cytological confirmation of primary hepatocellular carcinoma (HCC), or diagnosis based on the Clinical Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 edition) issued by the National Health Commission of the People's Republic of China.\n* 2\\. BCLC stage C at the time of first-line systemic treatment.\n* 3\\. Oligoprogression must be confirmed by imaging or histopathology during first-line systemic therapy (FLST). The number of oligoprogressive lesions is limited to 1-5, involving no more than 1-3 organs or systems. These lesions may represent either new metastatic sites or progression of pre-existing lesions. In addition, they must fit one of the two classifications defined in the ESTRO-EORTC consensus on oligometastases: repeat oligoprogression or induced oligoprogression. Oligoprogression may occur within intrahepatic lesions. In the case of lymph node progression, each lymphatic drainage region is considered a separate lesion. For example, the para-aortic lymph nodes (number 16a and number 16b) are each counted as separate lymph node regions.\n* 4\\. Patients must have experienced oligoprogression while receiving their current FLST and must not have previously received any other FLST that resulted in disease progression. Additionally, the current FLST must have maintained disease stability (SD) for at least three months prior to the occurrence of oligoprogression. Furthermore, the expected survival time must be ≥6 months.\n* 5\\. Oligoprogressive lesions must be eligible for radiotherapy and should have at least one measurable lesion that meets RECIST v1.1 criteria; Bone metastases without soft tissue formation are eligible but are considered non-measurable lesions; Bone metastases with soft tissue formation that meet RECIST v1.1 measurable criteria are considered measurable lesions.\n* 6\\. Liver function must be assessed as Child-Pugh score ≤7 points.\n* 7\\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1.\n* 8\\. Participants must be able to understand and voluntarily sign a written informed consent prior to the initiation of any study-specific procedures and must agree to comply with the treatment and follow-up requirements of the study.\n* 9\\. Male or female patients between 18 and 75 years of age.\n* 10\\. Availability of tumor and blood samples for biomarker assessment.\n\nExclusion Criteria:\n\n* 1\\. Patients who received FLST as adjuvant treatment after curative surgery for HCC.\n* 2\\. Tumor progression occurring within 3 months after initiation of FLST.\n* 3\\. Patients with combined hepatocellular-cholangiocarcinoma (cHCC-CC)\n* 4\\. History of grade ≥3 serious adverse events due to FLST.\n* 5\\. Presence of brain, peritoneal or omental metastases with bleeding after FLST.\n* 6\\. Previous radiation therapy to the site of the oligoprogressive lesion.\n* 7\\. Active untreated hepatitis B, defined as HBsAg positive with HBV DNA levels above the upper limit of normal in the participating center's laboratory.\n* 8\\. Oligoprogressive lesions not amenable to radiotherapy.\n* 9\\. Alpha-fetoprotein (AFP) level ≥10,000 ng\u002FmL at the time of oligoprogression.\n* 10\\. Diagnosis of malignancy other than liver cancer within 3 years prior to enrollment (excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, and\u002For carcinoma in situ).\n* 11\\. Currently participating in any interventional clinical research treatment or having received any other investigational drug or investigational device therapy within the last 4 weeks prior to enrollment.\n* 12\\. Presence of autoimmune disease or other conditions requiring long-term steroid use.\n* 13\\. Severe impairment of the heart, lungs, kidneys, or other vital organs, active infections (other than viral hepatitis), or other serious comorbidities that render the patient unable to tolerate treatment.\n* 14\\. known or suspected allergy to any study drug or to any drug related to this study.\n* 15\\. History of organ transplantation\n* 16\\. Pregnant or breastfeeding women\n* 17\\. Any other factor that the investigator believes may affect the enrollment of patients or the evaluation of study results.",{"count":451,"type":22},132,[205],"This multicenter, prospective, randomized, controlled, open-label, two-arm Phase III clinical trial is designed to evaluate whether adding radiotherapy to oligoprogressive lesions while continuing first-line systemic therapy at the time of oligoprogression can effectively prolong progression-free survival compared to early switching to second-line systemic therapy in oligoprogressive hepatocellular carcinoma.",[455,456,109,457],"OligoProgressive Metastatic Disease","Hepatocellular Carcinoma (HCC)","Systemic Therapy",[459,460,461,462],"oligoprogressive","HCC","radiotherapy","first-line systemic therapy","2025-07-31",{"date":465,"type":38},"2025-08-01",{"date":467,"type":38},"2025-07-21",{"date":469,"type":22},"2028-07-01",{"name":44,"class":45},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":478,"maxAge":80,"enrollmentInfo":479,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":46},"100601125","early-screening-cohort-study-of-multiple-gastrointestinal-tumors-100601125","NCT07106424","Early Screening Cohort Study of Multiple Gastrointestinal Tumors","Liquid Biopsy for Early Screening Cohort Study of Multiple Gastrointestinal Tumors","Inclusion Criteria:\n\n* gastrointestinal cancer screening population\n* age 40-75\n* no prior history of tumors\n\nExclusion Criteria:\n\n* Severe heart disease, heart failure;\n* Severe respiratory disease, dyspnea, continuous asthma, or those with serious brain diseases;\n* Severe spinal deformity, or patients with aneurysms;\n* Physically weak and unable to tolerate endoscopy, or those who have difficulty remaining calm and self-controlled;\n* Acute corrosive inflammation of the gastrointestinal tract, or those suspected of having a gastrointestinal perforation;\n* Large amounts of ascites, severe abdominal distension, or severe esophageal varices;\n* Those with a tendency to bleed (abnormal coagulation function), or those taking anticoagulant medications. The latter must discontinue the medication for one week and have normal coagulation function before undergoing endoscopy;\n* Pregnant women;\n* Those with a history of iodine allergy, etc.\n* Patients who have been diagnosed with tumors or have a history of prior tumors.","40 Years",{"count":480,"type":22},4000,"Gastrointestinal tumors, including esophageal cancer, gastric cancer, and colorectal cancer, are among the most common and highly prevalent malignant tumors in Shandong Province. Currently, most patients seek medical attention only after clinical symptoms appear, by which time the disease has already reached an intermediate or advanced stage. This leads to increased treatment costs and poorer therapeutic outcomes. Early detection and intervention through screening are effective measures to improve the cure rate of gastrointestinal tumors and reduce their incidence and mortality rates.\n\nThis project leverages the Shandong Province Tumor Screening and Early Diagnosis \\& Treatment Platform and is based on the ongoing Shandong Gastrointestinal Cancer Screening Cohort. It aims to collect 4,000 plasma samples from individuals undergoing simultaneous screening for esophageal, gastric, and colorectal cancers. Using Nanjing Shihe Medical Laboratory's independently developed multi-cancer early detection liquid biopsy product for gastrointestinal cancers, the study will further validate the performance of liquid biopsy in multi-cancer screening by correlating results with endoscopic findings (gastroscopy and colonoscopy).",[483],"Early Detection of Cancer",{"date":485,"type":38},"2025-08-06",{"date":487,"type":38},"2024-09-10",{"date":489,"type":22},"2030-09-10",{"name":44,"class":45},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":319,"minAge":18,"maxAge":19,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":502,"conditions":503,"keywords":504,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":511,"leadSponsor":513,"locationsCount":46},"100600164","phase-4-efficacy-and-safety-of-lobaplatin-and-carboplatin-as-neoadjuvant-therapy-in-her-2-positive-breast-cancer-100600164","NCT07093931","Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer","A Phase Ⅲ Study to Evaluate Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in Participants With HER-2 Positive Breast Cancer.","Inclusion Criteria:\n\n* Newly diagnosed breast cancer\n* 18-70 Years, female;\n* life expectancy is not less than 3 months\n* Histologically confirmed HER2 positive ( human epidermal growth factor receptor 2 \\[ HER2 \\] positive, estrogen receptor \\[ ER \\] and progesterone receptor \\[ PR \\] negative or positive );\n* Stage at presentation: T1c N1-2 or T2-4 N0-2;\n* at least one measurable lesion according to RECIST 1.1;\n\nAdequate function of major organs meets the following requirements:\n\n* Neutrophils ≥ 1.5×10\\^9\u002FL\n* Platelets ≥ 100×10\\^9\u002FL\n* Hemoglobin ≥ 90g\u002FL\n* lymphocyte≥0.5×10\\^9\u002FL\n* Total bilirubin≤ 1.5 × the upper limit of normal (ULN)\n* ALT and AST ≤ 3 × ULN\n* ALP≤ 2.5 × ULN\n* BUN and Cr ≤ 1.5 × ULN\n* TSH≤ ULN\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* QTcF ≤ 470 ms\n* Provides tumor tissue specimen to assess tumor programmed death-ligand 1 (PD-L1); .For women of childbearing potential: agreement to use contraceptive methods. Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 72 hours prior to initiation of study drug.\n\nExclusion Criteria:\n\n* Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer\n* Inflammatory breast cancer\n* patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission\n* Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment\n* Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies .Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n* Major surgical procedure within 4 weeks prior to initiation of study treatment\n* Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus\n* Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases\n* Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study .Has a known history of Human Immunodeficiency Virus (HIV).\n* Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis\n* Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment\n* Has evidence of active tuberculosis within 1year prior to initiation of study treatment\n* Prior allogeneic stem cell or solid organ transplantation\n* Pre-existing motor or sensory neuropathy of a severity≥grade 2\n* Has significant cardiovascular disease\n* Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment\n* Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n* Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial .History of neurological or psychiatric disorders, including epilepsy or dementia.\n* any other situation evaluated by researchers",{"count":499,"type":22},468,[501],"PHASE4","The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II \u002F III HER-2 positive breast cancer.\n\nArms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.\n\nExperimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.",[360],[505,363,506,507],"HER-2 positive breast cancer","Neoadjuvant Therapt","lobaplatin","2025-07-22",{"date":211,"type":38},{"date":465,"type":22},{"date":512,"type":22},"2030-08-01",{"name":44,"class":45},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":527,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":46},"100591972","sfrt-and-scart-in-radiotherapy-for-bone-metastases-with-soft-tissue-100591972","NCT06987370","SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue","A Phase II Randomized Controlled Clinical Study on the Efficacy and Safety Evaluation of Radiotherapy Mode Based on SFRT and SCART Technologies for Bone Metastatic Malignant Tumors With Soft Tissue Formation","Inclusion Criteria:\n\n1\\. Sign a written informed consent form before implementing any trial-related procedures; 2. Male or female, aged 18 years or above and 75 years or below; 3. Have a histopathologically confirmed single primary tumor (patients with a pathological diagnosis of small cell carcinoma or undifferentiated carcinoma are excluded); 4. ECOG PS 0-2; 5. Have at least one target lesion: bone metastasis with a soft tissue mass confirmed by CT or MRI. The shortest diameter of the soft tissue is greater than 30mm; 6. The number of metastatic lesions is ≤ 5 and the number of metastatic organs is ≤ 3; 7. The expected survival time is ≥ 3 months; 8. The main organ functions are normal (within 14 days before enrollment), that is, the following criteria are met:\n\n1. The blood routine examination criteria should meet:\n\n   1. Hemoglobin (HB) ≥ 90g\u002FL;\n   2. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL;\n   3. Platelet count (PLT) ≥ 75×10⁹\u002FL;\n2. There is no functional organic disease, and the following criteria should be met:\n\n   1. When there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, alkaline phosphatase (ALP) ≤ 3× ULN; when there is liver metastasis, ALT and AST ≤ 5× ULN, serum total bilirubin ≤ 3× ULN, and alkaline phosphatase (ALP) ≤ 5× ULN;\n   2. Serum creatinine level Cr ≤ 1.5×ULN (if the serum creatinine is elevated, a 24-hour urine collection is required, except for those with a 24-hour creatinine clearance rate \\> 50ml\u002Fmin);\n   3. Urine protein \\\u003C 2+. If the test strip result is ≥ 2+, the 24-hour urine protein must be \\\u003C 2g, or the urine protein-to-creatinine ratio (UPC) must be \\\u003C 2;\n   4. International normalized ratio (INR) and activated partial thromboplastin time (APTT): ≤ 1.5×ULN;\n\nExclusion Criteria:\n\n1. Pathological fracture confirmed by CT or MR.\n2. Prior radiotherapy to the target lesion.\n3. Pregnant or lactating women.\n4. Acute infection or other serious underlying diseases.\n5. Obvious history of neurological and mental diseases, including dementia that may affect the ability to understand and give informed consent.\n6. History or evidence of diseases, treatments or abnormal laboratory test values that may interfere with the test results and prevent the subject from participating in the study throughout the whole process, or other situations that the researcher deems inappropriate for enrollment. The researcher believes that there are other potential risks that make the subject unsuitable for participating in this study.",{"count":522,"type":22},90,[157],"This is a randomized, controlled, prospective phase II, two-arm clinical study designed to evaluate the efficacy and safety of using either Spatially Fractionated Radiotherapy (SFRT) or Stereotactic Central Ablative Radiotherapy (SCART) for treating the soft tissue components of malignant bone metastases. The study plans to enroll 90 patients with bone metastases accompanied by soft tissue formation, who will be randomized in a 2:1 ratio to the SFRT\u002FSCART group or the conventional radiotherapy (CRT) group.The primary endpoint is the objective response rate (ORR). Tumor response to treatment will be assessed every 12 weeks (±7 days) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary endpoints include pain relief rate, progression-free survival (PFS), and safety. In addition, adverse events (AEs) will be monitored throughout the study.",[526],"Bone Metastases in Subjects With Advanced Cancer",[528,529,530,531],"bone metastases","bone metastases with soft tissue","SFRT","SCART","2025-07-04",{"date":534,"type":38},"2025-07-08",{"date":536,"type":38},"2025-06-01",{"date":538,"type":22},"2027-11-30",{"name":44,"class":45},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":319,"minAge":18,"maxAge":80,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":554,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":46},"100588516","phase-2-iparomlimab-and-tuvonralimab-with-chemoradiation-for-the-treatment-of-locally-recurrent-and-oligometastatic-cervical-cancer-100588516","NCT06942416","Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer","Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin\u002FCarboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer","Inclusion Criteria:\n\n1. Signed written informed consent prior to any trial-related procedures;\n2. Female, aged ≥18 and ≤75 years;\n3. ECOG PS 0-1;\n4. Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria;\n5. Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph node metastases within the same region = 1 lesion;Liver metastases ≤1 lesion;Lung metastases ≤3 lesions\n6. At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1;\n7. Available tumor tissue sample for biomarker assessment;\n8. Expected survival ≥6 months;\n9. Normal organ function (within 7 days pre-enrollment):\n\n(1) Hematological criteria (no transfusion\u002Fgranulocyte\u002Fplatelet-stimulating drugs within 14 days):\n\n1. Hemoglobin (Hb) ≥80 g\u002FL\n2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n3. Platelets (PLT) ≥50×10⁹\u002FL (2) No functional organic disease:\n\na) ALT\u002FAST ≤2.5×ULN, total bilirubin ≤1.5×ULN, ALP ≤3×ULN, albumin ≥30 g\u002FL b) Serum Cr ≤1.5×ULN (if \\>1.5×ULN, CrCl ≥50 mL\u002Fmin by Cockcroft-Gault formula) c) PT prolongation ≤6 sec, APTT ≤1.5×ULN d) TSH ≤ULN (if abnormal, FT3\u002FFT4 must be normal) f) LVEF \\>50% 10. Prior anti-tumor treatment toxicities recovered to ≤Grade 1 (CTCAE v5.0) pre-treatment, excluding:\n\n* Alopecia\u002Fpigmentation (any grade)\n* Peripheral neuropathy (≤Grade 2)\n* Other toxicities where benefit-risk favors treatment 11. Non-sterilized\u002Fchildbearing-potential females must:\n* Use medical contraception (IUD\u002Foral contraceptives\u002Fcondoms) during treatment + 3 months post-treatment\n* Negative serum\u002Furine HCG within 7 days pre-enrollment\n* Non-lactating 12. Expected compliance with protocol follow-up following criteria:\n\n  1. Prior immunotherapy (e.g., immune checkpoint inhibitors);\n  2. Pathological diagnosis of gastric-type adenocarcinoma;\n  3. Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions: vitiligo; childhood asthma fully resolved without intervention in adulthood. Exclusion: asthma requiring bronchodilator therapy;\n  4. Current use of immunosuppressants or systemic\u002Fabsorbable topical corticosteroids (equivalent to \\>10 mg\u002Fday prednisone) for immunosuppression, continued within 2 weeks before enrollment;\n  5. History of Grade 3-4 immune-related adverse events (irAEs) associated with prior anti-tumor immunotherapy;\n  6. Poorly controlled cardiac conditions:\n\n  \u003C!-- -->\n\n  1. NYHA Class II or higher heart failure\n  2. Unstable angina\n  3. Myocardial infarction within 6 months\n  4. Clinically significant supraventricular\u002Fventricular arrhythmia requiring treatment\n  5. QTc \\>450 ms (males) or \\>470 ms (females); 7. Coagulation abnormalities (INR \\>1.5 or PT \\>16 s), bleeding tendency, or current thrombolytic\u002Fanticoagulant therapy; 8. Prior radiotherapy\u002Fchemotherapy\u002Fhormonal therapy\u002Fsurgery\u002Ftargeted therapy completed \\\u003C4 weeks before study treatment (or \\\u003C5 drug half-lives, whichever is longer); unresolved toxicities (excluding alopecia) from prior therapies \\>CTCAE Grade 1; 9. Poorly controlled third-space effusion requiring drainage before first trial drug administration; 10. Significant hemoptysis (≥2.5 mL\u002Fday) within 2 months before randomization; 11. Known hereditary\u002Facquired bleeding\u002Fthrombotic disorders (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism); 12. Active infection or unexplained fever \\>38.5°C during screening\u002Fbefore first dose; 13. Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction; 14. Immunodeficiency (e.g., HIV infection) or active hepatitis:\n\n     * HBV DNA \\> upper limit of normal (ULN)\n     * HCV RNA \\> ULN; 15. Use of other investigational drugs within 4 weeks before first dose; radiotherapy\u002Flocal therapy within 2 weeks without full recovery; 16. Concurrent\u002Fprior malignancies (except cured basal cell carcinoma\u002Fcervical carcinoma in situ); 17. Planned concurrent systemic anti-tumor therapy during the study; 18. Live vaccination within 4 weeks before treatment or planned during the study; 19. Other conditions potentially requiring study termination per investigator judgment:\n     * Severe comorbidities (including psychiatric disorders) requiring treatment\n     * Critical lab abnormalities\n     * Social\u002Ffamily factors compromising safety or data\u002Fsample collection.",{"count":548,"type":22},36,[25],"The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin\u002Fcarboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are:\n\n1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?\n2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?\n\nParticipants will:\n\n* Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin\u002FCarboplatin and radiation therapy according to a specified protocol.\n* Visit the clinic for regular checkups and tests throughout the treatment period.\n* Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.\n* Provide hematologic、tissue and stool samples to explore biomarkers.\n\nThis study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.",[552,326,553],"Cervical Cancer","Oligometastatic",[110,330,331,555,332,334,335,336,337,338,556],"Carboplatin","Iparomlimab and Tuvonralimab","2025-04-16",{"date":559,"type":38},"2025-04-24",{"date":561,"type":38},"2025-02-28",{"date":563,"type":22},"2028-12-31",{"name":44,"class":45},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":319,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":46},"100581226","phase-1-phase-i-ii-clinical-study-of-taurine-for-external-use-in-the-prevention-and-treatment-of-acute-radiation-skin-injury-100581226","NCT06847555","Phase I-II Clinical Study of Taurine for External Use in the Prevention and Treatment of Acute Radiation Skin Injury","Inclusion Criteria:\n\n* Breast cancer patients scheduled for conventional fractionated adjuvant\n* radiotherapy.\n* 18 years or older\n* ECOG score 0-1\n* No previous history of other neoplasms.\n* No previous chest radiotherapy.\n* Heart, lung function, liver function and kidney function were within normal range.\n* Voluntary informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, women in childbearing years who do not use effective contraception；\n* Patients with mental disease or nervous system disease, unable to clearly describe treatment response (such as cerebrovascular accident sequela);\n* Those who have serious heart, liver, kidney and other organ diseases or diabetes and are not expected to complete the treatment plan;\n* serious, uncontrolled diseases and infections;\n* Pregnant or lactating patients.\n* Allergic to taurine and any of its components.\n* Has participated in other clinical trials.\n* knot tissue disease\n* active hepatitis\n* Obvious diseases that the investigator considers should be excluded from this study",{"count":21,"type":22},[182,25],"Acute radiation skin injury is the most common side effect of radiation therapy in patients with chest tumors, which can be manifested as erythema, dry peeling, wet peeling, and severe ulcers.\n\nEven with current advanced radiotherapy techniques, such as intensity-modulated reverse radiation therapy (IMRT), about one-third of patients develop grade 2 or higher skin damage during radiotherapy. Radiation skin damage can cause discomfort to patients, thus affecting their daily life and reducing their quality of life. In severe cases, it can even reduce the efficacy due to prolonged treatment time. Therefore, prevention and treatment of acute radiation skin injury is a difficult problem to be solved urgently in clinical practice.\n\nEven with current advanced radiotherapy techniques, such as intensity-modulated reverse radiation therapy (IMRT), about one-third of patients develop grade 2 or higher skin damage during radiotherapy. Radiation skin damage can cause discomfort to patients, thus affecting their daily life and reducing their quality of life. In severe cases, it can even reduce the efficacy due to prolonged treatment time. Therefore, prevention and treatment of acute radiation skin injury is a difficult problem to be solved urgently in clinical practice.\n\nFrom previous studies, we found that taurine is an active substance that regulates normal physiological activities of the body and is widely distributed in various tissues and organs of the body. This substance has many advantages. Many previous studies have shown that taurine also has a wide range of biological functions such as anti-inflammatory, analgesic, maintaining osmotic pressure balance, improving visual function, regulating blood sugar, nerve conduction, endocrine activity, regulating lipid digestion and absorption, increasing cardiac contractility, improving immunity, enhancing cell membrane antioxidant capacity, protecting myocardial cells, etc.\n\nConsidering the multiple medical values of taurine and its safety, we intend to conduct a phase I-II clinical study of taurine for external use in the prevention and treatment of acute radiation skin injury for radiation skin injury, with the study period from January 25,2024 to January 25,2027. The purpose is to evaluate the safety of taurine in the prevention and treatment of acute radiation skin injury in breast cancer patients after adjuvant radiotherapy. Possible benefits: Reduce the incidence and severity of radiation skin damage.",[575],"To Evaluate the Safety of Taurine in Preventing Acute Radiation Skin Injury Induced by Adjuvant Radiotherapy in Breast Cancer Patients","2025-02-24",{"date":578,"type":38},"2025-02-26",{"date":580,"type":22},"2025-05-25",{"date":582,"type":22},"2027-09-25",{"name":44,"class":45},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":591,"maxAge":18,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":46},"100578859","phase-2-evaluation-of-the-efficacy-and-safety-of-pazopanib-in-combination-with-tgiciv-for-recurrent-or-refractory-rhabdomyosarcoma-in-children-or-adolescents-100578859","NCT06816771","Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI\u002FCIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents","Evaluation of Efficacy and Safety of Pazopanib Combined with TGI\u002FCIV(nab⁃Paclitaxel+ Gemcitabine + Ifosfamide\u002Fcyclophosphamide +Irinotecan + Vinorelbine) in the Treatment for Children or Adolescents with Recurrent\u002Frefractory Rhabdomyosarcoma--an Open-label, Single-arm, Single-cente,phase II Clinical Trial","Inclusion Criteria\n\n1. Histologically or cytologically confirmed rhabdomyosarcoma (RMS).\n2. Patients diagnosed with recurrent\u002Frefractory RMS based on clinical diagnostic criteria. Recurrence is defined as disease recurrence confirmed after achieving complete remission and completing at least one line of standard treatment; refractory is defined as disease progression as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) after at least four cycles of first-line chemotherapy.\n\n   First-line standard treatment can refer to the \"Diagnosis and Treatment Guidelines for Rhabdomyosarcoma in Children and Adolescents (2019 Edition)\".\n3. Patients must have measurable lesions as per RECIST 1.1 criteria.\n4. Age ≥ 2 years and ≤ 18 years, with no gender restrictions.\n5. Karnofsky Performance Scale (KPS) score of 70-100% (\\> 12 years) or Lansky Performance Scale score of 70-100% (≤ 12 years).\n6. Expected survival time ≥ 12 weeks.\n7. Before initiating any project-related procedures, the parents\u002Fguardians of the child or adolescent subjects must be able to understand, consent, and sign the informed consent form (ICF) and applicable assent form; the subjects must be able to express consent with the consent of their parents\u002Fguardians (if applicable).\n8. Adequate organ and bone marrow function, defined as follows:\n\nBone marrow function:\n\n1. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (≥ 0.5×109\u002FL if bone marrow metastasis)\n2. Platelet count ≥ 100×109\u002FL (≥ 75×109\u002FL if bone marrow metastasis) Hb ≥ 65 g\u002FL (blood transfusion is allowed)\n3. Hematopoietic growth factors: Treatment should be initiated at least 14 days after the last administration of long-acting growth factors or 1 day after the last administration of short-acting growth factors. renal function\n\n1\\) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) 2) If serum creatinine \\> 1.5 ULN, creatinine clearance rate \\> 70 ml\u002Fmin\u002F1.73 m² Liver function\n\n1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis)\n2. Total bilirubin ≤ 1.5 times ULN Cardiac function\n\n1\\) Echocardiography LVEF ≥ 50%; 2) No severe cardiac rhythm or conduction abnormalities on electrocardiogram.\n\nExclusion criteria:\n\n1. Received any of the following treatments within 2 weeks before treatment: radiotherapy, chemotherapy, or molecular targeted therapy for tumors; other investigational drugs; or live attenuated vaccines.\n2. Patients who have received anti-angiogenic targeted drugs such as apatinib, pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, crizotinib, famitinib, anlotinib, regorafenib, endostatin, etc. within the past 3 months.\n3. Central nervous system metastasis.\n4. A history of thrombosis within 3 months before enrollment and anticoagulation treatment for less than 6 weeks.\n5. Known bleeding tendency, significant clinical bleeding symptoms within 3 months before treatment or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, vasculitis, etc.; or thrombotic events within 6 months before treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; or need long-term anticoagulation treatment with warfarin or heparin, or need long-term antiplatelet treatment (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday).\n6. Uncontrolled hypertension and proteinuria in the recent period. And cannot be well controlled by antihypertensive drugs (infants \\> 100\u002F60 mmHg, preschool children (\\\u003C 6 years old) \\> 110\u002F70 mmHg, school-age children (6-12 years old) \\> 120\u002F80 mmHg, adolescents and adults \\> 140\u002F90 mmHg).\n7. Use of antiepileptic drugs.\n8. Long-term unhealed wounds, ulcers or fractures, major surgery within 28 days before enrollment or minor surgery within 7 days, abdominal fistula, gastrointestinal perforation.\n9. Uncontrolled severe infection.\n10. The presence of active heart disease within 6 months before treatment, including myocardial infarction, severe\u002Funstable angina, etc. Poorly controlled arrhythmias with left ventricular ejection fraction \\\u003C 50% on echocardiography (including QTcF intervals \\>450 ms in men and \\>470 ms in women).\n11. Any other malignancy was diagnosed within 3 years before treatment.\n12. Known allergy to the study drug or any of its excipient.\n13. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU\u002Fml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay).\n14. According to the judgment of the researchers, patients with large tumors, easy to rupture and bleeding, and bleeding caused by tumor retraction are at high risk.\n15. Concomitant medical conditions (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric conditions, etc.) or any other condition that, in the investigator's judgment, could seriously endanger the safety of the subject, confound the study results, or interfere with the completion of the study.","2 Years",{"count":593,"type":22},38,[25],"To evaluate the efficacy and safety of pazopanib combined with TGI\u002FCIV chemotherapy in children and adolescents with recurrent or refractory rhabdomyosarcoma.",[597],"Rhabdomyosarcoma, Recurrent, Refractory",[599,600],"rhabdomyosarcoma","pediatric","2025-02-07",{"date":603,"type":38},"2025-02-10",{"date":605,"type":22},"2025-02",{"date":607,"type":22},"2026-12-31",{"name":44,"class":45},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":631,"locationsCount":4},"100570978","phase-2-trilaciclib-in-preventing-hematopoietic-suppression-in-patients-with-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100570978","NCT06714266","Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Receiving Either Single Chemotherapy or Chemotherapy Combined with Immunotherapy\u002Ftargeted Therapy.","Inclusion Criteria:\n\n* 1\\. Written informed consent was obtained before enrollment.\n* 2\\. Age ≥18 years old, both male and female;\n* 3\\. Recurrent or metastatic head and neck squamous cell carcinoma without prior systemic therapy;\n* 4\\. the presence of at least one measurable lesion;\n* 5\\. ECOG PS = 0-1;\n* 6\\. Expected survival time ≥ 3 months\n* 7\\. Laboratory tests meet the following standards: Hemoglobin ≥ 100 g\u002FL (female), 110g\u002FL (male) Neutrophil count ≥ 2×109\u002FL Platelet count ≥100×109\u002FL; Creatinine ≤ 15mg\u002FL or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤5× ULN (in patients with liver metastases); Albumin ≥ 30 g\u002FL;\n* 8\\. Women: all women of childbearing potential must have a negative serum pregnancy test during the screening period and must be using a reliable contraceptive method from the time of informed consent until 3 months after the last dose;\n\nExclusion Criteria:\n\n* 1\\. Patients with known allergies to any of the drugs in the study;\n* 2\\. Participated in other drug clinical trials within 4 weeks before the study;\n* 3\\. a history of major bleeding, with any bleeding event of CTCAE4.0 grade 3 or above within 4 weeks before screening;\n* 4\\. patients with hypertension that is not well controlled by single antihypertensive medication (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); 8. Clinically significant (e.g., active) cardiovascular disease - e.g., cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤ 6 months before randomization), unstable angina, congestive heart failure of New York Heart Association (NYHA) class II or higher, or severe arrhythmias that could not be controlled with medications or that could potentially affect trial treatment;\n* 5\\. Previous arterial\u002Fvenous thrombosis events occurred within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization due to previous chemotherapy, which was judged by the investigator to be cured), and pulmonary embolism;\n* 6\\. Renal insufficiency: urine routine proteinuria \\> 2+ and confirmed 24-hour urinary protein quantitation \\> 1.0 g;\n* 7\\. Symptomatic brain metastases (proven or suspected);\n* 8\\. Presence of severe or uncontrolled infection;\n* 9\\. Those who have a history of psychotropic drug abuse and cannot be abstinent or have a history of mental disorder;\n* 10\\. A history of immunodeficiency, including testing positive for HIV, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation; He had a history of autoimmune diseases.\n* 11\\. Use of high-dose glucocorticoids for 4 weeks.\n* 12\\. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc.;\n* 13\\. Concomitant medical conditions that, in the investigator's judgment, seriously compromise patient safety or interfere with patient completion of the study. He had received a previous hematopoietic stem-cell or bone marrow transplant\n* 14\\. Allergy to the study drug or its components;\n* 15\\. Those who were deemed unsuitable for the study by the investigator.\n* 16\\. Electrolyte disorder, low calcium, low potassium, low phosphorus.",{"count":5,"type":22},[25],"This prospective, single-arm, exploratory, phase II study was designed to evaluate the efficacy and safety of Trilaciclib in reducing chemotherapy-induced neutropenia in patients with recurrent or metastatic head and neck squamous cell carcinoma. Eligible subjects screened by the inclusion and exclusion criteria will receive chemotherapy alone or combined with immune\u002Ftargeted therapy and Trilaciclib for 4-6 cycles of continuous treatment. If the efficacy is not progressive after 4-6 cycles of treatment, the investigators can combine with Trilaciclib during immune and\u002For targeted maintenance therapy according to the specific conditions of the subjects until disease progression or intolerance. The efficacy of Trilaciclib will be evaluated by the incidence of grade ≥3 neutropenia during chemotherapy as the primary endpoint.\n\nAfter the progression of treatment, if the subjects were treated with chemotherapy for subsequent treatment and were considered to be able to use Trilaciclib according to the evaluation of the investigator, the use of treaclib could be considered until the subjects had disease progression again or were intolerant to treatment.",[620],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[622,623,624],"Head and neck squamous cell carcinoma","Chemotherapy induced myelosuppression","Trilaciclib","2024-11-27",{"date":627,"type":38},"2024-12-03",{"date":629,"type":22},"2024-12-15",{"date":607,"type":22},{"name":44,"class":45},""]