[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sun Yat-sen University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":620},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,490,0,25,[9,50,79,99,123,145,173,201,228,253,279,304,331,358,376,398,420,448,470,490,514,535,554,579,602],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100652928","vipeeragent-for-adolescent-mental-health-a-three-arm-parallel-randomized-controlled-trial-100652928",false,"NCT07778758","VIPeerAgent for Adolescent Mental Health: A Three-Arm Parallel Randomized Controlled Trial","Efficacy of VIPeerAgent for Mental Health Intervention in Adolescents: A Three-Arm Parallel Randomized Controlled Trial With Non-Inferiority and Superiority Testing","Inclusion Criteria:\n\n* Adolescents and young adults aged 14-25 years. Experienced at least one moderate stressful life event within the past 6 months, with a score of moderate level or above on one or more items of the Stressful Life Events Scale.\n\nAble to read and communicate in Chinese. Willing to actively participate in the study and provide written informed consent.\n\nA Brief Symptom Inventory-53 (BSI-53) score \\\u003C 63, indicating the absence of a clinically diagnosed psychological disorder.\n\nExclusion Criteria:\n\n* A history of clinically diagnosed severe mental or psychiatric disorders, such as major depressive disorder or schizophrenia.\n\nPresence of suicidal ideation within the past 6 months or current suicidal ideation.\n\nReceipt of professional psychological treatment within the past 12 months.","ALL","14 Years","25 Years",{"count":21,"type":22},234,"ESTIMATED","INTERVENTIONAL",[25],"NA","This three-arm parallel randomized controlled trial aims to evaluate the effectiveness of VIPeerAgent, a virtual peer support agent, in improving mental health outcomes among adolescents and young adults aged 14-25 years experiencing psychological distress without a diagnosed mental disorder. Participants will be randomized to receive support from VIPeerAgent, a human peer mentor, or usual care. The study will assess whether VIPeerAgent is non-inferior to human peer support and superior to usual care in promoting mental health. Outcomes include mental health status, psychological resilience, coping strategies, perceived social support, and emotional intelligence. The findings will provide evidence for the effectiveness and scalability of AI-assisted peer support as an early intervention approach for youth mental health.",[28,29,30],"Youth Mental Health","Psychological Distress in Adolescents and Young Adults","Early Intervention",[32,33,34,35,36],"mental health","Agent","Randomized Controlled Trial","adolescence","youth","NOT_YET_RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":22},"2026-08-20",{"date":45,"type":22},"2026-12-10",{"name":47,"class":48},"Sun Yat-sen University","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":49},"100652607","phase-2-trastuzumab-rezetecan-and-carboplatin--bevacizumab-versus-investigators-choice-chemotherapy-in-patients-with-platinum-sensitive-recurrent-ovarian-cancer-100652607","NCT07776171","Trastuzumab Rezetecan and Carboplatin ± Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer","Trastuzumab Rezetecan and Carboplatin With or Without Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer: an Open-label, Multicenter, Randomized Controlled Phase II Study","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.\n2. Aged 18 to 75 years.\n3. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.\n4. Have received 1-3 prior lines of platinum-based chemotherapy and have experienced disease progression or recurrence ≥6 months after the last platinum-based treatment (platinum-sensitive relapse).\n5. Must have received prior treatment with a PARP inhibitor.\n6. Able to provide sufficient fresh or archival tumor tissue specimens for detection of HER2 expression levels.\n7. Have at least one measurable lesion per RECIST v1.1.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Expected survival of more than 3 months.\n10. Adequate major organ function.\n11. Subjects of childbearing potential must use at least one medically approved contraceptive measure (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 180 days after the end of study treatment; must have a negative serum\u002Furine HCG test before the first dose; and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma.\n2. Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin.\n3. Prior treatment with anti-HER2 therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone.\n4. Untreated or active central nervous system (CNS) metastases.\n5. Prior history of interstitial pneumonia\u002Finterstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required steroid treatment; current or suspected interstitial pneumonia\u002Finterstitial lung disease, non-infectious pneumonitis, or other active pneumonitis.\n6. Active ulcer, intestinal perforation, or intestinal obstruction.\n7. Known hereditary or acquired bleeding disorders (e.g., coagulation dysfunction, hemophilia) or thrombotic tendency.\n8. Toxicity from prior anti-tumor therapy that has not recovered to ≤ Grade 1 per NCI-CTCAE v6.0.\n9. Arterial\u002Fvenous thrombotic events (including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism) within 6 months before the first dose; however, if muscular venous thrombosis or catheter-related thrombosis associated with an infusion port is present before the first dose and the investigator deems it to be without risk, the subject may be enrolled.\n10. Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).\n11. Uncontrolled or severe cardiovascular disease, such as unstable angina, symptomatic congestive heart failure (NYHA class II-IV), myocardial infarction within 6 months before the first dose, or unstable angina or unstable arrhythmia within 1 month before the first dose.\n12. Prior surgery, radical radiotherapy, chemotherapy, macromolecular targeted therapy, or anti-tumor immunotherapy with completion (last dose) less than 4 weeks before the first dose; prior small-molecule targeted drugs with last dose less than 5 half-lives or 4 weeks (whichever is shorter) before the first dose; prior palliative radiotherapy or local therapy with completion less than 2 weeks before the first dose.\n13. Pleural effusion, pericardial effusion, or ascites that cannot be controlled with appropriate interventions.\n14. Severe infection within 1 month before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia.\n15. Concurrent or previous other malignancies, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years with documented evidence of no recurrence or metastasis.\n16. History of immunodeficiency (including HIV-positive test), other acquired or congenital immunodeficiency diseases, or history of organ transplantation; known active hepatitis B (defined as HBsAg-positive with HBV DNA ≥500 IU\u002FmL \\[or ≥2500 copies\u002FmL if the study site only uses copies\u002FmL, in which case the subject is not eligible\\]) or active hepatitis C (defined as positive hepatitis C virus antibody \\[HCV-Ab\\] and positive HCV-RNA at screening).\n17. Any clinical or laboratory abnormality or other reason that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical study.","FEMALE","18 Years","75 Years",{"count":61,"type":22},176,[63],"PHASE2","This study is a randomized, open-label, controlled phase II clinical trial.\n\nIt is planned to enroll 176 subjects with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer previously treated with Poly (ADP-ribose) polymerase inhibitors (PARPi).\n\nSubjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (trastuzumab Rezetecan + carboplatin ± bevacizumab) or the control treatment group (investigator's choice chemotherapy ± bevacizumab).",[66,67],"Ovarian Cancer","Platinum Sensitive Ovarian Cancer (PSOC)",[69,70,71],"Ovarian cancer","Epithelial Ovarian Cancer","Platinum-sensitive recurrent ovarian cancer","2026-08-17",{"date":43,"type":41},{"date":75,"type":22},"2026-09-30",{"date":77,"type":22},"2030-05-30",{"name":47,"class":48},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":49},"100652378","phase-2-radiotherapy-combined-with-capeox-chemotherapy-sintilimab-and-suvemcitug-in-locally-advanced-pmmr-rectal-cancera-prospective-clinical-trial-100652378","NCT07774754","Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial","RADIANT","Inclusion Criteria:\n\n* 1\\) Aged 18-75 years;\n\n  2\\) ECOG 0-1;\n\n  3\\) Histologically confirmed rectal adenocarcinoma;\n\n  4\\) Preoperative staging: cT3-4N0M0 or cT1-4N+M0;\n\n  5\\) Distance from the tumour's inferior margin to the anus ≤ 12 cm;\n\n  6\\) Tumour biopsy immunohistochemistry indicates pMMR, i.e. positive expression of all MSH1\u002FMSH2\u002FMSH6\u002FPMS2, and molecular testing indicates MSS (microsatellite-stable).\n\n  7\\) Haematological parameters: WBC \\> 4,000\u002Fmm³; PLT \\> 100,000\u002Fmm³; Hb should, in principle, be \\> 10 g\u002FdL; chronic anaemia (haemoglobin \\\u003C 10.0 g\u002FdL) is not an exclusion criterion and may be assessed by a multidisciplinary team;\n\n  8\\) Liver function: Serum total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin ≤ 3 × ULN is allowed)；aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN；\n\n  9\\) Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance \\> 50 mL\u002Fmin;\n\n  10\\) Other: not pregnant or breastfeeding; no other malignant diseases within the past 5 years or concurrently (excluding basal cell carcinoma of the skin or cervical carcinoma in situ); no mental illness preventing the provision of informed consent; no concomitant serious diseases that would shorten survival;\n\n  11\\) No previous surgery, chemotherapy or radiotherapy for rectal cancer;\n\n  12\\) No previous immunotherapy;\n\n  13\\) Previous endocrine therapy: no restrictions.\n\nExclusion Criteria:\n\n* 1\\) Failure to sign an informed consent form;\n\n  2\\) Immunohistochemistry of tumor biopsy specimens indicating dMMR or microsatellite instability testing indicating MSI-H;\n\n  3\\) Preoperative evidence of distant metastasis;\n\n  4\\) History of severe bleeding tendency or coagulation disorders; patients who have previously or currently require long-term anticoagulant therapy (e.g., patients with atrial fibrillation who have a CHADS2 score of ≥2).\n\n  5\\) History of myocarditis, cardiomyopathy, or malignant arrhythmias. History of unstable angina, congestive heart failure, or vascular disease (e.g., an aortic aneurysm requiring surgical repair or peripheral venous thrombosis) requiring hospitalization within 12 months prior to study treatment, or other cardiac conditions that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial infarction, or ischemia) ;\n\n  6\\) History of esophageal or fundic varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to study treatment;\n\n  7\\) History of any arterial thromboembolic event, venous thromboembolism of Grade 3 or higher according to NCI CTCAE Version 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment;\n\n  8)An acute exacerbation of chronic obstructive pulmonary disease (COPD) within 1 month prior to study treatment; current hypertension with a systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite treatment with oral antihypertensive medications; severe hypertension that is poorly controlled with medication;\n\n  9\\) History of HIV infection or active chronic hepatitis B or C, or other active, clinically significant infections;\n\n  10\\) Subjects with active pulmonary tuberculosis (TB) who are currently receiving antituberculosis therapy or who have received such therapy within 1 year prior to screening;\n\n  11\\) Cachexia, organ dysfunction;\n\n  12\\) History of pelvic or abdominal radiation therapy;\n\n  13\\) Multiple primary colorectal cancers;\n\n  14\\) Patients with seizures requiring treatment (e.g., with steroids or antiepileptic therapy);\n\n  15\\) History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin;\n\n  16\\) Substance abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results;\n\n  17\\) Known or suspected allergy to the study drug or to any medication administered in connection with this trial;\n\n  18\\) Any unstable condition or situation that may jeopardize the patient's safety or compliance;Pregnant or breastfeeding women of childbearing potential who are not using adequate contraception.",{"count":87,"type":22},18,[63],"This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib.\n\nPatients will receive long-course chemoradiotherapy (concurrent capecitabine, 1000 mg\u002Fm², twice daily, days 1-14, Q3W, 2 cycles; sintilimab, 200 mg, d1, IV drip, Q3W, 2 cycles), followed by 6 cycles of the Capeox regimen in combination with sintilimab and suvecitib, namely oxaliplatin 130 mg\u002Fm², d1, IV infusion, every 3 weeks; and capecitabine 1,000 mg\u002Fm², twice daily, days 1-14, every 3 weeks; sintilimab, 200 mg, Day 1, IV drip, every 3 weeks; suvectitumab (anti-angiogenic agent), 2.0\u002F1.5\u002F1.0 mg\u002Fkg, Day 1, IV drip, every 3 weeks. A total of 8 cycles of sintilimab and 6 cycles of suvectitumab were administered during the neoadjuvant treatment period.\n\nIf, following completion of neoadjuvant therapy, the subject has not achieved cCR\u002Fnear-cCR status, TME surgery or other therapeutic surgery shall be performed; the interval between the final dose of suvectitumab and surgery should be ≥6 weeks. If cCR\u002Fnear-cCR status is achieved, watchful waiting or other treatment options shall be discussed with the patient. The adjuvant treatment regimen following surgery shall be determined by the investigator based on the patient's pathological results.",[91],"Rectal Cancer",{"date":93,"type":41},"2026-08-19",{"date":95,"type":22},"2026-09-01",{"date":97,"type":22},"2031-09-01",{"name":47,"class":48},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":49},"100608089","early-phase-1-transcatheter-edge-to-edge-repair-in-moderate-and-exertional-induced-severe-mr-timer-100608089","NCT07197021","TEER In dynaMic sEvere Functional Mitral Regurgitation (TIMER)","TEER In dynaMic sEvere Functional Mitral Regurgitation：A Multicenter, Randomized, Controlled Trial","Key Inclusion Criteria:\n\n1. Clinically significant functional mitral regurgitation (MR=2+ at rest and MR≥3+ under stress) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and\u002For CRT, as appropriate\n2. Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC\u002FHFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.\n3. Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization\n4. Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg\u002FmL for BNP or 1000 pg\u002FmL for NT-proBNP after optimal medical and\u002For device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and\u002For CRT, as appropriate\n5. Left ventricular ejection fraction (LVEF) of ≥ 20% Note: LVEF needs to be determined by one of the following methods: transthoracic echocardiography (TTE), contrast ventriculography, gated blood pool scan, cardiac magnetic resonance) within 90 days prior to randomization\n6. Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness\n\nKey Exclusion Criteria:\n\n1. Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).\n2. Status 1 heart transplant or prior orthotropic heart transplantation.\n3. Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.\n4. Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization. Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.\n5. Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within 90 day prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization.\n6. Need for any cardiovascular surgery.\n7. Mitral valve surgery is considered the preferred therapeutic option for the subject\n8. Renal replacement therapy\n9. 6-Minute Walk Test (6MWT) distance \\> 475 meters\n10. Mitral Valve Area (MVA) by planimetry \\\u003C 4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory","90 Years",{"count":108,"type":22},540,[25],"Functional mitral regurgitation is a highly dynamic disease. Some patients exhibit only moderate(2+) functional mitral regurgitation at rest, which deteriorates to moderate-to-severe or severe FMR(3+ or 4+) during stress-termed dynamic severe functional mitral regurgitation. Observational studies link this condition to worse outcomes, with mitral valve intervention offering potential benefits; however, high-quality evidence remains lacking.\n\nThe Transcatheter Edge-to-Edge Repair In DynaMic sEvere Functional Mitral Regurgitation trial aims to assess the safety and effectiveness of transcatheter edge-to-edge repair plus guideline-directed medical therapy versus guideline-directed medical therapy alone in symptomatic chronic heart failure patients with dynamic severe functional mitral regurgitation, defined as moderate regurgitation at rest deteriorating to severe during handgrip stress echocardiography.\n\nThis prospective, multi-center, randomized trial enrolls patients with dynamic severe functional mitral regurgitation confirmed by a core laboratory using handgrip stress echocardiography. Patients are randomized 1:1 to transcatheter edge-to-edge repair plus medical therapy or medical therapy alone. The primary endpoint is the composite of Cardiovascular death or heart failure hospitalization over the entire period.\n\nThis trial will provide critical evidence on transcatheter edge-to-edge repair in patients with dynamic severe functional mitral regurgitation, informing future treatment recommendations.",[112],"Mitral Regurgitation Functional",[114,115,116],"hand grip","TEER","dynamic",{"date":93,"type":41},{"date":119,"type":22},"2027-01-01",{"date":121,"type":22},"2034-12-31",{"name":47,"class":48},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":49},"100652612","research-on-colorectal-cancer-recurrence-monitoring-and-individualized-treatment-based-on-mrd-100652612","NCT07775950","Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD","Inclusion Criteria:\n\n1. Voluntary participation in the study and provision of written informed consent.\n2. Age ≥18 years at the time of signing informed consent.\n3. Histologically confirmed colorectal adenocarcinoma with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status.\n4. Clinically confirmed stage IV disease.\n5. No prior immunotherapy for the current colorectal cancer.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. Availability of adequate pretreatment tumor tissue and peripheral blood samples for whole-exome sequencing (WES) and personalized circulating tumor DNA (ctDNA)\u002FMRD analysis.\n8. Life expectancy \\>12 months.\n9. Willing and able to comply with the study procedures and scheduled follow-up.\n\nExclusion Criteria:\n\n1. Presence of another malignancy.\n2. Prior immunotherapy for the current stage IV colorectal cancer.\n3. Organ transplantation within 3 months before enrollment.\n4. History of blood transfusion within 3 months before enrollment.\n5. Active, known, or suspected autoimmune disease, or evidence of active or chronic infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).\n6. Pregnancy or breastfeeding.\n7. Presence of a serious concurrent disease that, in the investigator's judgment, may substantially affect life expectancy or study participation.\n8. Failure to provide written informed consent.\n9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.",true,{"count":131,"type":22},100,[25],"This study aims to evaluate whether plasma molecular residual disease (MRD), assessed using circulating tumor DNA (ctDNA), can help optimize the duration of immunotherapy in patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.\n\nPatients with MSI-H\u002FdMMR metastatic colorectal cancer can achieve durable responses to immune checkpoint inhibitors, but the optimal duration of treatment remains uncertain. Prolonged immunotherapy may increase treatment burden and the risk of immune-related adverse events. ctDNA-based MRD testing may provide a sensitive method for detecting residual tumor burden and identifying patients who may be able to safely stop treatment.\n\nIn this study, patients receiving immunotherapy will undergo serial plasma MRD testing. After completing 1 year of immunotherapy, patients with two consecutive negative MRD results will be randomly assigned to either continue immunotherapy or stop treatment and enter observation. Patients will then be followed every 3 months for 2 years with MRD testing and routine clinical assessments, including imaging and laboratory examinations.\n\nThe study will compare clinical outcomes between the two groups and evaluate whether serial plasma MRD monitoring can support a more individualized approach to the duration of immunotherapy in MSI-H\u002FdMMR metastatic colorectal cancer.",[135,136],"Colorectal Cancer (MSI-H)","Molecular Residual Disease","RECRUITING","2026-08-16",{"date":43,"type":41},{"date":141,"type":41},"2026-06-23",{"date":143,"type":22},"2034-12-30",{"name":47,"class":48},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"100641398","phase-3-individualized-primary-clinical-target-volume-based-on-margin-expansion-for-nasopharyngeal-carcinoma-100641398","NCT07661771","Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma","Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma: A Non-Inferiority, Multicenter, Randomized Phase 3 Trial","CTV-MARGIN-NPC","Inclusion Criteria:\n\n1. Age: 18 Years to 65 Years.\n2. Eastern Cooperative Oncology Group performance status ≤1.\n3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma (non-keratinizing subtype).\n4. Tumor staged as T1-4N0-3M0 (AJCC 9th).\n5. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.\n6. Women of childbearing potential and male subjects with female partners of childbearing potential must agree to use reliable contraceptive measures from screening to 1 year after treatment.\n7. For subjects requiring chemotherapy, the following are additionally required:\n\n   1. normal bone marrow function (white blood cell count \\> 4 × 10\\^9\u002FL, hemoglobin \\> 90 g\u002FL, platelet count \\> 100 × 10\\^9\u002FL);\n   2. normal liver and kidney function (total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2.5 × upper limit of normal, alkaline phosphatase ≤ 2.5 × upper limit of normal, creatinine clearance rate ≥ 60 mL\u002Fmin).\n\nExclusion Criteria:\n\n1. Active tuberculosis: active tuberculosis within the past 1 year should be excluded regardless of treatment; a history of active tuberculosis \\> 1 year ago is exclusionary unless prior adequate anti-tuberculosis treatment is documented.\n2. Active infection requiring systemic treatment.\n3. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer.\n4. History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma.\n5. Prior or concurrent treatment for local or regional disease other than that specified in the research plan.\n6. Pregnant or lactating women (a pregnancy test is required for women of childbearing potential).\n7. Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast.\n8. History of psychiatric disorders, alcoholism or drug abuse, and other situations assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.\n9. For participants requiring chemotherapy, the following must also be excluded:\n\n   1. anti-human immunodeficiency virus positive or diagnosed with acquired immune deficiency syndrome;\n   2. uncontrolled heart disease (heart failure \\[NYHA Class ≥ 2\\], unstable angina, myocardial infarction in past 1 year, supraventricular or ventricular arrhythmia requiring treatment or intervention).\n10. For participants requiring immunotherapy, the following must also be excluded:\n\n    1. hepatitis B virus surface antigen positive and Hepatitis B virus DNA \\> 1000 copies\u002FmL;\n    2. anti-hepatitis C virus positive;\n    3. active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilators, exceptions are type I diabetes mellitus, hypothyroidism not requiring hormone replacement therapy, skin disorders not requiring systemic treatment \\[such as vitiligo, psoriasis or alopecia\\]);\n    4. previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;\n    5. chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day, subjects who use inhaled or topical corticosteroids are eligible) or any other form of immunosuppressive therapy;\n    6. allergy to macromolecular protein preparations, or any component of PD-1 monoclonal antibody;\n    7. receiving live vaccine within 30 days prior to the first dose of PD-1 monoclonal antibody.","65 Years",{"count":155,"type":22},568,[157],"PHASE3","This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.",[160],"Non-metastatic Nasopharyngeal Carcinoma",[162,163,164,165],"Radiotherapy","Target Delineation","Primary Clinical Target Volume","Margin",{"date":93,"type":41},{"date":168,"type":41},"2026-07-24",{"date":170,"type":22},"2034-07-30",{"name":47,"class":48},7,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":180,"minAge":58,"maxAge":59,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":49},"100652045","phase-2-neoadjuvant-pucotenlimab-and-becotatug-vedotin-for-locally-advanced-penile-cancer-100652045","NCT07767266","Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer","Pucotenlimab (HX008) Combined With Becotatug Vedotin (MRG003) as Neoadjuvant Therapy for Locally Advanced Penile Squamous Cell Carcinoma：A Multicenter, Single-Arm, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Aged 18-75 years, biologically male.\n2. Histologically confirmed penile squamous cell carcinoma, stage T4 any N M0 or any T N2-N3 M0 without distant metastasis.\n3. Treatment-naive; or relapsed patients with ≥12 months interval from last prior systemic therapy.\n4. At least one measurable target lesion per RECIST 1.1.\n5. ECOG performance status 0-2.\n6. Adequate bone marrow, liver and renal function as predefined lab thresholds.\n7. Expected survival ≥12 months.\n8. No severe uncontrolled organ dysfunction.\n9. Able to understand and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n1. Pre-existing grade ≥2 peripheral neuropathy interfering daily activities.\n2. Prior neoadjuvant therapy for penile cancer; previous use of PD-1\u002FPD-L1 inhibitors or EGFR ADCs including becotatug vedotin.\n3. Known hypersensitivity to pucotenlimab, becotatug vedotin or excipients.\n4. Active malignancy within 5 years (excluding cured basal cell skin carcinoma and low-risk prostate cancer).\n5. Uncontrolled severe cardiovascular disease, active hepatitis B\u002FC, active infection requiring antibiotics within 2 weeks before enrollment.\n6. Live vaccine administered within 30 days before first dosing.\n7. HIV infection, autoimmune disease requiring systemic therapy within 2 years, long-term systemic immunosuppressants.\n8. Other conditions judged by investigators to interfere with study treatment or assessment.","MALE",{"count":182,"type":22},29,[63],"This is an open-label, multicenter, single-arm Phase 2 clinical trial evaluating neoadjuvant pucotenlimab (anti-PD-1 immunotherapy) combined with becotatug vedotin (EGFR-targeted antibody-drug conjugate, ADC) for adults with locally advanced penile squamous cell carcinoma. Eligible patients have high-risk disease defined as T4 primary tumor with any nodal status or any T stage with N2-N3 lymph node metastasis and no distant metastasis.\n\nAll participants receive up to 4 cycles of combination neoadjuvant therapy every 3 weeks. After treatment completion, a multidisciplinary team will assess if consolidative surgery can be performed. Patients who undergo surgery will continue single-agent pucotenlimab adjuvant treatment for 17 additional cycles (approximately 1 year).\n\nThe primary goal is to measure the pathological complete response (pCR) rate. Secondary goals include objective response rate (ORR), progression-free survival (PFS),overall survival (OS) and safty profiles. Blood and tumor tissue samples will be collected to explore biomarkers that may predict treatment response and drug resistance. A total of 29 male patients will be enrolled.",[186,187],"Penile Cancer","Penile Squamous Cell Carcinoma (PSCC)",[189,190,191,192,193],"Penile cancer","Immunotherapy","Antibody-drug conjugate","Pucotenlimab","Becotatug Vedotin","2026-08-13",{"date":72,"type":41},{"date":197,"type":22},"2026-08-15",{"date":199,"type":22},"2029-08-15",{"name":47,"class":48},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100634734","phase-3-megestrol-acetate-for-fatigue-management-in-t-dxd-treated-breast-cancer-100634734","NCT07543536","Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer","A Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Trial Evaluating Megestrol Acetate for the Management of Fatigue in Advanced Breast Cancer Patients Treatment With Trastuzumab Deruxtecan","MEGA-TACT-BC3","Inclusion Criteria:\n\n1. Female, aged 18-75 years\n2. Pathologically confirmed inoperable or metastatic breast cancer with complete ER, PR, and HER2 status\n3. HER2-positive (IHC 3+ or IHC 2+ with FISH positive), HER2-low (IHC 1+ or IHC 2+ with FISH negative), or HER2-ultralow (IHC 0 with ≤10% weak incomplete membrane staining) \\[most recent specimen used\\]\n4. Investigator-assessed indication for Trastuzumab Deruxtecan (T-DXd) therapy\n5. No prior treatment with Trastuzumab Deruxtecan\n6. Received ≤5 lines (including 5 lines) of prior chemotherapy\n7. ECOG Performance Status 0-1\n8. Estimated life expectancy ≥12 weeks\n9. Adequate organ function\n10. Reliable contraception or negative serum\u002Furine pregnancy test within 7 days prior to enrollment; willing to use appropriate contraception during study and for 8 weeks after last dose\n11. Voluntary participation with good compliance\n\nExclusion Criteria:\n\n1. Severe underlying disease, comorbidities, active infection, or severe metabolic disorders\n2. Clinically significant severe fatigue at baseline (FACIT-F score \\\u003C30)\n3. Currently receiving other antitumor therapies\n4. Pregnant or lactating patients\n5. Poor compliance or unable to complete normal follow-up\n6. History of allergy to megestrol acetate or other components of the formulation\n7. History of thromboembolism (use with caution)\n8. Other malignancies diagnosed within 5 years, except: resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally radically treated prostate cancer, surgically radically treated ductal carcinoma in situ, or malignancies diagnosed \\>2 years ago with no current disease evidence and untreated for ≤2 years before randomization\n9. Any condition judged by investigator that may affect study conduct or outcome assessment",{"count":210,"type":22},132,[157],"This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of life for advanced breast cancer patients.",[214,215],"Advanced\u002FMetastatic Breast Cancer","HER2+, Low, or Ultralow Advanced\u002FMetastatic Breast Cancer",[217,218],"Megestrol Acetate","Megestrol Acetate + Trastuzumab Deruxtecan","2026-08-12",{"date":221,"type":41},"2026-08-14",{"date":223,"type":41},"2026-06-08",{"date":225,"type":22},"2031-04-01",{"name":47,"class":48},2,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":245,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":252,"locationsCount":227},"100652007","phase-2-neoadjuvant-presurgical-becotatug-vedotin-mrg003-plus-pucotenlimab-hx008-in-oral-cavity-squamous-cell-carcinoma-100652007","NCT07766889","Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma","Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma：A Phase 2 Open-Label Clinical Trial","Inclusion Criteria:\n\n* Voluntary participation with written informed consent, good compliance, and willingness to complete follow-up.\n* Age ≥18 years and ≤70 years, regardless of gender.\n* ECOG performance status score of 0 or 1.\n* Histopathologically confirmed, previously untreated, primary oral cavity squamous cell carcinoma (OSCC); central laboratory-confirmed PD-L1 Combined Positive Score (CPS) ≥1; clinical stage III-IVA (AJCC 8th edition) with potential for curative surgical resection as assessed by the investigator; no evidence of definite locoregional residual or distant metastasis.\n* Adequate organ function within 14 days prior to the first dose, without transfusion or hematopoietic growth factor support:\n* Bone marrow: ANC ≥1.5×10\\^9\u002FL; platelet count ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n* Liver: TBIL ≤1.5×ULN; AST\u002FALT ≤3.0×ULN; ALP ≤2.5×ULN; serum albumin ≥28 g\u002FL.\n* Kidney: creatinine clearance (Ccr) ≥40 mL\u002Fmin (calculated by Cockcroft-Gault formula) or serum creatinine ≤1.5×ULN.\n* Coagulation: INR ≤1.5×ULN and APTT ≤1.5×ULN (excluding patients receiving therapeutic anticoagulation).\n* Cardiac: LVEF ≥50% with no significant cardiac dysfunction.\n* Negative serum pregnancy test within 7 days prior to the first dose for women of childbearing potential; all fertile male and female participants must agree to use highly effective contraception from signing of informed consent through 1 year after the last dose of Pucotenlimab.\n\nExclusion Criteria:\n\n* Age \\>70 years or \\\u003C18 years.\n* History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* HIV infection.\n* HBsAg positive with HBV DNA \\>200 IU\u002FmL or 1000 copies\u002FmL.\n* HCV antibody positive.\n* Severe concurrent diseases that may pose significant risks or affect trial compliance, including unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \\>1.5×ULN), severe cognitive impairment, or psychiatric disorders.\n* Active pulmonary tuberculosis infection within the past 1 year, or history of active tuberculosis \\>1 year ago unless documented prior standard anti-tuberculosis treatment.\n* History of interstitial lung disease.\n* Active, known, or suspected autoimmune disease. Exceptions: type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia).\n* Systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 28 days prior to signing informed consent. Patients receiving ≤10 mg\u002Fday prednisone equivalent or inhaled\u002Ftopical corticosteroids are eligible.\n* Live vaccination within 30 days prior to signing informed consent or planned during the study.\n* Prior surgery, chemotherapy, radiotherapy, immunotherapy, or other anti-tumor therapy for head and neck cancer (excluding diagnostic procedures).\n* Known hypersensitivity to macromolecular protein preparations, or any component of Becotatug vedotin, Pucotenlimab, or cisplatin.\n* Pregnancy, lactation, or anticipated pregnancy during the study period.","70 Years",{"count":237,"type":22},32,[63],"This is a phase 2, open-label, single-arm clinical trial evaluating neoadjuvant therapy with Becotatug vedotin (MRG003) combined with Pucotenlimab (HX008) in patients with previously untreated, resectable stage III-IVA oral cavity squamous cell carcinoma (OSCC) with a PD-L1 Combined Positive Score (CPS) of 1 or higher.\n\nEligible participants will receive 3 cycles of neoadjuvant treatment (Becotatug vedotin 2.3 mg\u002Fkg plus Pucotenlimab 200 mg, intravenously, every 3 weeks), followed by radical surgery 2-3 weeks after the last cycle of neoadjuvant therapy. Postoperative adjuvant radiotherapy will be stratified based on pathological response and risk factors: patients achieving major pathological response (MPR, defined as ≤10% residual viable tumor) with negative margins and no extranodal extension (ENE) will receive de-escalated radiotherapy (50-54 Gy); patients not achieving MPR or with high-risk features will receive standard radiotherapy (60-66 Gy) with or without concurrent cisplatin chemotherapy.\n\nThe primary endpoint is major pathological response (MPR). Secondary endpoints include objective response rate (ORR), pathological complete response (pCR), event-free survival (EFS), overall survival (OS), and safety profile. Exploratory biomarkers will be assessed in tumor tissue and peripheral blood.\n\nA total of 32-33 participants will be enrolled using a Simon two-stage optimal design (α=0.05, power=80%).",[241,242,243,244],"Oral Squamous Cell Carcinoma","Head and Neck Cancer","Locally Advanced Head and Neck Cancer","Neoadjuvant Therapy",[246],"MRG003, Becotatug vedotin, Pucotenlimab, anti-PD-1, ADC, EGFR, neoadjuvant therapy, oral squamous cell carcinoma, OSCC, head and neck cancer","2026-08-11",{"date":72,"type":41},{"date":95,"type":22},{"date":251,"type":22},"2028-12-31",{"name":47,"class":48},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":278,"locationsCount":49},"100651004","radscopal-radiotherapy-plus-immunotherapy-for-chemotherapy-ineligible-patients-with-newly-diagnosed-metastatic-nasopharyngeal-cancer-a-single-center-open-label-phase-ii-study-100651004","NCT07756190","Radscopal Radiotherapy Plus Immunotherapy for Chemotherapy-Ineligible Patients With Newly Diagnosed Metastatic Nasopharyngeal Cancer: A Single-Center, Open-Label, Phase II Study","A Phase II Study of Radscopal Radiotherapy Combined With Immunotherapy as First-Line Treatment for Chemotherapy-Ineligible Patients With De Novo Metastatic Nasopharyngeal Carcinoma","RADIANCE","Inclusion Criteria:\n\n* 1\\. Age 18-80 years.\n* 2\\. Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma (TxNxM1 according to AJCC 9th edition), with ≤10 measurable metastatic lesions.\n* 3\\. At least one measurable nasopharyngeal lesion suitable for low-dose radiotherapy and at least one distant metastatic lesion suitable for stereotactic body radiotherapy.\n* 4\\. ECOG performance status 0-2.\n* 5\\. PD-L1 combined positive score (CPS) ≥1.\n* 6\\. Chemotherapy-ineligible, including patients medically unsuitable for platinum-based chemotherapy or patients who refuse standard platinum-based chemotherapy after being fully informed.\n* 7\\. Life expectancy ≥6 months.\n* 8\\. Adequate organ function, including ANC ≥1.0 × 10\\^9\u002FL, platelets ≥75 × 10\\^9\u002FL, hemoglobin ≥80 g\u002FL, ALT\u002FAST ≤3 × ULN, bilirubin ≤2 × ULN, creatinine clearance ≥30 mL\u002Fmin, and LVEF ≥45% or normal echocardiography.\n* 9\\. No major surgery within 1 month before enrollment.\n* 10\\. No immunosuppressive or immunomodulatory therapy within 1 month before immune checkpoint inhibitor treatment.\n* 11\\. Written informed consent and ability to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C18 years.\n* 2\\. \\>10 metastatic lesions, meningeal metastasis, spinal cord compression, or lesions unsuitable for safe stereotactic body radiotherapy.\n* 3\\. Other malignancy within 5 years, except cured basal cell carcinoma, squamous cell carcinoma of the skin, papillary thyroid carcinoma, or cervical carcinoma in situ.\n* 4\\. Prior systemic immune checkpoint inhibitor therapy or prior nasopharyngeal radiotherapy.\n* 5\\. Active hepatitis B infection, defined as HBsAg positivity with HBV DNA \\>200 IU\u002FmL or \\>1000 copies\u002FmL.\n* 6\\. Positive hepatitis C virus antibody.\n* 7\\. Active, known, or suspected autoimmune disease, except type 1 diabetes, hypothyroidism requiring only hormone replacement, or skin disorders not requiring systemic treatment.\n* 8\\. Systemic corticosteroids equivalent to \\>10 mg prednisone daily or other immunosuppressive therapy within 28 days before informed consent, except low-dose, inhaled, or topical corticosteroids.\n* 9\\. Active tuberculosis, active tuberculosis within the previous year, or prior active tuberculosis without documented adequate anti-tuberculosis treatment.\n* 10\\. History of interstitial lung disease.\n* 11\\. Uncontrolled diabetes mellitus (fasting blood glucose \\>13.9 mmol\u002FL).\n* 12\\. Live vaccine within 30 days before informed consent or planned live vaccination.\n* 13\\. Known allergy to macromolecular protein preparations or to any component of sintilimab or ipilimumab.\n* 14\\. HIV infection.\n* 15\\. Any condition that may affect participant safety or compliance, including uncontrolled cardiovascular disease, active infection requiring systemic treatment, psychiatric illness, severe cognitive impairment, suicidal tendency, or relevant psychological, family, or social factors.","80 Years",{"count":263,"type":22},28,[63],"The RADIANCE trial plans to enroll patients with chemotherapy-ineligible de novo metastatic nasopharyngeal carcinoma (AJCC 9th edition, TxNxM1). Participants will receive Radscopal radiotherapy, consisting of low-dose radiotherapy to the primary lesions and stereotactic body radiotherapy to distant metastatic lesions, in combination with sintilimab and ipilimumab. The study will evaluate the objective response rate of the primary lesions, systemic disease control as measured by progression-free survival and overall survival, and the safety and tolerability of this treatment regimen.\n\nThe main questions this study aims to answer are:\n\nDoes this treatment improve efficacy with acceptable safety in chemotherapy-ineligible patients? Does Radscopal radiotherapy enhance systemic antitumor immunity, and what is the Radscopal Response Rate? What clinical and immunological factors are associated with the Radscopal effect, and what mechanisms may underlie this effect?",[267,268],"Nasopharyngeal Carcinoma (NPC)","Metastatic Nasopharyngeal Carcinoma",[268,190,162,270,271],"Combined Modality Therapy","Tumor Immunity","2026-08-05",{"date":274,"type":41},"2026-08-10",{"date":95,"type":22},{"date":277,"type":22},"2030-06-30",{"name":47,"class":48},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":49},"100650657","tunlametinib-in-combination-with-pucotenlimab-and-hydroxychloroquine-in-nras-mutant-melanoma-100650657","NCT07750067","Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma","Enhancing Immunogenicity in NRAS-Mutant Melanoma Via Autophagy Modulation: A Clinical and Mechanistic Study.","Inclusion Criteria:\n\n* Age ≥ 18 years of age, both genders.\n* Subjects with unresectable or metastatic melanoma (Stage III\u002FIV) confirmed by histology or cytology\n* The mutated NRAS genes were confirmed by sequencing.\n* Prior systemic antineoplastic therapy is allowed. All acute toxic effects of prior antitumor therapy must have resolved to grade 1 or lower before the start of the study drug, with the exception of alopecia (grade 1 or 2 permitted), neurotoxicity (grade 1 or 2 permitted), or bone marrow parameters (grade 1, 2, or 3 permitted).\n* ECOG, 0-2.\n* The life expectance should be at least 12 months.\n* Eligible subjects had not received chemotherapy for locally advanced or metastatic disease and had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).\n* To ensure eligibility, the following criteria must be met regarding major organ and bone marrow functions: Adequate bone marrow function: absolute neutrophil count (ANC)≥ 1.5\\^109\u002FL, platelet count (PLT)≥ 100\\^109\u002FL, and hemoglobin level (HB)≥ 9 g\u002FdL (no transfusion received within 14 days). Serum total bilirubin (TBIL) must be ≤ 1.5 times the upper limit of normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limits of normal, serum creatinine ≤1.5, and Creatinine clearance had to be greater than 50 mL\u002Fmin. Creatinine clearance, as an estimate of glomerular filtration rate (eGFR), was calculated according to the Cockcroft and Gault (C\\&G) equation (26): (140 - age \\[years\\] × weight \\[kg\\] × 0.85 for male)\u002F 72\\*serum creatinine (μmol\u002FL). The International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) were a maximum of 1.5 fold the upper limit of normal (This provision applies only to Subjects not receiving anticoagulant therapy; for Subjects receiving anticoagulant therapy, anticoagulation should be within the therapeutic range.). Urine protein ≤ 1+; if urine protein \\> 1+, a 24-hour urine collection for protein quantification is required, and the total protein must be ≤ 1 g; FT3, FT4, and TSH levels should be normal, or any abnormalities should be clinically insignificant; lactate dehydrogenase (LDH) ≤ 2 × upper limit of normal (ULN).\n* A urine pregnancy test must be negative within 7 days before enrollment for women of childbearing potential.Male and female Subjects of reproductive\u002Fchildbearing potential must use highly effective contraception (e.g., oral contraceptives, IUDs, abstinence, or barrier plus spermicide) during the entire trial and for 12 months after treatment ends.\n* The subject voluntarily joins the study, has good compliance, and is cooperative with follow-up evaluations.\n\nExclusion Criteria:\n\n* Subjects who have previously received anti-PD-1 antibody, anti-PD-L1\u002FPD-L2 antibody therapy, and\u002For VEGFR TKI therapy.\n* Subjects currently receiving systemic anti-tumor therapy.\n* Subjects who have participated in or are currently participating in other drug\u002Ftherapy clinical trials within 4 weeks prior to enrollment (calculated from the date of the last dose of the previous trial).\n* Subjects who have undergone major surgery within 4 weeks prior to enrollment, or have not recovered from surgical side effects, or have received live vaccination within 4 weeks prior to enrollment.\n* Subjects with a history of other invasive malignancy within the previous 5 years other than nonmelanoma skin cancer were excluded, except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early-stage prostate cancer, and cervical carcinoma in situ.\n* Subjects who have received hematopoietic growth factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to enrollment.\n* Subjects with positive test results for HIV antibody or Treponema pallidum antibody (based on test results from a Grade A tertiary hospital, including the study center).\n* Subjects with active hepatitis B or hepatitis C who have not received antiviral therapy: if HBsAg or HBcAb is positive, HBVDNA should be tested (with results above the upper limit of normal range at the research center); if HCV antibody is positive, HCVRNA should be tested (with results above the upper limit of normal range at the research center).\n* Subjects with known allergy to humanized anti-PD-1 monoclonal antibody drugs and their components; known allergy to MEK inhibitors (e.g., Tunlametinib) and any of their excipients; known allergy to autophagy inhibitors (e.g., hydroxychloroquine) and any of their excipients.",{"count":287,"type":22},37,[63],"This study evaluates the combination of the autophagy inhibitor hydroxychloroquine (HCQ), the MEK inhibitor tunlametinib, and the anti-PD-1 antibody pucotenlimab in patients with locally advanced or metastatic melanoma. The primary objectives are to assess the objective response rate (ORR) and progression-free survival (PFS). Secondary objectives include evaluating adverse events (type, severity, and incidence), duration of response (DOR), disease control rate (DCR), and overall survival (OS), as well as exploring the molecular mechanisms by which autophagy modulation enhances immunogenicity in mutant melanoma. Further exploratory analyses will examine the mechanisms by which autophagy inhibition enhances tumor sensitivity to PD-1 blockade, thereby establishing experimental and theoretical grounds for refining future clinical approaches.",[291,292],"Melanoma Metastatic","NRAS Mutation",[294,192,295,296,297],"Tunlametinib","Hydroxychloroquine","NRAS mutation","melanoma",{"date":274,"type":41},{"date":300,"type":41},"2026-04-01",{"date":302,"type":22},"2030-07-28",{"name":47,"class":48},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":235,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":49},"100564561","reduction-of-postoperative-radiotherapy-in-head-and-neck-squamous-cell-carcinoma-100564561","NCT06630780","Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma","A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma","REPORT-HNSCC","Inclusion Criteria:\n\n* Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma\n* Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer\u002Foropharyngeal cancer had positive lymph nodes in the IV\u002FV region with imaging diagnosis or biopsy confirmation before surgery. HPV\u002F P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node \\> 3cm or multiple positive cervical lymph nodes before surgery\n* The pathology of at least one cervical lymph node was determined by pCR；\n* Karnofsky's physical status score ≥70 points；\n* Age: 18 \\~ 70 years old；\n* Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109\u002FL, platelets (PLT) ≥ 75×109\u002FL\n* Patients participate voluntarily and sign informed consent forms.\n\nExclusion Criteria:\n\n* Previous head and neck radiation treatment\n* Severe complications；\n* Pregnant or lactating women\n* Who were deemed unsuitable for inclusion by the researchers.",{"count":313,"type":22},50,[25],"To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.",[317],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[319,320,321,322,323],"HNSCC","Post-radical surgery","Adjuvant Radiotherapy","Radiation dose reduction","Quality of life",{"date":325,"type":41},"2026-08-07",{"date":327,"type":41},"2024-09-26",{"date":329,"type":22},"2029-12-31",{"name":47,"class":48},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":49},"100650857","phase-2-neoadjuvant-chemoradiotherapy-combined-with-ctla-4-monoclonal-antibody-plus-pd-1-monoclonal-antibody-for-locally-advanced-esophageal-cancer-100650857","NCT07751055","Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer","A Prospective, Single-Arm Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal Cancer","NEOCRTE2601","Inclusion Criteria:\n\n1. Histologically confirmed resectable thoracic esophageal squamous cell carcinoma (ESCC); pretreatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of UICC staging system.\n2. Treatment-naive patients without prior anti-tumor therapy.\n3. Expected survival duration \\> 6 months.\n4. Aged between 18 and 75 years, either male or female.\n5. Adequate function of major vital organs meeting the following laboratory criteria:\n\n   1. White blood cell (WBC) ≥4.0×10⁹\u002FL; absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n   2. Platelet count ≥100×10⁹\u002FL;\n   3. Hemoglobin ≥9 g\u002FdL;\n   4. Serum albumin ≥2.8 g\u002FdL;\n   5. Total bilirubin ≤1.5 × ULN; ALT, AST and\u002For ALP ≤2.5 × ULN;\n   6. Serum creatinine ≤1.5 × ULN, or creatinine clearance \\>60 mL\u002Fmin.\n6. Eastern Cooperative Oncology Group (ECOG) PS score: 0-1.\n7. Capable of understanding the study protocol and signing written informed consent.\n8. Absence of severe complications including active massive gastrointestinal hemorrhage, perforation, jaundice, bowel obstruction, or non-malignant fever \\>38℃.\n9. Female and male patients of childbearing potential must use effective contraception throughout relevant study period.\n10. Good treatment compliance and availability for scheduled follow-up of efficacy and adverse events per study protocol.\n\nExclusion Criteria:\n\n1. Patients who have received prior anti-tumor therapies including chemotherapy, radiotherapy, surgery, immunotherapy, etc.\n2. Patients with known or suspected hypersensitivity to any components of CTLA-4 inhibitors, sintilimab or other monoclonal antibodies, as well as chemotherapeutic agents (nab-paclitaxel and cisplatin).\n3. Patients with pre-existing hemorrhagic disorders.\n4. Patients with unresectable disease due to other uncontrollable conditions.\n5. Female patients who are pregnant or breastfeeding.\n6. Patients lacking capacity to provide informed consent due to psychological, familial or social reasons.\n7. Patients with peripheral neuropathy graded ≥ Grade 2 per CTCAE criteria.\n8. Patients with a prior history of other malignancies besides esophageal cancer, except for non-melanoma skin cancer, cervical carcinoma in situ, or previously cured early-stage prostate cancer.\n9. Patients with more than 10 years of diabetes mellitus and poorly controlled blood glucose.\n10. Patients with severe impairment of cardiac, pulmonary, hepatic or renal function, hematological diseases or cachexia that preclude tolerance to chemotherapy, radiotherapy or surgery.\n11. Patients with active or past history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism), or history of immunodeficiency diseases (HIV positive, other acquired or congenital immunodeficiency disorders), or previous history of solid organ or allogeneic hematopoietic stem cell transplantation.\n12. Patients with prior history of interstitial lung disease or non-infectious pneumonia.\n13. Subjects with active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10⁴ copies\u002FmL) or active hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of quantification of the assay).",{"count":340,"type":22},51,[63],"This is a prospective, single-arm phase II clinical trial intended to investigate the efficacy of neoadjuvant CTLA-4 monoclonal antibody combined with PD-1 monoclonal antibody plus preoperative chemoradiotherapy for locally advanced esophageal cancer. A total of 44 patients with resectable esophageal squamous cell carcinoma (ESCC) will be enrolled.All enrolled subjects will receive induction therapy with the combination of a CTLA-4 inhibitor and a PD-1 inhibitor. Three weeks afterwards, patients will transition to concurrent chemoradiotherapy combined with PD-1 inhibitor. Intensity-modulated radiotherapy (IMRT) will be delivered at a total dose of 40 Gy in 20 fractions. Radical esophagectomy with two-field thoracic and abdominal lymph node dissection will be performed 6-8 weeks after completion of chemoradiotherapy.The primary objective of this trial is to evaluate the efficacy and safety of the triplet regimen consisting of CTLA-4 inhibitor plus PD-1 inhibitor combined with preoperative chemoradiotherapy in locally advanced esophageal cancer, so as to further optimize the multimodal therapeutic strategy for esophageal cancer.",[344],"Esophageal Squamous Cell Carcinoma (ESCC)",[346,347,348,349,350],"chemotherapy","neoadjuvant","immune checkpoint inhibitor","locally advanced","CTLA-4 monoclonal antibody","2026-08-03",{"date":325,"type":41},{"date":354,"type":22},"2026-08-01",{"date":356,"type":22},"2030-12-31",{"name":47,"class":48},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":373,"leadSponsor":375,"locationsCount":49},"100650791","phase-2-golidocitinib-plus-anthracycline-based-therapy-for-untreated-nodal-t-follicular-helper-tfh-cell-lymphoma-100650791","NCT07753642","Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma","A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma","Key inclusion Criteria:\n\n1. Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma according to the 2022 WHO classification.\n2. Previously untreated with systemic anti-lymphoma therapy.\n3. Age ≥18 and \\\u003C75 years.\n4. At least one measurable or evaluable lesion according to the Lugano 2014 criteria.\n5. An expected survival time of more than 12 weeks.\n6. An ECOG performance status score of 0-1.\n7. Adequate organ and bone marrow function.\n8. Provision of written informed consent and willingness to comply with all study procedures.\n\nKey exclusion Criteria:\n\n1. Hemophagocytic syndrome.\n2. Central nervous system or meningeal involvement by lymphoma.\n3. Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.\n4. Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.\n5. Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.\n6. Patients with severe or uncontrolled cardiovascular disease.\n7. Patients with a history of interstitial lung disease, except for asymptomatic radiation-induced interstitial lung disease.\n8. Patients with gastrointestinal conditions that may interfere with oral administration or drug absorption.\n9. Patients with known hypersensitivity to golidocitinib or its excipients.\n10. Pregnant or breastfeeding women and participants of childbearing potential unwilling to use effective contraception.\n11. Patients who have received systemic corticosteroids or other immunosuppressive therapy within 14 days before the start of study treatment.\n12. Patients considered unsuitable for participation by the investigator.",{"count":366,"type":22},47,[63],"This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma.",[370],"Nodal T-follicular Helper Cell Lymphoma",{"date":325,"type":41},{"date":197,"type":22},{"date":374,"type":22},"2029-08-30",{"name":47,"class":48},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":57,"minAge":58,"maxAge":261,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"100650223","phase-2-culmerciclib-plus-anlotinib-and-endocrine-therapy-for-hr-positiveher2-negative-metastatic-breast-cancer-with-brain-metastases-100650223","NCT07745257","Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive\u002FHER2-Negative Metastatic Breast Cancer With Brain Metastases","Efficacy and Safety of Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive\u002FHER2-Negative Metastatic Breast Cancer With Brain Metastases：a Multicenter, Single-arm, Phase Ⅱ Trial","Inclusion Criteria:\n\n* Women aged ≥ 18 years\n* ECOG PS of 0-1\n* Life expectancy of at least 12 weeks\n* histologically or cytologically documented HR+\u002FHER2- breast cancer\n* radiologically confirmed brain parenchymal metastases without the need for immediate local therapy\n* measurable brain metastasis lesion according to RANO-BM criteria\n* Must have active brain metastases, defined as newly diagnosed brain metastases or progressive brain metastases following prior local therapy\n* Prior systemic therapy must meet all the following criteria：\n\n  1. No more than 3 lines of prior systemic therapy for advanced disease\n  2. No more than 1 line of chemotherapy or antibody-drug conjugate (ADC) administered in the advanced setting\n  3. No prior CDK4\u002F6 inhibitor therapy for advanced disease, or only 1 line of CDK4\u002F6 inhibitor therapy with treatment duration \\> 6 months\n* Adequate hematological, hepatic and renal function\n* Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 180 days after the last dose of experiment treatment\n* Patients must be able to participate and comply with treatment and follow-up\n\nExclusion Criteria:\n\n* Patients with leptomeningeal metastases, brainstem metastases or skull metastases\n* Prior receipt of anti-angiogenic agents or Culmerciclib\n* Unresolved Grade ≥2 toxicities (per CTCAE Version 6.0) attributable to any prior therapy, except alopecia\n* Patients with visceral crisis,defined as severe organ dysfunction assessed by symptoms, signs, laboratory examinations and rapid disease progression\n* Inability to swallow capsules or tablets\n* Any severe and\u002For uncontrolled medical disease\n* Other malignancies diagnosed within 5 years, excluding cured non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma\n* Radiographic evidence of tumor invasion of major vessels, or high risk of tumor invasion into major vessels resulting in life-threatening hemorrhage as assessed by the investigator\n* Patients with arterial or venous thromboembolic events within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism\n* Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment\n* Any other condition that the investigator considers inappropriate to participate in this trial",{"count":384,"type":22},40,[63],"This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2\u002F4\u002F6 inhibitor Culmerciclib and endocrine therapy in patients with HR+\u002FHER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.",[388],"HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases","2026-07-30",{"date":391,"type":41},"2026-08-04",{"date":393,"type":22},"2026-08-28",{"date":395,"type":22},"2028-07-28",{"name":47,"class":48},9,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":417,"leadSponsor":419,"locationsCount":49},"100649414","phase-2-culmerciclib-in-hrher2-advanced-breast-cancer-100649414","NCT07732491","Culmerciclib in HR+\u002FHER2+ Advanced Breast Cancer","A Phase II, Multicenter, Open-Label, Single-Arm Study of Culmerciclib Combined With Anti-HER2 Targeted Therapy and Endocrine Therapy as Maintenance Treatment in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged 18 years and older with pathologically confirmed metastatic or locally advanced unresectable breast cancer.\n2. Hormone receptor-positive and HER2-positive disease. HER2 positivity is defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by fluorescence in situ hybridization (FISH). If multiple tumor specimens have been tested, the most recent test result shall be used. Hormone receptor positivity is defined as estrogen receptor (ER) expression of at least 10%.\n3. Patients must have available tumor tissue specimens for biomarker analyses including whole-exome sequencing.\n4. Patients with brain metastases are eligible if they have asymptomatic central nervous system (CNS) metastases, defined as no CNS symptoms or symptoms are controlled and do not require urgent radiotherapy.\n5. Prior radiotherapy, chemotherapy, or anti-HER2 targeted therapy received in the neoadjuvant or adjuvant setting is permitted.\n\n5、Patients must have achieved a response to first-line systemic anti-tumor therapy for locally recurrent or metastatic disease, with at least 4 cycles of chemotherapy completed and no evidence of radiographic progression.\n\n6、Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. 7、Life expectancy of at least 12 weeks. 8、Adequate major organ function as defined by the following criteria: Hematologic function: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count ≥75×10⁹\u002FL, hemoglobin ≥85 g\u002FL (without transfusion or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening).\n\nBiochemical function: total bilirubin (TBIL) \\\u003C1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5×ULN (or \\\u003C5×ULN in patients with liver metastases); blood urea nitrogen (BUN) and creatinine ≤1×ULN or calculated creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n\n9、Women of childbearing potential must have practiced reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must be willing to use appropriate contraception during the study and for 8 weeks after the last dose of study drug.\n\n10、Patients must voluntarily sign informed consent, be willing and able to comply with the study protocol and follow-up visits.\n\nExclusion Criteria:\n\n1. Patients with extensive leptomeningeal metastases that are poorly controlled with corticosteroids or other dehydrating agents, or requiring urgent radiotherapy.\n2. Symptomatic active brain metastases requiring urgent cranial radiotherapy. Patients with asymptomatic CNS metastases are allowed.\n3. Disease progression after whole-brain radiotherapy or stereotactic radiosurgery to all intracranial lesions.\n4. Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, unless the condition has been stable for at least 1 month and corticosteroids have been discontinued for \\>2 weeks.\n5. History of grade 3 or 4 allergic reactions related to study drugs.\n6. History of clinically significant cardiovascular, hepatic, respiratory, renal, hematologic, endocrine, or neuropsychiatric disorders.\n7. Acute or chronic active hepatitis B (defined as hepatitis B surface antigen and\u002For hepatitis B core antibody positive with HBV DNA ≥1×10³ copies\u002FmL or ≥200 IU\u002FmL) or acute or chronic active hepatitis C antibody positive; patients with positive hepatitis C antibody but negative RNA test are eligible.\n8. Prior anti-tumor therapy with unresolved adverse events\u002Freactions before study initiation.\n9. History or evidence of any condition, therapy, or laboratory abnormality that might interfere with the study results or preclude the patient's full participation, or other conditions deemed unsuitable for enrollment by the investigator.\n10. Any severe underlying disease, comorbidity, or active infection.\n11. Concurrent receipt of other anti-tumor therapy.\n12. History of epilepsy or seizure predisposition.\n13. Pregnant or breastfeeding women.\n14. Poor compliance or inability to attend scheduled follow-up visits.\n15. Known hypersensitivity to the study drugs.\n16. Diagnosis of another malignancy within 3 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated with curative surgery, or malignancy diagnosed \\>2 years prior with no evidence of disease and not treated within ≤2 years before randomization.\n17. Other conditions judged by the investigator that may interfere with the conduct or outcome of the study.",{"count":406,"type":22},35,[63],"This is a phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as maintenance treatment in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer.\n\nCulmerciclib is a novel oral cyclin-dependent kinase 2\u002F4\u002F6 (CDK2\u002F4\u002F6) inhibitor. It has been approved in China for use in combination with fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who have progressed on prior endocrine therapy.\n\nPatients enrolled in this study will receive culmerciclib at a stepwise escalating dose of 120 mg, 150 mg, and 180 mg once daily, in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy. Treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up.\n\nThe primary endpoint is progression-free survival. Secondary endpoints include objective response rate, disease control rate, clinical benefit rate, overall survival, and safety.",[410,411,412],"Breast Cancer","Metastastic Breast Cancer","HER2+ Advanced Breast Cancer","2026-07-23",{"date":415,"type":41},"2026-07-29",{"date":354,"type":22},{"date":418,"type":22},"2035-12-31",{"name":47,"class":48},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":435,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":445,"leadSponsor":447,"locationsCount":49},"100648959","phase-3-folfiri-plus-bevacizuamb-and-ql1706-in-second-line-treatment-for-mcrc-100648959","NCT07729605","FOLFIRI Plus Bevacizuamb and QL1706 in Second-Line Treatment for mCRC","FOLFIRI Plus Bevacizuamb With or Without Iparomlimab and Tuvonralimab as Second-Line Treatment for Metastatic Colorectal Cancer: A Randomized Controlled Trial","FIRBIT","Inclusion Criteria:\n\n* 1\\. Willing and able to provide written informed consent. 2. Age ≥ 18 years old. 3.Histologically confirmed metastatic colorectal adenocarcinoma with pMMR\u002FMSS status. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5.Discontinued first-line oxaliplatin-based doublet chemotherapy for metastatic colorectal cancer due to intolerable toxicities or disease progression; OR developed recurrent metastatic disease within 6 months after the last dose of adjuvant chemotherapy. 6.Presence of evaluable lesions on imaging examinations. 7. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment. 8.Willing and able to comply with study procedures and scheduled visit schedules\n\nExclusion Criteria:\n\n* 1.Patients complicated with digestive tract diseases including duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions judged by the investigator to potentially cause gastrointestinal hemorrhage or perforation; or massive pleural effusion or ascites requiring intervention. 2.Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. 3. Radiological evidence of brain metastases. 4. Prior treatment with irinotecan hydrochloride, or prior receipt of PD-1 and\u002For CTLA-4 immunotherapy in the first-line setting. 5. Autoimmune diseases requiring continuous systemic steroid therapy. 6. History of laparotomy, thoracotomy or intestinal resection within 28 days prior to enrollment; or unhealed wounds (excluding suture wounds from central venous catheter implantation), gastrointestinal ulcers or traumatic fractures. 7. Any of the following events occurring within 12 months before study enrollment: myocardial infarction, severe\u002Funstable angina pectoris, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure. 8.Confirmed human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases. 9. Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea; interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, acute pneumonia, etc.). 10. Breastfeeding or pregnant women; lack of effective contraceptive. 11. Other severe physical or psychiatric illnesses, or laboratory abnormalities that may increase the risks of study participation or interfere with study outcomes; or patients deemed unsuitable for this study by the investigator.",{"count":429,"type":22},270,[157],"Thsi study is a randomised, parallel-controlled phase II\u002FIII trial evaluating FOLFIRI plus bevacizumab with or without QL1706 as second-line therapy for metastatic colorectal cancer. The primary endpoint is PFS. Secondary endpoint includes overall survival, objective response rate, safety profiles, immune-related adverse events, and patient quality of life. Exploratory analyses focus on dynamic shifts in tumour immune microenvironment and biomarkers, aiming to identify predictive signatures for therapeutic efficacy and immune toxicities.",[433,434],"Colorectal Cancer Metastatic","Microsatellite Stable (MSS) Colorectal Cancer (CRC)",[436,437,438,439,440],"PD-1\u002FCTLA-4","QL1706","Bevacizumab","FOLFIRI","Second-line","2026-07-22",{"date":443,"type":41},"2026-07-27",{"date":389,"type":22},{"date":446,"type":22},"2029-07-30",{"name":47,"class":48},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":4},"100648886","phase-2-dapagliflozin-add-on-in-unresectable-hcc-with-metabolic-syndrome-100648886","NCT07729592","Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome","A Single-Center, Phase II, Randomized Controlled Clinical Study to Evaluate Dapagliflozin as an Addition to First-Line Treatment for Unresectable Hepatocellular Carcinoma With Metabolic Syndrome","Inclusion Criteria:\n\n1. Patients diagnosed with hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) stage B (with large tumor burden exceeding the up-to-seven criteria) or stage C, as determined by consensus of a multidisciplinary hepatobiliary surgical team, corresponding to TNM stages II-IV with preserved liver function (intermediate to advanced HCC), who are deemed unresectable.\n2. No prior systemic therapy for HCC.\n3. First-line treatment regimen must include an immune checkpoint inhibitor with\u002Fwithout interventional therapy .\n4. Diagnosis of metabolic syndrome according to the National Cholesterol Education Programme-Adult Treatment Panel III (NCEP-ATP III) criteria, requiring at least 3 of the following 5 criteria:\n\n(1) Central obesity (waist circumference): ≥ 90 cm in males, ≥ 80 cm in females; (2) Elevated triglycerides: ≥ 150 mg\u002FdL (1.7 mmol\u002FL), or receiving specific treatment for this lipid abnormality; (3) Reduced high-density lipoprotein cholesterol (HDL-C): \\\u003C 40 mg\u002FdL (1.0 mmol\u002FL) in males, \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in females, or receiving specific treatment for this lipid abnormality; (4) Elevated blood pressure: systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or previously diagnosed hypertension and receiving antihypertensive treatment; (5) Elevated fasting glucose: ≥ 100 mg\u002FdL (5.6 mmol\u002FL), or previously diagnosed type 2 diabetes mellitus.\n\n5\\. Age between 18 and 75 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy \\> 3 months. 8. At least one measurable lesion according to RECIST version 1.1 (i.e., longest diameter ≥ 10 mm on contrast-enhanced spiral CT or contrast-enhanced MRI, or short-axis diameter ≥ 15 mm for enlarged lymph nodes; lesions previously treated with local therapy may be considered target lesions only if disease progression has been clearly documented per RECIST v1.1).\n\n9\\. Adequate organ function, meeting the following laboratory criteria:\n\n* White blood cell count ≥ 4.0 × 10⁹\u002FL\n* Neutrophil count ≥ 1.5 × 10⁹\u002FL\n* Platelet count ≥ 80.0 × 10⁹\u002FL\n* Hemoglobin ≥ 90 g\u002FL\n* Serum albumin ≥ 2.8 g\u002FdL\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n* ALT\u002FAST\u002FALKP ≤ 2.5 × ULN\n* Serum creatinine ≤ 1.5 × ULN or creatinine clearance \\> 60 mL\u002Fmin\n* No concomitant severe organic disease. 10. Ability to understand and willingness to provide written informed consent prior to any study-specific procedures, and agreement to comply with the study medication administration and post-treatment follow-up schedule as per protocol.\n\nExclusion Criteria:\n\n1. Concomitant severe impairment of vital organ function (including cardiac, pulmonary, renal, or other major organ systems), active infections other than viral hepatitis, or other severe comorbid conditions that would render the patient unable to tolerate treatment.\n2. Prior treatment with any sodium-glucose cotransporter 2 (SGLT2) inhibitor, including but not limited to canagliflozin, ertugliflozin, dapagliflozin, empagliflozin, luseogliflozin, and tofogliflozin.\n3. Presence of contraindications to any component of the combination therapy, including immune checkpoint inhibitors, targeted therapy, or interventional therapy.\n4. History of other active malignancies.\n5. Concurrent autoimmune diseases, or other conditions requiring long-term systemic corticosteroid therapy.\n6. Known or suspected hypersensitivity to the study drug or to any agent administered in association with this trial.\n7. History of organ transplantation.\n8. Pregnant or breastfeeding women.\n9. Any other condition that, in the investigator's judgment, may interfere with patient enrollment or evaluation of study outcomes.\n10. Refusal to comply with the follow-up requirements as specified in the protocol, or refusal to provide written informed consent.",{"count":456,"type":22},44,[63],"The goal of this interventional study (clinical trial) is to evaluate the efficacy and safety of adding dapagliflozin to first-line standard therapy in patients with unresectable hepatocellular carcinoma (HCC) and comorbid metabolic syndrome.\n\nThe main questions it aims to answer are:\n\nDoes the addition of dapagliflozin to first-line therapy improve the objective response rate (ORR) compared with first-line therapy alone in this patient population?\n\nWhat are the differences between the two treatment groups in terms of overall survival (OS), progression-free survival (PFS), and safety\u002Ftolerability profiles?\n\nResearchers will compare the combination group (dapagliflozin plus first-line standard therapy) with the control group (first-line standard therapy alone) to determine whether the addition of dapagliflozin provides superior clinical benefit.\n\nParticipants in the combination group will receive dapagliflozin in addition to their prescribed first-line standard therapy, while participants in the control group will receive first-line standard therapy alone. All participants will be regularly monitored for tumor response, survival outcomes, and adverse events throughout the study period.\n\nThe findings of this trial are expected to provide clinical evidence supporting the use of dapagliflozin as an adjunctive therapy in patients with advanced unresectable HCC and metabolic syndrome, potentially enhancing the tumor response rate to existing standard-of-care treatments.",[460],"Hepatocellular Carcinoma (HCC)",[462,463],"HCC","dapagliflozin",{"date":443,"type":41},{"date":466,"type":22},"2026-07",{"date":468,"type":22},"2029-07",{"name":47,"class":48},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":235,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100633553","phase-2-maintenance-immunotherapy-with-deferred-salvage-radiotherapy-after-response-to-chemoimmunotherapy-in-recurrent-nasopharyngeal-carcinoma-100633553","NCT07528183","Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma","Maintenance Immunotherapy With Deferred Salvage Radiotherapy in Patients With an Objective Response to Chemoimmunotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma: A Multicenter Phase 2 Single-Arm Trial","Inclusion Criteria:\n\n1. Age 18-70 years, any gender.\n2. primary tumour recurrent T classificationT2-T4, regional lymph nodes recurrent N classificationN0-N2, no distant metastasis (recurrent M0); overall recurrent stage II-III according to the American Joint Committee on Cancer Union for International Cancer Control 9th edition stage-classification system.\n3. Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery.\n4. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).\n5. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.\n6. ECOG performance status 0-1.\n7. Expected survival ≥ 3 months.\n8. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma\n9. No contraindications to immunotherapy, chemotherapy, or re-irradiation.\n10. Adequate organ function within 14 days before first dose, defined as:\n\n    Hematology：Hemoglobin ≥ 90 g\u002FL，ANC ≥ 1.5 × 10⁹\u002FL，Platelet count ≥ 100 × 10⁹\u002FL Renal Function：Creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) \u002F eGFR ≥ 50 mL\u002Fmin Liver Function：Total bilirubin ≤ 1.5 × ULN，AST and ALT ≤ 2.5 × ULN.\n11. INR or PT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range，APTT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range.\n\nExclusion Criteria:\n\n1. known pre-existing radiation-induced complications, including soft tissue necrosis, brain injury, neck fibrosis, or other radiation-induced complications of grade 3 or above\n2. Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.\n3. Prior treatment with PD-1\u002FPD-L1 or CTLA-4 inhibitors.\n4. History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.\n5. Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma\u002Fatopy.\n6. Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms.\n7. Hepatitis B: HBsAg positive with peripheral blood HBV DNA more than 1000 copies\u002FmL or 200 IU\u002FmL\n8. Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative\n9. HIV infection\n10. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia).\n11. Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis.\n12. Major surgery within 4 weeks before enrollment, or unhealed surgical wound.\n13. Pregnant or breastfeeding women, or those planning pregnancy during the study period.\n14. Known allergy or hypersensitivity to study drugs or their excipients.\n15. Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.",{"count":478,"type":22},62,[63],"Re-irradiation is the most common clinical treatment for recurrent nasopharyngeal carcinoma; however, it is associated with severe complications which seriously affect patients' quality of life.\n\nExploring deferred salvage radiotherapy until nasopharyngeal or cervical progression after PD 1 plus GP chemotherapy and immunotherapy maintenance is of great significance for improving the long-term survival and quality of life of patients with unresectable locally recurrent NPC.\n\nThus, the investigators plan to conduct a multicenter, prospective, single-arm phase II clinical trial to evaluate the efficacy and safety of maintenance Immunotherapy with deferred salvage radiotherapy with an objective response to chemoimmunotherapy in patients with unresectable locally recurrent NPC .",[482],"Nasopharyngeal Cancinoma (NPC)","2026-07-21",{"date":413,"type":41},{"date":441,"type":22},{"date":487,"type":22},"2034-07-22",{"name":47,"class":48},4,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":261,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":504,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":49},"100630968","phase-2-celecoxib-plus-r-chop-vs-r-chop-in-newly-diagnosed-advanced-cd5-dlbcl-100630968","NCT07494565","Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL","A Multicenter, Prospective, Randomized, Open-Label, Phase II Study of Celecoxib Combined With R-CHOP Versus R-CHOP in Patients With Newly Diagnosed Advanced CD5-Positive Diffuse Large B-Cell Lymphoma (CD5+ DLBCL)","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 80 years, either gender, life expectancy \\> 6 months.\n2. Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL), CD20-positive, and immunohistochemically CD5-positive .\n\n   Note: Patients must provide a local pathological report before screening or sufficient fresh or paraffin-embedded tissue to confirm the CD5+ IHC result.\n3. No prior therapy for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except palliative local radiotherapy for tumor-related symptoms), or surgical treatment (except tumor\u002Fpathologic biopsy and non-lymphoma-directed surgical resection).\n4. At least one assessable or measurable lesion according to the Lugano 2014 criteria:\n\n   * Lymph node lesion: longest diameter \\> 1.5 cm;\n   * Extranodal lesion: longest diameter \\> 1.0 cm.\n5. International Prognostic Index (IPI) score 0-5, stage III-IV disease.\n6. ECOG performance status 0-2.\n7. Laboratory results must meet the following criteria prior to the first dose:\n\n   \\- Bone marrow function: WBC ≥ 3×10⁹\u002FL, HGB ≥ 90 g\u002FL, ANC ≥ 1.5×10⁹\u002FL, PLT ≥ 80×10⁹\u002FL;\n   * Liver function: TBIL ≤ 1.5×ULN; ALT or AST ≤ 2.5×ULN (≤ 5×ULN if liver involvement); ALP ≤ 3×ULN in patients without bone involvement;\n   * Renal function: serum creatinine ≤ 1.5×ULN, or estimated glomerular filtration rate ≥ 50 mL\u002Fmin by the Cockcroft-Gault equation;\n   * PT, APTT, INR ≤ 1.5×ULN unless receiving anticoagulation.\n8. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography at screening.\n9. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, agree to use effective contraception during study participation and for ≥ 12 months after the last dose.\n\nMale patients must agree to use effective contraception during study participation and for ≥ 3 months after the last dose.\n\n10\\. Understand and voluntarily provide written informed consent.\n\n\\---\n\nExclusion Criteria:\n\n1. History of primary or secondary central nervous system (CNS) lymphoma or CNS lymphoma involvement.\n2. Current or previous diagnosis of the following lymphoma subtypes: primary CNS DLBCL, primary mediastinal (thymic) large B-cell lymphoma, primary effusion DLBCL, double-hit DLBCL with BCL2 and MYC rearrangements, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classic Hodgkin lymphoma\u002FBurkitt lymphoma (gray-zone lymphoma), primary cutaneous DLBCL, indolent lymphoma, Burkitt lymphoma, EBV-positive mucocutaneous ulcer, DLBCL associated with chronic inflammation, lymphomatoid granulomatosis, intravascular large B-cell lymphoma, ALK-positive large B-cell lymphoma, plasmablastic lymphoma, HHV8-positive DLBCL NOS, primary testicular lymphoma.\n3. Transformed lymphoma derived from other lymphoma types, including follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma.\n4. Previous organ transplantation or hematopoietic stem cell transplantation.\n5. Other malignancy diagnosed within 5 years prior to the first dose or concurrent malignancy, \\*\\*except\\*\\*:\n\n   other malignancy treated with surgery alone and achieving disease-free survival (DFS) for 5 consecutive years; cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder cancer \\[Ta (non-invasive tumor), Tis (carcinoma in situ), T1 (tumor invades lamina propria)\\].\n6. Previous treatment with cytotoxic agents for other diseases (e.g., rheumatoid arthritis) within 5 years prior to the first dose, or previous use of any anti-CD20 antibody.\n7. Previous use of any monoclonal antibody within 3 months prior to the first dose.\n8. Participation in another interventional clinical trial within 3 months prior to the first dose.\n9. Known hypersensitivity or contraindication to any study intervention, including:\n\n   * Contraindications to celecoxib, including hypersensitivity to celecoxib (e.g., known sulfonamide allergy, history of asthma, urticaria, or other allergic reactions induced by NSAIDs);\n   * Active peptic ulcer or gastrointestinal bleeding;\n   * Known hypersensitivity to rituximab or murine monoclonal antibody products;\n   * Contraindication to any component of the CHOP regimen, including previous anthracycline therapy;\n   * Diabetic patients unable to tolerate prednisone in the regimen.\n10. Use of glucocorticoids \\> 30 mg\u002Fday prednisone or equivalent for indications other than lymphoma symptom control:\n\n    \\- If receiving corticosteroid therapy ≤ 30 mg\u002Fday prednisone or equivalent, a stable dose must be documented for at least 4 weeks before Cycle 1 Day 1;\n\n    \\- If urgent glucocorticoid therapy (up to 100 mg prednisone or equivalent for a maximum of 7 days, Days -7 to -1) is required for lymphoma symptom control before the first dose, all tumor assessments must be completed before glucocorticoid initiation.\n\n    Major surgery (excluding diagnostic procedures) within 1 month prior to randomization.\n11. Severe peripheral or central nervous system disease, e.g., history of progressive multifocal leukoencephalopathy.\n12. Previous anti-DLBCL therapy, including chemotherapy, targeted therapy, immunotherapy, definitive radiotherapy with curative intent (except palliative non-curative radiotherapy), or surgical treatment (except biopsy).\n13. Adverse events from prior therapy not resolved to ≤ CTCAE Grade 1 (except Grade 2 peripheral neuropathy, alopecia, hypothyroidism controlled by hormone replacement, or type 1 diabetes mellitus well controlled with insulin).\n14. Administration of live attenuated viral vaccine within 1 month prior to enrollment.\n15. Uncontrolled infection (i.e., clinically unstable) requiring parenteral antibiotics, antivirals, or antifungals within 7 days before the first dose; prophylactic use is permitted.\n16. Active HBV infection or active HCV infection. Patients with controlled HBV\u002FHCV may be included cautiously at the investigator's discretion after effective antiviral intervention.\n17. HIV infection and\u002For acquired immunodeficiency syndrome.\n18. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with study drug absorption.\n19. Significant cardiovascular disease, including any of the following:\n\n    \\- Cardiac insufficiency ≥ NYHA Class II, or LVEF \\\u003C 50% by echocardiography;\n\n    \\- History of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmia requiring continuous antiarrhythmic therapy;\n\n    \\- Myocardial infarction, serious arrhythmia, or unstable angina within 6 months before the first dose;\n\n    \\- History of clinically significant QTc prolongation, or QTc interval \\> 470 ms (females) \u002F \\> 450 ms (males) at screening;\n\n    \\- Other cardiovascular disease deemed inappropriate by the investigator;\n    * Uncontrolled hypertension despite combination therapy with 2 antihypertensive agents (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on at least 2 measurements).\n20. Pulmonary fibrosis or interstitial pneumonia (except radiologic interstitial changes without symptoms or functional impairment), or history of pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction.\n21. Arterial or venous thrombotic event within 6 months before the first dose, including cerebrovascular accident (cerebral hemorrhage, cerebral infarction, transient ischemic attack), deep vein thrombosis, pulmonary embolism.\n\nPatients with intermuscular vein thrombosis or infusion port-related thrombosis may be included if deemed low risk by the investigator.\n\n22\\. Renal failure requiring hemodialysis or peritoneal dialysis, or history of nephrotic syndrome.\n\n23\\. Current or previous autoimmune disease requiring treatment, except hypothyroidism on stable replacement therapy and type 1 diabetes mellitus.\n\n24\\. History of alcoholism or drug abuse. 25. Any other serious or unstable medical condition (other than excluded malignancies), psychiatric disorder, or condition that may compromise patient safety, informed consent, or compliance with study procedures, in the investigator's judgment.\n\n26\\. Pregnant or breastfeeding female patients, or fertile patients unwilling to use effective contraception.\n\n27\\. Patients deemed ineligible for the study by the investigator.\n\n\\---",{"count":498,"type":22},60,[63],"To evaluate the efficacy of celecoxib combined with R-CHOP versus R-CHOP in the treatment of newly diagnosed advanced CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL).The primary endpoint is Complete Response Rate (CRR)",[502,503],"Diffuse Large B-Cell Lymphoma (DLBCL)","CD5 Positive",[505,506,507],"CD5+ DLBCL","Celecoxib","R-CHOP",{"date":441,"type":41},{"date":510,"type":41},"2026-03-06",{"date":512,"type":22},"2029-05-05",{"name":47,"class":48},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":49},"100647778","phase-2-efficacy-and-safety-of-tunlametinib-combination-therapy-in-the-treatment-of-second-line-and-above-metastatic-colorectal-cancer-100647778","NCT07714447","Efficacy and Safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer","Efficacy and Safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer: a Multicentre, Multicohort, Phase 2 Trial.","Inclusion Criteria:\n\n* Age ≥ 18 years of age, both genders.\n* ECOG, 0-1.\n* Patients with metastatic colorectal cancer confirmed by histology or cytology\n* Previous genetic test results can determine the gene status (mutation or wild type) of the RAS\u002FRAF\u002FMEK\u002FERK pathway (MAPK pathway), and the results of genetic testing or immunohistochemical testing can confirm whether it is MSS\u002FpMMR or MSI-H\u002FdMMR (if MSI-H\u002FdMMR has been treated with PD-1 antibody, only the A cohort (MEK inhibitor + EGFR monoclonal antibody cohort) can be screened; if MSI-H\u002FdMMR has not been treated with PD-1 antibody, the B cohort (MEK inhibitor + EGFR monoclonal antibody + PD-1 monoclonal antibody cohort) can be screened; if BRAF V600E mutation is present, the B cohort or C cohort (MEK inhibitor + EGFR monoclonal antibody \u002F BRAF inhibitor + PD-1 monoclonal antibody cohort) can be screened).\n* Patients were required to have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Previous treatment with at least one line of standard therapy failed (disease progression or intolerable side effects), and the patient is scheduled to receive ≥ 2 lines of treatment; for neoadjuvant or adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after discontinuation of treatment, it should be counted as the first line of treatment (assessed by the investigator according to RECIST 1.1);\n* The life expectance should be at least 3 months.\n* To ensure eligibility, the following criteria must be met regarding major organ and bone marrow functions:\n\n  1. . Hematological Parameters: A complete blood count must indicate hemoglobin levels of ≥90 g\u002FL (with no blood transfusions administered within the preceding 14 days), an absolute neutrophil count of ≥1.5 × 10⁹\u002FL, and a platelet count of ≥100 × 10⁹\u002FL.\n  2. . Liver Function: Liver function tests should reveal alanine aminotransferase (ALT) levels ≤2.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) levels ≤2.5 × ULN, total bilirubin levels ≤1.5 × ULN, and albumin levels ≥30 g\u002FL. In cases where liver metastases are present, ALT and AST levels may be elevated to ≤5 × ULN, while total bilirubin must remain ≤1.5 × ULN.\n  3. . Renal Function: Renal function should be assessed with serum creatinine levels ≤1.5 × ULN or a creatinine clearance, calculated using the Cockcroft-Gault formula, of \\>60 mL\u002Fmin.\n  4. . Cardiac Function: Cardiac assessment via echocardiography should indicate a left ventricular ejection fraction (LVEF) of ≥55%. Additionally, the corrected QT interval (QTcF) on electrocardiogram should be ≤480 ms, with creatine kinase (CK) levels ≤1 × ULN and troponin or high-sensitivity troponin levels ≤1 × ULN.\n  5. . Coagulation Function: Coagulation parameters must include an international normalized ratio (INR) of ≤1.5 × ULN and activated partial thromboplastin time (APTT) of ≤1.5 × ULN.\n  6. . Urinalysis: Urinalysis should demonstrate urine protein levels of \\\u003C2+. If urine protein levels are ≥2+, a 24-hour urine protein quantification test is required. Patients with quantitative urine protein levels \\\u003C1 g\u002F24 h are considered eligible, while those with levels ≥1 g\u002F24 h are ineligible. Furthermore, patients exhibiting urine protein levels ≥2+ who have not undergone quantitative testing are also excluded.\n* Participants may administer it orally.\n* Females of childbearing potential had to have a negative pregnancy test at enrolment and agree to use an approved contraceptive method during and for 3 months after the study. Males of childbearing potential agreed to use effective birth control or abstinence during the study and for 3 months after the last treatment.\n* All the subjects read and signed the informed consent.\n* Paraffin-embedded tissue blocks or ≥10 slides.\n\nExclusion Criteria:\n\n* Researchers must consider contraindications when selecting treatment drugs, such as allergies to any drug component.\n* subjects who have previously used the cohort's treatment drugs (EGFRi, MEKi, BRAFi, immunotherapy) are excluded from screening.\n* Within 4 weeks before the first use of the drug, underwent major surgery (excluding biopsies and minor outpatient surgeries, such as the placement of vascular access) or experienced serious trauma;\n* There is the presence of clinically symptomatic third space effusion (such as large pleural effusion or ascites) that cannot be controlled through drainage or other methods;\n* Subjects with symptomatic or untreated brain metastases, leptomeningeal metastases, or spinal cord compression, except for the following conditions: asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain lesions, no need for corticosteroids or antiepileptic drug treatment, and imaging confirms stability of lesions for ≥4 weeks; for patients who have undergone stereotactic brain radiotherapy or surgical treatment, if there has been no disease progression in the brain for 3 months or more, they can be included;\n* Impaired cardiac function or clinically significant cardiovascular diseases, including any of the following:\n\n  1. Acute coronary syndrome occurring within 6 months prior to treatment initiation, including acute myocardial infarction, unstable angina, coronary artery bypass graft surgery, coronary angioplasty, and stent implantation;\n  2. Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ II); evidence of clinically significant arrhythmias and\u002For conduction abnormalities within 6 months prior to treatment initiation or currently;\n  3. Poorly controlled hypertension (systolic blood pressure ≥ 150 and\u002For diastolic blood pressure ≥ 100 mmHg under medication control);\n  4. Abnormalities in heart valve morphology recorded by echocardiography (≥ grade 2), Note: Patients with grade 1 heart valve morphology abnormalities (such as mild regurgitation\u002Fstenosis) are allowed to enroll, but patients with moderate valve thickening are prohibited from enrolling;\n  5. History of congenital long QT syndrome; or taking medications known to prolong the QT interval and unable to ensure discontinuation during the study.\n* A history of retinal diseases during the past or screening, such as: retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetic retinopathy, hypertensive retinopathy, retinal capillary dilatation (Costs disease), retinal pigment epithelial detachment (RPED), etc.; presence of risk factors for RVO during screening (for example, uncontrolled glaucoma or high intraocular pressure, history of hyperviscosity or hypercoagulable syndromes); retinal diseases such as RPED.\n* Interstitial lung disease or interstitial pneumonia, including patients with clinically significant radiation pneumonia (i.e., those affecting daily activities or requiring intervention treatment);\n* Positive for human immunodeficiency virus (HIV) antibodies, positive for syphilis antibodies (Anti TP), positive for hepatitis C virus (HCV) antibodies and HCV RNA, positive for hepatitis B virus surface antigen (HBsAg) and HBV DNA (positive HBsAg requires further testing for HBV DNA, with HBV DNA ≥ 200 IU\u002Fml or ≥ 10\\^3 copies\u002Fml).\n* There is an active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[patients who can be controlled by thyroid hormone replacement therapy can be included\\]), the subject has a skin disease that does not require systemic treatment (such as vitiligo, psoriasis, alopecia), is on insulin treatment and has controlled type 1 diabetes, or had a complete remission in childhood and no further intervention is needed in adulthood can be included (patients with asthma requiring medical intervention with bronchodilators cannot be included).\n* It is known that there is a history of acute or chronic pancreatitis within 6 months before the start of treatment.\n* History of allogeneic bone marrow transplantation or organ transplantation.\n* Within 2 weeks prior to the initial administration of the drug, there are uncontrolled active infectious diseases (e.g., requiring intravenous administration of antibiotics, antifungals, or antiviral medications), or unexplained fever \\>38.5°C occurs during the screening period \u002F before the first dose of the drug.\n* Incurable electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia detected through blood biochemical tests).\n* Past or currently existing neuromuscular diseases related to elevated CK (such as inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome).\n* Venous or arterial thrombotic events that occurred within the first 6 months prior to the initial use of the drug, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhages, cerebral infarctions), deep vein thrombosis, and pulmonary embolism, etc..\n* Symptoms of grade 3 bleeding as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) occurred within 4 weeks prior to the first use of the drug.\n* Patients with a history of other malignant tumors in the past 5 years are excluded, except for those who have been completely cured of skin basal cell carcinoma or skin squamous cell carcinoma and cervical carcinoma in situ, and\u002For any malignant tumor patients who have been cured with no disease or who have been disease-free for at least 5 consecutive years.\n* A clear history of neurological or psychiatric disorders, including epilepsy and dementia;\n* Have received any of the following antitumor treatments prior to the initial study of drug administration (either on the market or in clinical trials): ① Antitumor immunotherapy within 3 weeks; ② Large molecular targeted antitumor therapy such as Bevacizumab within 3 weeks; ③ Chemotherapy or clearly antitumor traditional medicine within 2 weeks; ④ Small molecule targeted antitumor drug treatment within 2 weeks or within 5 half-lives (whichever is longer); ⑤ Subjects who have undergone palliative radiation therapy for bone metastasis within 2 weeks are excluded, but those who have received radiation treatment with an area of ≥30% of the bone marrow within 2 weeks are not allowed to be included;\n* Before studying drug administration, all related toxic reactions from antitumor treatments (such as hair loss, skin pigmentation, grade 2 chemotherapy-related peripheral neurotoxicity, grade 2 toxicities caused by immune checkpoint inhibitors like elevated blood sugar or hypothyroidism, etc.) have not recovered to a level of ≤ grade 1 (as determined by NCI CTCAE v5.0);\n* Patients may be used in conjunction with other anticancer drugs (bisphosphonates for the treatment of bone metastases are acceptable);\n* Uncontrolled comorbidities, including but not limited to severe diabetes (fasting blood glucose \\> 250 mg\u002Fdl or 13.9 mmol\u002FL), or other severe diseases requiring systemic treatment;\n* Vaccination with live vaccines or attenuated vaccines within 4 weeks prior to the first dose (Note: If enrolled, participants must not receive live vaccines during the study treatment period and within 30 days after the last dose of the investigational drug);\n* For premenopausal female subjects (postmenopausal female patients must have been menopausal for at least 12 months to be considered infertile), a positive pregnancy test result; during the study and at least 30 days after the last administration of the study drug, females of childbearing potential who are hoping to become pregnant, breastfeeding, or unwilling to use effective contraceptive methods (including female partners of male subjects).\n* subjects who are undergoing treatment and cannot discontinue (for at least 1 week prior to study treatment initiation and during the study) any intravenous or oral medications that are strong inducers or strong inhibitors of CYP2C9 or CYP3A4; or patients who are taking medications with a narrow therapeutic window that are metabolized by CYP1A2.\n* Inability to swallow capsules or refractory nausea and vomiting, malabsorption, external bile diversion, or any significant small bowel resection that may interfere with the complete absorption of the study drug.\n* Any other condition or circumstance that, in the investigator's judgment, would preclude safe participation in or compromise the objectives of the study.",{"count":522,"type":22},91,[63],"This study investigated the efficacy and safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer.",[526,527],"CRC (Colorectal Cancer)","BRAF","2026-07-20",{"date":483,"type":41},{"date":531,"type":22},"2026-11-30",{"date":533,"type":22},"2029-02-26",{"name":47,"class":48},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":235,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":551,"leadSponsor":553,"locationsCount":49},"100647401","phase-3-efficacy-and-safety-of-tpc-induction-chemotherapy-combined-with-nimotuzumab-and-toripalimab-immune-sandwich-regimen-versus-full-course-immunotherapy-for-locally-advanced-nasopharyngeal-carcinoma-100647401","NCT07706985","Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab \"Immune Sandwich\" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma","Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab \"Immune Sandwich\" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma: A Multicenter, Randomized, Open-Label, Non-Inferiority Phase III Clinical Study","Inclusion Criteria:\n\n* Aged between 18 and 70 years, regardless of gender\n* Histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma\n* Locoregionally advanced nasopharyngeal carcinoma classified as Stage III-IVA per the 8th AJCC staging system, excluding T3-4N0 and T3N1 disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate organ and bone marrow function as demonstrated by laboratory test results obtained within 7 days prior to enrollment. No blood products, hematopoietic growth factors, albumin, or other intravenous\u002Fsubcutaneous corrective medications are permitted within 14 days before laboratory testing. Specific criteria are listed below.Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet (PLT) count ≥ 75 × 10⁹\u002FL; Hemoglobin (HGB) ≥ 9.0 g\u002FdL;Liver function: Total Bilirubin (TBIL) ≤ 2 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5 × ULN; serum albumin ≥ 28 g\u002FL; Alkaline Phosphatase (ALP) ≤ 5 × ULN. Renal function: Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated via the Cockcroft-Gault formula). For patients with urine protein ≥ 2+ on routine urinalysis, a 24-hour urine collection is required, with total 24-hour urinary protein quantification \\\u003C 1 g. Coagulation function: International Normalized Ratio (INR) ≤ 2.3, or prothrombin time (PT) prolongation ≤ 6 seconds\n* Able to provide written informed consent and comply with all protocol-specified study visits and related procedures.\n\nExclusion Criteria:\n\n* Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and\u002For radically resected carcinoma in situ\n* Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Class II-IV) or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography\n* Patients with acute or chronically active hepatitis B or hepatitis C infection: HBV DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL; HCV RNA \\>10³ copies\u002FmL; concurrent positive hepatitis B surface antigen (HBsAg) and anti-HCV antibody. Subjects with viral loads below the above thresholds after nucleotide antiviral therapy are eligible for enrollment\n* Past or current history of pulmonary diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or severely impaired pulmonary function\n* Active tuberculosis (TB) receiving anti-tuberculosis treatment, or having received anti-tuberculosis therapy within 1 year before the first study drug dose.\n* Human immunodeficiency virus (HIV) infection (positive HIV 1\u002F2 antibody), or known syphilis infection requiring treatment\n* Severe active or poorly controlled infections. Severe infection requiring hospitalization within 4 weeks before the first dose, including but not limited to complications from infection, bacteremia, or severe pneumonia\n* History of active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) are permitted. Known history of primary immunodeficiency. Subjects with only positive autoantibodies will be assessed by the investigator to confirm the presence of autoimmune disease\n* Female patients who are pregnant or breastfeeding\n* Prior radiotherapy, chemotherapy, or surgery for nasopharyngeal and cervical lesions (excluding biopsy)\n* History of hypersensitivity to any study drug or its components",{"count":543,"type":22},566,[157],"Immunotherapy combined with chemoradiotherapy has become standard care for locally advanced nasopharyngeal carcinoma, yet radiotherapy-induced lymphopenia may impair the efficacy of concurrent PD-1 blockade. Existing evidence supports synergistic anti-tumor activity between the anti-EGFR antibody nimotuzumab and toripalimab. This multicenter, open-label, non-inferiority Phase III trial randomizes eligible stage III-IVA LA-NPC patients 1:1 to two arms. The experimental group receives an \"immune sandwich\" regimen: TPC induction plus nimotuzumab and toripalimab, concurrent radiotherapy with weekly nimotuzumab only, followed by toripalimab maintenance. The control arm adopts full-course toripalimab throughout induction, concurrent radiotherapy and adjuvant phases. The primary endpoint is 3-year event-free survival, with secondary endpoints covering overall survival, local\u002Fdistant control rates, objective response rate and treatment-related toxicities. A total of 566 subjects will be enrolled to verify whether the simplified sandwich strategy delivers non-inferior survival with better safety profiles.",[267],"2026-07-15",{"date":549,"type":41},"2026-07-16",{"date":528,"type":22},{"date":552,"type":22},"2033-07-20",{"name":47,"class":48},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":153,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":575,"leadSponsor":577,"locationsCount":578},"100597931","phase-2-ivonescimab-combined-with-chemoradiotherapy-in-high-risk-locoregionally-advanced-nasopharyngeal-carcinoma-100597931","NCT07064902","Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma","Ivonescimab Combined With Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II, Multicenter, Single-Arm Clinical Trial","Inclusion Criteria:\n\n1. Age between 18 and 65 years.\n2. Histologically confirmed non-keratinizing carcinoma (according to WHO classification).\n3. ECOG performance status of 0 or 1.\n4. Previously untreated nasopharyngeal carcinoma staged as T3N2M0 or Stage III according to the AJCC 9th edition.\n5. Adequate bone marrow function, defined as white blood cell count \\> 4×10⁹\u002FL, hemoglobin \\> 90 g\u002FL, and platelet count \\> 100×10⁹\u002FL.\n6. Adequate liver and renal function, defined as total bilirubin ≤ 1.5 × ULN; AST and\u002For ALT ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; and creatinine clearance ≥ 60 mL\u002Fmin.\n7. Normal thyroid function, amylase, lipase, pituitary function, inflammatory markers, myocardial enzymes, and ECG. For patients over 50 years old with a smoking history, pulmonary function test results must be normal. For patients with ECG abnormalities or a cardiovascular history not meeting exclusion criteria #8, echocardiography and cardiac function tests must be normal.\n8. Signed informed consent and willingness to comply with all scheduled visits, treatment procedures, laboratory tests, and other study-related requirements.\n9. Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use reliable contraception from screening until 1 year after completion of treatment.\n\nExclusion Criteria:\n\n1. Tumor invasion of major blood vessels or significant recent (within 1 month) nasopharyngeal or nasal bleeding (\\>5 mL).\n2. HBsAg positive with HBV DNA \\> 1×10³ copies\u002FmL, or anti-HCV antibody positive.\n3. HIV antibody positive or diagnosed with AIDS.\n4. Active tuberculosis or history of active tuberculosis within the past year, unless adequately treated.\n5. Active, known, or suspected autoimmune disease, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, or asthma requiring bronchodilator therapy; exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement, and localized skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia).\n6. History of interstitial lung disease or pneumonitis requiring corticosteroid treatment within the past year.\n7. Chronic systemic corticosteroid therapy (≥10 mg\u002Fday prednisone or equivalent) or use of other immunosuppressive therapy; inhaled or topical corticosteroids are allowed.\n8. Uncontrolled cardiovascular disease, including NYHA Class ≥ 2 heart failure, unstable angina, myocardial infarction within 1 year, or supraventricular\u002Fventricular arrhythmias requiring intervention.\n9. Pregnant or breastfeeding women; pregnancy testing is required for women of childbearing potential.\n10. History or presence of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma.\n11. Known hypersensitivity to monoclonal antibodies or any component of ivonescimab.\n12. Active systemic infection requiring treatment within 1 week before study treatment.\n13. Receipt of live vaccine within 30 days prior to the first dose of ivonescimab.\n14. History of organ transplantation.\n15. History of psychiatric illness, substance abuse, alcohol or drug dependence.\n16. Any other condition which, in the opinion of the investigator, could compromise patient safety or compliance with the study protocol, including severe uncontrolled comorbidities, serious abnormal lab findings, or psychosocial risk factors.",{"count":562,"type":22},48,[63],"This trial aims to study the role of Ivonescimab combined with chemoradiotherapy in high-Risk locoregionally advanced nasopharyngeal carcinoma.",[267],[567,568,569,570,190,571],"PD-1\u002FVEGF bispecific antibody","Chemoradiotherapy","Anti-PD-1 Therapy","Ivonescimab","Bispecific Antibody","2026-07-14",{"date":549,"type":41},{"date":354,"type":22},{"date":576,"type":22},"2028-06-30",{"name":47,"class":48},3,{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":49},"100647334","phase-2-an-umbrella-designed-prospective-multicenter-randomized-open-label-superiority-trial-evaluating-multi-biomarker-guided-precision-therapy-for-first-line-treatment-of-advanced-esophageal-squamous-cell-carcinoma-100647334","NCT07709533","An Umbrella-designed Prospective Multicenter Randomized Open-label Superiority Trial Evaluating Multi-biomarker-guided Precision Therapy for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma","A Prospective, Multicenter, Randomized, Open-label, Superiority Clinical Trial With an Umbrella Trial Design Framework to Evaluate the Efficacy of a Precision Treatment Strategy Guided by Multiple Biomarkers in the First-line Therapy of Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Aged between 18 and 75 years (calculated on the date of signing the informed consent form);\n2. Patients with metastatic esophageal squamous cell carcinoma (ESCC) confirmed by histopathology or cytology;\n3. Treatment-naïve patients with no prior anti-tumor therapy;\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, with an expected survival of more than 3 months;\n5. Judged by the investigator to be suitable for first-line chemotherapy;\n6. Presence of at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);\n7. Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study period and for 6 months after the end of study treatment; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment and shall not be breastfeeding. Male patients must agree to use effective contraception throughout the study period and for 6 months after the end of study treatment.\n\n   Version: 1.0, Version Date: March 18, 2026\n8. Voluntarily participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Brain metastases with symptoms or symptom control duration less than 2 months;\n2. History of or concurrent other malignant tumors within the past 3 years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n3. Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):\n\n   1. Absolute Neutrophil Count (ANC) \\\u003C 1.5 × 10⁹\u002FL;\n   2. Platelet count \\\u003C 100 × 10⁹\u002FL;\n   3. Hemoglobin \\\u003C 90 g\u002FL.\n4. Hepatic abnormalities:\n\n   1. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) \\> 2.5 × Upper Limit of Normal (ULN) in patients without liver metastases; ALT, AST or ALP \\> 5 × ULN in patients with liver metastases;\n   2. Serum total bilirubin \\> 1.5 × ULN (\\> 3 × ULN for patients with Gilbert's syndrome);\n   3. Decompensated liver cirrhosis (Child-Pugh liver function grade B or C);\n   4. Positive Hepatitis B Surface Antigen (HBsAg) with Hepatitis B Virus (HBV) DNA load ≥ 2000 IU\u002FmL. Patients with positive HBsAg and HBV DNA load \\\u003C 2000 IU\u002FmL must receive anti-HBV therapy for at least 2 weeks prior to the first study drug administration;\n   5. Positive Hepatitis C Virus (HCV) antibody with detectable HCV RNA.\n5. Renal abnormalities:\n\n   1. Serum creatinine \\> 1.5 × ULN or estimated creatinine clearance \\\u003C 60 mL\u002Fmin calculated by the Cockcroft-Gault formula;\n   2. Urinalysis showing urine protein ≥ ++, confirmed with 24-hour urinary protein quantification \\> 1.0 g;\n   3. Renal failure requiring hemodialysis or peritoneal dialysis;\n   4. Medical history of nephrotic syndrome.\n6. Bleeding risks:\n\n   1. Abnormal coagulation function: Activated Partial Thromboplastin Time (APTT) or Thrombin Time (TT) \\> 1.5 × ULN, or International Normalized Ratio (INR) \\> 1.5 (\\> 2.5 for subjects receiving anticoagulant therapy);\n   2. History of hemorrhage (hemoptysis), coagulopathy, or ongoing use of warfarin, aspirin, low-molecular-weight heparin and other antiplatelet drugs (except prophylactic aspirin at a dose ≤ 100 mg\u002Fday);\n   3. Any signs or history of bleeding diathesis regardless of severity;\n   4. Active gastrointestinal bleeding defined as hematemesis, hematochezia or melena within the past 3 months without evidence of resolution confirmed by gastroscopy or colonoscopy;\n   5. Any Grade ≥ 3 bleeding event per CTCAE occurring within 4 weeks prior to the first study drug administration.\n\n   Version: 1.0, Version Date: March 18, 2026\n7. Cardiovascular and cerebrovascular abnormalities:\n\n   1. Subjects with any of the following conditions within 12 months before the first study drug administration: grade ≥ II myocardial ischemia or myocardial infarction, arrhythmia, grade ≥ III cardiac insufficiency, uncontrolled angina, coronary\u002Fperipheral artery bypass graft surgery, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, etc.;\n   2. Deep vein thrombosis or pulmonary embolism occurring within 6 months before the first study drug administration;\n   3. Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% assessed by Doppler echocardiography;\n   4. Average Fridericia-corrected QT interval (QTcF) (from at least 3 consecutive electrocardiograms): ≥ 450 ms for male patients, ≥ 470 ms for female patients;\n   5. Uncontrolled hypertension refractory to medication (systolic blood pressure ≥ 150 mmHg and diastolic blood pressure ≥ 100 mmHg recorded in at least two measurements).\n8. History of immunodeficiency:\n\n   1. Confirmed Human Immunodeficiency Virus (HIV) infection;\n   2. Other acquired or congenital immunodeficiency disorders;\n   3. Scheduled or prior solid organ transplantation, hematopoietic stem cell transplantation within 60 days before the first study drug administration, or significant graft-versus-host disease;\n   4. Patients requiring immunosuppressants, systemic or absorbable local hormonal therapy for immunosuppressive purposes that must be continued within 7 days before the first study drug administration (excluding daily glucocorticoid dose \\\u003C 10 mg prednisone or equivalent steroids).\n9. Active or uncontrolled severe infection (Grade ≥ 2 per CTCAE);\n10. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage (judged by the investigator);\n11. Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody, or any other antibodies targeting T cell co-stimulatory or checkpoint pathways (e.g., OX40, CD137, etc.);\n12. Complicated with severe or poorly controlled diseases judged by the investigator to carry substantial risks for study participation (e.g., poorly controlled diabetes with screening fasting plasma glucose (FPG) \\> 10 mmol\u002FL);\n13. Participation in another clinical trial of anti-tumor agents within 28 days prior to screening.",{"count":587,"type":22},347,[63],"This is a prospective, multicenter, randomized, open-label, umbrella superiority clinical trial for patients with advanced metastatic esophageal squamous cell carcinoma who have not received prior anti-tumor treatment.\n\nAll eligible participants will be randomly assigned into two cohorts: Cohort A (standard treatment group) and Cohort B (biomarker-guided precision treatment group).\n\nPatients in Cohort A will receive first-line standard therapy consisting of TP chemotherapy plus PD-1 inhibitor.\n\nAll patients in Cohort B will first complete three biomarker tests, then be divided into 4 sub-groups based on biomarker results to receive biomarker-directed additional treatment combined with the same standard backbone therapy. Participants with all negative biomarkers or failed biomarker testing will receive the identical standard treatment as Cohort A.\n\nThe primary objective is to compare the survival benefit between biomarker-guided multi-strategy precision therapy and conventional standard first-line treatment.",[591],"Valid MeSH Conditions",[593,594],"Esophageal squamous cell carcinoma","TGF-β","2026-07-13",{"date":549,"type":41},{"date":598,"type":22},"2026-07-07",{"date":600,"type":22},"2029-06-30",{"name":47,"class":48},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":617,"leadSponsor":619,"locationsCount":49},"100647129","phase-3-efficacy-and-safety-of-becotatug-vedotin-mrg003-combined-with-anti-pd1-as-maintenance-therapy-for-recurrent-and-metastatic-nasopharyngeal-carcinoma-100647129","NCT07705243","Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma","Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma: A Randomized, Controlled, Multicenter Phase III Clinical Study","Inclusion Criteria:\n\n* Aged between 18 and 75 years at diagnosis, regardless of gender;\n* Histologically confirmed nasopharyngeal carcinoma;\n* Patients with advanced nasopharyngeal carcinoma with confirmed distant metastasis (Stage IVb per AJCC 8th edition; Stage IV per AJCC 9th edition), or recurrent nasopharyngeal carcinoma unsuitable for locoregional or curative therapy;\n* Achieved stable disease (SD) assessed per RECIST v1.1 or maintained positive plasma EBV DNA after 4 to 6 cycles of first-line chemotherapy combined with immunotherapy;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n* Expected survival of at least 12 weeks;\n* No prior systemic chemotherapy administered within 6 months before diagnosis (excluding patients with disease progression more than 6 months after neoadjuvant chemotherapy, adjuvant chemotherapy, or definitive concurrent chemoradiotherapy);\n* At least one measurable lesion as defined by RECIST v1.1;\n* Adequate organ and bone marrow function as defined below:\n\n  1. HGB ≥90 g\u002FL, WBC ≥4×10⁹\u002FL, PLT ≥100×10⁹\u002FL.\n  2. Liver function: TBIL \\\u003C1.5 × ULN; ALT and\u002For AST \\\u003C2.5 × ULN. For patients with liver metastases, ALT or AST \\\u003C5 × ULN. For patients with liver or bone metastases, ALP \\\u003C5 × ULN.\n  3. Renal function: creatinine \\\u003C1.5 × ULN.\n  4. Coagulation: INR of PT \u002F PTT \\\u003C1.5 × ULN;\n* Able to provide written informed consent and comply with all protocol-specified procedures including laboratory tests and follow-up visits;\n* Female subjects of childbearing potential and male subjects with childbearing potential partners must agree to use effective contraception from screening through 6 months after the last dose of study treatment (e.g., condoms, regular oral contraceptives as prescribed).\n\nExclusion Criteria:\n\n* Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0);\n* History of hypersensitivity to any study drug;\n* Expected survival less than 3 months;\n* Active hepatitis B (positive HBsAg or HBcAb with HBV DNA ≥ 2000 IU\u002FmL) or active hepatitis C (positive HCV antibody with HCV RNA above the lower limit of quantification at the study site). For patients with normal liver function receiving antiviral therapy, eligibility shall be determined by the investigator;\n* Patients with positive HIV antibody;\n* Active bacterial, fungal, viral infection requiring systemic treatment, or interstitial pneumonia within 1 week prior to the first administration of study drugs;\n* Received anti-tumor therapies including chemotherapy, small-molecule inhibitors, immunotherapy (e.g., interleukins, interferons, thymosins) within 4 weeks or 5 half-lives (whichever is shorter, with a minimum interval of 2 weeks) before the first dose of study drugs;\n* Received anti-tumor therapies including chemotherapy, small-molecule inhibitors, immunotherapy (e.g., interleukins, interferons, thymosins) within 4 weeks or 5 half-lives (whichever is shorter, with a minimum interval of 2 weeks) before the first dose of study drugs;\n* Underwent major surgery within 3 months prior to the first dose, or planned to receive major surgery during the study period;\n* Severe thromboembolic events within 6 months before screening, such as cerebrovascular accidents (including transient ischemic attack) and pulmonary embolism;\n* Active malignant tumors within 2 years prior to the first administration of study drugs, excluding nasopharyngeal carcinoma under investigation and any locally curable tumors that have received radical treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ);\n* Severe cardiovascular diseases within 6 months before enrollment, including but not limited to:\n\n  1. Acute myocardial infarction, unstable angina, coronary angioplasty or stenting, deep vein thrombosis, stroke;\n  2. New York Heart Association (NYHA) Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  3. Electrocardiogram (ECG) abnormalities of significant clinical relevance at screening as assessed by the investigator;\n* Pregnant or breastfeeding women;\n* Presence of any severe and\u002For uncontrolled diseases that, in the investigator's judgment, may interfere with the patient's participation in the study (including but not limited to uncontrolled diabetes, dialysis-dependent renal disease, severe liver disease, life-threatening autoimmune and hemorrhagic diseases, substance abuse, neurological disorders);\n* Any other conditions deemed inappropriate for participation by the investigator.",{"count":610,"type":22},86,[157],"This multicenter randomized controlled Phase III trial assesses the efficacy and safety of becotatug vedotin plus anti-PD-1 antibody as maintenance therapy for recurrent\u002Fmetastatic nasopharyngeal carcinoma. Eligible patients aged 18-75 must have stable disease or positive plasma EBV DNA after 4-6 cycles of first-line chemoimmunotherapy, with adequate organ function and good physical status. A total of 86 subjects will be randomly split 1:1: the control group receives single anti-PD-1 maintenance, while the experimental group gets anti-PD-1 combined with becotatug vedotin in 21-day cycles for up to 2 years. Regular blood tests and tumor scans will be performed to monitor efficacy and adverse events graded by CTCAE v5.0; biological samples will be collected for biomarker research with consent. The primary endpoint is IRC-reviewed progression-free survival, with secondary endpoints covering overall survival, tumor response rates and safety. Overseen by an independent ethics committee, the trial ensures full data confidentiality. Participants sign informed consent and can withdraw anytime without interference to their routine cancer care, exploring a superior maintenance regimen for this high-risk NPC group.",[482],"2026-07-12",{"date":547,"type":41},{"date":528,"type":22},{"date":618,"type":22},"2029-07-20",{"name":47,"class":48},""]