[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hebei Medical University Fourth Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":565},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,39,66,95,115,138,158,185,205,227,252,273,292,313,334,359,380,399,420,439,457,476,500,520,545],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100644054","cardiac-safety-management-and-immune-microenvironment-changes-after-thoracic-radiotherapy-a-prospective-observational-study-100644054",false,"NCT07669493","Cardiac Safety Management and Immune Microenvironment Changes After Thoracic Radiotherapy: A Prospective Observational Study","Cardiac Safety Management and Immune Microenvironment Changes in Thoracic Cancer Patients Receiving Different Radiotherapy Modalities: A Prospective Observational Study","Inclusion Criteria:\n\nPatients willing to participate the research and sign the informed consent file; Patients aged ≥18 years; KPS≥70; Pathological diagnosis for lung cancer, metastatic lung cancer, esophageal cacner, breast cancer and thymus tumor; Patients received thoracic radiotherapy; No functional heart disease; LVEF≥50%\n\nExclusion Criteria:\n\nPatients received thoracic radiotherapy previously; Patients with severe organic and functional disease; Unqualified patients with sufficient reasons; Cannot or no willing to sign the informed consent file","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about cardiac safety monitoring after thoracic radiotherapy in adults with thoracic tumors.\n\nThe main question it aims to answer is:\n\nDose dynamic monitoring of cardiac biomarkers, electrocardiography, echocardiography, peripheral blood immune cell subsets, cytokines, chemokines, lipid profiles, and lipid metabolism markers help identify early clinical or subclinical cardiac changes after thoracic radiotherapy? Are cardiac substructure radiation dose parameters associated with early cardiac safety outcomes? Participants receiving thoracic radiotherapy as part of their regular medical care will complete cardiac safety assessments at the end of radiotherapy, 1 month after radiotherapy, and 3 months after radiotherapy.",[25],"MACE, Arrhythmia, Pericardial Effusion and Survival","RECRUITING","2026-06-21",{"date":29,"type":30},"2026-06-25","ACTUAL",{"date":32,"type":30},"2026-01-17",{"date":34,"type":21},"2027-01-01",{"name":36,"class":37},"Hebei Medical University Fourth Hospital","OTHER",1,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100643850","phase-4-sbrt-plus-ql1706-as-second-line-therapy-for-hepatocellular-carcinoma-100643850","NCT07668570","SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma","A Prospective, Single-Arm, Single-Center Exploratory Clinical Study of Stereotactic Body Radiation Therapy Combined With QL1706 in the Second-Line Treatment of Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Male or female patients aged 18 to 75 years, inclusive.\n* Eastern Cooperative Oncology Group performance status score of 0 or 1.\n* Pathologically confirmed hepatocellular carcinoma, based on at least one lesion or previous biopsy confirming hepatocellular carcinoma.\n* Child-Pugh class A, score 5 to 6, or Child-Pugh class B, score 7 only.\n* Barcelona Clinic Liver Cancer stage C or earlier.\n* Not suitable for curative treatment such as surgical resection or liver transplantation, or refusal of curative treatment such as surgical resection or liver transplantation after first-line therapy.\n* At least one measurable lesion confirmed by the investigator according to modified RECIST.\n* All intrahepatic tumor lesions must be considered suitable for stereotactic body radiation therapy by the investigator.\n* At least 700 cc of normal liver volume must be preserved, with a mean radiation dose to this volume of no more than 15 Gy.\n* Received one prior line of systemic therapy and experienced radiographic disease progression or intolerance.\n* Prior local treatment, such as transarterial chemoembolization, hepatic arterial infusion chemotherapy, or radiofrequency ablation, is allowed if the interval between the prior local treatment and initiation of study treatment is at least 28 days.\n* Adequate organ and bone marrow function, defined as all of the following:\n\n  * Hemoglobin at least 9.0 g\u002FdL.\n  * Absolute neutrophil count at least 1.5 × 10\\^9\u002FL or greater than 1500\u002Fmm\\^3.\n  * Platelet count at least 75 × 10\\^9\u002FL or greater than 75,000\u002Fmm\\^3.\n  * Serum bilirubin no more than 1.5 times the institutional upper limit of normal.\n  * Aspartate aminotransferase and alanine aminotransferase no more than 2.5 times the institutional upper limit of normal.\n  * Creatinine clearance greater than 45 mL\u002Fmin, measured directly, calculated by the Cockcroft-Gault formula, or measured by 24-hour urine collection.\n* Female patients of childbearing potential must have a negative urine or serum pregnancy test before the first dose of study treatment.\n* Male or female patients of reproductive potential must agree to use adequate contraception from the first dose of study treatment until 180 days after the last dose of study treatment.\n* Life expectancy of more than 6 months, as assessed by the investigator.\n* Able to understand and comply with study requirements and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Histologically confirmed combined hepatocellular-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or other non-hepatocellular primary liver malignancy.\n* Prior yttrium-90 radioembolization.\n* Hepatitis B viral load greater than 2000 IU\u002FmL despite effective antiviral therapy.\n* More than 3 discrete hepatic nodules.\n* Presence of extrahepatic metastasis or M1 disease.\n* Current participation in another study with investigational treatment, or participation in an investigational drug or device study within 4 weeks before the first dose of study treatment.\n* Immunodeficiency disease, or use of systemic corticosteroids at a daily dose greater than 10 mg prednisone or equivalent on the day of the first dose of study treatment or within 14 days before the first dose of study treatment.\n* Active tuberculosis, or inadequately treated latent tuberculosis infection with a high risk of recurrence in the investigator's judgment.\n* Hypersensitivity to recombinant humanized anti-PD-1 or anti-PD-L1 monoclonal antibodies, recombinant humanized anti-CTLA-4 monoclonal antibodies, or any of their components.\n* Receipt of anticancer therapy within 4 weeks before Day 1 of study treatment, or failure of toxicities from prior therapy to recover to Grade 1 or lower or to baseline level.\n* Other progressive malignancy requiring active treatment.\n* Autoimmune disease requiring systemic treatment within the past 2 years, including immunomodulators, corticosteroids, or immunosuppressants. Replacement therapy such as thyroxine, insulin, or physiologic hormone replacement for adrenal or pituitary insufficiency is not considered systemic treatment. Prior organ transplantation, including liver transplantation.\n* History or evidence of active non-infectious pneumonitis.\n* Active infection requiring systemic therapy.\n* Psychiatric illness or history of substance abuse that may interfere with study compliance.\n* Receipt of a live vaccine within 30 days before the planned initiation of study treatment.\n* Planned pregnancy or breastfeeding.\n* Any medical history, treatment, or laboratory abnormality that, in the investigator's judgment, may interfere with study results, affect full participation in the study, or not be in the patient's best interest.","75 Years",{"count":48,"type":21},36,"INTERVENTIONAL",[51],"PHASE4","This is a prospective, single-arm, single-center exploratory clinical study designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with QL1706 in patients with hepatocellular carcinoma who have received one prior line of systemic therapy and experienced radiographic disease progression or intolerance.\n\nEligible patients will receive SBRT to all evaluable intrahepatic lesions at a total dose of 25-50 Gy delivered in 5 fractions. Within 7-14 days after completion of SBRT, patients will receive QL1706 at 7.5 mg\u002Fkg by intravenous infusion every 3 weeks. Treatment with QL1706 will continue until confirmed disease progression, intolerable toxicity, patient request to withdraw, withdrawal of informed consent, or other protocol-defined treatment discontinuation criteria, whichever occurs first.\n\nThe primary endpoint is objective response rate assessed by the investigator according to modified RECIST criteria. Secondary endpoints include local control rate of SBRT target lesions, progression-free survival, overall survival, disease control rate, and the incidence of adverse events and serious adverse events. Exploratory endpoints include dynamic changes in serum tumor biomarkers and immune-related indicators, as well as their association with clinical outcomes. A total of 36 patients are planned for enrollment.",[54],"HCC - Hepatocellular Carcinoma",[56,57,58],"Hepatocellular carcinoma","second-line","SBRT","NOT_YET_RECRUITING",{"date":29,"type":30},{"date":62,"type":21},"2026-07",{"date":64,"type":21},"2030-07",{"name":36,"class":37},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":73,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":49,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":38},"100643678","phase-2-pyrotinib-plus-trastuzumab-and-chemotherapy-for-her2-positive-early-breast-cancer-100643678","NCT07635342","Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer","Efficacy and Safety of Pyrotinib and Trastuzumab Combined With Pegylated Liposomal Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel for Injection Albumin Bound as Neoadjuvant Therapy for Early HER2-Positive Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 to 65 years.\n* Patients with previously untreated invasive breast cancer confirmed by pathological examination.\n* HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.\n* Clinical stage T2N0-3M0 or any T\u002FN1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.\n* At least one measurable lesion according to RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function, meeting all of the following criteria:\n* Hemoglobin ≥100 g\u002FL.\n* Absolute neutrophil count ≥1.5 × 10\\^9\u002FL.\n* Platelet count ≥100 × 10\\^9\u002FL.\n* Total bilirubin ≤1 × upper limit of normal (ULN).\n* Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN.\n* Alkaline phosphatase ≤2.5 × ULN.\n* Blood urea nitrogen and serum creatinine ≤1.5 × ULN.\n* Left ventricular ejection fraction ≥55% by echocardiography.\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the study and for 8 weeks after the last dose of study treatment.\n* Patients must voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.\n* Concurrent receipt of any other anti-tumor therapy.\n* Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.\n* Stage IV breast cancer.\n* Breast cancer not confirmed by pathological examination.\n* History of other malignancies within 5 years, except cured carcinoma in situ of the cervix.\n* Severe dysfunction of major organs, including the heart, liver, or kidney.\n* Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that may affect drug administration or absorption.\n* Participation in another drug clinical trial within 4 weeks before enrollment.\n* Known history of allergy to any component of the study treatment.\n* History of immunodeficiency, including positive HIV test, hepatitis C virus infection, active hepatitis B virus infection, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* History of any cardiac disease, including clinically significant arrhythmia requiring medication, myocardial infarction, heart failure, or any other cardiac disease judged by the investigator to make the patient unsuitable for this study.\n* Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception throughout the study.\n* Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or affect completion of the study, including but not limited to uncontrolled severe hypertension, severe diabetes mellitus, or active infection.\n* Clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n* Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.","FEMALE","65 Years",{"count":76,"type":21},182,[78],"PHASE2","This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer.\n\nEligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.",[81],"HER2-positive Breast Cancer",[83,84,85,86],"Neoadjuvant Therapy","Pyrotinib","Trastuzumab","Pathological Complete Response","2026-06-03",{"date":89,"type":30},"2026-06-09",{"date":91,"type":30},"2024-04-30",{"date":93,"type":21},"2029-12-31",{"name":36,"class":37},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":101,"targetDuration":4,"studyType":49,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":38},"100637452","phase-2-a-clinical-study-of-shr-1701-combined-with-chemotherapy-for-the-perioperative-treatment-of-locally-advanced-resectable-siewert-type-ii-adenocarcinoma-of-the-esophagogastric-junction-100637452","NCT07607210","A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction","Inclusion Criteria:\n\n1.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- \u002F IHC 1+ \u002F IHC -)； 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria)； 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:\n\n1. routine blood tests:\n\n   1. HB≥90g\u002FL；\n   2. ANC≥1.5×109\u002FL；\n   3. PLT≥100×109\u002FL；\n2. biochemical examination:\n\n   1. ALT and AST\\\u003C2.5ULN（liver metastasis: ALT and AST\\\u003C5ULN）；\n   2. TBIL≤1.5ULN；\n   3. Creatinine ≤1.5ULN； 9.Left ventricular ejection fraction is \\>50%； 10.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; 11. Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.\n\nExclusion Criteria:\n\n1. Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);\n2. Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;\n3. Cardia or pyloric obstruction;\n4. Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;\n5. Known hypersensitivity to any monoclonal antibody or component of a chemotherapy agent (such as tegafur or albumin-bound paclitaxel) (history of Grade 3 or higher hypersensitivity reaction);\n6. Previous exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, or CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;\n7. Receipt of an attenuated live vaccine within 4 weeks prior to the first dose of study treatment, or planned administration during the study period;\n8. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the start of study treatment (dose \\> 10 mg\u002Fday of prednisone or other corticosteroids of equivalent potency);\n9. History of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose;\n10. Congenital or acquired immunodeficiency (e.g., HIV infection);\n11. The investigator determines that the subject has other factors that may affect the study results or lead to the premature termination of the study, such as alcohol abuse, substance abuse, other serious illnesses (including mental disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that may compromise the subject's safety;\n12. Pregnant or breastfeeding women;\n13. Evidence of medical history or disease that may interfere with trial results or prevent the subject from participating in the study throughout its duration, abnormal treatment or laboratory test results, or other circumstances deemed by the investigator to make the subject unsuitable for enrollment; or other potential risks identified by the investigator that render the subject unsuitable for participation in this study.",{"count":102,"type":21},38,[78],"Evaluating the efficacy and safety of SHR-1701 combined with chemotherapy for the perioperative treatment of locally advanced resectable Siewert type II adenocarcinoma of the esophagogastric junction.",[106],"Siewert Type II Adenocarcinoma of the Esophagogastric Junction","2026-05-20",{"date":109,"type":30},"2026-05-26",{"date":111,"type":21},"2026-06-01",{"date":113,"type":21},"2028-03-31",{"name":36,"class":37},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":122,"targetDuration":4,"studyType":49,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":38},"100640153","phase-2-a-clinical-study-of-liposomal-irinotecan-for-second-line-therapy-in-metastatic-colorectal-cancer-100640153","NCT07585279","A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer","Liposomal Irinotecan-based Regimen Versus Irinotecan-based Regimen in Second-Line Treatment for Metastatic Colorectal Cancer (IRIS-02): A Randomized, Controlled Phase II\u002FⅢ Study","Inclusion Criteria:\n\n1. Aged ≥ 18 years old and ≤ 75 years old.\n2. Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;\n3. Patients must have at least one measurable lesion according to RECIST 1.1 criteria.\n4. Had received first-line treatment based on oxaliplatin.\n5. Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;\n6. Expected survival time ≥3 months.\n7. Adequate organ function, meeting the following laboratory test standards:\n\n1\\) Bone marrow function: Neutrophils≥1.5×109\u002FL, Platelets≥100×109\u002FL, Hemoglobin≥90 g\u002FL, White blood cells ≥3.0×109\u002FL; 2) Liver function:Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase≤2.5×upper limit of normal (ULN), when there is liver metastasis, ≤ 5×ULN; Total bilirubin≤1.5×ULN; 3) Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥ 60 ml\u002Fmin, Urine protein≤2+; 4) Coagulation function: Activated partial thromboplastin time and International Normalized Ratio ≤1.5 × ULN; 5) Thyroid function: Thyroid stimulating hormone≤ULN; If abnormal, additional tests for FT3 and FT4 should be conducted and their levels should be normal; 6) Albumin≥3 g\u002FdL; 8. Pregnant women of childbearing age with negative pregnancy test and non-lactating, participants with reproductive capacity must receive effective contraceptive measures; 9. Patients and\u002For legal representative must have the ability to understand and voluntarily sign a written informed consent.\n\nExclusion Criteria:\n\n1. Patients with a history of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell carcinoma of the skin.\n2. Prior treatment with irinotecan or liposomal irinotecan-based chemotherapy, or prior treatment with immune checkpoint inhibitors (including but not limited to PD-1 inhibitors, PD-L1 inhibitors, and CTLA-4 inhibitors).\n3. Patients with left-sided colorectal cancer, RAS\u002FBRAF wild-type, who did not receive cetuximab in first-line therapy.\n4. Patients with known mismatch repair dysfunction or microsatellite instability ;\n5. Patients with a large amount of pleural effusion or ascites that require drug intervention treatment;\n6. Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, who show persistent signs\u002Fsymptoms without improvement despite appropriate antimicrobial therapy.\n7. Known active HIV infection; untreated active HBV or HCV infection.\n8. Patients with uncontrolled systemic diseases, including: cardiac disease of NYHA Class II or above; uncontrolled hypertension (defined as systolic blood pressure≥140 mmHg and\u002For diastolic blood pressure≥90 mmHg despite standard antihypertensive therapy) or a history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus; etc.\n9. Patients with active autoimmune diseases, or with a history of autoimmune disease within 2 years prior to enrollment that still requires systemic therapy. Exceptions include participants with well-controlled type 1 diabetes, hypothyroidism controlled with hormone replacement alone, skin disorders not requiring systemic treatment, or those in whom recurrence is not anticipated in the absence of external triggers.\n10. Patients with primary immunodeficiency diseases or with a history;\n11. Patients who have received immunosuppressant treatment within 14 days before enrollment or require daily systemic steroid treatment (such as \\> 20 mg\u002Fday prednisone or equivalent drugs), except those treated with nasal, inhalation or other routes of local glucocorticoid therapy;\n12. Patients with severe gastrointestinal diseases;\n13. History of abdominal surgery, thoracic surgery, or intestinal resection within 28 days prior to enrollment.\n14. Had interstitial lung disease or non-infectious pneumonia requiring glucocorticoid treatment;\n15. Known hypersensitivity or intolerance to the investigational drugs or their excipients.\n16. History of pulmonary hemorrhage or hemoptysis of grade 2 or higher (defined as at least 2.5 mL of bright red blood) within 1 month prior to enrollment.\n17. History of arterial thromboembolism, severe bleeding (excluding surgical bleeding), or active thromboembolic or severe bleeding events within 6 months prior to enrollment.\n18. Had symptomatic central nervous system metastasis;\n19. Had strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1;\n20. Receipt of intravenous antitumor therapy within 28 days, or oral antitumor medication within 14 days, prior to the first dose of study drug.\n21. Patients judged by the investigator to be unsuitable to participate in this study.",{"count":123,"type":21},408,[78,125],"PHASE3","Phase II - Treatment Regimen Exploration Stage:\n\n1. Evaluate the safety and efficacy of the following three treatment regimens:\n\n   Liposomal irinotecan + 5-FU\u002FLV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU\u002FLV + bevacizumab (Group B) Irinotecan + 5-FU\u002FLV + bevacizumab (Group C)\n2. Provide a basis for selecting the treatment regimen for the confirmatory phase.\n3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens.\n\nPhase III - Efficacy Confirmation Stage:\n\nCompare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.",[128,129,130],"Metastatic Colorectal Cancer (CRC)","Liposomal Irinotecan","Second-Line","2026-05-07",{"date":133,"type":30},"2026-05-13",{"date":107,"type":21},{"date":136,"type":21},"2032-02-28",{"name":36,"class":37},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":73,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100634502","a-real-world-study-on-the-impact-of-different-adjuvant-treatment-regimens-on-prognosis-in-non-pcr-patients-with-her2-positive-breast-cancer-after-neoadjuvant-therapy-100634502","NCT07540520","A Real-World Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy","Retrospective Real-World Cohort Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy","Inclusion Criteria:\n\n* Histopathologically confirmed HER2-positive breast cancer (i.e., immunohistochemistry (IHC) staining result of 3+, or HER-2 2+ with fluorescence in situ hybridization showing HER-2 gene amplification);\n* Received neoadjuvant therapy with chemotherapy combined with trastuzumab before surgery: including at least 6 cycles of chemotherapy, with at least 4 cycles of taxane-based chemotherapy; and at least 4 cycles of trastuzumab treatment (including trastuzumab biosimilars and subcutaneous formulations);\n* Completion of radical surgery, postoperative pathology confirms the presence of invasive carcinoma in the breast and\u002For axillary lymph nodes after neoadjuvant therapy.\n* Hormone receptor status is known.\n\nExclusion Criteria:\n\n* Combine other systemic malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;\n* Stage IV metastatic breast cancer;\n* Incomplete clinical pathology and follow-up data; Study endpoints",{"count":146,"type":21},2000,"This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.",[149],"Early Breast Cancer","2026-04-14",{"date":152,"type":30},"2026-04-20",{"date":154,"type":21},"2026-08-02",{"date":156,"type":21},"2026-12-31",{"name":36,"class":37},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":49,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":38},"100633608","phase-2-neoadjuvant-shr-a1811-combined-with-pertuzumab-in-her2-positive-breast-cancer-an-exploratory-clinical-study-100633608","NCT07528898","Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study.","Exploratory Clinical Study of Neoadjuvant SHR-A1811 Combined With Pertuzumab in Patients With HER2-Positive Breast Cancer","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 and ≤70 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n3. At least one measurable lesion according to RECIST version 1.1.\n4. Histologically confirmed invasive breast cancer with clinical stage:\n\nStage II (T2N0-1M0 or T3N0M0), or Stage III (T2N2-3M0, T3N1-3M0, or T4N0-3M0). 5.HER2-positive invasive breast cancer confirmed by histopathology, defined as: HER2 immunohistochemistry (IHC) 3+, or HER2 IHC 2+ with fluorescence in situ hybridization (FISH) positivity, as determined by the pathology department of the participating center. 6.Adequate organ function, defined as:\n\n1. Hematologic function (no blood transfusion, blood products, granulocyte colony-stimulating factor \\[G-CSF\\], or other hematopoietic growth factors within 14 days prior to testing):\n\n   Hemoglobin (Hb) ≥100 g\u002FL; Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Platelet count (PLT) ≥100 × 10⁹\u002FL.\n2. Biochemical function:\n\n   Total bilirubin (TBIL) ≤1 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; Alkaline phosphatase (ALP) ≤2.5 × ULN; Blood urea nitrogen (BUN) and serum creatinine (Cr) ≤1.5 × ULN.\n3. Cardiac function:\n\nLeft ventricular ejection fraction (LVEF) ≥55% by echocardiography; QT interval corrected by Fridericia's formula (QTcF) ≤450 ms. 7.Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and agree to use effective contraception during the study and for at least 8 weeks after the last dose of study treatment.\n\n8.Willingness to participate in the study, provide written informed consent, and comply with study procedures and follow-up.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Prior receipt of any anti-tumor therapy not specified in the study protocol, including but not limited to chemotherapy, radiotherapy, targeted therapy, or endocrine therapy for the current breast cancer.\n2. Concurrent receipt of any other anti-tumor therapy during the study. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. Stage IV (metastatic) breast cancer.\n3. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix.\n4. Severe dysfunction of major organs, including but not limited to cardiac, hepatic, or renal insufficiency.\n5. Participation in another interventional clinical trial within 4 weeks prior to enrollment.\n6. Known hypersensitivity to any component of the study drugs; history of immunodeficiency, including positive human immunodeficiency virus (HIV) test, active hepatitis C virus (HCV) infection, active hepatitis B infection, congenital or acquired immunodeficiency disorders, or history of organ transplantation.\n\n   History of significant cardiac disease, including but not limited to:\n\n   Clinically significant arrhythmia requiring treatment; Myocardial infarction; Heart failure;\n7. Any other cardiac condition that, in the investigator's judgment, makes the participant unsuitable for the study.\n8. Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at baseline or unwilling to use effective contraception throughout the study period.\n9. Any serious concomitant disease that, in the investigator's judgment, may compromise patient safety or interfere with study participation, including but not limited to uncontrolled hypertension, severe diabetes, or active infection.\n\n   History of neurological or psychiatric disorders, including epilepsy or dementia.\n10. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.","70 Years",{"count":167,"type":21},100,[78],"This is a multicenter, two-arm, exploratory clinical study designed to evaluate the efficacy and safety of a response-guided neoadjuvant treatment strategy in patients with HER2-positive early or locally advanced breast cancer.\n\nBreast cancer is the most common malignancy in women worldwide, and HER2-positive disease accounts for approximately 15-20% of cases and is associated with aggressive tumor biology and a higher risk of recurrence. The introduction of HER2-targeted therapies, including trastuzumab and pertuzumab, has significantly improved patient outcomes. However, a proportion of patients exhibit suboptimal response to standard neoadjuvant therapy, highlighting the need for more effective treatment strategies.\n\nIn this study, approximately 100 eligible patients will be enrolled. All patients will initially receive 2 cycles of standard neoadjuvant therapy with trastuzumab, pertuzumab, and chemotherapy (THP or TCbHP). Tumor response will be assessed according to RECIST version 1.1 criteria. Patients with tumor reduction greater than 40% will continue the same regimen for an additional 4 cycles. Patients with tumor reduction of 40% or less will switch to an alternative regimen consisting of SHR-A1811, a novel HER2-targeted antibody-drug conjugate, in combination with pertuzumab for 4 cycles.\n\nSHR-A1811 is an investigational HER2-targeted antibody-drug conjugate designed to deliver a cytotoxic payload directly to tumor cells, potentially overcoming resistance to prior HER2-targeted therapies. Emerging clinical data have demonstrated promising anti-tumor activity and manageable safety in HER2-positive breast cancer.\n\nClinical data, including baseline characteristics, imaging findings, and pathological markers such as Ki-67, will be collected throughout the study. Efficacy will be evaluated based on imaging assessments according to RECIST 1.1 criteria and pathological response at surgery, while safety will be monitored during treatment.\n\nThe primary objective of this study is to explore whether switching to SHR-A1811 in combination with pertuzumab in patients with suboptimal early response can improve pathological complete response (pCR) rates. Secondary objectives include evaluation of safety and tolerability of the treatment strategies.\n\nThis study aims to provide evidence for an individualized, response-adapted neoadjuvant treatment approach in HER2-positive breast cancer, and to optimize treatment outcomes for patients with inadequate response to standard therapy.",[171],"Breast Cancer",[173,174,175,176,177],"HER2-positive","Neoadjuvant therapy","Antibody-drug conjugate","SHR-A1811","HER2-targeted therapy","2026-04-07",{"date":150,"type":30},{"date":181,"type":21},"2026-05",{"date":183,"type":21},"2029-07",{"name":36,"class":37},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":73,"minAge":18,"maxAge":46,"enrollmentInfo":192,"targetDuration":4,"studyType":49,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":38},"100630801","phase-2-dalpiciclib-with-or-without-entinostat-and-letrozole-in-hrher2--early-breast-cancer-100630801","NCT07492394","Dalpiciclib With or Without Entinostat and Letrozole in HR+\u002FHER2- Early Breast Cancer","An Open-Label, Randomized, Phase II Study of Dalpiciclib in Combination With Entinostat and Letrozole Versus Dalpiciclib Plus Letrozole as Neoadjuvant Therapy in Patients With HR-positive, HER2-negative Early Breast Cancer","Inclusion Criteria:\n\n\\- Inclusion Criteria\n\n1. Female patients aged ≥18 and \\\u003C75 years, including postmenopausal, premenopausal, or perimenopausal. Postmenopause is defined as:Prior bilateral oophorectomy, or age ≥60 years; orAge \\\u003C60 years, natural postmenopause (spontaneous cessation of menses for ≥12 months without other pathological or physiological cause) with estradiol (E2) and FSH in postmenopausal range; orPremenopausal or perimenopausal women willing to receive LHRH agonist (OFS) therapy during the study.\n2. Histologically confirmed estrogen receptor (ER)-positive (\\>10%) invasive breast cancer, regardless of PR expression, and HER2-negative according to the 2018 ASCO\u002FCAP HER2 testing guidelines (IHC 0+ or IHC 2+ with ISH-negative, amplification ratio \\\u003C2.0).\n3. At least one measurable lesion according to RECIST 1.1; clinical stage T1c-T2, cN1-2, or T3-T4, cN0-2.\n4. No prior anticancer therapy for breast cancer, including chemotherapy,endocrine therapy, or targeted therapy.\n5. Ability to swallow oral medications.\n6. Baseline left ventricular ejection fraction (LVEF) ≥50%.\n7. Adequate organ function:Hematology (within 1 week):Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;White blood cell count (WBC) ≥3.0 × 10⁹\u002FL;Platelet count ≥90 × 10⁹\u002FL;Hemoglobin ≥90 g\u002FL Liver and kidney function (within 1 week):Total bilirubin (TBIL) ≤ upper limit of normal (ULN);ALT and AST ≤1.5 × ULNBUN and creatinine ≤1.5 × ULN, with creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula)\n8. ECG: Corrected QT interval ≤470 ms (12-lead ECG)\n9. Willingness and ability to undergo all required biopsy procedures.\n10. Women of childbearing potential must have a negative pregnancy test before study entry and agree to use medically acceptable contraception during the study; postmenopausal women are exempt.\n11. Voluntary participation with signed informed consent, good compliance, and willingness to adhere to follow-up requirements.\n\nExclusion Criteria:\n\n\\- Exclusion Criteria\n\n1. Pregnant or breastfeeding women, or women with a positive pregnancy test at baseline; women of childbearing potential unwilling to use effective contraception during the study.\n2. Bilateral breast cancer or inflammatory breast cancer.\n3. Stage IV (metastatic) breast cancer at initial diagnosis.\n4. History of congestive heart failure, unstable angina, significant arrhythmia, or myocardial infarction.\n5. Active pulmonary disease, including interstitial lung disease, pneumonia, pulmonary fibrosis, or other acute lung conditions.\n6. Significant liver disease, such as acute or fulminant hepatitis, impaired coagulation factor synthesis, or other severe hepatic dysfunction.\n7. For patients positive for HBsAg or HBV core antibody, peripheral blood HBV DNA must be \\\u003C1×10³ IU\u002FmL to be eligible.\n8. Any concurrent disease or condition that may interfere with study participation or affect patient safety (e.g., active or uncontrolled infection).\n9. Other invasive malignancies (including second primary breast cancer) that may interfere with study outcomes or compliance.\n10. Prior chemotherapy, endocrine therapy, or biologic therapy for breast cancer (except diagnostic biopsy for primary breast cancer).\n11. Major surgery within 4 weeks prior to study entry or unresolved significant medical conditions.\n12. Tumors that are non-measurable during the study treatment.\n13. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation.",{"count":193,"type":21},60,[78],"Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.\n\nA total of 60 premenopausal, perimenopausal, and postmenopausal patients with HR+\u002FHER2- breast cancer who meet the inclusion criteria will be enrolled. During the study, clinical information will be collected according to standard practice, including demographic data, tumor imaging, and pathological results (e.g., Ki-67). Investigator-assessed outcomes will be used as the final results.\n\nAfter 14 days of treatment, patients who provide consent will undergo a second biopsy to evaluate the rate of complete cell-cycle arrest. Safety assessments and imaging evaluations will be performed at treatment completion or upon study withdrawal. Informed consent must be obtained at each study center before participation.\n\nTreatment arms:\n\nArm A (30 patients):\n\nDalpiciclib 125 mg orally once daily on Days 1-21 of each 28-day cycle (3 weeks on, 1 week off), for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Entinostat 3 mg orally once weekly (Days 1-28 of each 28-day cycle), for 6 cycles\n\nArm B (30 patients):\n\nDalpiciclib 150 mg orally once daily on Days 1-21 of each 28-day cycle, for 6 cycles Letrozole 2.5 mg orally once daily continuously for 6 cycles Premenopausal and perimenopausal women will also receive ovarian function suppression (OFS), such as with a GnRHa agent.\n\nAfter signing informed consent, patients will begin neoadjuvant therapy with dalpiciclib plus entinostat and letrozole ± OFS. Ultrasound assessments will be conducted every two treatment cycles and before surgery under the same imaging conditions as baseline. Bone scans will be performed at the end of neoadjuvant treatment. MRI of the breast will be performed at baseline, after two cycles, and before surgery to assess treatment efficacy. Treatment discontinuation will occur if toxicity is intolerable, consent is withdrawn, or the investigator determines it is necessary.\n\nAdjuvant therapy:\n\nAfter surgery, patients will receive physician's choice of therapy (TPC).\n\nSafety follow-up:\n\nPatients will be followed until they start another anticancer therapy, all adverse events have resolved to Grade 0-1 or baseline level, or death-whichever occurs first.",[171],"2026-03-29",{"date":199,"type":30},"2026-04-02",{"date":201,"type":30},"2025-09-12",{"date":203,"type":21},"2031-12-31",{"name":36,"class":37},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":49,"phases":213,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":38},"100630635","phase-1-trilaciclib-in-combination-with-chemotherapy-in-patients-with-cdk46-dependent-solid-tumors-100630635","NCT07490236","Trilaciclib in Combination With Chemotherapy in Patients With CDK4\u002F6-Dependent Solid Tumors","Exploration of Indications and Establishment of a Primary Prevention Prediction Model for Trilaciclib in Combination With Chemotherapy in Patients With CDK4\u002F6-Dependent Solid Tumors, and Investigation of the Mechanisms of Related Influencing Factors","Inclusion Criteria:\n\n* patients for whom primary prophylaxis with trilaciclib is indicated per Model A will receive primary prophylactic treatment.\n\nExclusion Criteria:\n\n* patients for whom primary prophylaxis with trilaciclib is not indicated per Model A will receive secondary prophylaxis according to protocol.",{"count":167,"type":21},[214],"PHASE1","Trilaciclib, an innovative first-in-class therapy that protects bone marrow at the source, has been approved for use in CDK4\u002F6-independent small-cell lung cancer. However, clinical practice shows that patients with solid tumors frequently experience treatment-related pancytopenia involving neutrophils, erythroid lineage, and platelets after antineoplastic therapy, with a particularly high incidence of grade 3-4 myelosuppression. This poses serious threats to patient safety and delays the timely, standard administration of anticancer treatments. Therefore, it is imperative to investigate the expansion of trilaciclib's indications to solid tumors and its underlying mechanisms, and to establish a primary prophylaxis prediction model for solid tumor patients receiving chemotherapy.\n\nThis study is designed in three parts:\n\n1. Retrospective study: Collect real-world clinical data from patients with solid tumors who received trilaciclib for bone marrow protection during antineoplastic therapy, identify relevant multifactorial determinants, and use statistical methods to develop Primary Prophylaxis Prediction Model A.\n2. Prospective study: Based on Model A, patients will be allocated into two experimental cohorts. Experimental Cohort 1: patients for whom primary prophylaxis with trilaciclib is indicated per Model A will receive primary prophylactic treatment. Experimental Cohort 2: patients for whom primary prophylaxis with trilaciclib is not indicated per Model A will receive secondary prophylaxis according to protocol. Outcomes will include the incidence of grade 3-4 myelosuppression, factors potentially influencing trilaciclib's marrow-protective effect, objective response rate (ORR) and progression-free survival (PFS) over 4-6 cycles, and changes in immunologic parameters.\n3. Mechanistic exploration: Factors identified by the prediction model as influencing the need for trilaciclib primary prophylaxis will serve as mechanistic targets. Through in vivo and in vitro experiments using flow cytometry and single-cell sequencing, we will validate trilaciclib's bone marrow-protective effects across animal models of solid tumors with varying CDK4\u002F6 dependence, and assess changes in tumor efficacy endpoints, T-lymphocyte subsets, and tumor immune microenvironment markers following trilaciclib monotherapy or combination with standard anticancer regimens.",[217,218],"Trilaciclib","CDK4\u002F6-dependent Solid Tumors","2026-03-19",{"date":221,"type":30},"2026-03-24",{"date":223,"type":30},"2023-01-01",{"date":225,"type":21},"2028-08-01",{"name":36,"class":37},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":233,"enrollmentInfo":234,"targetDuration":235,"studyType":22,"phases":4,"briefSummary":236,"conditions":237,"keywords":240,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":38},"100603014","construction-and-evaluation-of-tumor-immunotherapy-and-organ-damage-early-warning-system-based-on-multi-omics-100603014","NCT07131007","Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics","Inclusion Criteria:\n\n· Patients with cancer who are receiving immune checkpoint inhibitor treatment.\n\nExclusion Criteria:\n\n* Active phase of severe autoimmune disease.\n* Severe organ dysfunction.\n* Presence of active infection.\n* Pregnancy or lactation.\n* Allergy to drug components.","80 Years",{"count":146,"type":21},"48 Months","This project is based on the in-depth analysis and integration of multi-omics data, including but not limited to genomics, transcriptomics, proteomics, and metabolomics. It aims to construct a comprehensive early-warning system for organ function damage in immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) during tumor immunotherapy. The core objective of this system is to enhance the overall safety and efficacy of tumor immunotherapy.\n\nFirst, the project leverages a database to mine the differential omics data of tumor immunotherapy patients with combined organ dysfunction (including combined and non-combined severe infections) within the scope of this project. By integrating biochemical indicators and related hemodynamic data, it constructs a risk early-warning system for organ damage in patients undergoing tumor immunotherapy, while verifying its clinical value and guiding significance.\n\nThe specific contents mainly include: capturing specific molecules of organ damage in severe patients after tumor immunotherapy, screening genes, proteins, and metabolic products related to organ damage (including the heart, lungs, brain, liver, kidneys, gastrointestinal tract, etc.), and identifying new specific organ damage biomarkers under different pathogenic factors such as tumor immunotherapy, infections, and irAEs. It collects general clinical information, biochemical indicators, and hemodynamic indicators, and combines multi-omics data to establish an organ damage prediction model. Machine learning algorithms are used for optimization to construct an early-warning system.\n\nModel optimization within the system will be carried out, along with prospective clinical research and multi-dimensional verification. By evaluating the accuracy and cost-effectiveness of the model, it provides decision-making support for clinicians and promotes the development of personalized treatment.",[238,239],"Malignant Neoplasm","Organ Damage",[241,242,243,244],"Tumor immunotherapy","Immune checkpoint inhibitors","Immune - related adverse events","organ damage",{"date":246,"type":30},"2026-03-23",{"date":248,"type":30},"2025-09-15",{"date":250,"type":21},"2029-01-01",{"name":36,"class":37},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":49,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100627395","phase-2-short-course-radiotherapy-in-tnt-combined-with-enlonstobart-for-pmmr-larc-100627395","NCT07448077","Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC","Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* 1.age \\>=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .\n\n  4.Staged as T3-4 NanyM0 or T1-2N+ M0 according to the AJCC 8th edition. 5.Rectal cancer: \\\u003C10 cm from the anal verge. 6.Adequate organ function:\n  1. Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL. ii. Platelet count ≥ 100 × 10⁹\u002FL . iii. Hemoglobin ≥ 90 g\u002FL.\n  2. Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Creatinine ≤ 1.5 × ULN ; Renal: Calculated Creatinine Clearance (CrCl) ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n  3. Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n\n     7\\. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment.\n\n     8\\. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments.\n\n     Exclusion Criteria:\n     1. Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma.\n     2. Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer.\n     3. Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment.\n     4. Has active infection, including but not limited to HIV, or positive HBV\u002FHCV viral load requiring antiviral therapy for control and stabilization.\n     5. Significant cardiovascular disease, such as myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, or hypertension that remains uncontrolled above 160\u002F100 mmHg despite optimal therapy.\n     6. History of other malignant tumors, excluding non-melanoma skin cancer and cervical carcinoma in situ that have been curatively treated and disease-free for ≥ 5 years.\n     7. Uncontrolled diabetes (HbA1c \\> 8%) or thyroid dysfunction requiring medication for abnormal TSH.\n     8. Severe chronic intestinal conditions，including but not limited to Crohn's disease or active ulcerative colitis.\n     9. The investigators believe that patients were inappropriate for participation.",{"count":260,"type":21},128,[78],"Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer",[264],"Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer","2026-02-25",{"date":267,"type":30},"2026-03-04",{"date":269,"type":21},"2026-03-01",{"date":271,"type":21},"2030-06-30",{"name":36,"class":37},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":279,"targetDuration":281,"studyType":22,"phases":4,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":38},"100626317","real-world-study-on-the-prevention-of-neutropenia-after-tumor-treatment-with-mecapegfilgrastim-injection-100626317","NCT07434063","Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection","Inclusion Criteria:\n\n* 1\\. Patients with malignant tumors confirmed by histopathology or cytology; 2. Age ≥18 years old; 3. After referring to various guidelines, the researchers believed that the subjects:\n\n  1. Patients who are currently receiving treatment regimens with high FN risk;\n  2. Patients who are currently receiving treatment regimens for moderate FN risk and meet any one of the factors that increase the risk coefficient;\n  3. FN or dose-limiting neutropenia events have occurred in previous treatment cycles;\n  4. In addition to the above, the researchers believe that the medication regimens will cause neutropenia and affect the normal treatment of the subjects; 4. Researchers believe that they can benefit; 5. Voluntarily participate in this clinical trial and be able to sign the informed consent form in person.\n\nExclusion Criteria:\n\n* 1\\. Those who are allergic to the test drug； 2. Those with mental or neurological disorders who are unable to cooperate； 3. Pregnant or lactating female patients; Women of childbearing age who refuse to take contraceptive measures； 4. Those who were considered unsuitable for inclusion by the researchers.",{"count":280,"type":21},200,"42 Days","This study is a multicenter, observational real-world study, aiming to observe and evaluate the efficacy and safety of prophylactic application of Mecapegfilgrastim Injection in tumor patients after radiotherapy\u002Fchemotherapy\u002Fimmunotherapy in the real world to prevent neutropenia.The subjects who met the inclusion criteria of the protocol were defined as those who needed radiotherapy\u002Fchemotherapy\u002Fimmunotherapy after being diagnosed with solid malignant tumors. The researchers believed that the subjects needed to use Mecapegfilgrastim Injection for primary\u002Fsecondary prevention after receiving tumor treatment.",[284],"Neutropenia","2026-02-24",{"date":265,"type":30},{"date":288,"type":30},"2025-06-18",{"date":290,"type":21},"2027-06-30",{"name":36,"class":37},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":299,"targetDuration":4,"studyType":49,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":38},"100624513","phase-2-ctdna-monitoring-guides-the-treatment-of-nsclc-with-befotertinib-combined-with-radiotherapy-100624513","NCT07410611","ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy","Dynamic ctDNA Monitoring Guides a Single-Arm, Multicenter, Exploratory Study of Befotertinib Combined With Radiotherapy for EGFR-Mutated Oligometastatic NSCLC","Inclusion Criteria:\n\n1. Age 18-75 years at the time of signing the informed consent form, both males and females are eligible;\n2. Histologically confirmed newly diagnosed or treatment-naïve oligometastatic stage IV NSCLC (AJCC 9th edition) with ≤3 involved organs and ≤5 metastatic lesions. Regional lymph node involvement (regardless of number) is not counted as metastatic sites; non-regional lymph node involvement is classified as a metastatic lesion;\n3. Presence of an EGFR sensitizing mutation (19Del or 21L858R);\n4. At least one measurable lesion according to RECIST v1.1;\n5. ECOG performance status 0-1;\n6. Life expectancy ≥12 weeks;\n7. No prior systemic anti-tumor therapy for advanced NSCLC, including standard chemotherapy, biologic therapy, targeted therapy, immunotherapy, or investigational drug treatment before starting the study drug. Patients who have received adjuvant or neoadjuvant therapy (chemotherapy and\u002For radiotherapy) are eligible if there has been no progression within 6 months after completion of such therapy;\n8. Adequate organ function (no transfusion, growth factor support, or medical correction within 14 days before screening):\n\n   Hematology:\n   1. Hemoglobin (HB) ≥90 g\u002FL;\n   2. Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n   3. Platelet count (PLT) ≥100 × 10⁹\u002FL;\n   4. White blood cell count (WBC) ≥4.0 × 10⁹\u002FL and ≤15 × 10⁹\u002FL.\n\n   Blood biochemistry (no transfusion or albumin infusion within 14 days before screening):\n   1. AST and ALT ≤1.5 × ULN (≤5 × ULN if liver metastases are present);\n   2. Alkaline phosphatase (ALP) ≤2.5 × ULN;\n   3. Total bilirubin (TBiL) ≤1.5 × ULN;\n   4. Albumin (ALB) ≥30 g\u002FL;\n   5. Serum creatinine (Cr) ≤1.5 × ULN and creatinine clearance (CrCL) ≥60 mL\u002Fmin (Cockcroft-Gault formula);\n   6. Activated partial thromboplastin time (APTT) ≤1.5 × ULN, and INR or PT ≤1.5 × ULN.\n9. Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion; a negative serum or urine pregnancy test within 7 days before enrollment is required, and the patient must not be breastfeeding. Male participants must agree to use contraception during the study and for 6 months afterward;\n10. Voluntary participation in the study, provision of written informed consent, good compliance, and willingness to provide blood samples.\n\nExclusion Criteria:\n\n1. Small cell lung cancer or non-small cell lung cancer mixed with histologic types such as small cell lung cancer or neuroendocrine carcinoma;\n2. Confirmed EGFR exon 20 insertion mutation or non-classical mutations such as L861Q, G719X, or S768I;\n3. Prior systemic anti-tumor therapy for advanced\u002Fmetastatic NSCLC (e.g., standard chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc.);\n4. Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression, or imaging (CT or MRI) findings of brain or leptomeningeal disease at screening (except those with previously treated brain metastases who have been stable and without progression for ≥4 weeks before enrollment, and confirmed by brain MRI, CT, or venography to have no evidence of intracranial hemorrhage);\n5. Known history of hypersensitivity to the active or inactive excipients of Befotertinib or to drugs with similar chemical structures or classes;\n6. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.;\n7. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid treatment;\n8. Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, active bleeding, etc., that in the investigator's judgment would compromise patient participation or protocol compliance, or any active infection including uncontrolled hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);\n9. QTc prolongation \\>470 ms or any clinically significant arrhythmia;\n10. Any condition that, in the investigator's judgment, would preclude participation in this study, including patients deemed unlikely to comply with study procedures, constraints, and requirements, or other situations at the investigator's discretion.",{"count":300,"type":21},84,[78],"Befotertinib is a third-generation EGFR-TKI independently developed in China. In first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR mutations, it has demonstrated a median progression-free survival (PFS) of 22.1 months, representing the longest reported PFS data among currently available third-generation EGFR-TKIs. Building on the clinical advantages of this agent and addressing the unmet therapeutic needs in oligometastatic NSCLC, this study aims to conduct a prospective exploration by dynamically monitoring circulating tumor DNA (ctDNA) to guide the application of befotertinib combined with radiotherapy in patients with EGFR mutation-positive oligometastatic NSCLC.",[304],"Patients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological Examination","2026-02-08",{"date":307,"type":30},"2026-02-13",{"date":309,"type":21},"2026-02-10",{"date":311,"type":21},"2030-02-28",{"name":36,"class":37},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":49,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":38},"100613429","phase-2-clinical-study-of-adbelimumab-in-the-adjuvant-treatment-of-esophageal-squamous-cell-carcinoma-100613429","NCT07266480","Clinical Study of Adbelimumab in the Adjuvant Treatment of Esophageal Squamous Cell Carcinoma.","A Randomised, Controlled Clinical Study of Adebrelizumab for the Adjuvant Treatment of Esophageal Squamous Cell Cancer.","Inclusion Criteria:\n\n1.Age:≥18 years old, male or female; 2.Histopathologically confirmed esophageal squamous cell cancer with initial clinical stage cT1b-2N1-3M0 or cT3-4aN0-3M0 in the thoracic esophagus; 3.Radical surgery with R0 resection 4-16 weeks prior to randomisation; 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5.Expected survival ≥ 12 months; 6.Left ventricular ejection fraction is \\>50%; 7.Normal functioning of major organs, i.e. meeting the following criteria:\n\n1. routine blood tests:\n\n   1. HB≥90g\u002FL；\n   2. ANC≥1.5×109\u002FL；\n   3. PLT≥100×109\u002FL；\n2. biochemical examination:\n\n   1. ALT and AST\\\u003C2.5ULN（liver metastasis: ALT and AST\\\u003C5ULN）；\n   2. TBIL≤1.5ULN；\n   3. creatinine ≤1.5ULN； 8.Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.\n\nExclusion Criteria:\n\n1. Patients initially diagnosed as unresectable (e.g. large metastatic lymph nodes) and treated with conversion therapy;\n2. Patients with severe postoperative complications who are not suitable for adjuvant therapy;\n3. Patients who have received any form of adjuvant therapy after surgery;\n4. Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;\n5. Pre-existing other malignancies, unless complete remission was achieved at least 5 years prior to enrolment and no other treatment is expected to be required during the study period;\n6. Patients with active, known or suspected autoimmune disease, including but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma\u002Fallergies that have been in complete remission and do not require any intervention in adulthood may be considered for inclusion, but medical intervention with bronchodilator is required patients may not be included;\n7. People with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;\n8. Pregnant or breastfeeding women and women of childbearing age with a history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation who are not using contraception during the trial period;\n9. Presence of clinically uncontrolled cardiac symptoms or disease, including but not limited to, such as (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 6 months, (4) clinically significant supraventricular or ventricular arrhythmia not clinically intervened with or poorly controlled after clinical intervention;\n10. Not suitable for enrolment in the investigator's comprehensive assessment.",{"count":321,"type":21},142,[78],"Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer.",[325],"Squamous Oesophageal Cancer","2025-12-04",{"date":328,"type":30},"2025-12-05",{"date":330,"type":30},"2025-09-01",{"date":332,"type":21},"2030-09-01",{"name":36,"class":37},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":49,"phases":343,"briefSummary":344,"conditions":345,"keywords":350,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":38},"100615237","phase-2-iparomlimab-and-tuvonralimab-combined-with-apatinib-and-irinotecan-hydrochloride-for-the-treatment-of-advanced-alpha-fetoprotein-producing-gastric-cancer-afpgc-100615237","NCT07289997","Iparomlimab and Tuvonralimab Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC)","Iparomlimab and Tuvonralimab Injection Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC) That Progresses From First-line PD-1 Combined Chemotherapy, A Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Age≥18 years, both male and female are acceptable.\n3. Unresectable，Locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has been diagnosed by histopathological or cytological examination, with serum alpha-fetoprotein \\> 20.0 ng\u002FmL at the time of diagnosis. There is at least one measurable lesion (according to the RECIST v1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm; lesions that have received local treatment in the past can be used as target lesions after comfirmed progression according to the RECIST v1.1).\n4. Failure of previous first-line PD-1 combined chemotherapy treatment (disease progression during or after treatment); Those who relapse within 6 months (less than 183 days) after the end of adjuvant\u002Fneoadjuvant chemotherapy (oxaliplatin combined with fluorouracil) can be included in the study, and PD-1 inhibitors need to be combined in the first-line treatment.\n5. ECOG 0-1;\n6. Expected survival time ≥12 weeks;\n7. The functions of vital organs within 7 days before enrollment meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment) :\n\n   \\\u003C1\\> Absolute neutrophil count ≥1.5×109\u002FL; \\\u003C2\\> platelet count ≥80×109\u002FL; \\\u003C3\\>Hemoglobin ≥9g\u002FdL; \\\u003C4\\>Total bilirubin \\\u003C 1.5 times ULN; \\\u003C5\\>ALT and AST \\\u003C 2.5 times ULN (\\\u003C 5 times ULN in patients with liver metastasis); \\\u003C6\\> serum creatinine ≤1 times ULN; \\\u003C7\\>The endogenous creatinine clearance rate ≥ 50ml\u002Fmin.\n8. Women of childbearing age should take effective contraceptive measures.\n9. Good compliance and cooperation with follow-up visits.\n\nExclusion Criteria:\n\n1. Inability to comply with the research plan or procedures;\n2. It is known to be in a HER2-positive state;\n3. Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other tissue types, or adenocarcinoma mixed with other tissue types of gastric cancer;\n4. The patient currently has any diseases or conditions that affect the absorption of the drug;\n5. Combined with severe cardiovascular diseases, such as uncontrollable heart failure, coronary heart disease, arrhythmia, uncontrollable hypertension, etc.\n6. Patients with active brain metastases. Patients with asymptomatic brain metastases who have not received prior treatment and whose total number of brain metastases is ≤3 and the longest diameter is \\\u003C 1cm can be enrolled. Patients who have previously received treatment for brain metastases can be enrolled if they are clinically stable, have no evidence of new or expanded brain metastases, and have not used steroids for ≥14 days before the study intervention.\n7. Known to be allergic to the drug used in this test;\n8. Previously received immune checkpoint inhibitors other than anti-PD-1 \u002FPD-L1 antibodies or other drugs\u002Fantibodies acting on T-cell co-stimulation or checkpoint pathways;\n9. Significant clinically significant bleeding symptoms or a clear bleeding tendency occurred within 3 months before enrollment; Gastrointestinal perforation and\u002For gastrointestinal fistula occurred within 6 months before enrollment; Arterial\u002Fvenous thrombotic events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.\n10. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or hepatitis C (previous history of hepatitis B virus infection regardless of drug control, hepatitis B virus DNA≥1×104 copies \u002FmL or 2000 IU\u002Fml);\n11. Known history of primary immunodeficiency or active pulmonary tuberculosis;\n12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n13. There is a known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive);\n14. Significant malnutrition (weight loss of 5% within one month of signing the informed consent form or 15% within three months, or a reduction of half or more in food intake within one week), except for more than four weeks after the correction of malnutrition before the administration of the first dose of the study drug;\n15. History of other primary malignant tumors, excluding:\n\n    \\\u003C1\\>Malignant tumors that achieved complete remission for at least 2 years before enrollment and did not require additional treatment during the study period; \\\u003C2\\>Non-melanoma skin cancer or malignant freckle-like nevus that has been fully treated and has no evidence of disease recurrence; \\\u003C3\\>Carcinoma in situ that has received adequate treatment and has no evidence of disease recurrence.\n16. Female patients who are pregnant or breastfeeding;\n17. According to the researcher's judgment, those with concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;\n18. The researchers considered patients unsuitable for inclusion in this study.",{"count":342,"type":21},39,[78],"This study is a single-arm study aimed at evaluating the efficacy and safety of Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan hydrochloride in the treatment of advanced alpha-fetoprotein gastric cancer (AFPGC) that progresses from first-line PD-1 combined with chemotherapy. The study enrolled patients with advanced gastric cancer and gastroesophageal junction cancer whose serum alpha-fetoprotein was greater than 20.0 ng\u002FmL at the initial diagnosis and progressed after first-line PD-1 combined chemotherapy in a single center of the Fourth Hospital of Hebei Medical University. All patients underwent gastroscopy and were pathologically confirmed as Her-2 negative gastric adenocarcinoma, and had received PD-1 inhibitor treatment as the first-line treatment. Staged examinations include enhanced CT of the abdominal and pelvic cavities, plain CT scan of the chest, and color Doppler ultrasound of superficial lymph nodes. The enrolled patients received apalolitovolrelimab 5.0mg\u002Fkg, Q3W, d1; Apatinib mesylate, 0.25g, once daily; Irinotecan hydrochloride, 200mg\u002Fm², Q3W, d1. Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years.\n\nThe primary endpoint of the study was to assess the objective response rate (ORR) of combination therapy. Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and the incidence of adverse events, etc",[346,347,348,349],"AFP Gastric or Gastroesophageal Junction Adenocarcinoma","PD-1\u002FCTLA-4","AFPGC","Immunotherapy",[351,348,347],"immunotherapy",{"date":353,"type":30},"2025-12-17",{"date":355,"type":30},"2025-09-28",{"date":357,"type":21},"2028-09",{"name":36,"class":37},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":49,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":38},"100615238","phase-2-the-efficacy-and-safety-of-iparomlimab-and-tuvonralimab-injection-combined-with-chemotherapy-as-the-first-line-treatment-for-esophageal-squamous-cell-carcinoma-100615238","NCT07290010","The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma","A Clinical Trial to Explore the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 years old, gender not limited;\n2. Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types);\n3. For patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy\u002Fchemoradiotherapy, or radical concurrent chemoradiotherapy , the time from the last treatment to disease recurrence is more than 6 months;\n4. ECOG 0-1;\n5. According to RECIST v1.1, there is at least one measurable lesion;\n6. Be capable of providing newly obtained or archived tissue samples for immunohistochemical analysis of PD-L1 expression;\n7. The patient's organ functions are normal, with no serious abnormalities in blood, heart, lung, liver or kidney functions, and no immune deficiency diseases.\n8. The patient has normal coagulation function and no active bleeding or thrombotic diseases.\n9. Expected survival time ≥12 weeks;\n10. Male subjects who are female of childbearing age or whose sexual partners are female of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period.\n11. Voluntarily sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan\n\nExclusion Criteria:\n\n1. Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy;\n2. Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction;\n3. There is a risk of perforation after stent implantation in the esophageal or tracheal cavity;\n4. Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past;\n5. Other malignant tumors diagnosed within 5 years prior to the first administration, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and\u002For effectively resected cervical cancer and\u002For breast cancer in situ;\n6. Severe infection occurs (CTCAE\\>grade 2), or active pulmonary inflammation;\n7. Previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment;\n8. Patients with active tuberculosis infection;\n9. Participate in another interventional clinical study simultaneously, unless participating in an observational (non-interventional) clinical study or being in the follow-up stage of an interventional study;\n10. Patients with congenital or acquired immune deficiencies, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit), or patients with co-infection of hepatitis B and hepatitis C;\n11. There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n12. Having undergone major surgical operations (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first dose of the study treatment or expecting to undergo major surgeries during the study treatment period;\n13. It is known that there are symptomatic central nervous system metastases and\u002For cancerous meningitis (except for stable brain metastases that do not require steroid treatment);\n14. It is known that there is an active autoimmune disease requiring symptomatic treatment or a history of the disease within the past 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy, and type 1 diabetes who only need insulin replacement therapy can be enrolled).\n15. Female patients who are pregnant or breastfeeding;\n16. Any serious or uncontrolled systemic disease that researchers believe may increase the risk of participation in patients",{"count":7,"type":21},[78],"This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months.\n\nThe main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.",[370],"Esophageal Squamous Cell Carcinoma (ESCC)",[351,372,347,373],"ESCC","Esophageal Squamous Cell Carcinoma",{"date":353,"type":30},{"date":376,"type":30},"2025-09-26",{"date":378,"type":21},"2028-06",{"name":36,"class":37},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":49,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":4},"100606772","phase-2-radiotherapy-combined-with-ql1706-and-bevacizumab-for-unresectable-non-metastatic-hepatocellular-carcinoma-100606772","NCT07179900","Radiotherapy Combined With QL1706 and Bevacizumab for Unresectable Non-metastatic Hepatocellular Carcinoma","Exploration of Radiotherapy Combined With QL1706 and Bevacizumab for the Conversion Treatment of Unresectable Non-metastatic Hepatocellular Carcinoma: A Prospective, Open-label, Randomized Controlled Clinical Study","Inclusion Criteria:\n\nAge ≥ 18 years old, gender not limited; PS score 0-2; Pathologically or clinically diagnosed as primary HCC and has not received other anti-HCC treatment; No history of other malignant tumors or treatment; Patients with BCLC stage B or C before treatment and no distant metastasis, and surgical assessment indicates that first-line surgical resection is not feasible; Liver function grade Child-Pugh A or B ≤ 7 points; For patients with active HBV infection, antiviral treatment should be initiated at least 7 days before treatment and they should agree to continue antiviral treatment during the study period; No severe cardiovascular or cerebrovascular diseases; Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the treatment period and 6 months after treatment; if the serum or urine pregnancy test is negative within 14 days before inclusion in the study, and the patient must be non-lactating; men should agree to take contraceptive measures during the study period and 6 months after the study; Voluntarily sign the written informed consent form and commit to comply with the protocol during the study period, including accepting treatment and scheduled visits and examinations, including follow-up; The expected survival must be at least 12 weeks.\n\nExclusion Criteria:\n\nPatients who do not meet the above main inclusion criteria; Patients who refuse to sign the informed consent form; Patients with pathological types of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma; or those with postoperative pathology suggesting metastatic cancer or primary cancer of other tissue types; Patients with portal hypertension diagnosed by preoperative enhanced abdominal CT and endoscopy, with a history of esophageal variceal bleeding, severe hypersplenism syndrome or refractory ascites; Patients diagnosed with severe active scleroderma, lupus, other rheumatic diseases or autoimmune diseases within the past 3 months before study recruitment; patients with a history of clinically severe autoimmune diseases or those requiring systemic steroids or immunosuppressants will not be allowed to participate in this study; Patients with a history of cognitive dysfunction or mental illness that affects treatment compliance; Patients whom the investigator deems unsuitable for participation in this study.",{"count":193,"type":21},[78],"This project is a prospective, open-label, randomized controlled clinical study. It plans to enroll 60 patients with unresectable HCC and no distant metastasis, randomly assigned to the experimental group and the control group, with 30 cases in each group. The experimental group was treated with radiotherapy combined with immunotherapy and Bevacizumab, while the control group was treated with immunotherapy and Bevacizumab. The efficacy of the patients and the conversion rate to surgery were evaluated.",[391],"Hepatocellular Carcinoma",{"date":393,"type":30},"2025-12-11",{"date":395,"type":21},"2025-12",{"date":397,"type":21},"2028-10",{"name":36,"class":37},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":73,"minAge":18,"maxAge":46,"enrollmentInfo":406,"targetDuration":4,"studyType":49,"phases":408,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":38},"100524357","phase-2-dalpiciclib-plus-ai-neoadjuvant-endocrine-therapy-compared-with-neoadjuvant-chemotherapy-in-early-breast-cancer-ebc-100524357","NCT06107673","Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）","A Phase II Randomized, Non-inferiority Study Comparing the Efficacy and Safety of Dalpiciclib Combined With AI With Neoadjuvant Chemotherapy in ER+ HER2- Postmenopausal Breast Cancer Patients","Inclusion Criteria:\n\n1. Sign the informed consent form to participate in the clinical research.\n2. Confirmed postmenopausal females diagnosed with invasive breast cancer.\n3. Clinical stage T1-3N1M0.\n4. Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (++) but in situ hybridization (ISH) indicates negative. Strong positive for ER: ER immunohistochemistry test shows 50% or more tumor cells positive.\n5. No prior breast cancer-related treatment.\n6. No concurrent cardiac diseases, baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I).\n7. ECOG score of 0-1, meeting the indications and basic requirements for chemotherapy without major organ dysfunction.\n8. Within 1 week prior to enrollment, routine blood tests are essentially normal: Absolute neutrophil count (NEUT#) ≥ 1.5×10\\^9 \u002FL; White blood cell count (WBC) ≥ 3.0×10\\^9 \u002FL; Platelets ≥ 90×10\\^9 \u002FL; Hemoglobin ≥ 90 g\u002FL.\n9. Within 1 week prior to enrollment, liver and kidney function tests are essentially normal: Total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN); Alanine aminotransferase and aspartate aminotransferase (ALT\u002FAST) ≤ 2× ULN; Serum creatinine ≤ 1.5× ULN or creatinine clearance rate (Ccr) ≥ 60 ml\u002Fmin.\n10. For women of childbearing age, negative serum or urine pregnancy test results before participation; premenopausal women during the study period should use medically acceptable methods of contraception.\n11. Exhibits good compliance.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, and women of childbearing age who have a positive pregnancy test at baseline and do not agree to use effective contraception during the study.\n2. Patients with a known history of severe allergic reactions to any investigational drug components (NCI-CTCAE Grade \\> 3) or with any clearly documented drug allergy.\n3. Patients with bilateral breast cancer or inflammatory breast cancer.\n4. Patients with metastatic (stage IV) breast cancer at initial diagnosis.\n5. Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction.\n6. Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc.\n7. Current diagnosis of severe liver-related diseases such as acute hepatitis, fulminant hepatitis, coagulation factor synthesis disorders. If HBV surface antigen or HBV core antibody are positive, the peripheral blood HBV DNA titer should be \\\u003C 1×10\\^3 IU\u002Fml for eligibility.\n8. Any other serious medical condition or comorbidity that may interfere with participation in the study or may significantly affect the safety of the subject (e.g., active or uncontrolled infections, active or requiring antiviral therapy for liver and bile diseases).\n9. Other invasive malignancies (including second primary breast cancer) that may interfere with the evaluation of study endpoints and compliance with the protocol.\n10. Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer).\n11. Patients who have undergone major surgery within 4 weeks prior or have significant unresolved medical conditions.\n12. Patients with non-measurable tumors during treatment.\n13. Any other condition that the investigator deems unsuitable for the participation of the subject in the study.",{"count":407,"type":21},144,[78],"This study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive（ER≥50%），HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior safety profile.",[171],[412,174,413],"HER2- ER+","Dalpiciclib",{"date":393,"type":30},{"date":416,"type":30},"2023-09-30",{"date":418,"type":21},"2028-12-01",{"name":36,"class":37},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":49,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":38},"100479652","phase-4-chemotherapy-combined-with-bevacizumab-neoadjuvant-therapy-for-her2-negative-breast-cancer-100479652","NCT05525767","Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer","Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer","Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Signed the informed consent and volunteered to join the study with good compliance;\n\n3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER\u002FPR positive and HER2 negative) :\n\n* HER2 negative was defined as 0\u002F1+ on standard IHC test; HER2\u002FCEP17 ratio was less than 2.0 or HER2 gene copy number was less than 4.\n* ER positive and\u002For PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%;\n\n  4\\. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0);\n\n  5\\. The main organs function well and meet the following standards:\n\nA) Hemoglobin (HGB)≥90g\u002FL;\n\nB) Neutrophil absolute value (NEUT)≥1.5×109\u002FL;\n\nC) Platelet count (PLT)≥ 100×109\u002FL;\n\nD) leukocyte ≥3.0×109\u002FL;\n\nE) Total bilirubin \\\u003C1.5 ULN (upper limit of normal)\n\nF) Creatinine \\\u003C 1.5×ULN\n\nG) AST\u002FALT \\\u003C 1.5×ULN;\n\n6\\. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);\n\n7\\. The investigators determined that the patients were suitable for treatment with bevacizumab.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer;\n2. Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.;\n3. Patients who are participating in other intervention studies;\n4. Women with confirmed pregnancy or lactation;\n5. According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.",{"count":428,"type":21},75,[51],"This is an prospective, multicenter, single-arm clinical study.",[432],"Solid Tumor",{"date":393,"type":30},{"date":435,"type":30},"2022-03-31",{"date":437,"type":21},"2028-12-31",{"name":36,"class":37},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":73,"minAge":18,"maxAge":165,"enrollmentInfo":446,"targetDuration":4,"studyType":49,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":4},"100479400","phase-2-olaparib-in-the-treatment-of-brca12-unmutated-and-brca1-promoter-methylated-recurrent-and-metastatic-triple-negative-breast-cancer-100479400","NCT05522491","Olaparib in the Treatment of BRCA1\u002F2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer","An Open-label, Single-arm, Single-center Exploratory Clinical Study of Olaparib in the Treatment of BRCA1\u002F2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age 18-70 years old, female; 2. Histologically confirmed recurrent and metastatic TNBC patients without BRCA1\u002F2 mutation and BRCA1 promoter methylation.\n\nNote: Triple-negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (HER2) negative. ER and PR negative were defined as: ER\\\u003C1% positive, PR\\\u003C1% positive. HER2 negativity was defined as: HER2 (-) or (1+) or HER2 (2+) FISH negative by immunohistochemistry.\n\n3\\. The number of treatment lines at the stage of recurrence and metastasis should not exceed 2 lines.\n\n4\\. According to RECIST1.1 criteria, there is at least one evaluable lesion; 5. ECOG physical condition score ≤ 1 point; 6. Expected survival period ≥ 3 months;\n\nExclusion Criteria:\n\n* 1\\. Pregnant, breastfeeding women, or those who are fertile and unwilling to take effective contraceptive measures; 2. Patients who have received chemotherapy, radiotherapy, targeted therapy and other anti-tumor treatments within 4 weeks before enrollment; 3. Previous use of PARP inhibitors, including olaparib and other PARP inhibitors; 4. Known serious cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina pectoris, or known heart failure in the past 6 months, QT interval\\>450ms; 5. The toxicity of the previous treatment regimen has not recovered before enrollment, and there are still toxic reactions of grade 1 or above (except for alopecia); 6. Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or patients with total gastrectomy; 7. Patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases; 8. History of severe central nervous system disease (including epilepsy patients); 9. In the past 5 years, suffering from a second primary malignant tumor other than breast cancer and receiving related treatment; 10. Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections; 11. Patients who are allergic to this test drug or similar drugs; 12. Those who have participated in clinical trials of other drugs within 28 days before screening, or plan to participate in any other clinical trials during this study; 13. Any other disease or condition of clinical significance (such as active or uncontrolled infection, etc.) that the investigator believes may affect compliance with the protocol or affect the patient's signing of ICF",{"count":447,"type":21},30,[78],"This is an open-label, single-arm, single-center,exploratory clinical study.",[432],{"date":393,"type":30},{"date":453,"type":21},"2026-09-01",{"date":455,"type":21},"2031-09-01",{"name":36,"class":37},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":38},"100483670","efficacy-and-safety-of-dalpiciclib-in-hormone-receptor-positive-advanced-breast-cancer-100483670","NCT05578053","Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer","Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer: a Multicenter, Observational, Real-world Study","Inclusion Criteria:\n\n1. age ≥ 18 years, postmenopausal or premenopausal female or male patients, female patients must meet one of the following: a) previous bilateral oophorectomy, or age ≥ 60 years; b) age \\\u003C 60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; c) premenopausal or perimenopausal female patients can also be enrolled, but must be willing to receive LHRH agonist therapy during the study;\n2. pathological examination confirmed HR-positive male\u002Ffemale breast cancer patients, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy with the purpose of cure;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n4. Serum pregnancy test must be performed within 28 days before enrollment in women of childbearing age and the result is negative,And male\u002Ffemale patients are willing to use a medically recognized highly effective contraceptive during the study and within 1 year after the last dose of study drug;\n5. non-pregnant or non-lactating female patients；\n6. do not participate in other ongoing studies at the same time ；\n7. agreed by the patient himself or her legal representative and have signed an informed consent form, willing and able to comply with scheduled visits, study treatment plan, laboratory tests and other trial procedures.\n\nExclusion Criteria:\n\n1. any evidence of serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorders, active infections, including hepatitis B, C, and human immunodeficiency virus, or severely impaired bone marrow reserve or organ function, including liver and kidney damage, which, in the opinion of the investigator, would greatly alter the balance of wind benefit\u002Frisk.\n2. at the time of initiation of dalpiciclib treatment, the patient has not recovered from any CTCAE grade ≥ 3 toxicity caused by previous treatment\n3. known history of hypersensitivity to dalpiciclib or excipients or drugs with similar chemical structure to dalpiciclib\n4. patients who are considered unsuitable for inclusion by the investigator.",{"count":465,"type":21},420,"This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.",[171],"2025-09-10",{"date":470,"type":30},"2025-09-11",{"date":472,"type":30},"2024-09-13",{"date":474,"type":21},"2030-12-01",{"name":36,"class":37},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":73,"minAge":18,"maxAge":165,"enrollmentInfo":483,"targetDuration":4,"studyType":49,"phases":485,"briefSummary":486,"conditions":487,"keywords":490,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":38},"100374721","phase-2-nab-paclitaxel-plus-carboplatin-versus-nab-paclitaxel-plus-capecitabine-in-the-treatment-of-advanced-triple-negative-breast-cancer-100374721","NCT04159142","Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer","Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Females with age between 18 to 70 years old;\n2. Histologically confirmed triple negative breast cancer;\n3. No more than one-line prior treatment for locally advanced or metastatic breast cancer;\n4. Have at least one measurable lesion as per the RECIST criteria (version 1.1);\n5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;\n6. Patients with life expectancy of at least 3 months;\n7. Bone marrow function：neutrophils (≥1.5×10\\^9\u002FL), platelets (≥100×10\\^9\u002FL), hemoglobin (≥90 g\u002FL);\n8. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;\n9. Patients had good compliance with the planned treatment, understood the research process and written informed consent.\n\nExclusion Criteria:\n\n1. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;\n2. Brain metastasis;\n3. Recurrence or metastasis within 6 months after capecitabine withdrawal;\n4. Recurrence or metastasis within 6 months after platinum withdrawal;\n5. Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;\n6. Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;\n7. Patients who had Grade 2 or above Peripheral neuropathy;\n8. Patients with severe systemic infection or other serious diseases;\n9. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;\n10. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;\n11. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;\n12. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;\n13. The researchers considered the patients who were not suitable for enrollment.",{"count":484,"type":21},414,[78],"This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \\\u003C1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.\n\nThe purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.",[488,489],"Triple Negative Breast Cancer","Nab-paclitaxel",[489,491,492,488,493],"Carboplatin","Capecitabine","Maintenance therapy",{"date":470,"type":30},{"date":496,"type":30},"2019-11-20",{"date":498,"type":21},"2028-09-20",{"name":36,"class":37},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":73,"minAge":18,"maxAge":165,"enrollmentInfo":507,"targetDuration":4,"studyType":49,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":38},"100373153","phase-2-nab-paclitaxel-plus-carboplatin-versus-nab-paclitaxel-plus-epirubicin-in-the-neoadjuvant-therapy-for-breast-cancer-100373153","NCT04138719","Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer","Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer","Inclusion Criteria:\n\n1. Females with age between 18 to 70 years old;\n2. Histologically confirmed primary invasive breast cancer;\n3. Histologically confirmed triple negative breast cancer;\n4. Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.\n5. Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.\n6. Have at least one measurable lesion as per the RECIST criteria (version 1.1);\n7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;\n8. LVEF≥55%；\n9. Bone marrow function：neutrophils (≥1.5×10\\^9\u002FL), platelets (≥100×10\\^9\u002FL), hemoglobin (≥90 g\u002FL);\n10. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;\n11. Patients had good compliance with the planned treatment, understood the research process and written informed consent.\n\nExclusion Criteria:\n\n1. Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;\n2. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;\n3. Patients with severe systemic infection or other serious diseases;\n4. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;\n5. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;\n6. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;\n7. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;\n8. The researchers considered the patients who were not suitable for enrollment.",{"count":508,"type":21},520,[78],"This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \\\u003C1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.\n\nNeoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery.\n\nThe purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application.\n\nThe total number of patients to be included in this study is 520 patients.",[171,512,489],"Triple-negative Breast Cancer",[512,489,491,514],"Epirubicin",{"date":470,"type":30},{"date":496,"type":30},{"date":518,"type":21},"2028-06-20",{"name":36,"class":37},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":526,"sex":73,"minAge":527,"maxAge":4,"enrollmentInfo":528,"targetDuration":530,"studyType":22,"phases":4,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":38},"100544969","clinical-study-of-breast-conserving-surgery-combined-with-intraoperative-radiotherapy-for-early-breast-cancer-100544969","NCT06375798","Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer","Inclusion Criteria:\n\n1. Age ≥55 years old；\n2. Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0；\n3. Patients who are willing to preserve milk and intend to undergo breast-conserving surgery；\n4. If invasive breast cancer is confirmed, the surgical margin negative ≥2mm should be met. If DCIS is confirmed, the surgical margin should be negative ≥3mm；\n5. ER≥ 30% and PR≥ 1%, HER2 negative；\n6. Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Simultaneous diagnosis of bilateral or multifocal breast cancer；\n2. Previous ipsilateral breast cancer and\u002For prior chest wall radiation therapy；\n3. There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest；\n4. The investigators did not consider the patient suitable for participation in any other conditions of the study.",true,"55 Years",{"count":529,"type":21},620,"5 Years","A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery.",[171,533],"HER2-negative Breast Cancer",[535,536,537],"Breast preservation surgery","Breast cancer invasion","radiotherapy","2025-09-09",{"date":248,"type":30},{"date":541,"type":30},"2020-11-19",{"date":543,"type":21},"2026-11-19",{"name":36,"class":37},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":49,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":38},"100597330","phase-2-involved-field-radiotherapy-tnt-combined-with-pd-1-inhibitor-for-pmmr-locally-advanced-rectal-cancer-neo-field-i-100597330","NCT07057089","Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)","Clinical Exploration of Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer: a Prospective, Open-label, Randomized Controlled Trial (Neo-Field I)","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n3. Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;\n4. Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);\n5. The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;\n6. Pre-enrollment laboratory indicators meet the following indicator ranges： 1)Blood: absolute neutrophils ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, hemoglobin ≥90g\u002FL; 2)Liver and kidney function: ALT\u002FAST ≤ 2.5 x ULN, total bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60mL\u002Fmin (Cockcroft-Gault formula)； 3)Coagulation: INR ≤ 1.5, APTT ≤ 1.5 x ULN (for those not receiving anticoagulation)；\n7. Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatment session;\n8. Voluntary written informed consent and commitment to complete the full treatment and follow-up program.\n\nExclusion Criteria:\n\n1. Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;\n2. Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;\n3. Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；\n4. Presence of active infection (e.g. HIV, HBV\u002FHCV viral load positive requiring stabilization on antiretroviral therapy)；\n5. Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \\>160\u002F100 mmHg)；\n6. History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years)；\n7. Uncontrolled diabetes mellitus (HbA1c \\> 8%), abnormal thyroid function (TSH outside normal range and requiring pharmacologic intervention)；\n8. Severe chronic bowel disease (e.g., Crohn's disease, active ulcerative colitis)； Patients deemed by the investigator to be unsuitable for participation in this study.",{"count":553,"type":21},90,[78],"The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.",[557],"Locally Advanced Rectal Cancer","2025-08-11",{"date":560,"type":30},"2025-08-14",{"date":562,"type":30},"2025-07-01",{"date":474,"type":21},{"name":36,"class":37},""]