[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-therapy":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,45,70,94,120,145,184,214,238,258,288,309,331,352,380,401,429,460,485,516,538,561,589,618,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100620547","mechanism-of-enhanced-efficacy-of-ivonescimab-in-neoadjuvant-therapy-for-non-small-cell-lung-cancer-100620547",false,"NCT07359040","Mechanism of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer","Mechanisms of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer","Inclusion Criteria:\n\nPatients with non-small cell lung cancer (Stage IB-IIIB) who require radical surgery following neoadjuvant therapy.\n\nExclusion Criteria:\n\n1. Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;\n2. Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);\n3. Pregnancy or lactation;\n4. Insufficient sample quality;\n5. Severe organ dysfunction (e.g. cardiac or renal insufficiency);\n6. Other judgments by the Investigator that the patient should not participate in the study.","ALL",{"count":19,"type":20},80,"ESTIMATED","5 Years","OBSERVATIONAL","This is an exploratory clinical study focusing on the neoadjuvant treatment of non-small cell lung cancer (NSCLC). The study primarily aims to compare the efficacy and safety of Ivonescimab, a novel PD-1\u002FVEGF bispecific antibody, with those of conventional PD-1 inhibitors. Beyond evaluating its direct therapeutic benefits, this research also seeks to elucidate the potential mechanisms underlying the enhanced efficacy of Ivonescimab. Additionally, the study will conduct secondary exploratory analyses, including the identification and validation of predictive and prognostic biomarkers, as well as multi-omics profiling to investigate the molecular mechanisms of action. Collectively, these efforts aim to provide comprehensive experimental data to support the rational clinical application of Ivonescimab and the development of precision medicine strategies for NSCLC.",[25,26,27,28],"Non-Small Cell Lung Cancer","Neoadjuvant Therapy","PD-1 Inhibitors","Immunotherapy",[30,31,25],"Neoajuvant therapy","Ivonescimab","RECRUITING","2026-06-02",{"date":35,"type":36},"2026-06-03","ACTUAL",{"date":38,"type":36},"2025-07-01",{"date":40,"type":20},"2027-10-30",{"name":42,"class":43},"Peking University People's Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":50,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100637294","phase-2-firmonertinib-in-perioperative-treatment-of-resectable-stage-ii-iiib-egfr-mutated-lung-adenocarcinoma-100637294","NCT07622706","Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma","Inclusion Criteria:\n\n* 1.Prior to the initiation of any study-related procedures, including examinations, sample collection, or analyses, written informed consent was obtained from all participating patients.\n\n  2.Male or female, aged \\>=18 years; 3.Histologically or cytologically confirmed primary lung adenocarcinoma within 60 days prior to study entry.\n\n  4.Stage II-IIIB disease (AJCC 9th edition) confirmed by systematic imaging (contrast-enhanced chest\u002Fabdominal CT, brain CT\u002FMRI, bone scan, or PET\u002FCT), with lesions eligible for radical resection.\n\n  5.EGFR mutation-positive (19Del and\u002For L858R, with or without T790M) as determined by NGS testing of tumor tissue or blood.\n\n  6.At least one measurable lesion with a longest diameter \\>=10 mm on baseline CT scan (except lymph nodes, which must have a short-axis diameter \\>=15 mm), and suitable for accurate and repeated measurement.\n\n  7.ECOG performance status 0-1. 8. Female patients should take adequate and effective contraception, must not breastfeed, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to demonstrate infertility:\n  1. Postmenopausal, defined as older than 50 years of age and having no menstruation for at least 12 months after stopping all exogenous hormone therapy.\n  2. For women under 50 years old, if there is no menstruation for 12 months or longer after stopping exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are in the postmenopausal range, they are considered postmenopausal.\n  3. Documented irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.\n\n  9\\. Male patients should be willing to use barrier contraception, i.e., condoms.\n\nExclusion Criteria:\n\n* 1.Tumors with squamous cell carcinoma, large cell carcinoma, or neuroendocrine components such as small cell carcinoma.\n\n  2.Presence of EGFR exon 20 insertion mutation detected by genetic testing. 3.Prior exposure to other antitumor therapies before enrollment. 4.Major surgery within 4 weeks prior to the first dose of study drug (including surgery for the primary tumor, excluding procedures for vascular access).\n\n  5.Scheduled or planned medical procedures (e.g., endoscopy or biopsy) or surgical operations within the next 4 months.\n\n  6.The patient is pregnant or breastfeeding. 7.Use of strong CYP3A4 inhibitors within 7 days, or strong CYP3A4 inducers within 21 days prior to the first dose of study drug; use of traditional Chinese medicines or herbal preparations indicated for antitumor treatment, those with tumor adjuvant effects, or any other agents with known antitumor activity within 14 days prior to the first dose.\n\n  8.History of other malignancies or concurrent malignancies, except for those that have been definitively treated with curative intent and with no evidence of recurrence for at least 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, or papillary thyroid carcinoma).\n\n  9.Patients with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for participation by the investigator. These include but are not limited to: uncontrolled hypertension, diabetes, chronic heart failure (NYHA class III-IV), unstable angina, myocardial infarction within the past year, active bleeding disorders; hepatitis B (including all HBsAg-positive patients), hepatitis C (HCV antibody positive), or human immunodeficiency virus (HIV) infection; as well as patients with active infections requiring intravenous treatment.\n\n  10.Patients with severe gastrointestinal dysfunction or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medication, uncontrolled nausea and vomiting, or a history of extensive gastrointestinal resection.\n\n  11\\. Meets any of the following cardiac assessment criteria: (1) Resting ECG corrected QT interval (QTc) \\>470 msec, with QTc corrected using the Fridericia formula (if the initial ECG shows QTc \\>470 ms, repeat the ECG twice and take the average of the three QTc results). (2) Any clinically significant abnormalities in heart rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or third-degree atrioventricular block, etc. (3) Any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death in first-degree relatives under 40 years old, or taking any concomitant medication known to prolong the QT interval that cannot be discontinued.\n\n  12\\. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, or patients with clinical manifestations suspected to be interstitial lung disease.\n\n  13\\. Any of the following laboratory test results indicating insufficient bone marrow or organ reserve function: (1) Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL; (2) Platelet count \\\u003C100×10\\^9\u002FL; (3) Hemoglobin \\\u003C90 g\u002FL; (4) Alanine aminotransferase (ALT) \\>2.5× upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) \\>2.5×ULN; (6) Total bilirubin \\>1.5×ULN or, in the case of Gilbert's syndrome (unconjugated hyperbilirubinemia), \\>3×ULN; (7) Creatinine clearance \\\u003C50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); (8) Prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT) \\>=1.5 times ULN; 14. Known or suspected allergy to pralsetinib or any other component of its formulation; 15. Other situations where the patient is unable to comply with study procedures, restrictions, or requirements, and the investigator considers that such patient should not or is unsuitable to participate in the study; 16. Patients currently or previously participating in any other anti-tumor clinical study.","18 Years",{"count":54,"type":20},60,"INTERVENTIONAL",[57],"PHASE2",[59,60,26],"NSCLC","EGFR Positive Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-05-28",{"date":35,"type":36},{"date":65,"type":20},"2026-05-30",{"date":67,"type":20},"2029-11-30",{"name":69,"class":43},"Peking University Cancer Hospital & Institute",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":77,"minAge":52,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":55,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100637744","phase-2-ql1706-combined-with-cisplatinpaclitaxel-as-neoadjuvant-therapy-for-cervical-cancer-100637744","NCT07617818","QL1706 Combined With Cisplatin\u002FPaclitaxel as Neoadjuvant Therapy for Cervical Cancer","A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin\u002FPaclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)","Inclusion Criteria:\n\n* Female patients aged 18-65 years.\n* Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n* FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.\n* Pelvic MRI completed before enrollment.\n* ECOG performance status of 0-2.\n* Adequate organ and bone marrow function.\n* No prior immunotherapy for malignant tumors.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Presence of uncontrolled concomitant malignancies.\n* Active autoimmune disease or history of autoimmune disease with potential recurrence.\n* Interstitial lung disease or uncontrolled pneumonitis.\n* Active hepatitis B or hepatitis C infection.\n* Known HIV infection.\n* Receipt of live vaccines within 30 days before first dose.\n* Uncontrolled cardiovascular disease.\n* Known hypersensitivity to study drugs.\n* Any condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.","FEMALE","65 Years",{"count":80,"type":20},50,[57],"This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.\n\nThe primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.\n\nAdditionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H\u002FdMMR status, and vaginal microbiota before and after treatment.",[84,26,28],"Cervical Cancer","2026-05-26",{"date":87,"type":36},"2026-06-01",{"date":89,"type":20},"2026-06-15",{"date":91,"type":20},"2029-12-15",{"name":93,"class":43},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":55,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100639555","oral-paclitaxel-as-neoadjuvant-therapy-in-elderly-nsclc-a-phase-ii-trial-100639555","NCT07599163","Oral Paclitaxel as Neoadjuvant Therapy in Elderly NSCLC: A Phase II Trial","A Phase II, Multicenter Clinical Study of Oral Paclitaxel Solution as Neoadjuvant Therapy in Elderly Patients With Non-Small Cell Lung Cancer","Eligibility Criteria\n\nInclusion Criteria:\n\n* Age 70-85 years, any gender\n* ECOG performance status 0-1\n* Pathologically confirmed non-small cell lung cancer (NSCLC), clinical stage IIA-IIIB (8th edition AJCC)\n* No distant metastasis, deemed resectable with curative intent\n* Negative for sensitive driver mutations including EGFR, ALK, and ROS1 by molecular pathology\n* Adequate function of major organs, defined as:\n* Bone marrow: ANC ≥1.5×10⁹\u002FL, platelet ≥100×10⁹\u002FL, hemoglobin ≥9 g\u002FdL\n* Liver function: total bilirubin ≤1.5×ULN; ALT, AST ≤2.5×ULN\n* Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin; urine protein \\\u003C +; if +, 24-h urine protein \\\u003C 500 mg\n* Normal blood glucose or well-controlled diabetes\n* Pulmonary function: baseline FEV1 ≥2 L; if FEV1 \\\u003C 2 L, postoperative predicted FEV1 \\> 800 mL confirmed by surgical evaluation\n* Cardiac function: no myocardial infarction, unstable angina, severe arrhythmia, or cardiac insufficiency within the past 1 year\n* Patients and families are fully informed and voluntarily provide written informed consent\n\nExclusion Criteria:\n\n* Previous lobectomy, radiotherapy, or systemic antitumor therapy\n* Synchronous other malignancy with \\\u003C5 years of cure (except carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin)\n* History of active autoimmune disease or requirement for systemic immunosuppressive therapy\n* Active infection requiring systemic therapy, including active tuberculosis, HIV infection, chronic hepatitis B\u002FC with active replication, or syphilis\n* Severe cardiac, hepatic, renal, or metabolic disease that cannot tolerate surgery or study treatment\n* Previous interstitial lung disease, drug-induced pneumonitis, or radiologic evidence of active interstitial lung disease\n* Uncontrolled massive pleural effusion or pericardial effusion\n* Major surgery, severe trauma, or other investigational drug therapy within 4 weeks\n* Recent vaccination with antitumor vaccines or live vaccines\n* Other conditions deemed inappropriate for enrollment or likely to affect trial outcomes by the investigator","70 Years","85 Years",{"count":104,"type":20},75,[106],"NA","This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). A total of 75 eligible elderly NSCLC patients who need neoadjuvant treatment are planned to be enrolled. The study takes Shanghai Pulmonary Hospital as the main center, Zhejiang Cancer Hospital and Guangdong Provincial People's Hospital as sub-centers, adopts a single-arm study design, and the research subjects are elderly NSCLC patients who need neoadjuvant treatment. The core indicators for efficacy evaluation include pathological complete response rate (pCR), major pathological response rate (MPR, residual tumor cells ≤10%), imaging response rate (according to RECIST 1.1 criteria), 2-year event-free survival rate (EFS), 2-year overall survival rate (OS), surgical resection rate, and R0 resection rate; safety evaluation mainly observes the incidence of adverse events. The statistical methods adopt the relevant specifications for single-arm exploratory studies. Efficacy analysis is carried out in the full analysis set and per-protocol set, and safety analysis is performed using the safety analysis set; for continuous variables, paired t-test or Wilcoxon signed-rank test is used according to the distribution; categorical variables are analyzed descriptively; for the main rate-type outcome indicators, the incidence rate and 95% confidence interval (Clopper-Pearson method) are reported; survival outcome indicators are estimated using the Kaplan-Meier method and relevant parameters are reported.",[109,26,110],"Non-Small-Cell Lung Cancer","Paclitaxel","2026-05-19",{"date":113,"type":36},"2026-05-20",{"date":115,"type":20},"2026-06-08",{"date":117,"type":20},"2030-12-30",{"name":119,"class":43},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":55,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":44},"100638524","phase-2-nimotuzumab-combined-with-pd-1-inhibitors-and-chemotherapy-in-the-treatment-of-locally-advanced-head-and-neck-squamous-cell-carcinoma-100638524","NCT07601737","Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age 18 to 75 years inclusive.\n2. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition.\n3. Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. For oropharyngeal carcinoma: mandatory p16 immunohistochemistry (testing within standard of care is acceptable; repeat testing not required). p16 testing is not required for other tumor locations.\n6. Availability of tumor tissue (archived or newly obtained) for PD-L1 testing (prior testing is acceptable; repeat testing not required).\n7. At least one measurable lesion per RECIST 1.1.\n8. Life expectancy ≥ 6 months.\n9. Adequate hematologic function:\n\n   White blood cell count ≥ 4.0 × 10⁹\u002FL Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL\n10. Adequate renal function:\n\n    Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR\n\n    Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin calculated by Cockcroft-Gault formula:\n\n    Female: CrCl (mL\u002Fmin) = (140 - age) × body weight (kg) × 0.85 \u002F (72 × serum creatinine (mg\u002FdL)) Male: CrCl (mL\u002Fmin) = (140 - age) × body weight (kg) × 1.00 \u002F (72 × serum creatinine (mg\u002FdL))\n11. Adequate hepatic function:\n\n    Total bilirubin ≤ 1.5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n12. Female subjects: negative pregnancy test within 2 weeks before first study drug, non-lactating.\n\n    Females: highly effective contraception required during study and for 6 months after last study drug.\n\n    Males: highly effective contraception required during study and for 6 months after last study drug.\n13. Written informed consent obtained prior to any study-specific procedures, and willingness to comply with all study visits and protocol requirements.\n\nExclusion Criteria:\n\n1. Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment.\n2. Participation in another interventional clinical trial within 30 days prior to screening.\n3. In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol.\n4. Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection.\n5. History of other malignancy within the past 5 years (except cured basal cell carcinoma of the skin).\n6. History of primary immunodeficiency disease.\n7. Presence of uncontrolled comorbidities, including heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders, etc.\n8. Known HIV infection, active viral hepatitis, or active tuberculosis.\n9. Underwent major surgery within 90 days prior to the first study drug, or planning major surgery unrelated to this cancer treatment.\n10. Hypersensitivity to any study drug or their components.\n11. Pregnant (confirmed by serum or urine HCG test) or lactating woman; or subject of childbearing potential unwilling or unable to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment (applicable to both males and females).\n12. Investigator considers the subject not suitable for study participation.\n13. Unwilling to participate or unable to provide written informed consent.\n14. Receipt of a live vaccine within 30 days before the first study drug administration.","75 Years",{"count":129,"type":20},182,[57],"This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.",[133,134,135,26],"Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma (HNSCC)","Head & Neck Cancer","2026-05-15",{"date":138,"type":36},"2026-05-22",{"date":140,"type":36},"2026-04-20",{"date":142,"type":20},"2030-04-30",{"name":144,"class":43},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":55,"phases":154,"briefSummary":156,"conditions":157,"keywords":168,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":44},"100574403","phase-2-total-neoadjuvant-therapy-and-organ-preservation-versus-surgery-for-rectal-cancer-100574403","NCT06758830","Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.","Total Neoadjuvant Therapy for Rectal Cancer - a New Standard of Care?","Part One\n\nInclusion Criteria:\n\n* Over 18 years of age.\n* Participants who agreed to participate in the study signed an informed consent form.\n* The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2.\n* Pathologically confirmed rectal adenocarcinoma.\n* Tumor up to 10 cm from the anus.\n* Magnetic resonance imaging (MRI) of the pelvis and computed tomography (CT) of the thorax and abdomen were performed to confirm the diagnosis.\n* cT1N1, T2-T3 N0 - 1, M0, MRF -, EMVI -.\n* Normal bone marrow function: blood leucocytes \\> 3.5 × 10⁹\u002Fl, neutrophils \\> 1.5 × 10⁹\u002Fl, platelets \\> 100 × 10⁹\u002Fl.\n* Normal renal function: creatinine within 1,5 × normal.\n* Normal liver function: blood bilirubin levels within 1,5 times normal, AST, ALT levels within 2,5 times the upper limit.\n\nExclusion Criteria:\n\n* Prior ST or Ch.\n* Participants who are not eligible for pelvic MRI.\n* Participants who have had a malignancy in the last 5 years, except for treatment for basal cell or squamous cell skin cancer or in situ cervical cancer.\n* ECOG status ≥ 3.\n* Distant metastases detected.\n* Participants with uncontrolled therapeutic or psychiatric conditions.\n* Infectious diseases requiring antibiotic treatment.\n\nPart Two\n\nInclusion Criteria:\n\n* Over 18 years of age.\n* Participants who agreed to participate in the study signed an informed consent form.\n* ECOG score between 0 and 2.\n* Pathological confirmed rectal adenocarcinoma.\n* Stage I to III rectal cancer confirmed.\n* The tumor is localized up to 12 cm from the anus.\n* Participants who refused to participate in the first part of the study or did not meet the inclusion criteria for the first part.\n* Participants have received preoperative CRT or TNT or are in the planning stages of neoadjuvant treatment.\n\nExclusion Criteria:\n\n* New cancer two years after CRT.\n* Stage IV cancer before treatment.\n* Participants refusing to participate in the study or unable to sign the informed consent.",{"count":153,"type":20},400,[57,155],"PHASE3","This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinical response to TNT, followed by a watch-and-wait approach, are comparable to those of patients who undergo surgery first. Additionally, the study aims to identify potential prognostic and predictive markers for rectal cancer and examine survival rates and factors influencing responses to chemoradiotherapy (CRT) or TNT.\n\nThe study is divided into two parts:\n\n\\*\\*Part One:\\*\\* Participants with cT1N1, T2-T3 N0-1 rectal cancer, MRF-, and EMVI-, with surgery as one of the possible first-line treatment options, will be randomized into two groups. The experimental group will consist of participants receiving TNT, including CRT and consolidation chemotherapy (Ch). If these participants achieve a complete or near-complete clinical response, they will be observed using a watch-and-wait strategy, which is a non-operative approach. The control group will consist of participants who undergo surgical treatment initially.\n\n\\*\\*Part Two:\\*\\* All participants with rectal cancer who have received CRT or TNT will be included. Additionally, participants diagnosed with rectal cancer who are scheduled for CRT or TNT but declined to participate in Part One or do not meet the inclusion criteria will also be included.",[158,159,26,160,161,162,163,164,165,166,167],"Rectal Cancer","Total Neoadjuvant Treatment","Radiotherapy","Chemotherapy","Organ Preservation","Radiotherapy Side Effect","Chemotherapy Side Effects","Chemoradiotherapy","Low Anterior Resection Syndrome","Quality of Life",[169,159,170,160,161,165,162,163,171,172,173,174,166],"Rectal cancer","Neoadjuvant therapy","Chemotherapy side effects","Quality of Lifte","Fatigue","Postoperative complications","2026-05-06",{"date":177,"type":36},"2026-05-11",{"date":179,"type":36},"2025-01-06",{"date":181,"type":20},"2029-12-27",{"name":183,"class":43},"National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":55,"phases":194,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":44},"100573228","phase-1-surgery-after-verifying-existing-disease-in-locally-advanced-operable-lung-cancer-a-pilot-study-100573228","NCT06743555","Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study","Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer (SAVED LUNG Study): A Pilot Study","SAVED LUNG","Inclusion Criteria:\n\n* \\> 18 years of age\n* The participant has provided documented informed consent for the trial.\n* Histologically confirmed (by core biopsy) NSCLC and confirmed clinical stages II-III (excluding N2) NSCLC (AJCC 8th edition) amenable to receive neoadjuvant chemo-immunotherapy defined by: nivolumab 3mg\u002Fkg Q3W in combination with platinum doublet chemotherapy (cisplatin or carboplatin with paclitaxel or pemetrexed Q3W) for 3 cycles.\n* PD-L1 tumor proportion score \\>50%\n* Has no history of immunodeficiency, HBV, HCV, HIV.\n* For female participants:\n\n  1. Has no active pregnancy (Refer to \"Female participants\").\n  2. For a woman of child-bearing potential (WOCBP), use of a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 180 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore for her own use for the purpose of reproduction during this period.\n  3. A WOCBP must have a negative highly sensitive pregnancy test (\\[urine or serum\\] as required by local regulations) within either 24 hours (urine) or 72 hours (serum) before the first dose of study intervention.\n  4. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Has adequate hematological, renal and hepatic function per Investigator discretion required for platinum-doublet chemotherapy plus immunotherapy.\n* Has signed the written consent.\n\nExclusion Criteria:\n\n* Has one of the following tumor locations\u002Ftypes:\n\n  1. NSCLC involving the superior sulcus\n  2. Large cell neuro-endocrine cancer (LCNEC)\n  3. Sarcomatoid tumor\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.\n* Has a known additional malignancy that is progressing or requires active treatment within the past (5 years). Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, bladder carcinoma, or carcinoma in situ (eg, in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy are not excluded.",{"count":193,"type":20},14,[195],"PHASE1","The SAVED LUNG study is a pilot Phase I trial evaluating safety and feasibility of observation versus standard-of-care surgery in operable Stage II-III (excluding N3) NSCLC patients (PD-L1 ≥50%) who achieve complete clinical response following neoadjuvant platinum-doublet chemotherapy and immunotherapy. Participants are randomized to observation or surgery after rigorous restaging, with primary endpoints focusing on safety and feasibility. Secondary objectives include rates of cross-over to surgery, event-free survival, and overall survival, while exploratory endpoints examine ctDNA clearance and its association with clinical response.",[25,28,26,198,199],"Thoracic Surgery","Complete Response",[59,201,202,203,204],"Neoadjuvant immunotherapy","Complete response","Surveillance","PD-L1","2026-04-24",{"date":207,"type":36},"2026-04-28",{"date":209,"type":20},"2026-05-01",{"date":211,"type":20},"2032-02",{"name":213,"class":43},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":127,"enrollmentInfo":221,"targetDuration":4,"studyType":55,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":44},"100611776","phase-2-neoadjuvant-ivonescimabak112-combined-with-chemotherapy-in-patients-with-resectable-esophageal-squamous-cell-carcinoma-100611776","NCT07244978","Neoadjuvant Ivonescimab（AK112） Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma","A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Ivonescimab（AK112） Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. signed informed consent;\n2. patients age 18 to 75 years old\n3. primary resectable, histologically confirmed esophageal squamous cell cancer;\n4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).\n5. ECOG PS 0-1.\n6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;\n\nExclusion Criteria:\n\n1. with significant cardiovascular disease;\n2. current treatment with anti-viral therapy or HBV;\n3. Female patients who are pregnant or lactating;\n4. history of malignancy within 5 years prior to screening;\n5. active or history of autoimmune disease or immune deficiency;\n6. signs of distant metastases.",{"count":222,"type":20},49,[57],"In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. It is recommended that a treatment strategy be employed that integrates surgery with radiotherapy, chemotherapy, or immunotherapy, in order to enhance overall survival by improving local-regional tumor control and addressing microscopic metastases. Clinical research indicates that combining anti-PD-1\u002FL1 and anti-VEGF antibodies enhances anti-tumor effects in esophageal squamous cell carcinoma. Ivonescimab, a humanized bispecific monoclonal antibody targeting PD-1\u002FVEGF. This single-arm, prospective, exploratory study is planned to evaluate the combination of ivonescimab and chemotherapy in neoadjuvant therapy for resectable esophageal squamous cell carcinoma, with the aim of providing new therapeutic options for this condition.",[226,26],"Esophageal Squamous Cell Carcinoma",[228,229,230,231,226],"ivonescimab","anti-PD-1","anti-VEGF","Neoadjuvant","2026-04-21",{"date":205,"type":36},{"date":87,"type":20},{"date":236,"type":20},"2032-12-31",{"name":93,"class":43},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":77,"minAge":52,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":55,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":44},"100634590","digital-mind-body-therapy-for-neoadjuvant-breast-cancer-100634590","NCT07541664","Digital Mind-Body Therapy for Neoadjuvant Breast Cancer","Effectiveness and Safety of a Digital Mind-Body Therapy Based on Digital Music and Biofeedback in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Treatment","Inclusion Criteria:\n\n1. Participants voluntarily agree to take part in this study and provide written informed consent.\n2. Female, aged ≥18 years.\n3. Histologically confirmed invasive breast cancer.\n4. Planned to receive neoadjuvant therapy.\n5. Completion of psychosomatic assessment prior to initiation of neoadjuvant therapy, with at least two of the following domains reaching mild or higher severity: anxiety, depression, insomnia, or psychological distress (severity classified according to established clinical cut-off values of the respective assessment scales).\n6. Good compliance and willingness to adhere to follow-up.\n7. Normal hearing, without severe hearing impairment.\n8. Possession of a smartphone and ability to independently operate mobile applications.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis.\n2. History of other malignancies, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers with disease-free survival \\>5 years.\n3. Immunodeficiency or human immunodeficiency virus (HIV) infection.\n4. Severe dysfunction of the heart, lungs, liver, or kidneys.\n5. Uncontrolled infection or active infection.\n6. Pregnant or lactating women.\n7. Markedly abnormal psychological or cognitive status that precludes completion of psychosomatic assessment.\n8. Prior diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychiatric disorders secondary to medical conditions.",{"count":246,"type":20},66,[106],"This study is a single-center, randomized controlled, prospective trial investigating the application of Digital Mind-Body Therapy based on digital music and biofeedback (DMBT) during neoadjuvant treatment in patients with locally advanced breast cancer.",[26],"2026-04-14",{"date":232,"type":36},{"date":253,"type":36},"2026-03-25",{"date":255,"type":20},"2027-03-31",{"name":257,"class":43},"Fudan University",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":77,"minAge":52,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":267,"conditions":268,"keywords":273,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":44},"100615182","circulating-micrornas-and-response-to-neoadjuvant-chemotherapy-in-breast-cancer-100615182","NCT07289282","Circulating microRNAs and Response to Neoadjuvant Chemotherapy in Breast Cancer","The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response","miRNA-NAC","Inclusion Criteria:\n\n* Histologically confirmed breast cancer\n* Planned to receive neoadjuvant chemotherapy\n* Biologically female\n* Age ≥ 18 years\n* Ability to provide informed consent\n* Adequate organ function to receive standard NAC (based on routine clinical evaluation)\n\nExclusion Criteria:\n\n* Presence of metastatic disease at diagnosis\n* Prior systemic chemotherapy for breast cancer\n* Pregnancy or breastfeeding\n* Active infection or uncontrolled comorbid conditions interfering with study participation\n* Any condition preventing collection of blood samples",{"count":19,"type":20},"This prospective observational study aims to investigate subtype-specific circulating microRNAs (miRNAs) and their association with response to neoadjuvant chemotherapy (NAC) in patients with breast cancer. Serum samples will be collected before NAC and prior to surgery, and changes in miRNA expression levels will be evaluated. Pathological complete response (pCR) and Miller-Payne scoring will be used to assess treatment response after NAC. The study also explores whether changes in circulating miRNA profiles can predict treatment response across different breast cancer subtypes. The findings may help identify biomarkers that support treatment planning and personalized therapy strategies.",[269,26,270,271,272],"Breast Cancer","Pathological Response","Invasive Breast Carcinoma","MicroRNAs",[274,275,276,277,278],"microRNA","Circulating microRNAs","Neoadjuvant Chemotherapy","Pathological Complete Response","Predictive Biomarkers","2026-03-30",{"date":281,"type":36},"2026-03-31",{"date":283,"type":36},"2025-12-15",{"date":285,"type":20},"2026-12",{"name":287,"class":43},"Atlas University",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":101,"enrollmentInfo":296,"targetDuration":4,"studyType":55,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":44},"100537713","phase-2-capox-and-pd-1-antibody-combined-with-or-without-radiotherapy-for-mss-locally-advanced-rectal-cancer-100537713","NCT06281405","CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer","A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)","TORCH-iTNT","Inclusion Criteria\n\n1. Age 18-70 years old, female and male;\n2. Pathological confirmed adenocarcinoma;\n3. The distance from anal verge ≤ 10 cm;\n4. MSI\u002FMMR status: MSS\u002FpMMR;\n5. Clinical stage T3-4 and\u002For N+, without distance metastases;\n6. At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;\n7. KPS ≥ 70;\n8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;\n9. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\\^9\u002FL, Hb ≥ 90 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL, ALT\u002F AST ≤ 2.5 ULN, Cr ≤ 1 ULN;\n10. With good compliance and signed the consent form.\n\nExclusion Criteria\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n6. Uncontrolled infection which needs systemic therapy;\n7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;\n9. Allergic to any component of the therapy.",{"count":297,"type":20},192,[57],"TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4\u002FN+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy\u002F5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.",[301,26],"Locally Advanced Rectal Cancer",{"date":303,"type":36},"2026-04-03",{"date":305,"type":36},"2024-03-28",{"date":307,"type":20},"2028-12-31",{"name":257,"class":43},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":127,"enrollmentInfo":316,"targetDuration":4,"studyType":55,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":330,"locationsCount":44},"100631784","phase-2-camrelizumab-chemotherapy-and-ivarmacitinib-in-patients-with-resectable-esophageal-squamous-cell-carcinoma-100631784","NCT07505186","Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma","A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of the Combination of Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. signed informed consent;\n2. patients age 18 to 75 years old\n3. primary resectable, histologically confirmed esophageal squamous cell cancer;\n4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).\n5. ECOG PS 0-1.\n6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist．\n\nExclusion Criteria:\n\n1. with significant cardiovascular disease;\n2. current treatment with anti-viral therapy or HBV;\n3. Female patients who are pregnant or lactating;\n4. history of malignancy within 5 years prior to screening;\n5. active or history of autoimmune disease or immune deficiency;\n6. signs of distant metastases.",{"count":317,"type":20},45,[57],"In the management of locally advanced esophageal squamous cell carcinoma, the outcomes associated with surgical resection, whether conducted alone or supplemented with postoperative adjuvant radiotherapy and chemotherapy, have been suboptimal. Immune checkpoint inhibitors (ICIs) have shown potential in enhancing the immune system's capacity to target and eliminate cancer cells. Evidence suggests that the concurrent administration of JAK inhibitors with ICIs may improve anti-cancer efficacy, increase patient response rates, and prolong progression-free survival compared to ICIs alone. This prospective, exploratory study aims to assess the efficacy of combining camrelizumab, chemotherapy, and Ivarmacitinib in neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma, with the objective of broadening therapeutic options for this malignancy.",[226,26],[322,323],"Camrelizumab","Ivarmacitinib","2026-03-26",{"date":326,"type":36},"2026-04-01",{"date":209,"type":20},{"date":329,"type":20},"2033-12-31",{"name":93,"class":43},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":101,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":44},"100631304","fap-targeted-petnir-in-lung-malignant-tumors-100631304","NCT07498933","FAP-targeted PET\u002FNIR in Lung Malignant Tumors","Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation","Inclusion Criteria:\n\n* Age between 18 and 70 years old;\n* Have complete clinical and imaging data;\n* Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer;\n* Able to retain sufficient tumor tissue for testing and research;\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Previously combined with other malignant tumors or received other anti-tumor treatments;\n* Failure to collect sufficient tumor tissue for testing and research;\n* The duration of neoadjuvant therapy is less than 3 cycles;\n* The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing;\n* Lack of clinical and imaging data;\n* There are situations where other researchers consider it inappropriate to participate in this study",{"count":339,"type":20},200,"Single center, prospective, diagnostic study. Patients with stage II-IIIB resectable NSCLC diagnosed by pathology were included. After receiving standard neoadjuvant therapy (chemotherapy\u002Fimmunotherapy\u002Fcombination therapy), FAPI-PET\u002FCT and fluorescence imaging were performed one week before surgery. During the surgery, a near-infrared fluorescence navigation system was used to locate the tumor lesion. After surgery, the tumor bed range was determined by pathological gold standards (HE staining+immunohistochemistry), and the predictive efficacy and localization accuracy of FAPI-PET\u002Ffluorescence were compared and analyzed.",[25,342,26],"PET\u002FCT",[344,345,26,25],"PET Imaging","NIR Imaging",{"date":326,"type":36},{"date":348,"type":36},"2025-06-03",{"date":350,"type":20},"2027-12-31",{"name":42,"class":43},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":55,"phases":362,"briefSummary":363,"conditions":364,"keywords":368,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":377,"locationsCount":379},"100630797","phase-2-fulzerasib-sequential-sintilimab-plus-platinum-doublet-neoadjuvant-therapy-for-resectable-kras-g12c-mutant-nsclc-100630797","NCT07492342","Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC","Evaluation of Efficacy and Safety of Fulzerasib Sequentially Combined With Sintilimab Plus Platinum-Doublet Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer With KRAS G12 Mutation: a Single-Arm, Phase II Clinical Trial","K-NADIR","Inclusion Criteria:\n\n1. Sign the Informed Consent Form (ICF) and be able to comply with the visit and related procedures as stipulated in the protocol.\n2. Be male or female, aged ≥18 years old.\n3. Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC).\n4. Clinical stage IB to IIIA disease, according to the 8th edition of the TNM classification for lung cancer as defined by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).\n5. All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation; and must have no sensitive mutations of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK).\n6. The patient is deemed by a thoracic surgeon to be a candidate for curative resection (R0 resection) and has adequate pulmonary function to undergo the planned pulmonary resection.\n7. Have at least one measurable lesion according to RECIST 1.1 criteria.\n8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n9. Have not received any systemic anti-tumor treatment for locally advanced or metastatic NSCLC before.\n10. Have adequate organ and bone marrow function (subjects who have received any cell or growth factor therapy within 2 weeks before the first administration of the study drug should be excluded), defined as follows:\n\n1\\) Blood routine: Absolute neutrophil count (ANC) ≥1.5×109\u002FL or within the normal range; platelet (PLT) count ≥100×109\u002FL; hemoglobin (HGB) content ≥9.0 g\u002FdL.\n\n2\\) Liver function: Serum total bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN.\n\n3\\) Renal function: Serum creatinine (Cr) ≤1.5×ULN or clearance of creatinine (CCr) ≥50 mL\u002Fmin, calculated by the Cockcroft-Gault formula (using actual body weight); urine routine test shows urine protein \\\u003C2+; for subjects with urine protein ≥2+ at baseline as detected by urine test strips, a 24-hour urine collection should be performed and the protein content in 24-hour urine should be \\\u003C1 g (if both methods are used, the value obtained from 24-hour urine collection will be used to determine eligibility).\n\n4\\) Coagulation function: Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN and International Normalized Ratio (INR) ≤ 1.5; 11. Female subjects of childbearing age or male subjects whose partners are of childbearing age must take effective contraceptive measures throughout the treatment period and for 180 days after the treatment.\n\n12.Female subjects have evidence of postmenopausal status, or the urine or serum pregnancy test results of premenopausal female subjects are negative.\n\nExclusion Criteria:\n\n1. Histological or cytological pathology confirms the presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumors, or mesenchymal tumor components.\n2. Tumor invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina.\n3. Superior sulcus (Pancoast) tumor.\n4. Presence of tumor nodules in the contralateral lung lobe. Biopsy is required to confirm if contralateral lung nodules are clinically suspected.\n5. Documented brain metastasis. Patients with suspected brain metastasis must undergo brain imaging for further confirmation.\n6. Have significant cardiovascular or cerebrovascular diseases, such as:\n\n1)Experienced definite cardiovascular abnormal events within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or undergone angioplasty, vascular stent implantation, coronary artery bypass surgery, etc.\n\n2)Have clinically significant QT\u002FQTcF interval prolongation (QTcF \\> 470ms for females or \\> 450ms for males).\n\n7.Significant or active gastrointestinal disease characterized by diarrhea as the major symptom.\n\n8.Receipt of strong inhibitors or strong inducers of CYP3A4 or P-gp within 14 days prior to the first dose of study treatment, or within 5 half-lives of such agents (whichever is longer), or use of traditional Chinese medicine within 7 days prior to the first dose of study treatment.\n\n9.Participants who have received known CYP2D6, CYP3A4, P-gp, and BCRP sensitive substrates within 14 days or 5 half-lives (whichever is longer) before the first dose of this study, and the therapeutic window of the substrate is narrow, unless agreed by the investigator and the sponsor to be enrolled.\n\n10.Receipt of proton pump inhibitors (PPIs) or H2 receptor antagonists within 7 days prior to the first dose of study treatment.\n\n11.Systemic therapy with Chinese herbal medicines with anti-tumor indications or immunomodulatory agents (including thymopeptides, interferons, interleukins) within 2 weeks prior to the first dose of study treatment.\n\n12.Participants who are simultaneously involved in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the follow-up stage after the end of an interventional study.\n\n13.Participants who have received live attenuated vaccines within 4 weeks before the first dose of study treatment or plan to receive them during the study period.\n\nNote: Inactivated virus vaccines for seasonal influenza by injection are allowed within 4 weeks before the first dose of study treatment; however, live attenuated influenza vaccines are not allowed.\n\n14.Patients requiring long-term systemic corticosteroid use. Any other form of immunosuppressive therapy within 7 days prior to randomization.\n\nNote: Topical glucocorticoids (nasal, inhaled, or other routes), physiological doses of systemic glucocorticoids (≤10 mg\u002Fday prednisone or equivalent), or use for pre-medication (e.g., prevention of contrast agent allergy) are permitted.\n\n15.Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or presence of non-healing wounds, ulcers, or fractures.\n\n16.History of radiation pneumonitis, idiopathic pneumonitis, active pneumonitis, pulmonary fibrosis, diffuse interstitial lung disease, or organizing pneumonia (e.g., bronchiolitis obliterans).\n\n17.Participants with known allergies to study treatment or any of its components.\n\n18.Known primary immunodeficiency. 19.Active autoimmune or inflammatory disease (including inflammatory bowel disease \\[e.g., colitis, Crohn's disease\\], diverticulitis \\[excluding diverticulosis\\], celiac disease, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis (Wegener's syndrome), Graves' disease, hypophysitis, uveitis, etc.), or history of such disease within the previous 2 years.\n\nPatients with vitiligo, psoriasis, alopecia that do not require systemic therapy within the past 2 years, hypothyroidism requiring only thyroid hormone replacement, and type 1 diabetes mellitus requiring only insulin replacement are eligible.\n\n20.Have major acute or chronic infections, including:\n\n1. Active infections requiring systemic treatment;\n2. Positive human immunodeficiency virus antibody (HIV-Ab) at baseline;\n3. Active hepatitis B virus (HBV) infection (positive HBsAg and positive HBV-DNA). For patients with negative HBsAg and positive HBcAb, HBV-DNA testing is required; patients with positive HBV-DNA are excluded;\n4. Active hepatitis C virus (HCV) infection (positive HCV-Ab and positive HCV-RNA);\n5. Active pulmonary tuberculosis,, receiving anti-tuberculosis therapy, or having received anti-tuberculosis therapy within 1 year prior to the first dose of study treatment\n6. Active syphilis. 21.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n22.Diagnosis of another malignancy within 5 years prior to the first dose,except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,radically resected carcinoma in situ, radically treated localized prostate cancer, papillary thyroid carcinoma, and similar diseases.\n\n23.Uncontrolled concurrent disease, including:\n\n1)Serious infection occurring within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; or therapeutic oral or intravenous antibiotics administered within 2 weeks prior to initiation of study treatment; 2)Symptomatic congestive heart failure (New York Heart Association Class III-IV), left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiography, or uncontrolled cardiac arrhythmia; 3)Uncontrolled hypertension despite standard therapy (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg); 4)Uncontrolled or symptomatic hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or serum calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN); 5)Esophageal or gastric varices requiring immediate intervention (e.g., banding or sclerotherapy), or subjects with evidence of portal hypertension (including splenomegaly on imaging) or a history of variceal bleeding considered to be at high risk of bleeding by the investigator or in consultation with a gastroenterologist or hepatologist; endoscopic evaluation must be performed within 3 months prior to enrollment; 6)History of deep vein thrombosis or any other severe thromboembolism within 3 months prior to enrollment (implanted venous access port or catheter-related thrombosis, or superficial venous thrombosis is not considered severe); 7）Any life-threatening hemorrhagic event within 3 months prior to enrollment; 8)Uncontrolled metabolic disorders or other acute or chronic non-malignant organ or systemic diseases, or paraneoplastic syndromes that may confer high medical risk and\u002For uncertainty in survival assessment; 9)History of gastrointestinal perforation and\u002For fistula within 6 months prior to enrollment; 10)Subjects at risk of intestinal obstruction or perforation (including but not limited to acute diverticulitis, intra-abdominal abscess, history of intra-abdominal cancer), or history of extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; 11)Significant malnutrition requiring intravenous nutritional supplementation, unless malnutrition had been corrected for more than 4 weeks prior to the first dose of study treatment; 12)Post-placement of intraluminal esophageal or tracheal stents; 13)Other acute or chronic medical conditions that may increase risk related to study participation or study drug administration, interfere with the interpretation of study results, or are deemed by the investigator to render the subject ineligible for the study; 14)Neurological, psychiatric, or social conditions that would impair compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent (e.g., schizophrenia, history of drug abuse, etc.).\n\n24.Pregnant or lactating women",{"count":361,"type":20},30,[57],"This is an exploratory study evaluating the efficacy and safety of neoadjuvant therapy with fulzerasib sequentially combined with sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation.\n\nApproximately 30 treatment-naïve patients with stage IB-IIIA (AJCC 8th edition) NSCLC and confirmed KRAS G12C mutation will be enrolled.\n\nEligible subjects will receive 6 weeks of fulzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy.\n\nAn end-of-treatment visit will be performed within 7 days after the last dose of neoadjuvant therapy.",[365,366,367,26],"Resectable NSCLC","KRAS G12C Mutation","Stage IB-IIIA NSCLC",[26,369,370,371],"Fulzerasib","Sintilimab","Platinum-Based Combination Chemotherapy","2026-03-19",{"date":253,"type":36},{"date":375,"type":36},"2026-01-29",{"date":350,"type":20},{"name":378,"class":43},"Jianxing He",3,{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":387,"targetDuration":389,"studyType":22,"phases":4,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":400},"100622834","prediction-of-outcome-to-neoadjuvant-therapy-in-non-small-cell-lung-cancernsclc-100622834","NCT07388771","Prediction of Outcome to Neoadjuvant Therapy in Non-small Cell Lung Cancer（NSCLC）","A Study on Multimodal Data Prediction of Outcome to Neoadjuvant Therapy in NSCLC","Inclusion Criteria:\n\n1. pathologically diagnosed non-small cell lung cancer\n2. The treatment plan is：receiving neoadjuvant chemo-immunotherapy during the study period, followed by surgical resection\n\nExclusion Criteria:\n\n1. recurrent or metastatic lung cancer;\n2. patients with other primary tumors",{"count":388,"type":20},500,"6 Months","This observational study aims to construct and validate the performance of a multimodal predictive model in forecasting the outcomes of neoadjuvant therapy in patients with NSCLC.\n\nThe core research question is: Can a multi-model approach predict outcomes of neoadjuvant therapy for non-small cell lung cancer and provide clinical recommendations?",[59,26],"2026-03-18",{"date":372,"type":36},{"date":395,"type":36},"2025-12-01",{"date":397,"type":20},"2026-10",{"name":399,"class":43},"Qian Chu",2,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":55,"phases":410,"briefSummary":411,"conditions":412,"keywords":417,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":44},"100628199","phase-2-neoadjuvant-chemoradiotherapy-plus-tislelizumab-with-or-without-probio-m9-in-pmmrmss-locally-advanced-rectal-cancer-100628199","NCT07458529","Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Rectal Cancer","Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)","NCRIT-PM9","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG performance status 0-2\n* Biopsy-proven rectal adenocarcinoma\n* Distal tumor margin within 10 cm of the anal verge\n* No distant metastasis\n* Clinical stage II or III based on MRI (T4b excluded)\n* Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or MRI (measurable lesion according to RECIST 1.1)\n* Willing and able to comply with the study protocol\n* Willing to provide blood and tissue specimens for research purposes\n* No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)\n* No history of immune system disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, HIV infection, etc.)\n* No significant dysfunction of major organs (heart, lung, liver, kidney)\n* No jaundice or gastrointestinal obstruction\n* No acute or ongoing infection\n* Adequate hematologic and biochemical function including:\n\n  * Neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Hemoglobin ≥ 80 g\u002FL\n  * Platelets ≥ 100 × 10\\^9\u002FL\n  * Serum creatinine ≤ 1.5 × ULN\n  * Total bilirubin ≤ 1.5 × ULN\n  * ALT and AST ≤ 2.5 × ULN\n* No social or psychiatric disorders that may interfere with study participation\n* Women of childbearing potential must have a negative pregnancy test before enrollment and must use effective contraception from study entry until 60 days after the last dose of study drug\n\nExclusion Criteria:\n\n* History of multiple primary cancers or concomitant malignant tumors other than rectal cancer\n* Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years\n* History of recent major surgery\n* Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)\n* Uncontrolled or severe concomitant diseases of any kind\n* Known allergy or hypersensitivity to any components of the study drugs\n* Estimated life expectancy ≤ 5 years due to any cause\n* Planned or prior organ or bone marrow transplantation\n* Use of immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment\n* History of central nervous system disorders that may impair the ability to provide informed consent or affect compliance with oral medication (investigator discretion)\n* Other conditions that may interfere with study results or lead to premature discontinuation of study treatment (e.g., alcoholism or drug abuse)\n* Pregnant or breastfeeding women, or women planning to become pregnant during the treatment period",{"count":80,"type":20},[57],"This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).",[413,26,28,414,415,416],"Rectal Cancer, Adenocarcinoma","Probio-M9","Tislelizumab","Randomized",[414,418,419],"tislelizumab","locally advanced rectal cancer","2026-03-08",{"date":422,"type":36},"2026-03-10",{"date":424,"type":36},"2026-02-10",{"date":426,"type":20},"2030-12-01",{"name":428,"class":43},"Seventh Medical Center of PLA General Hospital",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":77,"minAge":52,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":55,"phases":440,"briefSummary":441,"conditions":442,"keywords":445,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":44},"100625852","phase-2-pragmatic-study-to-optimize-neoadjuvant-treatment-and-surgical-de-escalation-in-hrher2--early-breast-cancer-using-oncotype-dx-and-abemaciclib-100625852","NCT07428018","Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","VIOLET","Inclusion Criteria:\n\n* female aged 18 years or older\n* primary, histologically confirmed diagnosis of invasive breast carcinoma,\n* estrogen receptor (ER)-positive tumor, defined as ≥10% by immunohistochemistry and measured as per ASCO\u002FCAP guidelines (Allison et al.2020). Any progesterone receptor expression is acceptable (as per local assessment)\n* documented human epidermal growth factor receptor-2 (HER2)-negative tumor as per ASCO\u002FCAP guidelines, assessed locally,\n* stage II-IIIB as per AJCC TNM classification (8th edition). Absence of distant metastases (with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure),\n* candidate to receive neoadjuvant chemotherapy according to the indication of a multidisciplinary tumor board,\n* not eligible to receive upfront breast conservative surgery (but considered potentially eligible to receive a BCS in case of tumor downstaging) AND\u002FOR not candidate to sentinel lymph node dissection because of clinical node positive disease\n* Eastern Cooperative Oncology Group Performance Status 0-1,\n* The patient is able to swallow oral medications\n* normal hematologic parameters:\n\n  a.) absolute neutrophil count ≥ ≥1500\u002Fmm3 (1.5 × 10 9\u002FL), b) platelets ≥ 100 × 10 9\u002FL, c)hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL)). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* normal renal function: serum creatinine concentration ≤1.5 ULN or calculated clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula,\n* normal liver function:\n\n  a.)serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted., b)AST and ALT ≤ 3 × ULN, c)alkaline phosphatase ≤ 2.5 × ULN,\n* women of child bearing potential must have documented negative pregnancy test within 2 weeks (preferably 7 days) prior to study entry and must agree to effective non-hormonal contraception (barrier method - condoms, diaphragm -also in conjunction with spermicidal jelly, or total abstinence) after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed during the trial,\n* willingness to undergo breast surgery after optimal neoadjuvant treatment, and to provide blood and tumor samples for the study purposes, including the submission for central assessment of Oncotype Dx test.\n\nExclusion Criteria:\n\n* presence of distant metastases (stage IV) or stage IIIC disease,\n* inflammatory or locally-advanced, inoperable breast cancer\n* previous invasive ipsilateral breast cancer at any time,\n* previous or concomitant invasive malignancy. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), if adequately treated:\n\n  1. basal or squamous cell carcinoma of the skin,\n  2. melanoma in situ,\n  3. in situ non-breast carcinoma without invasion,\n  4. contra- or ipsilateral in situ breast carcinoma,\n  5. non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence,\n  6. stage I papillary thyroid cancer,\n  7. stage Ia carcinoma of the cervix,\n  8. stage Ia or b endometrioid endometrial cancer,\n  9. borderline or stage I ovarian cancer\n* known history of uncontrolled or symptomatic angina, uncontrolled hypertension (≥ 180\u002F110 mmHg), uncontrolled diabetes mellitus, dyspnea at rest, chronic therapy with oxygen, a New York Heart Association (NYHA) class III or IV congestive heart failure, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* females who are pregnant or lactating (lactation has to stop before study entry)\n* the patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea),\n* The patient has had major surgery within 14 days prior to study entry.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to study entry, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\])\n* contraindications or known hypersensitivity to the trial medication or excipients,\n* use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment","90 Years",{"count":439,"type":20},150,[57],"This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)\u002FHER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and\u002For sentinel node biopsy",[269,443,444,26],"HER2 + Breast Cancer","HR Positive",[446,447,448,449,450],"breast","oncotype dx","abemaciclib","neoadjuvant treatment","surgical deescalation","2026-03-03",{"date":453,"type":36},"2026-03-05",{"date":455,"type":20},"2026-04-30",{"date":457,"type":20},"2029-04-30",{"name":459,"class":43},"Mario Negri Institute for Pharmacological Research",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":102,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":44},"100615385","to-conduct-multi-omics-integrated-studies-in-peripheral-blood-such-as-fragment-omics-metabolomics-and-epigenetics-and-establish-non-invasive-dynamic-follow-up-monitoring-programs-during-perioperative-and-postoperative-periods-observational-study-100615385","NCT07291921","To Conduct Multi-omics Integrated Studies in Peripheral Blood, Such as Fragment Omics, Metabolomics and Epigenetics, and Establish Non-invasive Dynamic Follow-up Monitoring Programs During Perioperative and Postoperative Periods (Observational Study)","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Male or female, aged ≥ 18 and \\\u003C 85 years.\n3. Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.\n4. Tumor tissue and blood samples obtainable at all protocol-specified time-points.\n5. No pure ground-glass nodule on imaging.\n6. Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.\n\nExclusion Criteria:\n\n1. Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate\u002Finadequate histology.\n2. Insufficient or poor-quality blood or tissue samples.\n3. Pure ground-glass nodule on imaging.\n4. History of any malignancy within the past 5 years.\n5. Contraindication to surgery preventing radical resection.\n6. Non-radical (R2) resection.\n7. Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.\n8. Refusal or withdrawal of informed consent.\n9. Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).",{"count":467,"type":20},100,"This project aims to innovatively integrate multi-omics data, including plasma metabolomics, radiomics, and cfDNA multi-level information, combined with survival data (e.g., RFS), to establish a novel multidimensional approach for noninvasive postoperative recurrence monitoring in lung cancer using artificial intelligence algorithms. The goal is to develop a new noninvasive recurrence monitoring system for lung cancer.",[470,26,28,471],"Lung Neoplasms","Minimal Residual Disease",[59,201,473,474,475,476,477],"Perioperative monitoring","Liquid biopsy","MRD","Minimal residual disease","Multiple omics","2026-02-27",{"date":451,"type":36},{"date":481,"type":36},"2025-05-08",{"date":483,"type":20},"2027-10-31",{"name":42,"class":43},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":493,"targetDuration":495,"studyType":22,"phases":4,"briefSummary":496,"conditions":497,"keywords":501,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":44},"100625464","perioperative-outcomes-after-neoadjuvant-therapy-in-colorectal-cancer-100625464","NCT07422974","Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer","The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection","Neocolon","Inclusion Criteria:\n\n* Adults aged ≥18 years with histologically confirmed colorectal cancer\n* Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy)\n* Ability to understand the study protocol and provide written informed consent.\n* Both sexes\n* ASA classification II or III\n* Patients who received neoadjuvant therapy is investigational group and patients who did not receive neoadjuvant therapy is control group\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patients who are not conscious, not oriented, or unable to provide informed consent\n* Patients unable to understand the study protocol\n* Emergency surgical cases\n* Patients on chronic corticosteroid therapy",{"count":494,"type":20},68,"2 Months","This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.",[498,499,26,500],"Colorectal Carcinoma (CRC)","Complications","Endothelial Dysfunction",[502,26,503,504,505,506],"Colorectal Carcinoma","Microvascular Density","Treatment Outcome","Wound Healing","Critical care","2026-02-13",{"date":509,"type":36},"2026-02-20",{"date":511,"type":36},"2026-01-09",{"date":513,"type":20},"2027-05-01",{"name":515,"class":43},"Osijek University Hospital",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":55,"phases":525,"briefSummary":526,"conditions":527,"keywords":530,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":44},"100622900","phase-2-iparomlimab-and-tuvonralimab-ql1706-combination-with-lenvatinib-as-neoadjuvant-therapy-for-ccrcc-100622900","NCT07389629","Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC","The Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cancer With Partial Nephrectomy Indications But High Surgical Risk：A Single Arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form (ICF).\n2. Age at the time of enrollment is \\>= 18 and under 80 years old, with no gender restrictions.\n3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;\n4. Expected survival period \\>= 3 months.\n5. Preoperative biopsy pathology confirmed renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma;\n6. ECOG score 0 or 1;\n7. The patient is willing to undergo kidney preservation surgery;\n8. Indications for kidney preservation surgery are available, but limited renal cancer with high difficulty of kidney preservation surgery (stage T1N0M0 or T2N0M0, must meet R.E.N.A.L. score \\>= 10);\n9. At least one measurable lesion (according to mRECIST v1.1 standard) that is suitable for repeated and accurate measurements.\n10. Good organ function, screening laboratory test results meet the following criteria: (1) Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment): a. Absolute neutrophil count (ANC) \\>= 1.5 × 10\\^9\u002FL (1500\u002Fmm\\^3); b. Platelet count (PLT) \\>= 100 × 10\\^9\u002FL (100000\u002Fmm\\^3); c. Hemoglobin (HB) \\>= 90 g\u002FL; (2) Liver: a. Serum total bilirubin (TBIL) \\\u003C= 1.5 × ULN; b. Alanine transaminase (ALT) and aspartate transaminase (AST) \\\u003C= 2.5 × ULN; For subjects with liver metastases, AST and ALT are \\\u003C= 5 × ULN, while serum albumin (ALB) is \\>= 28g\u002FL. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) are \\\u003C= 1.5 × ULN;\n11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.\n\nExclusion Criteria:\n\n1. lymph node metastasis;\n2. The tumor surrounds the renal artery;\n3. Renal vein cancer thrombus;\n4. Diffuse tumor growth, with no clear boundary from normal renal parenchyma;\n5. General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery;\n6. Have serious cardiovascular and cerebrovascular diseases, uncontrollable hypertension and diabetes;\n7. Patients who have long-term use of immunosuppressants after organ transplantation;\n8. Patients who are currently using immunosuppressive drugs;\n9. Patients with clear infection or fever;\n10. Patients with T-cell lymphoma and myeloma;\n11. Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months;\n12. Metastatic renal cell carcinoma.\n13. Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug;\n14. Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).\n15. Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.\n16. Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.\n17. Known history of mental illness, drug abuse, alcoholism, or drug use.\n18. Pregnant or lactating women.\n19. Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.","80 Years",{"count":7,"type":20},[57],"Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the kidney (R.E.N.A.L. score \\>= 10).",[528,529,26],"Iparomlimab and Tuvonralimab","Clear Cell Renal Cell Carcinoma",[528,529,170],{"date":532,"type":36},"2026-02-05",{"date":534,"type":36},"2025-11-21",{"date":307,"type":20},{"name":537,"class":43},"Sun Yat-sen University",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":102,"enrollmentInfo":545,"targetDuration":4,"studyType":55,"phases":547,"briefSummary":548,"conditions":549,"keywords":552,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":44},"100622633","phase-2-pucotenlimab-combination-with-vorolanib-as-neoadjuvant-therapy-for-ccrcc-100622633","NCT07386158","Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC","Phase II Single-arm Clinical Study of the Efficacy and Safety of Pucotenlimab in Combination With Vorolanib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form (ICF).\n2. Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.\n3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.\n4. Expected survival period ≥ 3 months.\n5. Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma\n6. ECOG score 0 or 1\n7. The patient is willing to undergo kidney preservation surgery\n8. Preoperative assessment of healthy kidney GFR\\\u003C60 ml\u002Fmin through renal dynamic imaging\n9. There are indications for kidney preservation surgery, but the surgery is difficult \\[① 4-7cm tumor located at the renal hilum or endogenous ≥ 75% (T1bN0M0); ② Tumors larger than 7cm (T2N0M0)\\] 9. There should be at least one measurable lesion (according to mRECIST v1.1 criteria) that is suitable for repeated and accurate measurements.\n10. Good organ function, laboratory test results during the screening period meet the following criteria:\n\n\u003C!-- -->\n\n1. Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment):\n\n   a. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (1500\u002Fmm3); b. Platelet count (PLT) ≥ 100 × 109\u002FL (100000\u002Fmm3); c. Hemoglobin (HB) ≥ 90 g\u002FL;\n2. Liver:\n\n   1. Serum total bilirubin (TBIL) ≤ 1.5 × ULN;\n   2. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN\n   3. Serum albumin (ALB) ≥ 28g\u002FL\n3. Coagulation function:\n\n   International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN 11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.\n\n   Exclusion Criteria:\n\n   • Renal vein cancer thrombus\n\n   • Diffuse tumor growth, with no clear boundary from normal renal parenchyma\n\n   • General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery\n\n   • Have serious cardiovascular and cerebrovascular diseases, uncontrollable\n\n   • hypertension and diabetes\n\n   • Patients who have long-term use of immunosuppressants after organ transplantation\n\n   • Patients who are currently using immunosuppressive drugs\n\n   • Patients with clear infection or fever\n\n   • Patients with T-cell lymphoma and myeloma\n\n   • Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months\n\n   • Metastatic renal cell carcinoma.\n\n   • Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug\n\n   • Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).\n\n   • Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.\n\n   • Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.\n\n   Known history of mental illness, drug abuse, alcoholism, or drug use.\n   * Pregnant or lactating women.\n   * Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.",{"count":546,"type":20},21,[57],"Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)",[550,551,26],"Vorolanib","Clear Cell Renal Cell Carcinoma (ccRCC)",[550,551,170],"2026-01-28",{"date":555,"type":36},"2026-02-04",{"date":557,"type":36},"2025-07-10",{"date":559,"type":20},"2026-12-31",{"name":537,"class":43},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":55,"phases":570,"briefSummary":571,"conditions":572,"keywords":576,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":400},"100571357","reduce-sedentary-behavior-during-cancer-treatment---the-redsedcan-study-100571357","NCT06719206","Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study","RedSedCan","Inclusion Criteria:\n\n* Individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in Uppsala and Västerås, Sweden.\n\nExclusion Criteria:\n\n* Individuals diagnosed with dementia.\n* Individuals diagnosed with severe psychiatric disease.\n* Individuals with severe loss of vision, or communicative ability.\n* Individuals who cannot walk independently indoors with or without a walking aid.\n* Individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.",{"count":569,"type":20},172,[106],"Summary\n\nReducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital support intervention during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.",[269,573,574,26,575],"Colorectal Cancer (CRC)","Prostate Cancer","Adjuvant Therapy",[577,578,579,580],"sedentary behavior","behavior change","intervention","Randomized controlled trial",{"date":582,"type":36},"2026-01-30",{"date":584,"type":36},"2025-03-01",{"date":586,"type":20},"2030-12-31",{"name":588,"class":43},"Mälardalen University",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":77,"minAge":597,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":55,"phases":600,"briefSummary":601,"conditions":602,"keywords":604,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":44},"100570261","phase-3-no-axillary-surgical-treatment-in-clinically-lymph-node-negative-patients-on-ultrasonography-after-neoadjuvant-chemotherapy-100570261","NCT06704945","No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy","No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy: A Prospective, Phase III Clinical Trial","Neo-NAUTILUS","Inclusion Criteria:\n\n* Women aged ≥19 years.\n* Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy.\n* Clinical staging prior to NAC: cT1-3, cN0, M0 (AJCC 8th Edition).\n* If pre-NAC staging is cT1-3, cN1, M0, must meet the following criteria:\n\n  1. HER2-positive or triple-negative breast cancer (TNBC).\n  2. At least 30% reduction in tumor size on MRI after NAC (comparing pre- and post-NAC MRI).\n* Negative axillary lymph node status on ultrasound after NAC.\n* Planned for breast-conserving surgery with completed neoadjuvant chemotherapy (at least half the planned regimen must be completed).\n* ECOG performance status of 0-2.\n* Signed written informed consent before enrollment.\n\nExclusion Criteria:\n\n* History of any cancer within the past 5 years.\n* Bilateral breast cancer.\n* Patients requiring mastectomy.\n* Tumor size \\>5 cm after NAC.\n* Male breast cancer.\n* Pregnant or breastfeeding women.\n* Inability to understand and complete questionnaires.","19 Years",{"count":599,"type":20},464,[155],"NEO-NAUTILUS is a prospective, multicenter, randomized phase III clinical trial to evaluate whether omitting axillary lymph node surgery (ALND or SLNB) in clinically lymph node-negative breast cancer patients after neoadjuvant chemotherapy is non-inferior to performing SLNB in terms of 5-year disease-free survival.",[269,26,603],"Sentinel Lymph Node Biopsy",[605,606,607,608,609],"Omission of axillary surgery after neoadjuvant chemotherapy","Breast cancer","Neoadjuvant chemotherapy","De-escalation","Omission of surgery","2026-01-26",{"date":553,"type":36},{"date":613,"type":36},"2025-06-04",{"date":615,"type":20},"2034-12-31",{"name":617,"class":43},"Seoul National University Hospital",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":77,"minAge":52,"maxAge":127,"enrollmentInfo":624,"targetDuration":4,"studyType":55,"phases":626,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":44},"100621550","phase-2-neoadjuvant-therapy-for-early-triple-negative-breast-cancer-a-response-guided-approach-using-iparomlimab-and-tuvonralimab-injection-in-combination-with-chemotherapy-100621550","NCT07372079","Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy","Inclusion Criteria:\n\n* Voluntarily join this study, sign the informed consent form, and demonstrate good compliance;\n* Age: 18-75 years old (at the time of signing the informed consent form);\n* ECOG PS score: 0-1; expected survival time exceeding 6 months;\n* Patients with primary breast cancer confirmed by histopathological or cytological examination;\n* Primary tumor diameter \\> 2 cm as measured by local standard assessment methods;\n* Judged by the investigator to meet the American Joint Committee on Cancer (AJCC) 8th edition breast cancer TNM staging criteria as cT2-cT4, cN0-cN3, cM0, with locally advanced or early-stage, unilateral, and histologically confirmed invasive breast cancer;\n* Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO\u002FCAP guidelines;\n* At least one measurable lesion according to RECIST 1.1;\n* The patient agrees to undergo breast cancer resection surgery when meeting the surgical criteria after neoadjuvant therapy;\n* PD-L1 expression status is known;\n* Major organ functions are in good condition;\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use acceptable and effective contraception from screening onward and agree to continue these precautions until 12 months after the last dose of the study drug; periodic abstinence and rhythm methods are not acceptable contraceptive methods.\n\nExclusion Criteria:\n\n* Patients with stage IV metastatic breast cancer or other patients deemed by the investigator as unable to achieve curative surgical resection through neoadjuvant therapy;\n* Patients with inflammatory breast cancer;\n* Patients who have had or currently have other malignancies within the past 3 years. The following two conditions may be eligible: other malignancies treated with a single surgical procedure, achieving continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\];\n* Breast cancer patients who have received antitumor therapies such as chemotherapy, endocrine therapy, or immune checkpoint inhibitors within the past 3 years, or who have undergone breast surgery (except diagnostic biopsy for primary breast cancer);\n* Patients who have undergone major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (except diagnostic biopsy for primary breast cancer);\n* Presence of any active autoimmune disease or a history of autoimmune disease;\n* Patients currently using immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (at a dose \\>10 mg\u002Fday prednisone or equivalent steroids) and continuing such treatment within 2 weeks prior to enrollment;\n* Allergy to any study drug or any component or excipient of the drug;\n* Patients with concomitant diseases judged by the investigator as seriously endangering the subject's safety or affecting study completion, or those deemed unsuitable for enrollment for other reasons.",{"count":625,"type":20},40,[57],"Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). This is a prospective clinical study that plans to enroll screened, eligible early-stage breast-cancer patients to receive neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive four additional AC cycles before surgery. A key feature is the incorporation of an response-guided neoadjuvant therapy（RGN）model to identify sensitive patients who can forgo anthracyclines, thereby reducing long-term cardiotoxicity.",[269,26,629,630],"Immune Checkpoint Inhibitors","QL1706","2026-01-19",{"date":553,"type":36},{"date":634,"type":20},"2026-04-05",{"date":636,"type":20},"2029-12-30",{"name":638,"class":43},"Tianjin Medical University Cancer Institute and Hospital",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":55,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":44},"100617915","phase-2-sintilimab-plus-bevacizumab-biosimilar-as-neoadjuvant-therapy-for-resectable-hepatocellular-carcinoma-100617915","NCT07324824","Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma","Sintilimab Combined With Bevacizumab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: A Single-Arm, Prospective Phase II Study","Inclusion Criteria:\n\n1. Able to provide informed consent and willing to sign an approved consent form;\n2. Aged ≥ 18 years;\n3. Clinically diagnosed or pathologically confirmed resectable hepatocellular carcinoma beyond the Milan criteria (CNLC Ib-IIa);\n4. No prior anti-HCC treatment;\n5. Child-Pugh class A.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n7. Expected survival time of \\> 6 months.\n8. Sufficient organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Known as cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and hepatic fibrolamellar carcinoma;\n2. History of organ transplantation or hepatic encephalopathy\n3. Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage\n4. History of esophageal or gastric variceal bleeding caused by portal hypertension within the past 6 months; Documented severe (Grade 3) varices identified by endoscopy within 3 months prior to enrollment; Evidence of portal hypertension and assessed by the investigator as being at high risk of bleeding.\n5. Arterial and venous thromboembolic events in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism history;\n6. Any life-threatening bleeding event occurring within the past 3 months;\n7. Severe bleeding tendency, coagulopathy, or ongoing thrombolytic therapy.\n8. Chronic requirement for medications that inhibit platelet function, such as aspirin (\\>325 mg\u002Fday), dipyridamole, or clopidogrel.\n9. Uncontrolled hypertension, defined as systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg despite optimal medical management; history of hypertensive crisis or hypertensive encephalopathy.\n10. Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Functional Class II-IV); symptomatic or poorly controlled arrhythmias; history of congenital long QT syndrome; or corrected QT interval (QTc) \\>500 ms at screening (calculated using Fridericia's formula).\n11. History of gastrointestinal perforation and\u002For fistula, intestinal obstruction (including incomplete obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic persistent diarrhea within the past 6 months.\n12. Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to enrollment; presence of unhealed wounds, ulcers, or fractures; or tissue biopsy or other minor surgical procedure within 7 days prior to enrollment, excluding venous catheterization for intravenous infusion.\n13. Past or current history of pulmonary diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impairment of lung function.\n14. Active acute or chronic hepatitis B or C infection, defined as: hepatitis B virus (HBV) DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL; hepatitis C virus (HCV) RNA \\>10³ copies\u002FmL; or concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies.\n15. Active tuberculosis (TB); ongoing anti-TB treatment; or anti-TB treatment completed within 1 year prior to the initiation of study treatment.\n16. Human immunodeficiency virus (HIV) infection (positive for HIV 1\u002F2 antibodies); known syphilis infection.\n17. Severe active infection or infection with poor clinical control.\n18. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to enrollment. Substitution therapy (e.g., thyroid hormone, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) is permitted. A history of known primary immunodeficiency is excluded. Patients with isolated positive autoimmune antibodies must be evaluated by the investigator to confirm the absence of underlying autoimmune disease.\n19. Use of immunosuppressive drugs within 4 weeks prior to enrollment, excluding intranasal, inhaled, or other topical corticosteroids, or systemic corticosteroids at physiological doses (i.e., ≤10 mg\u002Fday of prednisone or equivalent). Temporary use of corticosteroids for the management of dyspnea related to asthma, chronic obstructive pulmonary disease (COPD), or other conditions is permitted.\n20. Administration of live-attenuated vaccines within 4 weeks prior to enrollment or planned administration of live-attenuated vaccines during the study period.\n21. Use of immunomodulatory agents (including thymosin, interferons, or interleukins) within 2 weeks prior to enrollment, excluding local administration for the control of pleural effusion or ascites.\n22. Uncontrolled\u002Funcorrectable metabolic disorders, other non-malignant organ\u002Fsystemic diseases, or cancer-related sequelae that pose a high medical risk and\u002For introduce uncertainty in survival assessment.\n23. Diagnosis of other malignant tumors within 5 years prior to enrollment, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For curatively resected carcinoma in situ. For malignant tumors diagnosed more than 5 years prior to drug administration, pathological or cytological confirmation of recurrent or metastatic lesions is required.\n24. Prior receipt of any anti-angiogenic agents, anti-PD-1 antibodies, anti-PD-L1\u002FL2 antibodies, anti-CTLA-4 antibodies, or other immunotherapies.\n25. Known hypersensitivity to sintilimab, bevacizumab formulations, or their excipients; or history of severe hypersensitivity reactions to other monoclonal antibodies.\n26. Receipt of treatment in other clinical trials within 4 weeks prior to enrollment.\n27. Pregnant or breastfeeding female patients.\n28. Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory findings that, in the investigator's judgment, would: increase the risk associated with study participation or study drug administration; interfere with the interpretation of study results; or render the patient ineligible for study participation.",{"count":647,"type":20},37,[57],"Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Nevertheless, there is no standard neoadjuvant treatment regimen for HCC to date. In recent years, targeted therapy and immunotherapy are proved to improve the prognosis of advanced HCC patients. Previous study (ORIENT-32) has confirmed that, compared with sorafenib, sintilimab combined with bevacizumab biosimilar can delay tumor progression, reduce the risk of death, and exhibit a favorable safety profile in patients with advanced HCC. Therefore, we conducted a prospective, single-arm phase II study to investigate the efficacy of sintilimab combined with a bevacizumab biosimilar as neoadjuvant therapy in patients with resectable HCC beyond the Milan criteria.",[651,26,370,652],"Hepatocellular Carcinoma","Bevacizimab","2026-01-15",{"date":655,"type":36},"2026-01-16",{"date":657,"type":36},"2026-01-14",{"date":659,"type":20},"2030-01",{"name":537,"class":43}]