[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-chemotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-chemotherapy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,41,72,104,128,154,184,213,240,261,288,311,333,361,386,408,433,456,482,507,532,559],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100639879","ultrasound-monitoring-of-clipped-lymph-nodes-to-predict-axillary-response-after-chemotherapy-in-breast-cancer-100639879",false,"NCT07596472","Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer","A Prospective Diagnostic Clinical Study Based on Longitudinal Multimodal Ultrasound Evaluation of Clipped Lymph Nodes to Assess Axillary Pathological Response After Neoadjuvant Chemotherapy in Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n\nClinical stage of breast cancer: T1-T4, N1-N3, M0.\n\nAxillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy.\n\nIndicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen.\n\nThe biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement.\n\nCompletion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available.\n\nUnderwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound.\n\nSigned informed consent and willingness to complete all scheduled follow-ups.\n\nExclusion Criteria:\n\n* Bilateral breast cancer.\n\nPatients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only.\n\nPrior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment.\n\nPresence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult.\n\nPregnant or lactating women.\n\nPoor image quality on ultrasound or other imaging modalities.\n\nInability to provide informed consent due to psychological, family, or social factors","FEMALE","18 Years",{"count":19,"type":20},150,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. In this study, patients with biopsy-proven metastatic axillary lymph nodes will have a metallic clip placed in the positive node before chemotherapy. During and after treatment, the clipped lymph node will be monitored by ultrasound, including gray-scale imaging, shear wave elastography, and contrast-enhanced ultrasound. The changes in the morphological and functional features of the clipped node will be analyzed to establish a predictive model for axillary pathological complete response. The results are expected to help identify patients who may safely avoid unnecessary axillary lymph node dissection and improve individualized surgical decision-making.",[24,25,26,27],"Breast Cancer","Axillary Lymph Node Metastasis","Neoadjuvant Chemotherapy","Pathological Complete Response","NOT_YET_RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-19","ACTUAL",{"date":34,"type":20},"2026-05-20",{"date":36,"type":20},"2027-05-20",{"name":38,"class":39},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100624708","neoadjuvant-capeox-versus-upfront-surgery-for-locally-advanced-colon-cancer-with-elevated-cea-a-single-center-open-label-randomized-controlled-trial-100624708","NCT07413146","Neoadjuvant CAPEOX Versus Upfront Surgery for Locally Advanced Colon Cancer With Elevated CEA: A Single-Center, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\nAge 18 to 70 years (inclusive) at the time of written informed consent. ECOG performance status 0-1, without deterioration within 2 weeks prior to enrollment; anticipated life expectancy ≥12 weeks.\n\nHistologically or cytologically confirmed colon adenocarcinoma, non-MSI-H\u002FdMMR, with pathologic stage (AJCC\u002FUICC TNM 8th edition) of:\n\nHigh-risk stage II, or Stage III. High-risk stage II features include: T4, poor\u002Fundifferentiated histology (high grade; excluding MSI-H), lymphovascular invasion, perineural invasion, preoperative bowel obstruction or tumor perforation, positive\u002Funknown margin status, insufficient margin clearance, \\\u003C12 lymph nodes examined, or high-grade tumor budding.\n\nTumor location consistent with colon cancer: distal tumor margin ≥12 cm from the anal verge on preoperative endoscopy.\n\nBaseline serum CEA \\>5 ng\u002FmL prior to treatment. No evidence of distant metastasis (distant organ and\u002For distant lymph node metastasis) based on comprehensive clinical evaluation.\n\nAbility to provide required clinical data for study collection. Ability to provide adequate fresh tumor tissue from endoscopy and\u002For surgery for WES\u002FNGS to develop an individualized ctDNA MRD panel, and ability to provide required blood samples for ctDNA testing (baseline, postoperative \\~day 7, postoperative \\~day 30).\n\nCandidate for curative-intent R0 resection. Willing and able to comply with the protocol schedule, including regular follow-up visits and necessary treatments, and provides written informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following apply:\n\nPrior or concurrent other malignant tumor. Any severe comorbidity that, in the investigator's judgment, may significantly affect follow-up or short-term survival.\n\nAny other medical condition, or social\u002Fpsychological circumstance, that in the investigator's judgment makes the participant unsuitable for the study.\n\nMSI-H\u002FdMMR tumor. Evidence of metastatic disease by pathology, clinical assessment, or imaging, including isolated distant lesions, distant disease, or non-contiguous intraperitoneal metastasis.\n\nMultiple primary colon cancers. Underwent open surgery at a non-colon site within 14 days prior to enrollment. Unable to provide required tumor tissue for WES\u002FNGS or personalized MRD panel development, personalized MRD panel customization failure, or unable to provide required blood samples (baseline, postoperative \\~day 7, postoperative \\~day 30).\n\nHistory of blood transfusion within 2 weeks prior to surgery or intraoperatively.\n\nUnable to undergo contrast-enhanced CT or MRI for routine clinical follow-up. Fever ≥38°C within the past 7 days, or clinically significant active infection (including active tuberculosis), or active fungal\u002Fbacterial\u002Fviral infection requiring systemic therapy.\n\nInadequate bone marrow reserve or organ function meeting any of the following laboratory abnormalities (within 1 week prior to testing without corrective treatment):\n\nANC \\\u003C 1.5 × 10⁹\u002FL Platelets \\\u003C 90 × 10⁹\u002FL Hemoglobin \\\u003C 90 g\u002FL (\\\u003C9 g\u002FdL) ALT \\> 3 × ULN AST \\> 3 × ULN or total bilirubin \\> 1.5 × ULN Creatinine \\> 1.5 × ULN or creatinine clearance \\\u003C 45 mL\u002Fmin (Cockcroft-Gault) Albumin \\\u003C 28 g\u002FL Pregnant or breastfeeding, or planning pregnancy during the study period. Any other condition that, in the investigator's judgment, indicates the participant should not participate.","ALL","70 Years",{"count":50,"type":20},100,"INTERVENTIONAL",[53],"NA","The goal of this interventional clinical trial is to compare the efficacy of neoadjuvant chemotherapy versus upfront surgery in adults aged 18-70 years with stage II (high-risk)-III, non-MSI-H colon adenocarcinoma and elevated baseline CEA (\\>5 ng\u002FmL) undergoing curative-intent treatment. This single-center, open-label, randomized controlled study will evaluate 2-year disease-free survival (2y-DFS) as the primary endpoint, with all study-related procedures-including longitudinal ctDNA-based molecular residual disease (MRD) monitoring, Immunoscore assessment, tumor tissue sequencing, and surveillance imaging-provided at no cost to participants. The main questions it aims to answer are:\n\n* Does a treatment strategy involving neoadjuvant CAPOX followed by surgery improve 2y-DFS compared with upfront surgery followed by standard adjuvant chemotherapy?\n* Do postoperative ctDNA-MRD status and its longitudinal dynamics predict 2y-DFS?\n* Does combining ctDNA-MRD with Immunoscore enhance prognostic risk stratification for recurrence beyond either biomarker alone?\n\nParticipants will:\n\n* Be randomized 1:1 (N=100) to one of two treatment pathways:\n\n  * Arm A: Neoadjuvant CAPOX × 4 cycles → curative surgery (R0 planned) → postoperative management per standard practice\n  * Arm B: Upfront curative surgery → postoperative standard adjuvant chemotherapy per guideline → routine surveillance\n* Undergo baseline assessments prior to treatment initiation, including blood draw, colonoscopy, primary tumor next-generation sequencing (for personalized ctDNA-MRD assay development), and Immunoscore testing-all provided free of charge as part of the study.\n* Provide postoperative blood samples for ctDNA-MRD testing at approximately postoperative day \\~7 and day \\~30 (before adjuvant therapy start, if applicable).\n* During follow-up, provide serial blood samples every 3 months, aligned with routine surveillance visits, for repeat ctDNA-MRD analysis.\n* Receive standard-of-care postoperative surveillance (including imaging and clinical evaluations) through 2 years, with all study-mandated assessments covered by the trial.\n\nThis trial integrates clinical intervention with comprehensive biomarker profiling to determine whether early systemic therapy alters MRD dynamics and improves outcomes in high-risk, CEA-elevated colon cancer.",[56,57,26,58],"Minimal Residual Disease","Immunoscore","Colon Cancer (Stage II &Amp; III)",[60,56,57,61,62],"advanced stage colon cancer","neoadjuvant chemotherapy","upfront surgery","2026-02-09",{"date":65,"type":32},"2026-02-17",{"date":67,"type":20},"2026-02-24",{"date":69,"type":20},"2027-07-31",{"name":71,"class":39},"Sun Yat-sen University",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":51,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":40},"100533007","early-phase-1-neoadjuvant-therapy-and-contrast-enhanced-mammography-for-early-stage-breast-cancer-100533007","NCT06220214","Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer","Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status\n* Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy\u002Fsensitivity to contrast agent\n* Decreased kidney function\n* Diabetes",{"count":80,"type":20},30,[82],"EARLY_PHASE1","The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to \"see through\" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.\n\nParticipation may last up to 18 weeks.\n\nStudy procedures for this research are:\n\n* Undergoing 1-2 mammograms during and\u002For after your chemotherapy, but before primary breast surgery.\n* Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent\n* Let the research team record information from your medical record related to your condition and the treatment you receive.\n* Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.",[24,85,26,86,87,88],"Locally Advanced Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Cancer","TNBC, Triple Negative Breast Cancer",[90,91,92,93,61],"cedm","cedbt","contrast-enhanced digital mammography","contrast-enhanced digital breast tomosynthesis","RECRUITING","2026-01-13",{"date":97,"type":32},"2026-01-15",{"date":99,"type":32},"2024-03-06",{"date":101,"type":20},"2026-08-31",{"name":103,"class":39},"Alison Stopeck",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":51,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":40},"100599165","sentinel-lymph-node-biopsy-after-neoadjuvant-chemotherapy-in-ibc-100599165","NCT07080944","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial","SYMPHONY","Inclusion Criteria:\n\n* Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging\n* Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)\n* Ability to understand and willingness to sign informed consent document and comply with study procedures\n\nExclusion Criteria:\n\n* Patients with cN3 stage at diagnosis\n* Participants with stage IV (metastatic) breast cancer\n* Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained\n* Patients with a prior history of ipsilateral breast cancer\n* Pregnant patients\n* Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging\n* Patients not consenting to ALND",{"count":113,"type":20},75,[53],"This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin\u002Fchest wall involvement (cT4d) and heavy nodal burden at presentation (cN1\u002FN2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.",[117,118,26],"Invasive Breast Carcinoma","Sentinel Lymph Node Biopsy (SLNB)","2026-01-02",{"date":121,"type":32},"2026-01-06",{"date":123,"type":32},"2025-12-12",{"date":125,"type":20},"2030-08",{"name":127,"class":39},"European Institute of Oncology",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":51,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":40},"100592847","phase-3-megestrol-acetate-in-improving-neoadjuvant-chemotherapy-related-weight-loss-in-locally-advanced-crc-100592847","NCT06998758","Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC","Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Patients With Locally Advanced Colorectal Cancer: A Multicenter Randomized Controlled Clinical Trial","MATRIX","Inclusion Criteria:\n\n* Adult males and females aged between 18 and 75 years old.\n* Histologically confirmed colorectal adenocarcinoma.\n* Immunohistochemistry showing pMMR or MSI status determined as MSS.\n* Clinical stage cTxN1-2M0, with or without MRF positivity, and with or without EMVI positivity.\n* ECOG performance status 0-1, with a life expectancy of ≥6 months.\n* Deemed suitable for preoperative mFOLFOX6 neoadjuvant chemotherapy following multidisciplinary team discussion.\n* Written informed consent has been obtained from the patients.\n\nExclusion Criteria:\n\n* Patients with cardiac arrhythmias requiring anti-arrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure greater than NYHA Class II.\n* Patients with poorly controlled severe hypertension.\n* Patients with a history of HIV infection or active chronic hepatitis B or C (with high-copy viral DNA).\n* Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.\n* Patients with other active severe clinical infections (per NCI-CTC v.5.0).\n* Patients who have previously received chemotherapy.\n* Patients with a history of seizures requiring treatment (e.g., steroids or anti-epileptic therapy).\n* Patients with drug abuse or medical, psychological, or social conditions that may interfere with study participation or outcome assessment.\n* Patients with a known or suspected allergy to the study drug or any agents administered in relation to the trial.\n* Patients with any unstable condition that may jeopardize patient safety or compliance.\n* Pregnant or breastfeeding women, or fertile women not using adequate contraception.\n* Patients who refuse to sign the informed consent form.","75 Years",{"count":138,"type":20},60,[140],"PHASE3","Cancer-associated anorexia, a debilitating condition characterized by progressive appetite loss in oncology patients, contributes to pancytopenia, sarcopenia, and adipose tissue depletion. Megestrol acetate (MA) improves appetite and promotes weight gain through multiple mechanisms, playing a crucial role in the nutritional management of cancer patients. Total mesorectal excision (TME) following neoadjuvant chemotherapy has become the standard treatment strategy for patients with locally advanced colorectal cancer (LACRC). Despite its oncological benefits, neoadjuvant chemotherapy frequently induces grade ≥2 gastrointestinal toxicities (including nausea, emesis, and diarrhea) that exacerbate malnutrition through appetite suppression and negative energy balance. Previous studies have demonstrated that combining MA with first-line maintenance chemotherapy in patients with metastatic colorectal cancer significantly improves appetite, increases body weight, enhances quality of life, and improves prognosis. However, the safety and efficacy of MA during the neoadjuvant treatment phase of LACRC remain unclear. This multicenter, randomized controlled clinical trial aims to evaluate the effects of MA on chemotherapy--related weight loss, anorexia, nutritional status, and chemotherapy tolerance in patients with LACRC undergoing neoadjuvant chemotherapy. Additionally, this study will assess the safety profile of MA in this clinical setting.",[26,143],"Weight Loss",[145],"Megestrol Acetate","2025-12-10",{"date":123,"type":32},{"date":149,"type":32},"2025-11-11",{"date":151,"type":20},"2028-12-31",{"name":153,"class":39},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":164,"conditions":165,"keywords":170,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":40},"100609894","the-better-harder-faster-stronger-study-100609894","NCT07220512","The Better, Harder, Faster, Stronger Study","The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?","Inclusion Criteria:\n\n* Ability to understand and willingness to sign an IRB-approved informed consent.\n* Age \\> 55 years at the time of enrollment.\n* Newly diagnosed suspected ovarian\u002Fprimary peritoneal\u002Ffallopian tube carcinoma of any histological subtype, FIGO Stage II-IV, per enrolling investigator, or newly diagnosed suspected endometrial carcinoma of any histologic subtype, FIGO Stage II-IV, per enrolling investigator.\n* Planned for 3 or 4 cycles of NACT, with interval cytoreductive surgery planned thereafter.\n* Ability to read, understand, and write the English language.\n* As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* History of brain metastases.\n* History of poorly controlled psychiatric conditions, defined as hospitalization within the prior 3 months for psychiatric disorders, traumatic brain injury, cerebrovascular event, or dementia, per the enrolling investigator.\n* Use of anti-amyloid agents, cholinesterase inhibitors, or glutamate regulators at the time of enrollment.\n* Vision impairment that would impede completion of study assessments, per enrolling investigator.","55 Years",{"count":163,"type":20},35,"The purpose of this study is to evaluate changes in the electronic Frailty Index (eFI) score following 3-4 cycles of neoadjuvant chemotherapy (NACT) in participants with advanced ovarian and endometrial cancer.",[166,167,168,169,26],"Frailty at Older Adults","Ovarian Cancer","Endometrial Cancer","Cognitive Dysfunction",[171,172,173,174,61],"Frailty","ovarian cancer","endometrial cancer","cognitive dysfunction","2025-10-22",{"date":177,"type":32},"2025-10-24",{"date":179,"type":32},"2025-07-28",{"date":181,"type":20},"2027-05",{"name":183,"class":39},"Wake Forest University Health Sciences",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":194,"conditions":195,"keywords":200,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100605222","evaluation-of-seismocardiographyscg-for-assessing-fitness-and-predicting-outcomes-in-oesophageal-cancer-surgery-100605222","NCT07159711","Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery","Evaluation of Seismocardiography (SCG) as a Tool for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery","SEISMIC","Inclusion Criteria:\n\n* Age \\>=18\n* Diagnosis of Oesophageal cancer (T0-4 N0-3 M0, Oesophageal \u002F Gastro-Oesophageal Junction (GOJ) type 1-2 adenocarcinoma\n* Patients being considered for curative treatment (i.e. due to undergo NAC and Oesophagectomy \u002F Oesophago-Gastrectomy \\[open \u002F MIO \u002F hybrid \u002F robotic\\])\n* Patients able to give informed consent\n\nExclusion Criteria:\n\n* Pregnant patients.\n* Patients under the age of 18.\n* Patients undergoing primary Oesophagectomy +\u002F- Oesophago-Gastrectomy with no neoadjuvant therapy.\n* Patients undergoing Neoadjuvant chemoradiotherapy.\n* Patient's being treated with curative intent for Oesophageal Squamous cell carcinoma\n* Patients that are deemed not fit or suitable for Oesophagogastric cancer resection as part of a Multi-Disciplinary Team meeting decision.\n* Patients with implanted devices such as pacemakers or cardioverter-defibrillators.",{"count":193,"type":20},164,"Oesophageal cancer is a common cause of cancer death worldwide. Curative treatment involves chemotherapy and surgery but has significant risks. Therefore, patient selection and improving physical fitness to withstand such major treatment is important to reduce the risk of complications. Physical fitness is traditionally measured by a specialised exercise test called Cardiopulmonary exercise testing (CPET), which can take up to one hour and requires specialised staff and expensive equipment such as a graded exercise bike or treadmill. Seismofit is a small device (smaller than a smartphone) used to estimate fitness in patients in under three minutes while lying down at rest. It measures the vibrations generated by the heart and, together with patient height, weight, age, and gender, accurately estimates fitness using an algorithm developed in healthy patients. The device has never been tested in a large group of oesophageal cancer patients to see if it can be used to predict complications in patients undergoing cancer treatment.\n\nIn this study, patients undergoing Oesophageal cancer treatment with chemotherapy or chemoradiotherapy and surgery will have Seismofit measurements at various points during their treatment to see if we can predict complications and hospital stay. Secondly, this study will also evaluate the accuracy of Seismofit compared to the gold standard CPET results in cancer patients.",[196,197,198,199,26],"Oesophageal Cancer","Oesophageal Adenocarcinoma","Prehabilitation","Oesophagectomy",[201,199,202,198,203],"oesophageal cancer","Fitness","Neoadjuvant chemotherapy","2025-08-29",{"date":206,"type":32},"2025-09-08",{"date":208,"type":20},"2025-09-15",{"date":210,"type":20},"2027-06",{"name":212,"class":39},"Guy's and St Thomas' NHS Foundation Trust",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":47,"minAge":220,"maxAge":48,"enrollmentInfo":221,"targetDuration":4,"studyType":51,"phases":223,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":40},"100603926","phase-2-envafolimab-combined-with-neoadjuvant-chemotherapy-treat-stage-iib-resectable-osteosarcoma-patients-100603926","NCT07142863","Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients","Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma","Inclusion Criteria:\n\n* Patients voluntarily participate in the study and have good compliance, signing a written informed consent form before enrollment.\n* Age between 12 and 70 years, with no gender restrictions.\n* Patients diagnosed with non-metastatic, resectable osteosarcoma by pathology and clinical physician assessment.\n* Have measurable disease (according to RECIST 1.1 criteria, non-nodal lesions with a CT scan longest diameter ≥10 mm, and nodal lesions with a CT scan shortest diameter ≥15 mm).\n* No prior systemic anti-tumor treatment.\n* ECOG PS score: 0 to 1.\n* Adequate organ function:\n\n  1. Hematological parameters: Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL, Platelet (PLT) ≥70×10\\^9\u002FL, Hemoglobin (HGB) ≥90 g\u002FL.\n  2. Hepatic function: Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; Serum Albumin ≥28 g\u002FL; Alkaline Phosphatase (ALP) ≤5×ULN; patients on routine hepatic protection treatment meeting the above criteria and stable for at least one week after investigator assessment may be included.\n  3. Renal function: Creatinine (Cr) ≤1.5×ULN, or Creatinine clearance rate ≥50 mL\u002Fmin (using the standard Cockcroft-Gault formula).\n  4. Coagulation function: International Normalized Ratio (INR) ≤1.5, Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; if the subject is undergoing anticoagulant therapy, PT and INR within the intended range of the anticoagulant therapy is acceptable.\n\nExclusion Criteria:\n\n* Participants with a history of or concurrent diagnosis of other malignant tumors (except for cured cutaneous basal cell carcinoma and in situ cervical carcinoma).\n* Patients with recurrent postoperative or previously treated osteosarcoma with local or systemic anti-tumor therapy, or with metastasis.\n* Participants who have received the following treatments within 4 weeks prior to study initiation: radiation therapy for tumors, surgical procedures, chemotherapy, immunotherapy, or other investigational drugs.\n* Known allergies to any component of the study medication in participants. Participants with uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA Class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n* Participants with active infections or fever of unknown origin \\>38.5°C (measured in Celsius) during the screening period or before the first dose of study medication (fever due to tumors may be included at the discretion of the investigator).\n* Use of immunosuppressive drugs within 14 days prior to treatment initiation, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., daily dose of prednisone ≤10 mg or equivalent physiological doses of other corticosteroids).\n* History of active autoimmune diseases or a history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary glanditis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; participants with vitiligo or asthma that may be in complete remission in childhood and currently do not require medical intervention, or history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation).\n* Participants who have received live vaccines within 4 weeks prior to study medication or are likely to receive live vaccines during the study period.\n* Participants with a history of substance abuse, alcoholism, or drug addiction.\n* Participants deemed to be excluded from this study by the investigator, such as those with other factors that could potentially lead to premature termination of the study, such as other serious diseases (including psychiatric diseases) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that could affect participant safety, or collection of data and samples.","12 Years",{"count":222,"type":20},23,[224],"PHASE2","Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.",[227,228,26,229,230],"Osteosarcoma","Neoadjuvant Therapy","PD-L1 Antibody","Envafolimab","2025-08-26",{"date":233,"type":32},"2025-08-27",{"date":235,"type":20},"2025-08-25",{"date":237,"type":20},"2026-09-30",{"name":239,"class":39},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":136,"enrollmentInfo":246,"targetDuration":4,"studyType":51,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":40},"100598863","fasting-mimicking-diet-as-an-adjunct-to-neoadjuvant-chemotherapy-for-hormone-receptor-positive-breast-cancer-100598863","NCT07077018","Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed ER-positive , HER2-negative invasive ductal carcinoma meeting at least one of the following:1)T1c-T2 N1 with histological grade 2 (ER 1-10%) or grade 3. 2)N2-N3 or grade 3 and\u002For Ki67 ≥40%. 3)T3-T4\n* Age 18-75 years at enrollment\n* Body mass index (BMI) ≥18.5 kg\u002Fm²\n* Adequate hematological function:1）White blood cell count\\>3.0×10⁹\u002FL.2)Absolute neutrophil count ≥1.5×10⁹\u002FL.3)Platelets ≥100×10⁹\u002FL.\n* Adequate organ function:1）Total bilirubin ≤1.5 × upper limit of normal (ULN).2）ALT\u002FAST ≤2.5 × ULN. 3）Alkaline phosphatase ≤5 × ULN.4）Creatinine clearance ≥50 mL\u002Fmin-1)\n* ECOG performance status 0-2\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Prior history of any malignancy (including contralateral breast cancer)\n* Received any prior neoadjuvant chemotherapy cycle for current diagnosis\n* Uncontrolled endocrine disorders:1)Diabetes mellitus requiring insulin or oral hypoglycemics.2)Hyper\u002Fhypothyroidism requiring medication\n* Active autoimmune disease requiring systemic immunosuppressants\n* Current use of antipsychotic medications\n* Known hypersensitivity to FMD components (e.g., soy protein, milk protein, nuts)\n* Pregnancy or lactation.",{"count":247,"type":20},45,[53],"This is a phase II, Single-Arm Clinical Study evaluating the efficacy and safety of a fasting-mimicking diet (FMD) combined with neoadjuvant chemotherapy in patients with ER-positive, HER2-negative breast cancer.\n\nParticipants will be assigned to Intervention group: 4-day FMD cycles (827± 100kcal\u002Fday on Day 1, 637± 100kcal\u002Fday on Days 2-4) synchronized with T-EC chemotherapy.\n\nThe primary endpoint is pathological complete response (pCR) rate. Secondary endpoints include metabolic changes, immune markers, quality of life, and safety (CTCAE v5.0). A total patients will be enrolled to detect a 15% pCR improvement (25% vs. 10%, α=0.05, power=80%).",[251,24,26],"Fasting-Mimicking Diet","2025-07-20",{"date":254,"type":32},"2025-07-22",{"date":256,"type":20},"2025-07-12",{"date":258,"type":20},"2026-12-30",{"name":260,"class":39},"Guangdong Provincial People's Hospital",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":47,"minAge":4,"maxAge":4,"enrollmentInfo":269,"targetDuration":271,"studyType":21,"phases":4,"briefSummary":272,"conditions":273,"keywords":278,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":40},"100596869","bladder-cancer-staging-and-prediction-of-new-adjuvant-chemotherapy-efficacy-based-on-deep-learning-and-transfer-learning-in-ultrasound-magnetic-resonance-pathology-multimodal-multiscale-100596869","NCT07051083","Bladder Cancer Staging and Prediction of New Adjuvant Chemotherapy Efficacy Based on Deep Learning and Transfer Learning in Ultrasound-Magnetic Resonance-Pathology Multimodal Multiscale","Intelligent Diagnosis of Bladder Cancer Staging and Prediction of New Adjuvant Chemotherapy Efficacy Based on Deep Learning and Transfer Learning in Ultrasound-Magnetic Resonance-Pathology Multimodal Multiscale","MICS-BC","Inclusion Criteria:\n\n1. Ultrasound and other imaging examinations (CT, MR, etc.) suggest bladder masses and are suspicious for bladder cancer patients.\n2. The bladder is well filled, and no allergic reactions to ultrasound contrast agents are found.\n3. No surgery or radiotherapy\u002Fchemotherapy has been performed.\n4. Patients who meet the indications for surgical resection and are planned for surgical treatment, including one of the following:\n\n   1. Clinical symptoms consistent with suspected bladder cancer (such as gross hematuria, etc.);\n   2. Patients with confirmed primary or recurrent bladder cancer by cystoscopic biopsy;\n   3. Rapid urine cytology and urine cytology FISH testing suggest malignancy.\n\nExclusion Criteria:\n\n1. Individuals unable to tolerate surgery;\n2. Individuals allergic to ultrasound contrast agents, unable to undergo ultrasound contrast examination;\n3. Unsuccessful preoperative ultrasound contrast examination or non-compliant patients;\n4. Postoperative pathology does not indicate bladder cancer;\n5. Patients who have undergone chemotherapy or radiation therapy.",{"count":270,"type":20},480,"5 Years","Bladder cancer is the most common malignant tumor of the urinary system. The presence or absence of muscle invasion in early bladder cancer is an independent prognostic factor. The involvement of muscle invasion affects the choice of surgical methods and treatment. Preoperatively, the precise assessment of bladder cancer staging has important practical value. A more accurate preoperative assessment of bladder cancer staging can reduce overtreatment and provide a favorable basis for clinicians to choose more reasonable and effective surgical methods. Clinically, there has been a longstanding desire to diagnose the staging of bladder cancer through a simple, convenient, effective, and non-invasive examination. As relevant research progresses, a multi-omics diagnostic model will be beneficial in improving diagnostic efficiency. This project aims to establish a multi-omics artificial intelligence system based on deep learning and transfer learning to accurately diagnose the staging of bladder cancer and predict the efficacy of neoadjuvant chemotherapy. This system will assist in clinical treatment decision-making.",[274,275,276,26,277],"Bladder Cancer","Staging","Deep Learning","Contrast Enhanced Ultrasound",[274,279,275,276,26,277],"Multi-omics","2025-06-26",{"date":282,"type":32},"2025-07-03",{"date":284,"type":32},"2024-01-01",{"date":286,"type":20},"2026-12-31",{"name":38,"class":39},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":51,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":309,"locationsCount":4},"100591070","evaluating-bemotuzumab-to-improve-the-efficacy-of-neoadjuvant-chemotherapy-for-triple-negative-breast-cancer-tnbc-100591070","NCT06975644","Evaluating Bemotuzumab to Improve the Efficacy of Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer (TNBC)","A Prospective Clinical Study Evaluating Bemotuzumab Combined With Chemotherapy to Improve the Efficacy of Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n* 1.Voluntarily agree to participate in the clinical study and sign the informed consent form.\n* 2.Female patients aged ≥18 years at the time of signing the informed consent form.\n* 3.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a clinically recognized highly effective contraceptive method during the study and for 3 months after the last dose of the study drug.\n* 4.Adequate archival tumor tissue samples for HIM-type analysis (at least 15 unstained tumor biopsy slides from the most recent metastatic lesion; archival primary tumor samples from treatment-naïve patients are acceptable, or re-biopsied specimens may be submitted).\n* 5.Primary breast cancer meeting the following criteria:Histologically confirmed invasive breast cancer.Breast cancer staging (AJCC 8th edition): T1c-4, N0-2, M0.Histopathologically confirmed triple-negative invasive breast cancer (TNBC) meeting all criteria:HER2-negative: IHC 0\u002F1+ or IHC 2+ with negative in situ hybridization (ISH).ER-negative: IHC \\\u003C1%.PR-negative: IHC \\\u003C1%.Unstained tumor sections must be submitted to the central laboratory as per the study protocol for biomarker validation.\n* 6.Willingness to undergo surgery if deemed eligible after neoadjuvant therapy.\n* 7.Adequate organ function as defined by protocol-specified laboratory thresholds.\n* 8.Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n* 1\\. Pathological Staging a) Inflammatory breast cancer.b) Stage IV (metastatic) breast cancer, bilateral breast cancer, or multicentric breast cancer (defined as multifocal tumors involving more than one quadrant with lesions separated by ≥5 cm).\n* 2\\. Tumor-Related Conditions a) Radiologic evidence of tumor invasion into major blood vessels or investigator-determined high risk of life-threatening hemorrhage due to impending vascular compromise.b) Uncontrolled or symptomatic hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, \\>12 mg\u002FdL serum calcium, or albumin-corrected serum calcium \\> upper limit of normal \\[ULN\\]); or symptomatic hypercalcemia requiring ongoing bisphosphonate therapy.c) Other severe concurrent illnesses interfering with treatment plans, including significant pulmonary conditions\u002Fdiseases.\n* 3\\. Prior\u002FConcurrent Anticancer Therapies a) Previous or current systemic antitumor therapy for the current breast cancer (including chemotherapy, molecular targeted therapy, biologic therapy, or investigational agents).b) Participation in another clinical trial within 4 weeks prior to enrollment (3 months for monoclonal antibody trials) or planned participation during this study.c) Prior treatment with immune checkpoint inhibitors other than PD-1\u002FPD-L1 monoclonal antibodies (e.g., CTLA-4 inhibitors) or anti-angiogenic agents (including monoclonal antibodies or TKIs).d) Administration of live\u002Fattenuated vaccines within 28 days before the first dose or anticipated vaccination during the study.\n* 4\\. Medical History\u002FComorbidities a) Other malignancies within the past 5 years requiring systemic\u002Flocal therapy (excluding cured carcinoma in situ, cervical intraepithelial neoplasia, basal\u002Fsquamous skin cancer, or thyroid cancer).b) Major surgery within 28 days before the first dose (defined as requiring ≥3 weeks recovery) or palliative radiotherapy\u002Fablation within 2 weeks.c) Known\u002Fsuspected autoimmune diseases, except:Hypothyroidism managed with hormone replacement.Stable type 1 diabetes with controlled glycemia.d) Active viral hepatitis:HBV: HBsAg(+) or HBcAb(+) with HBV-DNA(+) (except those with HBV-DNA ≤2,500 copies\u002FmL or 500 IU\u002FmL after antiviral therapy).HCV: HCV-Ab(+) with HCV-RNA(+).Coinfection with HBV and HCV.e) HIV infection (HIV-Ab(+)).f) Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonitis).g) Severe infections:Hospital-required infections (e.g., bacteremia, pneumonia) within 4 weeks.Active CTCAE ≥Grade 2 infections requiring systemic antibiotics within 2 weeks.Unexplained fever \\>38.5°C during screening (tumor-related fever permitted per investigator).Active tuberculosis within 1 year.h) Prior allogeneic bone marrow or solid organ transplantation.i) Peripheral neuropathy ≥Grade 2 (CTCAE v5.0).j) History of neurological\u002Fpsychiatric disorders (e.g., epilepsy, dementia), drug\u002Falcohol abuse.k) Significant cardiac disease:Heart failure (LVEF \\\u003C50%).High-risk arrhythmias (resting HR \\>100 bpm, ventricular tachycardia, Mobitz II\u002Fthird-degree AV block).Unstable angina requiring antianginal therapy.Clinically significant valvular disease.ECG-confirmed transmural myocardial infarction.Uncontrolled hypertension (systolic \\>180 mmHg\u002Fdiastolic \\>100 mmHg).\n* 5\\. Treatment-Related Exclusions a) Systemic immunostimulants (e.g., interferon, interleukin-2) within 4 weeks before the first dose.b) Systemic immunosuppressants (e.g., glucocorticoids, azathioprine) within 2 weeks, except:Topical\u002Finhaled corticosteroids.Physiologic steroid replacement (≤10 mg\u002Fday prednisone equivalent).c) Hypersensitivity to study drug components or severe allergic reactions to monoclonal antibodies.\n* 6\\. Pregnancy\u002FLactation Pregnant\u002Flactating women or women of childbearing potential with positive baseline pregnancy tests or unwilling to use effective contraception.\n* 7\\. Investigator Discretion Any condition deemed by the investigator to compromise protocol compliance or patient safety.","80 Years",{"count":297,"type":20},55,[53],"Evaluating Bemotuzumab to improve the efficacy of neoadjuvant chemotherapy for Triple-Negative Breast Cancer (TNBC)",[301,26,302],"Triple-Negative Breast Cancer (TNBC)","Chemotherapy Effects","2025-05-17",{"date":305,"type":32},"2025-05-22",{"date":307,"type":20},"2025-09-01",{"date":286,"type":20},{"name":310,"class":39},"Zhejiang Provincial People's Hospital",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":319,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":40},"100528018","organoids-based-drug-sensitivity-in-neoadjuvant-chemotherapy-of-breast-cancer-100528018","NCT06155305","Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer","Consistency of Organoids Based Drug Sensitivity and Efficacy of Neoadjuvant Chemotherapy in Breast Cancer","ONAC","Inclusion Criteria:\n\n1. Signed informed consent form and willingness to participate in the clinical study.\n2. Female patients aged between 18 and 70 years old.\n3. Confirmed early-stage breast cancer eligible for surgery (AJCC stages I to IIIA), with a tumor diameter of ≥ 2cm detected by MRI and without distant metastasis (M0).\n\n   The largest lesion among multiple lesions has a diameter of ≥ 2cm.\n4. ECOG performance status score of 0-1.\n5. No significant abnormalities in liver and kidney function (BIL \\\u003C1.5-fold upper limit of normal (ULN)；ALT\\\u003C2.5×ULN; AST\\\u003C2.5×ULN；Crea≤1×ULN).\n\nExclusion Criteria:\n\n1. Received prior treatments.\n2. Locally advanced breast cancer not amenable to surgery or inflammatory breast cancer (AJCC stage unresectable III).\n3. Bilateral breast cancer.\n4. Multiple breast cancers distributed in different quadrants.\n5. Patients not suitable for neoadjuvant chemotherapy.",{"count":320,"type":20},58,"Breast cancer is the most common malignancy in women worldwide. Patients with breast cancer are often diagnosed at later stages and have a strong desire for breast conservation, necessitating neoadjuvant chemotherapy. Tumors of different molecular subtypes and individual variations among patients lead to significant differences in treatment efficacy. Precise assessment of patients' responses to treatment regimens is imperative in advancing prognosis of breast cancer. In this study, 58 patients diagnosed with breast cancer and scheduled for neoadjuvant therapy will be recruited. Patient-derived organoids from their tumor biopsies will be utilized to evaluate the sensitivity of chemotherapy regimen. These drugs primarily include Doxorubicin, Carboplatin, Cyclophosphamide, Paclitaxel, as well as targeted therapies such as Herceptin and Pertuzumab.",[323,24,26],"Organoids","2025-01-05",{"date":326,"type":32},"2025-01-07",{"date":328,"type":32},"2023-12-06",{"date":330,"type":20},"2025-12-01",{"name":332,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":51,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":40},"100571004","phase-3-standard-or-prolonged-neoadjuvant-chemotherapy-before-surgery-for-brlapc-100571004","NCT06714604","Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR\u002FLAPC","Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled","ADVANTAGE","Inclusion Criteria:\n\n* Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, version 1.2022\n* Histo- or cytologically confirmed adenocarcinoma (preferably EUS-guided)\n* T1-4, Nx, M0 according to AJCC 8th edition\n* ECOG 0-1 and considered fit for the planned chemotherapy at the local hospital and surgery at the two national centers for BR\u002FLAPC\n* Written informed patient consent\n\nExclusion Criteria:\n\n* Co-morbidity precluding pancreatic surgery or chemotherapy\n* Contraindications to any of the drugs in the proposed treatment regimens\n* ECOG ≥2\n* Neuropathy ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), version 6\n* Granulocyte count \\\u003C 1500 per cubic millimetre (\\\u003C 1,5 x 109\u002FL)\n* Platelet count \\\u003C 100 000 per cubic millimetre (\\\u003C 100 x 109\u002FL)\n* Serum creatinine \\> 1.5 UNL (upper limit normal range)\n* Albumin \\\u003C2,5 g\u002Fdl (\\\u003C25 g\u002FL)\n* Total bilirubin \\>3 x ULN\n* ASAT (SGOT) and ALAT (SGPT) \\>2.5 x institutional ULN\n* female patients in child-bearing age not using adequate contraception, pregnant or lactating women\n* mental or somatic disorders which could possibly interfere with informed consent, compliance or the planned treatments\n* previous oncologic treatment for PC within the past 5 years\n* participation in other clinical trial with an investigational product during the past 30 days\n* Any reason according to the investigator why the patient cannot comply with the protocol or is not suitable to participate","90 Years",{"count":343,"type":20},432,[140],"The goal of this multicenter randomized controlled phase III trial is to compare two durations of neoadjuvant chemotherapy (NAT) with mFOLFIRINOX or gemcitabine-nab-paclitaxel (GnP) before attempt for surgical resection in patients with borderline (BR) and locally advanced pancreatic cancer (LAPC). Patients with histologically confirmed non-metastatic BR\u002FLAPC evaluated to potentially tolerate any of the treatment regimens and pancreatic surgery will be randomized to receive either standard duration NAT with 6 cycles mFOLFIRINOX or 4 cycles GnP or prolonged duration NAT with either 12 cycles mFOLFIRINOX or 6 cycles GnP before attempt for surgical resection, provided there is no evidence of disease progression. The primary objective is to compare the overall survival at 24 months after randomization of all treated patients and among the resected patients with BR\u002FLAPC.",[347,348,349,26,350,351],"Locally Advanced Pancreatic Adenocarcinoma","Borderline Resectable Pancreatic Carcinoma","Pancreas Cancer","Surgery","Pancreatectomy","2024-11-28",{"date":354,"type":32},"2024-12-03",{"date":356,"type":32},"2023-10-18",{"date":358,"type":20},"2033-12-31",{"name":360,"class":39},"Sahlgrenska University Hospital",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":47,"minAge":368,"maxAge":295,"enrollmentInfo":369,"targetDuration":4,"studyType":51,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100479973","phase-3-neofol-r-trial-perioperative-versus-adjuvnat-folfirinox-in-resectable-pancreatic-cancer-100479973","NCT05529940","NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)","Efficacy of Perioperative Versus Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Trial (NeoFOL-R Trial)","Inclusion Criteria:\n\n\\- A. Age: 19 to 80 years old B. Patients with a score of 0 - 1 (ECOG) when selecting a study subject C. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological) D. Patients evaluated as resectable pancreatic cancer in preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021)\n\n* No arterial tumor contact (celiac asix, superior mesenteric artery, or common hepatic artery).\n* No tumor contact with the superior mesenteric vein or portal vein or ≤ 180°contact without vein contour irregularity.\n\nE. No distant metastases on preoperative imaging F. Patients with adequate organ function\n\n1. Bone marrow function: WBC 3,000\u002Fmm3 or more or ANC 1,500\u002Fmm3 or more, platelet ≥ 100K\u002Fmm3\n2. Liver function: Bilirubin ≤ 3 x upper normal limit (≤5.0 mg\u002FdL), AST\u002FALT ≤ 5 x upper normal limit (\\\u003C200 IU\u002FL)\n3. Renal function (Cr clearance ≥ 60 mL\u002Fmin) or (Cr \\\u003C 1.5 x upper normal limit) G. Persons physically capable of undergoing surgery H. Those who consented to the clinical trial I. Women of childbearing potential must have a negative serum pregnancy test within one week before starting the intervention drug. Men and women of childbearing potential must use effective contraception from screening through six months after the last dose.\n\nExclusion Criteria:\n\n\\- Patients who met any of the following criteria are not eligible to participate in this study.\n\nA. Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination (The resectability assessment depends on the presence of major vessel invasion, while invasion of adjacent organs is excluded from the criteria) B. Patients with a history of previous pancreatic surgery C. Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer D. Patients with distant metastases or recurrent pancreatic cancer E. Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland) F. Patients within five years of diagnosis of other organ malignancies (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ without evidence of disease) G. Pregnant and lactating women H. Serious concomitant systemic disorders, including active or ongoing systemic infections, symptomatic congestive heart failure, unstable angina, clinically significant cardiac arrhythmias, psychiatric disorders, or uncontrolled comorbid conditions that may limit compliance with study requirements, or any medical condition that, at the discretion of the investigator, could compromise patient safety, interfere with the assessment of safety and efficacy, or hinder participation in the clinical trial.","19 Years",{"count":370,"type":20},609,[140],"Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not only in racial differences, but also in average size and body surface area. Accordingly, there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for Asians. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC.\n\nObective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.\n\nStudy design: open-label, multicenter, randomized, phase 3 clinical trial Study population: Patients with resectable pancreatic cancer and ECOG performance 0 or 1.\n\nIntervention:\n\nInvervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat",[374,26,375],"Resectable Pancreatic Cancer","Effects of Chemotherapy","2024-11-25",{"date":378,"type":32},"2024-11-27",{"date":380,"type":32},"2023-04-01",{"date":382,"type":20},"2027-12",{"name":384,"class":39},"Seoul National University Hospital",2,{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":295,"enrollmentInfo":393,"targetDuration":4,"studyType":51,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":4},"100551425","phase-2-efficacy-and-safety-of-neoadjuvant-sintilimab-plus-flot-versus-sintilimab-plus-sox-phase-ii-clinical-trial-for-patients-with-locally-advanced-gastric-cancer-100551425","NCT06459921","Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer","Efficacy and Safety of Neoadjuvant Sintilimab Puls FLOT Versus Sintilimab Puls SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer","Inclusion Criteria:\n\n* 1\\. Age \\>=18 years and \\\u003C100 years.\n* 2\\. Diagnosed with locally advanced gastric cancer.\n* 3\\. Eastern Cooperative Oncology Group ECOG PS score 0-1.\n* 4\\. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.\n* 5\\. deficient mismatch repair identified by pathological detection.\n\nExclusion Criteria:\n\n* 1\\. Locally advanced unable to resect or metastatic tumors.\n* 2\\. Patients with recurrence of residual gastric cancer\n* 3\\. Patients refusing surgical resection after preoperative chemotherapy therapy.\n* 4\\. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.\n* 5\\. Patients with confirmed allergy to the study drug and\u002For its excipients.\n* 6\\. Severe malnutrition and active autoimmune diseases.\n* 7\\. Pregnant or lactating women.\n* 8\\. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.\n* 9\\. Patients with acute infections requiring antibiotic treatment.\n* 10\\. Patients with acute infections requiring antibiotic treatment.\n* 11\\. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.\n* 12\\. Positive test result for hepatitis B or hepatitis C virus.\n* 13\\. Untreated central nervous system metastatic peripheral neuropathy (\\>grade 1).\n* 14\\. History of malignancy within the past 5 years (with the exception of curative, localized cancer).\n* 15\\. Patients who are not expected to achieve R0 resection.\n* 16\\. Weight loss greater than or equal to 20% within 4 weeks before the first dose.\n* 17\\. Patients with multiple factors affecting oral medication.\n* 18\\. Vaccination within 4 weeks prior to the first dose of study drug.\n* 19\\. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.\n* 20\\. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.",{"count":394,"type":20},200,[224],"This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.",[26,398,399],"Sintilimab","Locally Advanced Gastric Cancer","2024-10-09",{"date":402,"type":32},"2024-10-10",{"date":404,"type":20},"2024-12-01",{"date":151,"type":20},{"name":407,"class":39},"Xijing Hospital",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":416,"targetDuration":4,"studyType":51,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":40},"100481842","phase-2-neoadjuvant-chemotherapy-combined-with-pd-1--radical-radiotherapy-in-locally-advanced-cervical-cancer-100481842","NCT05554276","Neoadjuvant Chemotherapy Combined With PD-1 + Radical Radiotherapy in Locally Advanced Cervical Cancer","Neoadjuvant Chemotherapy Combined With PD-1 Antibody + Radical Radiotherapy in Unresectable Locally Advanced Cervical Cancer Patients","PD-1","Inclusion Criteria:\n\n* Patients who were pathologically diagnosed with cervical squamous cell carcinoma and were assessed as unresectable.\n\nExclusion Criteria:\n\n* Any active or present autoimmune disease (eg, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism)",{"count":417,"type":20},36,[224],"Based on various external factors and differences in the basic characteristics of patients, in my country, it is not clear whether concurrent chemoradiotherapy can achieve optimal therapeutic effect in patients with pathologically diagnosed stage IIB or above locally advanced cervical cancer. Under the limitations of radiotherapy and surgery conditions in the region, some patients will try neoadjuvant chemotherapy combined with PD-1 antibody therapy before standard radiotherapy, hoping to reduce cancer focus and reduce infiltration. Thereby reducing the scope of radiotherapy, better ensure the efficacy of late radiotherapy and chemotherapy and reduce the side effects of radiotherapy. Judging from the review of such patients, neoadjuvant chemotherapy combined with PD-1 antibody therapy + radical radiotherapy seems to have certain efficacy and tolerance in the near future as expected. No statistical analysis has been done on the long-term survival of patients. This topic intends to treat inoperable locally advanced cervical cancer patients with neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy, and explore the treatment-related toxic and side effects and efficacy of neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy. It is hoped that through this study, it will provide a reference for the comprehensive treatment of inoperable locally advanced cervical cancer that has been pathologically diagnosed in the future.",[26,421,422,423],"PD-1 Antibody","Radiotherapy","Cervical Cancer","2024-07-24",{"date":426,"type":32},"2024-07-25",{"date":428,"type":32},"2023-08-01",{"date":430,"type":20},"2025-12-31",{"name":432,"class":39},"Shanghai Jiao Tong University Affiliated Sixth People's Hospital",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":51,"phases":443,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":455,"locationsCount":385},"100537698","vabb-after-neoadjuvant-therapy-to-avoid-surgery-pcr-to-avoid-breast-surgery-100537698","NCT06281210","Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery","Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment","BETTY-CRASY","Inclusion Criteria:\n\n* age\\> 18 years\n* infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0\n* single lesion\n* neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice\n* conservative surgery proposal\n* M0\n* tumour bed identified by breast markers placed in pre NACT by radiologist\n\nExclusion Criteria:\n\n* Bilateral or multicentric tumour\n* Presence of microcalcifications visualised on mammography\n* Presence of associated DCIS\n* Positive history of previous breast cancer\n* Positive history of medical or psychiatric conditions preventing adherence to the protocol\n* High risk patient",{"count":442,"type":20},77,[53],"This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.",[24,87,86,26],[447,448,61],"Triple negative breast cancer","HER2-positive breast cancer","2024-02-20",{"date":451,"type":32},"2024-02-28",{"date":453,"type":32},"2023-12-11",{"date":151,"type":20},{"name":127,"class":39},{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":51,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":4},"100529304","phase-2-irinotecan-liposome-for-resectable-pancreatic-cancer-with-or-without-addebelizumab-100529304","NCT06172036","Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab","A Multicenter, Multi-cohort, Randomized, Phase II Study of Irinotecan Liposome Combined With 5-FU \u002F LV and Oxaliplatin for Resectable Pancreatic Cancer With or Without Addebelizumab","CAPT-02","Inclusion Criteria:\n\n1. Age: 18 years old, male or female;\n2. According to the NCCN clinical practice guidelines (2023.V2 version), multidisciplinary and imaging evaluation for patients with resectable pancreatic cancer, resectable defined as: by imaging examination, the criteria of radical resection of tumor is no distant metastasis, the artery (trunk celiac, superior mesenteric artery or common hepatic artery), and the tumor did not invade the superior mesenteric vein and portal vein, or invasion but not more than 180 and the venous contour is normal.\n3. Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or research drug therapy; 4. At least one measurable lesion must be used as the target lesion (according to the RECIST v1.1 criteria);\n\n5\\. ECOG：0～1； 6. Expected survival period of 3 months; 7. Main organ function, meeting the following criteria (without receiving any blood components, cell growth factors within the 14 days prior to randomization):\n\n1. Neutrophils 1.5 \\* 109 \u002F L; platelets 80 \\* 109 \u002F L; 9 g\u002Fdl hemoglobin and 3 g\u002Fdl serum albumin;\n2. The upper limit of total bilirubin is 1.5 times (biliary obstruction allows biliary drainage); the upper limit of ALT and AST is 3 times (for patients of liver metastasis, it can be relaxed to 5 times the upper limit of normal);\n3. The upper limit of normal serum creatinine is 1.5 times, and the creatinine clearance is 60ml \u002F min;\n4. The upper limit of INR is 1.5 times and the upper limit of APTT is 1.5 times (for stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin and INR can be screened within the expected treatment range of anticoagulant);\n5. ECG: QTcF 450ms (male), 470ms (female);\n6. Cardiac color ultrasound: LVEF (left ventricular ejection fraction) 50%; 8. Women of childbearing age must have a negative blood pregnancy test within 3 days before randomization and be willing to use appropriate contraception during the trial and within 6 months of treatment. For men, it should be surgical sterilization, or consent to use appropriate methods of contraception during the study period and within 3 months after the end of treatment; 9. Subjects volunteered to join the study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with pancreatic cancer arising from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic pancreoblastoma, and solid-pseudopapillary tumors;\n2. Patients with known central nervous system metastases;\n3. Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);\n4. Within 2 weeks before randomization, the third space effusion (such as a large amount of pleural fluid) (no intervention after removing the drainage tube);\n5. Patients with clinical symptoms of ascites, requiring puncture, drainage, who have received ascites drainage within the previous 3 months (only a small amount of ascites on imaging and controllable, except those without clinical symptoms);\n6. Current subjects with interstitial pneumonia or interstitial lung disease, or a history requiring hormonal therapy, or other pulmonary fibrosis, mechanical pneumonia (e. g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, idiopathic pneumonia or active CT during screening that may interfere with the judgment and management of immune-related pulmonary toxicity; active tuberculosis;\n7. Patients with active autoimmune disease or a history of autoimmune disease that may relapse \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, optis, enteritis, vasculitis, nephritis, hyperthyroidism, reduced thyroid function (only controlled by hormone replacement therapy can be enrolled)\\]; skin diseases without systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes or asthma in childhood has been completely alleviated in adults without any intervention;\n8. Known peripheral neuropathy (CTCAE Grade 3);\n9. Known dihydropyrimidine dehydrogenase (low activity) or deficiency;\n10. Severe infection (CTCAE\\> 2), such as severe pneumonia, bacteremia, infectious complications, requiring hospitalization, occurred within 4 weeks of randomization; symptoms and signs of infection within 2 weeks of randomization (except in cases of prophylactic antibiotics);\n11. Received any of the following treatments:\n\n(1)Concomitant medication containing CYP3A4, CYP2C8 strong inhibitor \u002F strong inducer or strong UGT1A1 inhibitor within 2 weeks before randomization; (2)Immunosuppressants or systemic hormone therapy within 2 weeks prior to randomization to achieve immunosuppressive purposes (dose\\> 10mg prednisone \u002F day or other efficacy hormones); (3)Received radiation therapy within 2 weeks before randomization; (4)Receiving major surgery (such as thoracotomy, laparotomy, etc.) within 4 weeks before randomization; (5)Have received any other clinical study drug treatment within 4 weeks before randomization, except for an observational (non-interventional) clinical study or interventional clinical study follow-up.\n\n12\\. Abnormal coagulation, bleeding tendency or undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (100mg \u002F day), low molecular weight heparin (enoxaparin 40mg \u002F day and other low molecular weight heparin at its equivalent doses) is allowed; 13. cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure; (2) unstable angina; (3) myocardial infarction within 6 months; (4) patients with clinically significant supraventricular or ventricular arrhythmias who need treatment or intervention; 14. Malignant tumors other than pancreatic cancer within 5 years before randomization, except for adequately treated cervical carcinoma in situ, skin basal cell, or squamous epithelial cell carcinoma; 15. Those known to be allergic to PD-L1, irinotecan liposomal, other liposomal products, oxaliplatin, 5-FU, leucovorin and any of the components of the above products; 16. Those known to have acquired immune deficiency syndrome (AIDS) or HIV test positive, active syphilis; 17. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 18. By the judgment of the investigator, the subject has other factors that may be forced to terminate the study, such as non-compliance protocol, with other serious diseases (including mental illness) need to combine treatment, clinical significant laboratory value seriously abnormal, family or social factors, may affect the safety or trial data collection of subjects.",{"count":465,"type":20},180,[224],"To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) \u002F leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate",[26,374],[470,471,472],"resectable pancreatic cancer","irinotecan liposomes","Adebellizumab","2023-12-14",{"date":475,"type":32},"2023-12-15",{"date":477,"type":20},"2024-01-20",{"date":479,"type":20},"2027-01-20",{"name":481,"class":39},"Zhejiang University",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":295,"enrollmentInfo":490,"targetDuration":4,"studyType":51,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":505,"locationsCount":40},"100454805","camrelizumab-combined-with-neoadjuvant-chemotherapy-after-stent-placement-for-left-sided-obstructive-colonic-cancer-100454805","NCT05202314","Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer","Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement Versus Surgery Alone for Left-Sided Obstructive Colonic Cancer","NACSOC-02","Inclusion Criteria:\n\n* Radiologically proven colonic obstruction of the left colon\u002Fupper rectum presumed secondary to a carcinoma\n* Able to give written, informed consent\n* Primary tumor was resectable\n* ECOG score 0 or 1\n* Haemoglobin greater than 100 g\u002FL after transfusion before chemotherapy,\n* White blood cells greater than 3.0×10# \u002FL\n* Platelets greater than 100×10# \u002F L;\n* Glomerular filtration rate greater than 50 mL per minute as calculated by the Wright or Cockroft formula\n* Bilirubin less than 1.5×Upper Limit of Normal(ULN)\n* ALT and AST less than 2.5×ULN\n\nExclusion Criteria:\n\n* Distal rectal cancers(equal or less than 10cm from the anal verge)\n* Patients with signs of peritonitis and\u002For bowel perforation\n* Patients who did not give informed consent\n* Patients who were considered unfit for operative treatment or refuse surgery.\n* Patients with suspected or proven metastatic adenocarcinoma;\n* Patients with unresectable colorectal cancer, or planning for palliative treatment.",{"count":491,"type":20},20,[53],"Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore#the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. Immunotherapy has proven to be highly effective as first-line treatment of metastatic colorectal cancer (CRC). And immunotherapy also has emerged as a neoadjuvant approach, possibly changing treatment strategy for both primary resectable and metastatic CRC. We hypothesis that, regardless of the MSI state, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.",[495,26,496,497,498],"Colorectal Cancer","Stent","Obstruction","Immunotherapy","2023-02-19",{"date":501,"type":32},"2023-02-21",{"date":503,"type":32},"2021-12-12",{"date":258,"type":20},{"name":506,"class":39},"Beijing Chao Yang Hospital",{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":515,"targetDuration":4,"studyType":51,"phases":517,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":40},"100467472","phase-3-neoadjuvant-chemotherapy-followed-by-chemoradiation-versus-chemoradiation-for-stage-iiic-cervical-cancer-patients-a-randomized-phase-iii-trial-100467472","NCT05367206","Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial","Department of Radiation, Sun Yat-sen University","N6C","Inclusion Criteria:\n\n1. pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix；\n2. FIGO (2018 International Federation of Gynecology and Obstetrics) stage IIIC with carcinoma \\>4 cm in greatest dimension and\u002For lymph node \\>2 cm in short axis at initial diagnosis.\n3. age 18 to 70 years；\n4. Eastern Cooperative Oncology Group performance status 0 to 2；\n5. adequate organ function.\n\nExclusion Criteria:\n\n1\\. not at initial diagnosis; 2. with other kind of tumor.\n\n\\-",{"count":516,"type":20},280,[140],"Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma \\>4 cm in greatest dimension and\u002For lymph node \\>2cm in short axis.",[423,26,520],"Bulky Neoplasm",[522,61,523],"cervical cancer","bulky neoplasm","2022-05-09",{"date":526,"type":32},"2022-05-10",{"date":528,"type":32},"2022-03-14",{"date":530,"type":20},"2027-03-31",{"name":71,"class":39},{"id":533,"slug":534,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":539,"targetDuration":4,"studyType":51,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":40},"100406724","phase-2-efficacy-and-safety-of-dose-dense-chemotherapy-ddec-ddp-for-neoadjuvant-chemotherapy-of-her2-negative-breast-cancer-100406724","NCT04576143","Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer","Efficacy and Safety of Dose-dense Epirubicin and Cyclophosphamide Plus Paclitaxel as Neoadjuvant Chemotherapy for HER2-negative Early Breast Cancer：a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Female aged 18-70 years old;\n2. Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable), clinical stage IIA-IIIA;\n3. Definite reports on ER\u002FPR\u002FHER2 receptor showing all HER2 negative (HER2 is 0\\~1+ or 2+ but determined negative via fluorescence in situ hybridization (FISH) or chemiluminescent in situ hybridization (CISH) detected (no amplification) is defined as HER2 negative);\n4. According to RECIST 1.1, there is at least one measurable objective focus, tumor size \\> 2cm;\n5. Eastern Cooperative Oncology Group (ECOG) performance score is 0 or 1;\n6. Cardiac function: left ventricular ejection fraction (LVEF)≥55%;\n7. Normal bone marrow function: White blood cell count \\> 4 × 10\\^9\u002Fl, neutrophil count \\> 1.5 × 10\\^9\u002Fl, platelet count \\> 100 × 10\\^9\u002Fl and hemoglobin 9g\u002Fdl;\n8. Normal liver and renal function: aspartate aminotransferase (AST) and ALT ≤2.5 folds of the upper limit of normal values, total bilirubin ≤1.5 folds of the upper limit of normal values; Serum creatinine ≤1.5 folds of the upper limit of normal value.\n9. Informed consent form signed.\n\nExclusion Criteria:\n\n1. HER2 is positive;\n2. Metastasis at any location;\n3. Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;\n4. Severe systemic disease and\u002For uncontrollable infection, unable to be enrolled in this study;\n5. Known allergic or intolerable to chemotherapeutic agents;\n6. Previously suffering from malignant tumors within 5 years (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;\n7. Cardiovascular disease: LVEF \\\u003C50% (echocardiography) of New York Heart Association (NYHA) ≥ grade 2;\n8. Pregnant and breast-feeding women; Pregnancy test showed positive results before drug administration after enrolling in to the study; Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;\n9. Already enrolled into other clinical trials;\n10. The researchers judged the patients who were not suitable for this study.",{"count":540,"type":20},260,[224,140],"Recent clinical studies showed that breast cancer patients especially for those with lymph node metastasis may benefit from dose-dense chemotherapy, like adriamycin and cyclophosphamide (AC) q2w×4→ paclitaxel (P) q2w×4. However, the studies on dose-dense (dd) regimen chemotherapy is mostly based on postoperative adjuvant chemotherapy and the optimum of dose-dense chemotherapy has not been determined for Chinese population with HER2-negative breast cancer patients. In our study, a prospective, randomized, open-label, multi-center clinical study was conducted to compare the efficacy and safety of dose-dense chemotherapy regimen (dd epirubicin\u002Fcyclophosphamide (EC) followed by dd paclitaxel (P)) and conventional chemotherapy (epirubicin\u002Fcyclophosphamide (EC) followed by docetaxel (T)) as preoperative neoadjuvant chemotherapy in the treatment of HER2-negative breast cancer in Chinese population.",[544,26],"HER2-negative Breast Cancer",[546,547,548,549,550],"HER2-negative breast cancer","dose-dense chemotherapy","preoperative neoadjuvant chemotherapy","EC-T","ddEC-ddP","2021-08-09",{"date":553,"type":32},"2021-08-12",{"date":555,"type":32},"2020-09-20",{"date":557,"type":20},"2027-09-20",{"name":332,"class":39},{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":295,"enrollmentInfo":566,"targetDuration":4,"studyType":51,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":40},"100392023","phase-3-dragon-iii-phase-3-neoadjuvant-chemotherapy-flot-versus-sox-for-gastric-cancer-100392023","NCT04384601","Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer","Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: A Phase 3 Multi-center Randomized Controlled Trial","Inclusion Criteria:\n\n* Histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastric junction.\n* Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III\n* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)\n* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function.\n* Written informed consent\n\nExclusion Criteria:\n\n* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia\n* Distant metastases (including retroperitoneal lymph node)\n* Locally advanced inoperable disease (Clinical assessment)\n* Relapse of gastric cancer\n* Malignant secondary disease\n* Prior chemo or radio therapy\n* Inclusion in another clinical trial\n* Known contraindications or hypersensitivity for planned chemotherapy",{"count":567,"type":20},246,[140],"DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.",[571,26],"Gastric Cancer",[571,573,574,575,203],"Gastric Adenocarcinoma","Stomach Cancer, Adenocarcinoma","Chemotherapy Effect","2021-07-15",{"date":578,"type":32},"2021-07-19",{"date":580,"type":20},"2021-09",{"date":582,"type":20},"2027-09",{"name":584,"class":39},"Ruijin Hospital"]