[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,71,98,130,158,189,219,246],{"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":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100523465","phase-1-autologous-car-t-cells-targeting-cspg4-in-relapsedrefractory-hnscc-100523465",false,"NCT06096038","Autologous CAR-T Cells Targeting CSPG4 in Relapsed\u002FRefractory HNSCC","Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. Histologically or cytologically confirmed stage recurrent\u002Fmetastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.\n\nExclusion Criteria:\n\n1. Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.\n2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.\n3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.\n\nHow many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future.\n\nThere are two parts to this study. In part 1, blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.\n\nThe data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested.\n\nEligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.",[26,27,28,29],"Head and Neck Cancer","Relapse","Recurrent","Refractory Cancer",[31],"cellular therapy","RECRUITING","2026-07-06",{"date":35,"type":36},"2026-07-08","ACTUAL",{"date":38,"type":36},"2024-04-05",{"date":40,"type":20},"2028-08-01",{"name":42,"class":43},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100646617","phase-1-neoantigen-peptide-vaccine-plus-pembrolizumab-in-renal-cell-carcinoma-100646617","NCT07686744","Neoantigen Peptide Vaccine Plus Pembrolizumab in Renal Cell Carcinoma","A Phase I Clinical Trial of Personalized Neoantigen Peptide Vaccine in Combination With Pembrolizumab for the Safety and Efficacy in Patients With Advanced, Recurrent or Refractory Renal Cell Carcinoma","NPVPP","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed Stage III or IV, locally advanced, recurrent or metastatic renal cell carcinoma (RCC) not amenable to curative surgery\n2. Disease stability for ≥3 months after prior single pembrolizumab therapy, with documented progression or intolerance to standard treatment\n3. At least one measurable lesion per RECIST v1.1 (longest diameter ≥10 mm for non-lymph node lesions; short axis ≥15 mm for lymph nodes; or bone lesions confirmed by CT\u002FMRI)\n4. Age ≥18 years\n5. Estimated life expectancy ≥3 months\n6. ECOG performance status 0-3\n7. Availability of tumor tissue (biopsy or archival specimen) for whole exome sequencing (WES) and RNA sequencing (RNA-seq), with ≥50 tumor gene mutations detectable\n8. Adequate organ function as defined by laboratory parameters within 14 days prior to enrollment:\n\n   8.1 Hematologic: Absolute Neutrophil Count(ANC) ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL; 8.2 Hepatic: total bilirubin(TBIL) ≤1.5×Upper Limit of Normal(ULN), Aspartate Aminotransferase(AST)\u002FAlanine Aminotransferase(ALT) ≤2.5×ULN (≤5×ULN if liver metastases present); 8.3 Renal: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula); 8.4 Coagulation: international normalized ratio(INR) ≤1.5, activated partial thromboplastin time(APTT) ≤1.5×ULN; 8.5 Cardiac: Left Ventricular Ejection Fractions(LVEF) ≥50% by echocardiography;\n9. Ability to comply with study procedures and follow-up schedule;\n10. Signed informed consent form;\n11. For women of childbearing potential: negative serum pregnancy test (Human Chorionic Gonadotropin sensitivity ≤25 IU\u002FL) within 7 days prior to enrollment; agreement to use effective contraception during study and for 4 weeks after last dose;\n12. For men: agreement to use effective contraception during study and for 4 weeks after last dose.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Prior treatment with:\n\n   2.1 Two or more lines of immune checkpoint inhibitor (ICI) systemic therapy; 2.2 CTLA-4 inhibitor (e.g., ipilimumab); 2.3 Tumor vaccine therapy (including neoantigen vaccine, dendritic cell vaccine, etc.); 2.4 Chemotherapy specifically for renal cell carcinoma; 2.5 Allogeneic hematopoietic stem cell or solid organ transplantation;\n3. Active autoimmune disease or other immune-mediated disorders requiring systemic immunosuppressive therapy;\n4. Participation in another investigational drug study within 4 weeks prior to first dose;\n5. Active infection including:\n\n   5.1 Known Human Immunodeficiency Virus(HIV) infection; 5.2 Active hepatitis B (HBsAg positive and Hepatitis B Virus-DNA \\>500 IU\u002FmL) or hepatitis C (HCV-RNA positive); 5.3 Active tuberculosis (T-SPOT or PPD positive with clinical symptoms, or chest CT suggestive of active TB); 5.4 Severe infection requiring intravenous antibiotics within 2 weeks prior to enrollment, or uncontrolled systemic infection;\n6. Symptomatic central nervous system (CNS) metastases; exception: patients with treated CNS metastases stable for ≥4 weeks without neurological symptoms and without corticosteroid requirement;\n7. Uncontrolled comorbidities including:\n\n   7.1 Symptomatic congestive heart failure (New York Heart Association Class III-IV); 7.2 Unstable angina or myocardial infarction within 6 months; 7.3 Uncontrolled arrhythmia; 7.4 Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg despite standard treatment); 7.5 Active peptic ulcer or gastrointestinal bleeding; 7.6 Active interstitial lung disease or pulmonary fibrosis;\n8. Other malignancy within 5 years (except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin carcinoma);\n9. Live vaccine administration within 4 weeks prior to enrollment or planned during study (inactivated vaccines allowed);\n10. Known hypersensitivity to peptide vaccine components, adjuvants (e.g., Montanide ISA-51, Poly-ICLC), or pembrolizumab;\n11. Sarcomatoid or rhabdoid RCC as predominant histology (mixed histology allowed if non-pure sarcomatoid\u002Frhabdoid);\n12. Any condition that, in the investigator's opinion, would compromise patient safety or compliance;\n13. Any other condition that the investigator considers unsuitable for study participation.",{"count":54,"type":20},8,[23],"This is a Phase I, single-center, open-label, single-arm clinical trial to evaluate the safety and efficacy of personalized neoantigen polyepitope peptide vaccine combined with pembrolizumab in patients with advanced, recurrent or refractory renal cell carcinoma (RCC).\n\nBackground: Renal cell carcinoma is one of the most common malignancies of the urinary system. Although pembrolizumab has become a standard first-line treatment, the objective response rate (ORR) of monotherapy is only 20-40%, and most patients eventually develop primary or acquired resistance. Tumor neoantigens are specific antigens produced by tumor-specific gene mutations, with high immunogenicity and tumor specificity, making them ideal targets for tumor immunotherapy. Preliminary clinical studies have shown that neoantigen vaccines can produce synergistic effects when combined with pembrolizumab.\n\nStudy Design: This is an investigator-initiated trial (IIT) conducted at Peking University First Hospital. The study will enroll 5-8 patients in two stages: an initial safety assessment cohort (3 patients) followed by an expansion cohort (5 additional patients) if safety criteria are met. The study drug is a personalized neoantigen polyepitope peptide vaccine (Neo-RCC), produced by Mingzhibenyuan Medical Technology (Beijing) Co., Ltd., based on whole exome sequencing (WES) and transcriptome sequencing (RNA-seq) of each patient's tumor tissue. The vaccine is administered via subcutaneous injection in combination with Polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (Poly-ICLC) adjuvant, with a priming phase (5 injections on Days 0, 3, 7, 14, 21) and a boosting phase (3 injections on Weeks 6, 12, and 20), totaling 8 injections. Pembrolizumab (200 mg intravenous \\[IV\\] every 3 weeks \\[Q3W\\]) is administered concurrently as combination therapy.\n\nPrimary Objective: To evaluate the safety of the personalized neoantigen peptide vaccine in advanced RCC patients, as measured by the incidence and severity of treatment-emergent adverse events (TEAE) graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\nSecondary Objectives: To evaluate pharmacokinetic characteristics; to assess efficacy including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nKey Eligibility Criteria: Adults (≥18 years) with Stage III or IV, locally advanced, recurrent or metastatic non-surgical RCC who have achieved disease stability for ≥3 months after prior targeted therapy combined with pembrolizumab; measurable disease per RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status 0-3; adequate organ function; and ≥50 tumor gene mutations detectable from biopsy tissue.\n\nSafety Monitoring: A Data Safety Monitoring Board (DSMB) will oversee patient safety. Dose-limiting toxicities (DLT) are defined according to protocol-specified criteria. If ≥2 DLTs occur in the initial cohort, the adjuvant dose will be reduced by 50% and the study will proceed with a de-escalation cohort.",[58,59,28,60],"Renal Cell Carcinoma","Advanced","Refractory","NOT_YET_RECRUITING","2026-06-29",{"date":64,"type":36},"2026-07-07",{"date":66,"type":20},"2026-09-01",{"date":68,"type":20},"2029-09-01",{"name":70,"class":43},"Jian Lin",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":44},"100539550","phase-1-autologous-car-t-cells-targeting-b7h3-in-ovarian-cancer-ic9-carb7-h3-t-cells-100539550","NCT06305299","Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells","Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) and Containing the Inducible Caspase 9 Safety Switch in Subjects With Recurrent Platinum Resistant Epithelial Ovarian Cancer","Inclusion Criteria:\n\n1. Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:\n2. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject.\n3. Age ≥ 18 years at the time of consent.\n4. Eastern Cooperative Oncology Group (ECOG) of 0-2.\n5. The subject must have histologically or cytologically confirmed epithelial ovarian, peritoneal or fallopian tube cancer and must have a histological diagnosis of a high-grade serous histology based on local histopathological findings.\n6. Subject must have recurrent platinum-resistant or platinum-refractory disease defined as: A disease that has progressed by imagining while receiving platinum OR Disease that has recurred within 6 months of the last receipt of platinum-based chemotherapy. Rising CA-125 only is not considered as platinum-resistant or refractory disease.\n7. Having received at least 2 prior regimens (including front-line therapy).\n\nExclusion Criteria:\n\n1. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n2. The subject is not willing and not able to comply with study procedures based on the judgment of the investigator or protocol designee.\n\n10\\. The subject is not willing to undergo a biopsy prior to treatment, after infusion, and at the time of disease progression ), and the tumor is determined to be safe by the treating investigator for biopsy collection.","FEMALE",{"count":80,"type":20},27,[23],"The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated.\n\nThere are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.",[84,85,86,28],"Ovary Neoplasm","Ovarian Cancer","Epithelial Ovarian Cancer",[31,88,89],"biologic therapy","Platinum Resistant","2026-05-14",{"date":92,"type":36},"2026-05-19",{"date":94,"type":36},"2024-07-29",{"date":96,"type":20},"2036-04",{"name":42,"class":43},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100595302","association-between-exercise-patient-reported-outcomes-and-clinical-events-in-adult-cancer-survivors-100595302","NCT07030686","Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors","Inclusion Criteria:\n\nTarget trial (ideal RCT)\n\n* Adult (≥18 years of age) patients with history of primary invasive cancer under surveillance at Memorial Sloan Kettering Cancer Center (MSK).\n* Completion of an exercise survey (baseline) as part of MSK Cancer Survivorship Program and completion of a historical survey in the MSK Cancer Survivorship Program 9-15 months (time th) prior reporting non-exercising status \\[i.e., reporting \\\u003C10 metabolic equivalent-hours per week (MET-h\u002Fweek)\\]. Patients completing an additional exercise survey between th and baseline are excluded.\n* No evidence of recurrent or metastatic disease in the 15 months prior to the baseline exercise assessment\n* Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of the historical exercise survey in a MSK Cancer Survivorship Program. Adjuvant hormonal therapy is permitted at any time.\n* Undergoing surveillance in the Cancer Survivorship Program at MSK\n\nEmulation using observational data\n\n* Adult (≥18 years of age) cancer survivors under surveillance at Memorial Sloan Kettering Cancer Center (MSK) between 2011 and 2023.\n* Assessment of self-reported exercise status via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake (baseline assessment).\n* Non-exercising (i.e., reporting \\\u003C5 MET-h\u002Fweek) via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake 9-15 months prior to the baseline exercise assessment (historical exercise survey).\n* Documented history of the following absolute contraindications to moderate-intensity exercise at any time prior to the baseline exercise assessment, assessed using the Elixhauser ICD codes: Congestive heart failure, valvular disease, chronic pulmonary disease, or renal failure.\n* No evidence of recurrent or metastatic disease via radiological or pathological in EMR in the 15 months prior to the baseline exercise assessment.\n* Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of historical exercise survey (i.e., at least 3 months prior to t-1) as part of MSK Cancer Survivorship Program standard intake. Adjuvant endocrine therapy is permitted.",true,{"count":106,"type":20},1000,"OBSERVATIONAL","This protocol is a retrospective study using observational data to conduct a target trial emulation to examine the association of exercise on cancer specific endpoints and other clinical outcomes in cancer survivors.",[110,28,111,112,113],"Survivorship","Recurrence","Cancer","Remission",[110,115,116,117,118,119,120],"Exercise","cancer survivor","adult cancer survivor","no evidence of disease","20-101","Memorial Sloan Kettering Cancer Center","2026-04-27",{"date":123,"type":36},"2026-04-28",{"date":125,"type":36},"2020-03-19",{"date":127,"type":20},"2027-03-19",{"name":120,"class":43},4,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100631989","electroacupuncture-for-the-prevention-of-recurrent-lower-urinary-tract-infection-in-women-100631989","NCT07507851","Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women","A Randomized Controlled Trial of Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women","rLUTI","Inclusion Criteria:\n\n1. Female patients aged 18-75 years;\n2. Meeting the diagnostic criteria for recurrent lower urinary tract infections;\n3. No acute lower urinary tract infections at enrollment;\n4. Voluntary participation in this trial and signed informed consent. Only patients who meet all the above inclusion criteria can be enrolled in the study.\n\nExclusion Criteria:\n\n1. Currently receiving prophylactic antibiotics for lower urinary tract infection;\n2. Abnormal urinary tract anatomy (e.g., urinary calculi);\n3. Complicated or neurogenic genitourinary disorders, such as spinal cord injury, cauda equina injury, active pelvic inflammatory disease, active vaginitis, overactive bladder, interstitial cystitis;\n4. Requiring urinary catheterization;\n5. HIV infection, long-term use of immunosuppressants, infection with multidrug-resistant organisms, or uncontrolled diabetes mellitus;\n6. Pelvic organ prolapses of grade 2 or above;\n7. Post-void residual urine volume \\> 100 ml measured by B-ultrasound;\n8. Lactating, pregnant, or planning to conceive within the next 6 months;\n9. Implantation of a cardiac pacemaker;\n10. Malignant tumor; severe cardiac, pulmonary, cerebral, hepatic, renal, or hematological diseases, mental illness, or significant cognitive impairment;\n11. Previous history of electroacupuncture treatment;\n12. Subjects with potential poor compliance (e.g., living far from the hospital). Patients meeting any of the above exclusion criteria shall not be enrolled in the study.","75 Years",{"count":140,"type":20},312,[142],"NA","The goal of this clinical trial is to evaluate if electroacupuncture works to prevent recurrent lower urinary tract infections in female patients. It will also learn about the safety of electroacupuncture. The main questions it aims to answer are:\n\n1. Does electroacupuncture reduce the attacks of acute recurrent urinary tract infections in women?\n2. What medical problems do participants have when taking electroacupuncture?\n\nResearchers will compare electroacupuncture to sham electroacupuncture to assess if electroacupuncture works to prevent recurrent lower urinary tract infections.\n\nParticipants will:\n\n1. Take electroacupuncture or sham electroacupuncture for 30 minutes per session over a 6-month period. During the first month, treatment was administered 3 times weekly (once every other day); the second month, 2 times weekly (once every 2-3 days); and the 3-6 month, once monthly.\n2. Visit the hospital at the end of the 1st, 2nd, 3rd, and 6th months for follow-up evaluations.\n3. Keep a diary of their symptoms and the number of times they use an antibiotic.",[145,28,146,147],"Urinary Tract Infections","Electroacupuncture","Randomized Controlled Trial (RCT)","2026-03-30",{"date":150,"type":36},"2026-04-02",{"date":152,"type":20},"2026-04",{"date":154,"type":20},"2029-03",{"name":156,"class":43},"Yanjun Zhang, Baoyan Liu",2,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":168,"conditions":169,"keywords":176,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":44},"100623759","cervical-cancer-oligo-states-recurrence-metastasis-multicentre-outcomes-study-100623759","NCT07400809","Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.","Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study.","Retro-COSMOS","Inclusion Criteria:\n\n1. Cervical cancer with (induced) oligo-metastatic and\u002For oligo-recurrent cervix cancer whether treated or not treated with radiation. These patients may have received previous treatment within or outside approved clinical trials\u002Fstudies.\n2. Patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site.\n3. Patients treated with radical doses at the time of first diagnosis of oligo-metastasis\u002Foligo-recurrence and present with further oligo-progression.\n4. Patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted.\n\nExclusion Criteria:\n\n1. Gynaecological cancer other than cervical cancer.\n2. Persistent Poly-metastatic disease post systemic treatment\n3. Receiving investigational new drugs at the time of relapse as part of other ongoing trials.\n4. No clinical follow up after treatment",{"count":167,"type":20},350,"Systemic chemotherapy with or without palliative radiation represents the current standard of care in patients with recurrent or metastatic cervix cancer. In addition, pelvic radiotherapy including brachytherapy is also recommended. There is no consensus on the treatment of metastatic site in patients with oligo-metastatic or oligo-recurrent cervix cancer. Also, it is not clear if addition of local treatment to systemic chemotherapy benefits all patients with metastatic disease or a select few with limited systemic disease burden. It's presently unclear which patients derive maximum benefit with integration of radiation at both primary and metastatic site, who develop infield recurrence if performing salvage surgery, locally directed treatments or re-irradiation in addition to systemic chemotherapy improves overall outcomes. The heterogeneity in clinical practice provides an important opportunity to develop a framework for data collection and future studies within such subgroup of patients. In this retrospective study, we aim to determine overall survival, Infield progression free survival, overall progression free survival, dose response relationship of nodal and visceral progressions, and within setting of re-irradiation (infield progressions), severe adverse events and toxicity, risk groups identification, a nomogram which correlates risk groups with expected outcomes, and framework for tissue collection for translational research Investigators will record the parameters in a predesigned proforma without including personal identifiers.",[170,171,172,173,174,28,175],"Chemotherapy","Treatment Compliance","Radiotherapy","Cervix Cancer","Surgery","Metastasis",[177,178],"Recurrent and Metastatic Cervix Cancer","Oligo States","2026-02-12",{"date":181,"type":36},"2026-02-17",{"date":183,"type":36},"2023-08-23",{"date":185,"type":20},"2027-06-14",{"name":187,"class":188},"Tata Memorial Hospital","OTHER_GOV",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":138,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":200,"conditions":201,"keywords":204,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":44},"100620877","phase-2-a-phase-ii-study-of-utidelone-with-toripalimab-in-advanced-cervical-cancer-100620877","NCT07363330","A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer","Utidelone Combined With Toripalimab in Patients With Pretreated Recurrent or Metastatic Cervical Cancers: a Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Informed Consent: Patients must voluntarily sign an informed consent form prior to any study-related procedures.\n2. Age: Aged ≥18 years and ≤75 years.\n3. Diagnosis: Histologically or cytologically confirmed recurrent or metastatic cervical carcinoma.\n4. Performance Status: With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. Measurable Disease: With at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n6. Prior Therapy:\n\n   * Patients must have received at least one line of standard systemic chemotherapy for recurrent\u002Fmetastatic disease, OR\n   * Patients with rapid disease progression (occurring within 6 months) during or after prior neoadjuvant or concurrent chemoradiotherapy.\n7. Treatment-Related Toxicity: Recovery from all toxicities related to prior anti-cancer therapies to ≤ Grade 1 (according to CTCAE v5.0). Patients with alopecia of any grade are eligible.\n8. Adequate Hematological Function (within 1 week prior to enrollment, per local laboratory reference ranges):\n\n   * White blood cell count (WBC) ≥ 2.5 × 10⁹\u002FL.\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL.\n   * Platelet count (PLT) ≥ 100 × 10⁹\u002FL.\n   * Hemoglobin (Hb) ≥ 9.0 g\u002FdL (transfusion or erythropoietin use is permitted to meet this criterion).\n9. Adequate Liver and Kidney Functions (within 1 week prior to enrollment, per local laboratory reference ranges):\n\n   * Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN).\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases).\n   * Calculated creatinine clearance (Ccr) ≥ 60 mL\u002Fmin.\n10. Contraception: Patients of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days after the last dose of study treatment. A negative serum or urine pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment.\n11. Life Expectancy: Anticipated life expectancy of at least 12 weeks.\n12. Compliance: Patients must be able and willing to comply with the study protocol for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Concurrent Malignancy: History of other active malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin.\n2. Recent Anti-cancer Therapy: Any anti-cancer therapy (including chemotherapy, radical radiotherapy, hormonal therapy, biological therapy, or anti-cancer Chinese herbal medicine) within 4 weeks prior to the initiation of study treatment.\n3. Recent Major Surgery\u002FTrauma: Major surgical procedure (excluding diagnostic biopsy) or significant traumatic injury within 4 weeks prior to the first dose of study drug, or anticipation of the need for major surgery during the study period.\n4. Prior Neurotoxicity: History of ≥ Grade 3 neurological adverse reactions attributed to prior anti-microtubule therapy.\n5. Symptomatic CNS Metastases: Patients with symptomatic central nervous system (CNS) metastases.\n6. Pregnancy\u002FLactation: Women who are pregnant or breastfeeding.\n7. Hypersensitivity: Known or suspected hypersensitivity to any component of the study drugs or their excipients.\n8. Severe Comorbidities: Any uncontrolled or severe concurrent medical condition that, in the investigator's judgment, would preclude participation, including but not limited to:\n\n   * Severe cardiovascular or cerebrovascular disease.\n   * Uncontrolled diabetes mellitus or hypertension.\n   * Active severe infection.\n   * Active peptic ulcer disease.\n   * Uncontrolled psychiatric illness\u002Fdisorder.\n9. General Exclusion: Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or compliance, or make the patient unsuitable for study participation.\n10. Contraindication to Steroids: Conditions for which corticosteroid use is contraindicated.",{"count":197,"type":20},32,[199],"PHASE2","This is a Phase II clinical trial to evaluate the safety and efficacy of Utidelone, a genetically engineered epothilone derivative, combined with Toripalimab, a PD-1 inhibitor, in patients with recurrent or metastatic cervical cancer who have progressed after standard treatments. The study will also assess the safety profile of this combination therapy. The primary objectives of this study include: (1) to determine the objective response rate (ORR), meaning whether the treatment can reduce the size of tumors or make them disappear, according to the RECIST 1.1 criteria; (2) to evaluate the safety of the treatment and document the side effects experienced by participants. This study is for individuals who: (1) are between 18 and 75 years old; (2) have a confirmed diagnosis of recurrent or metastatic cervical cancer; (3) have previously received at least one standard chemotherapy regimen that is no longer controlling the cancer; (4) are in generally good health, as determined by the study investigators. In this single-arm study, all participants will receive the same treatment: Utidelone will be administered by intravenous (IV) infusion over 1.5 hours, once a day for 5 consecutive days, in each 21-day treatment cycle; Toripalimab will be administered by IV infusion over 1.5 hours, once on Day 6 of each 21-day cycle. Participants may continue receiving the study drugs as long as they are benefiting from the treatment and side effects are manageable. Doctors will assess tumor size using imaging scans (like CT or MRI) every 6 weeks to monitor how the cancer responds to treatment. The study will take place at Zhongnan Hospital of Wuhan University and plans to include approximately 32 participants.",[202,28,203],"Cervical Cancer","Metastatic",[205,206,207,208,209],"cervical cancer","recurrent \u002F metastatic","Utidelone","Toripalimab","phase Ⅱ trial","2026-01-22",{"date":212,"type":36},"2026-01-26",{"date":214,"type":20},"2026-02-01",{"date":216,"type":20},"2028-12-31",{"name":218,"class":43},"Zhongnan Hospital",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":44},"100498602","phase-2-partial-breast-re-irradiation-in-women-in-women-with-locally-recurrent-breast-cancer-previously-treated-with-conservative-surgery-and-whole-breast-irradiation-100498602","NCT05772390","Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation","Partial Breast Re-irradiation in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation: a Prospective Phase II Clinical Study","PBReI","Inclusion Criteria:\n\n1. Isolated ipsilateral unifocal breast lesions;\n2. Histologically confirmed invasive breast carcinoma or carcinoma in situ;\n3. Limited size (\\< 2 cm) without evidence of skin involvement;\n4. Negative histologic margins of resection;\n5. Negative axillary lymph nodes;\n6. No synchronous distant metastases;\n7. Bilateral breast mammogram or MRI within 120 days prior to study entry;\n8. For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant);\n9. ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence;\n10. Female, aged \\>18 years;\n11. Life expectancy of greater than 12 months;\n12. ECOG performance status \\<2;\n13. Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter;\n14. Participant is willing and able to give informed consent for participation in the study;\n\nExclusion Criteria:\n\n1. Regional recurrences (axillary, supraclavicular);\n2. Positive histologic margins at resection;\n3. Metastatic disease;\n4. Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;\n5. Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;\n6. Patients who had chemotherapy within 2 weeks prior to study RT;\n7. Participation in another clinical trial with any investigational agents within 30 days prior to study screening;\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements;\n9. Significant comorbidity precluding RT for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus);\n10. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix, endometrium or colon);\n11. Inaccessibility for follow-up;",{"count":228,"type":20},68,[199],"A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer",[232,28],"Breast Cancer",[234,235,236],"Partial re-irradiation","recurrent breast cancer","conservative surgery","2024-09-17",{"date":239,"type":36},"2024-09-19",{"date":241,"type":36},"2023-03-31",{"date":243,"type":20},"2032-03",{"name":245,"class":43},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":44},"100501340","phase-2-re-irradiation-therapy-of-locally-recurrent-rectal-cancer-with-carbon-ion-100501340","NCT05807984","Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion","A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer","Inclusion Criteria:\n\n* 1\\) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,\n* 2\\) received a radical operation for their primary tumor and regional lymph nodes,\n* 3\\) received chemo-radiation or radiation in pelvic before CIRT,\n* 4\\) received re-irradiation by CIRT after their pelvic radiotherapy.\n\nExclusion Criteria:\n\n* 1\\) received more than once prior radiotherapy in the same treatment field,\n* 2\\) time to the last radiotherapy was \\\u003C1 year,\n* 3\\) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (\\\u003C5 mm).","80 Years",{"count":255,"type":20},31,[199],"Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)",[259,28],"Rectal Cancer","2023-04-07",{"date":262,"type":36},"2023-04-11",{"date":264,"type":20},"2023-05-01",{"date":266,"type":20},"2026-12-31",{"name":268,"class":43},"Xin Cai"]