[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,272,0,25,[9,48,75,119,143,156,192,218,260,280,300,337,363,400,472,497,516,525,547,570,588,605,634,654,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053420","to-assess-the-correlation-of-high-resolution-specimen-pet-ct-imaging-using-the-xeos-aura-10-pet-ct-with-the-histopathology-results-and-long-term-outcome-of-patients-undergoing-resective-cancer-surgery-100053420",false,"NCT06970275","To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","PETRiS","Inclusion Criteria :\n\nAll patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT.\n\nPatients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent.\n\nExclusion Criteria:\n\n* Under the age of 18 years at the time of resective surgery.\n* Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":21,"type":22},850,"ESTIMATED","OBSERVATIONAL","This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.",[26,27,28,29],"Prostate Cancers","Breast Cancer","Head and Neck Cancer","Cancer",[31,32,33,34],"PET-CT","Registry","Imaging","cancer","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-11-19",{"date":43,"type":22},"2031-01-15",{"name":45,"class":46},"XEOS Medical","INDUSTRY",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100053842","postoperative-radiotherapy-for-intermediate--and-high-risk-patients-with-hnscc-greater-than-6-weeks-after-surgery-100053842","NCT06607406","Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery","A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC (Head and Neck Squamous Cell Carcinoma) Initiating Radiotherapy Greater Than 6 Weeks After Surgery (PORTRush)","Inclusion Criteria:\n\n* Pathologically confirmed head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx, hypopharynx, sinus, or lymph nodes of the neck of unknown primary.\n* Planned for curative intent postoperative radiotherapy based on pathologic risk factors.\n\n  * Patients with non-HPV-mediated oropharyngeal squamous cell carcinoma or non-oropharyngeal squamous cell carcinoma must have at least one of the following: pathologic tumor classification pT3-4, multiple lymph nodes involved with cancer, perineural invasion, lymphovascular invasion, close margins (within 2 mm for oropharyngeal cancer status post transoral resection; within 5 mm for all others) or cleared margins (initially positive, subsequently cleared in an additional specimen), extranodal extension (any extent), or positive surgical margins.\n  * Patients with HPV-mediated oropharyngeal squamous cell carcinoma must have at least one of the following pathologic risk factors: extranodal extension (any extent), positive surgical margins, or more than 4 lymph nodes involved with cancer.\n* Complete macroscopic surgical resection with curative intent for HNSCC with an anticipated interval between the primary surgical resection and initiation of postoperative radiotherapy greater than 42 days but less than or equal to 112 days from surgery. Note: the start date of the time to initiation of PORT is the first (primary) surgical resection. This does not include diagnostic procedures (e.g., biopsy, diagnostic tonsillectomy) or any subsequent surgical interventions for any reason (e.g., wound complications).\n* Age ≥ 18 years at the time of enrollment.\n* ECOG performance status of 0-1.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document directly, in English or Spanish, and to complete study-related forms and activities.\n\nExclusion Criteria:\n\n* Recurrent head and neck cancer that has recurred after prior courses of definitive RT or surgery followed by postoperative RT\u002FCRT. Note that individuals who have been treated with surgery alone and are now recurrent are eligible.\n* Second primary head and neck cancer after initial treatment of a prior head and neck cancer.\n* History of prior radiotherapy to the head and neck region, such that any portion of the anticipated target volume overlaps with any region that was previously targeted.\n* Active malignancy other than the head and neck cancer to be treated with PORT (excluding non-melanoma skin cancer, in situ carcinoma of any site).\n* Metastatic disease from the head and neck cancer to be treated with PORT defined as distant organ involvement outside of the head and neck and\u002For non-regional lymph node involvement outside of the head and neck.\n* Time from primary surgical resection to anticipated initiation of PORT greater than 112 days.\n* 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\n* Not a candidate for radiation therapy per treating clinician. For example, individuals who are pregnant or plan to become pregnant (due to the risks of the developing fetus) or any other contraindication to radiation therapy.",{"count":56,"type":22},75,"INTERVENTIONAL",[59],"NA","The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.",[28,62],"Head and Neck Squamous Cell Carcinoma HNSCC",[64,65],"Radiotherapy","Accelerated radiotherapy",{"date":38,"type":39},{"date":68,"type":39},"2025-01-21",{"date":70,"type":22},"2030-01",{"name":72,"class":73},"Wake Forest University Health Sciences","OTHER",3,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":57,"phases":85,"briefSummary":88,"conditions":89,"keywords":101,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100054087","phase-1-docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100054087","NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","120 Years",{"count":84,"type":22},120,[86,87],"PHASE1","PHASE2","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[28,90,91,92,93,94,95,96,97,98,99,100],"Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer",[102,103,104,105,106,107,108],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":112,"type":22},"2026-07-16",{"date":114,"type":22},"2037-10-01",{"name":116,"class":117},"National Cancer Institute (NCI)","NIH",1,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":57,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":118},"100054319","preventing-lymphedema-in-patients-undergoing-surgical-treatment-for-head-and-neck-cancer-through-vein-reconstruction-100054319","NCT07694726","Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction","Lymphedema Prevention With Facial Vein Preservation or Reconstruction During Neck Dissection for Operable Head & Neck Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Ability to comply with the study protocol, including follow up visits and additional requirements for data collection\n* Ability to provide informed consent\n* Patients requiring unilateral or bilateral neck dissection. Patients must undergo at least three level neck dissection which must include level 1B\n* Patients will undergo radiotherapy +\u002F-chemotherapy after surgery for HNC. Patients will be required to have adjuvant therapy after surgery to have similar risk of development of lymphedema.\n* No history of allergy to indocyanine green.\n\nExclusion Criteria:\n\n* Shellfish Allergy\n* Contraindication to surgery under general anesthesia\n* Prior head and neck surgery, radiation, or chemotherapy for HNC\n* Patients requiring sacrifice of the internal jugular vein or resection of neck skin for oncologic care\n* Anticipated partial or total laryngectomy\n* Pregnancy or lactation",{"count":127,"type":22},37,[59],"\\* The goal of this clinical trial is to learn if facial vein reconstruction after neck dissection works to reduce rates of lymphedema in adults getting surgical treatment for head and neck cancer.\n\nThis is a trial which aims to improve the rate of lymphedema for patients undergoing treatment for head and neck cancer. Our aim is to re-establish venous flow across the facial vein to improve lymphatic drainage after neck dissection.\n\n* The investigators will also evaluate lymphatic flow before and after facial vein reconstruction to determine if there is evidence of lymphedema.\n* The main questions this study aims to answer are:\n\n  1. Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients?\n  2. Determine if there are changes in lymphatic flow before and after facial vein reconstruction?\n\nAfter the study is completed, the investigators will compare rates of lymphedema and quality of life in patients with facial vein preservation\u002Freconstruction as compared to previous patients treated for head and neck cancer without facial vein reconstruction.\n\nParticipants will undergo the following:\n\n1. Oncologic and reconstructive surgery as normal. No changes in cancer treatment will occur due to the study.\n2. When necessary, participants will undergo facial vein reconstruction immediately after neck dissection\n3. Visit the clinic once every 3 months for routine checkups and tests. This is typical for most patients treated for head and neck cancer including those not enrolled in the trial.\n4. Fill out short questionnaires to help understand quality of life after head and neck cancer treatment\n5. Undergo lymphography in the OR and at the 1-year mark in the office. This is a simple test performed without radiation exposure. It requires 3 very small skin injections to perform the test.",[28],[132,133,134],"head and neck cancer","head and neck lymphedema","lymphedema","2026-07-09",{"date":38,"type":39},{"date":138,"type":22},"2026-07",{"date":140,"type":22},"2028-12",{"name":142,"class":73},"University of Pittsburgh",{"id":144,"slug":4,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":145,"targetDuration":4,"studyType":57,"phases":146,"briefSummary":88,"conditions":147,"keywords":148,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":155,"locationsCount":118},"100643883",{"count":84,"type":22},[86,87],[28,90,91,92,93,94,95,96,97,98,99,100],[102,103,104,105,106,107,108],"2026-07-01",{"date":151,"type":39},"2026-07-02",{"date":153,"type":22},"2026-07-07",{"date":114,"type":22},{"name":116,"class":117},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":57,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":191},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":164,"type":22},104,[59],"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[168,169,170,27,171,172,173,174,175,176,177,178,179,28,180,181,99,182,183],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Ovarian Cancer","Pancreatic Cancer","Rectal Cancer","Sarcoma",{"date":151,"type":39},{"date":186,"type":39},"2026-02-11",{"date":188,"type":22},"2027-08-31",{"name":190,"class":73},"Alliance for Clinical Trials in Oncology",18,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":57,"phases":201,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":214,"leadSponsor":216,"locationsCount":4},"100643980","phase-3-apg-157-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100643980","NCT07667296","APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Open-Label Phase 3 Study of APG-157 as Neoadjuvant Therapy or as Induction and Maintenance Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria\n\nCohort A (Resectable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity or oropharynx.\n3. Resectable disease appropriate for curative-intent surgery.\n4. Stage III-IVA disease according to AJCC criteria:\n\n   * Oropharynx, p16-positive: Stage III (T4, N0-N3, M0)\n   * Oropharynx, p16-negative: Stage III or IVa (T3-T4, N0-N2, M0)\n   * Oral cavity: Stage III or IVa (T3-T4, N0-N2, M0)\n5. Objectively medically ineligible for perioperative pembrolizumab according to protocol-defined objective criteria.\n6. HPV\u002Fp16 testing available for stratification.\n7. Measurable or evaluable disease.\n8. Life expectancy ≥12 months.\n9. ECOG Performance Status ≤2.\n10. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.\n11. Ability to comply with study procedures.\n\nCohort B (Unresectable \u002F Medically Inoperable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated LA-HNSCC of the oropharynx. Disease not suitable for curative-intent surgery.\n3. Stage III-IVA disease according to AJCC criteria:\n\n   * p16-positive Stage III (T4, N0-N3, M0) with \\>10 pack-year smoking history\n   * p16-negative Stage III or IVa (T3-T4, N0-N2, M0)\n4. HPV\u002Fp16 testing available for stratification.\n5. Presence of evaluable tumor burden.\n6. Eligible to receive definitive chemoradiotherapy.\n7. Life expectancy ≥12 months.\n8. ECOG Performance Status ≤2.\n9. Adequate organ function.\n10. Contraception requirements met.\n11. Ability to comply with study procedures.\n\nExclusion Criteria\n\nCohort A Specific:\n\n* Stage I-II disease\n* Stage IVb or Ivc disease\n* T4b unresectable disease\n* N3 disease where applicable\n* Medically eligible for perioperative pembrolizumab\n\nCohort B Specific:\n\n* Stage I-II disease\n* Disease not appropriate for curative-intent CRT\n* Active autoimmune disease requiring systemic therapy\n* Prior solid organ or allogeneic stem cell transplant\n* Ongoing immunosuppression \\>10 mg\u002Fday prednisone equivalent\n\nCommon Exclusion Criteria:\n\n* Primary tumor arising from the nasopharynx, hypopharynx, larynx, paranasal sinus, or unknown primary site.\n* Prior treatment for current head and neck squamous cell carcinoma.\n* Prior malignancy unless protocol exceptions met\n* Distant metastatic disease\n* Live vaccine within 30 days\n* Known hypersensitivity to APG-157 or its components.\n* Unresolved clinically significant toxicity\n* Recent participation in another investigational study\n* Active uncontrolled infection\n* Significant uncontrolled cardiovascular disease\n* Pregnancy or breastfeeding.\n* QTcF \\>500 msec or congenital long QT syndrome\n* Any condition compromising safety, compliance, or study interpretation\n\nRandomization ratio: 1:1 within each cohort\n\nStratification Factors:\n\nCohort A:\n\n* HPV\u002Fp16 status,\n* Planned platinum strategy,\n* PD-L1 CPS category\n\nCohort B:\n\n* HPV\u002Fp16 status\n* Planned platinum strategy\n* Geographic region.",{"count":200,"type":22},826,[202],"PHASE3","This Phase 3, multicenter, randomized, open-label study evaluates APG-157 in adults with newly diagnosed locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Two independently powered cohorts are enrolled based on treatment pathway. Cohort A evaluates APG-157 administered as neoadjuvant therapy before curative-intent surgery in participants with resectable oral cavity or oropharyngeal cancer who are medically ineligible for perioperative pembrolizumab. Cohort B evaluates APG-157 administered as induction therapy before definitive chemoradiotherapy and as maintenance therapy after chemoradiotherapy in participants with unresectable or medically inoperable disease. Participants are randomized 1:1 within each cohort to receive APG-157-based treatment or standard-of-care therapy. The primary hypothesis is that APG-157 given before definitive surgery followed by (chemo)radiotherapy improves event-free survival (EFS) compared to surgery and adjuvant (chemo)radiotherapy alone (Cohort A), and that APG-157 given as induction therapy prior to definitive chemoradiotherapy (CRT) followed by maintenance APG-157 improves EFS compared to definitive CRT alone (Cohort B).",[28,205,206,207,208,209,210],"Head and Neck (HNSCC)","Oropharyngeal","Oral Cavity","Oral Cavity Carcinoma","Oropharynx Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","2026-06-29",{"date":149,"type":39},{"date":138,"type":22},{"date":215,"type":22},"2032-12",{"name":217,"class":46},"Aveta Biomics, Inc.",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":227,"conditions":228,"keywords":243,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":118},"100644985","clonal-hematopoiesis-chemotherapy-and-radiation-effects-study-100644985","NCT07675967","Clonal Hematopoiesis Chemotherapy and Radiation Effects Study","CH CARE","Inclusion Criteria:\n\n* Participants to be included in this study include the following:\n* Adults age \\>18 years\n* Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers)\n* Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer).\n* Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.\n\nExclusion Criteria:\n\n* Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure\n* Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer)\n* Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study participation.",{"count":226,"type":22},5000,"The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers.\n\nThe study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs).\n\nUltimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.",[229,230,231,232,27,233,234,183,235,236,237,238,28,239,240,241,242],"Lung Cancer (Diagnosis)","Osteochondroma","Spitz Nevus","Solid Cancers","Gastric (Stomach) Cancer","Colorectal (Colon or Rectal) Cancer","Ovarian Adenocarcinoma","Uterine Adenocarcinoma","Endometrial Adenocarcinoma","Esophageal Adenocarcinoma","Therapy-Related Acute Myeloid Leukemia","Therapy-Related MDS","Clonal Hematopoiesis of Indeterminate Potential (CHIP)","Clonal Cytopenia of Undetermined Significance",[244,245,246,247,248,249,250,251],"Adult cancer survivors","Precursor Lesions","clonal hematopoiesis","chemotherapy","radiation","therapy-related myeloid neoplasms","CCUS","clonal hematopoiesis of indeterminate potential",{"date":253,"type":39},"2026-06-30",{"date":255,"type":39},"2025-04-04",{"date":257,"type":22},"2035-03-31",{"name":259,"class":73},"Dana-Farber Cancer Institute",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":57,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":118},"100609388","phase-1-phase-i-ii-trial-combining-pd-1-inhibition-and-neoadjuvant-proton-or-photon-radiation-therapy-in-recurrent-head-and-neck-squamous-cell-carcinoma-100609388","NCT07213934","Phase I\u002F II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma","WOPPPR: Window of Opportunity Phase I and Phase II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria (Both Phase I and Phase II)\n\n1. Patients must have histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma including oral cavity, laryngeal, hypopharyngeal, or oropharyngeal (HPV-) SCC.\n2. Patients must be a candidate for salvage surgical resection.\n3. Patients must have failed prior RT \\>6 months prior to recurrence with at least 30 Gy delivered to the current target volume.\n4. Disease must be limited to a single site or adjacent sites that can be treated in a single contiguous target volume for which the maximum total tumor dimension (GTV) must be \\\u003C7 cm.\n5. Patients must have a CPS PD-L1 of ≥1%. This may be tested on a new biopsy or archival tissue.\n6. Age ≥18 years.\n7. ECOG performance status ≤1 (or Karnofsky ≥70%, see Appendix A).\n8. Patients must have adequate organ and marrow function as defined below:\n\n   Platelets ≥100,000\u002FmcL Total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Creatinine ≤ 1.5x institutional upper limit of normal (ULN) OR glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m2 (see Appendix B).\n9. Archival tissue must be available for baseline analysis. Either a tumor block or at least 20 slides must be available.\n10. Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n11. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n12. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n13. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n14. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n15. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of pembrolizumab administration.\n16. Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria (Phase I \\& II)\n\n1. Patients who have metastatic disease.\n2. Patients who have ongoing adverse events from prior anti-cancer therapy that would preclude completion of the proposed study treatment at the opinion of the treating investigators.\n3. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.\n4. Prior treatment with PD-1 inhibitors in the last 6 months or progression on a PD-1 inhibitor at any time.\n5. Autoimmune disease or other pro-inflammatory conditions other than treated stable asthma, minor allergies (such as seasonal allergies), vitiligo or hypothyroidism.\n6. Active and ongoing steroid use \\>10 mg prednisone, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, COPD, allergic rhinitis).\n7. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.\n8. Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with breastfeeding should be discontinued if the mother is treated with pembrolizumab.",{"count":268,"type":22},40,[86,87],"The purpose of the Phase I study is to see if it is safe to use X-ray photon radiation (XRT) and proton radiation (PT) before surgery in patients with recurrent head and neck squamous cell carcinoma (rHNSCC).\n\nThe purpose of the Phase II study is to see if using XRT or PT before immunotherapy (pembrolizumab) prior to surgery benefits patients with recurrent head and neck squamous cell carcinoma (rHNSCC).",[28,272],"Recurrent Head and Neck Squamous Cell Carcinoma",{"date":149,"type":39},{"date":275,"type":39},"2025-10-08",{"date":277,"type":22},"2031-12",{"name":279,"class":73},"University of Cincinnati",{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":118},"100100354","identification-of-secreted-markers-for-tumor-hypoxia-in-patients-with-head-and-neck-or-lung-cancers-100100354","NCT00568490","Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers","Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma of the head and neck sites or non-small cell lung cancer, or relatives of patients with histologically confirmed squamous cell carcinoma of the head and neck.\n* Able to sign a Stanford IRB approved consent form\n\nExclusion criteria:\n\n* Refuse or unable to sign an IRB approved consent form.\n* Refuse to be contacted in the future for follow up.",{"count":287,"type":22},200,"The purpose of this study is to identify and confirm new blood and tissue markers for prognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, has been shown to increase the risk of tumor spread and enhance tumor resistance to the standard treatment of radiation and chemotherapy in head and neck and lung cancers. We have recently identified several proteins or markers in the blood and in tumors (including osteopontin, lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory that may be able to identify tumors with low oxygen levels or more aggressive behaving tumors.",[28,179,290,291,292],"Lip Cancer","Lip Neoplasms","Head and Neck Cancers",{"date":149,"type":39},{"date":295,"type":39},"1998-09-01",{"date":297,"type":22},"2027-06-30",{"name":299,"class":73},"Stanford University",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":310,"type":22},100,"This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[313,169,314,171,173,174,175,315,28,178,316,317,318,319,180,181,99,320,97,183,321,322,323,324,325,326,327],"Adenocarcinoma (NOS)","Bladder Cancer","Gastrointestinal Stromal Tumour","Melanoma","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Renal Cell Carcinoma","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-06-26",{"date":211,"type":39},{"date":331,"type":39},"2025-09-18",{"date":333,"type":22},"2028-03-30",{"name":335,"class":46},"AstraZeneca",17,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":344,"sex":18,"minAge":345,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":57,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":47},"100489869","cognitive-outcomes-after-brain-substructure-informed-radiation-planning-in-pediatric-patients-100489869","NCT05658731","Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients","CogRT","1. STRATUM A\n\n   1. Eligibility Criteria\n\n      * aged 1 to \\\u003C26 years of age\n      * tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit\n      * treatment must include radiation therapy (either proton or photon)\n      * patients must not have completed radiation therapy\n   2. Exclusion Criteria\n\n      * pregnancy\n      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological\u002Fneurodevelopmental disorders such as Down's syndrome or autism\n2. STRATUM B\n\n   1. Eligibility Criteria\n\n      * diagnosed with a brain tumor at \\\u003C26 years of age\n      * received radiation to the brain as part of therapy\n      * time from radiation start to study enrollment is ≥ 2 years\n      * there has not been disease recurrence from time of most recent radiation treatment to study enrollment\n   2. Exclusion Criteria\n\n      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological\u002Fneurodevelopmental disorders such as Down's syndrome or autism\n3. STRATUM C\n\n   1. Eligibility Criteria\n\n      * must be aged 5 to \\\u003C26 years of age\n      * must be able to complete research imaging without sedation\n   2. Exclusion Criteria\n\n      * must not have any major psychiatric, neurologic or medical diagnosis",true,"1 Year","26 Years",{"count":348,"type":22},338,[59],"The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients.\n\nPatients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.\n\nSurvivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed.\n\nHealthy children will also be enrolled and have research MRIs done.\n\nThe researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.",[352,28],"Brain Tumor",[354,355],"radiation therapy","pediatric",{"date":211,"type":39},{"date":358,"type":39},"2023-05-17",{"date":360,"type":22},"2035-12",{"name":362,"class":73},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":373,"conditions":374,"keywords":384,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":399},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":372,"type":22},2000,"This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[29,375,376,314,377,378,379,380,173,28,177,178,381,382,383],"Immunotherapy","Advanced Solid Tumors Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[375,385,386,29,33,387,388,389,390,391],"Live Tumor Biopsy","Elephas","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","2026-06-25",{"date":211,"type":39},{"date":395,"type":39},"2025-04-14",{"date":397,"type":22},"2038-04",{"name":386,"class":46},8,{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":407,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":57,"phases":410,"briefSummary":411,"conditions":412,"keywords":434,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":409,"type":22},300,[86,87],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[413,414,415,416,179,180,173,99,378,27,417,418,28,175,321,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Other Cancer","Locally Advanced","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-06-24",{"date":328,"type":39},{"date":466,"type":39},"2020-10-29",{"date":468,"type":22},"2027-12-31",{"name":470,"class":46},"PMV Pharmaceuticals, Inc",77,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":57,"phases":481,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":118},"100601411","tongue-proactive-strengthening-exercise-program-following-partialhemi-glossectomy-and-reconstruction-100601411","NCT07110142","Tongue Proactive Strengthening Exercise Program Following Partial\u002FHemi Glossectomy and Reconstruction","Impact of Tongue Proactive Strengthening Exercise Program on Speech and Swallowing Outcomes Following Partial\u002FHemiglossectomy and Reconstruction","T-PROSE","Inclusion Criteria:\n\n1. ≥18 years of age\n2. No prior history of head and neck cancer\n3. No prior history of radiation\n4. Planned to undergo resection of ≤50% of the native tongue (partial\u002Fhemiglossectomy) with immediate reconstruction, including free flap reconstruction, and with or without neck dissection\n5. Sufficiently fluent in written English, French, Spanish or Simplified Chinese to complete the study outcomes questionnaires\n\nExclusion Criteria:\n\n1. Distant metastasis at enrollment\n2. Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes\n3. Prior head and neck radiation\n4. Requires mandibulectomy or \\>50% resection of native tongue",{"count":268,"type":22},[59],"This study is being done to determine whether adding a proactive tongue strengthening exercise program using a biofeedback device (the Tongueometer) improves speech and swallowing outcomes after surgery for tongue cancer. Patients who undergo partial or hemiglossectomy often experience difficulties with speech and swallowing, which can significantly impact their quality of life. While speech and swallow therapy is typically provided in response to problems, this study investigates whether introducing structured tongue strengthening exercises with biofeedback early-can lead to better long-term outcomes. This research will help establish whether this approach should become part of standard post-operative care.",[484,28],"Oral Cancer",[486,487,488],"Speech-Language Pathology","Hemiglossectomy","Tongueometer","2026-06-23",{"date":392,"type":39},{"date":492,"type":39},"2025-12-10",{"date":494,"type":22},"2029-06",{"name":496,"class":73},"Case Comprehensive Cancer Center",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":57,"phases":505,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":118},"100600741","phase-1-phase-i-study-of-preconditioning-radiation-therapy-with-il-15-transduced-tgfbr2-ko-cartrop2-engineered-cord-blood-derived-nk-cells-in-patients-with-advanced-head-and-neck-cancer-radiance-nk-100600741","NCT07101432","Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)","Inclusion Criteria:\n\nPatients with histologically confirmed head and neck cancer, either HPV+ or HPV-, that is locally advanced AND unresectable OR metastatic (≤5 sites of disease), which has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available or are no longer effective, or refused such therapy.\n\nPatient tumors must demonstrate TROP2 expression of 2+ or 3+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories.\n\n* 2 weeks from the last cytotoxic chemotherapy at the time of lymphodepleting chemotherapy; ≥3 days from last TKI or other targeted therapies at the time of lymphodepleting chemotherapy; ≥3 months from any cell therapy for any malignancy at the time of lymphodepleting chemotherapy; prior radiation therapy is allowed at the time of consent.\n\nRT allowed to ≥1 disease sites prior to the lymphodepleting chemotherapy. If there are additional measurable non-irradiated disease sites, this may be evaluated for response as well. If multiple lesions are irradiated, we advise that a single lesion will be treated to a higher dose and other lesions considered for lower doses, and that one site always remain unirradiated if a patient has ≥2 sites of disease.\n\nAge ≥18 years. Because no dosing or adverse event data are currently available on the use of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells in combination with radiation therapy in patients \\\u003C18 years of age, children are excluded from this study.\n\nPatients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nLife expectancy ≥3 months per PI or treating physician's discretion.\n\nA female patient is eligible to participate if at least one of the following conditions applies:\n\na. Not a woman of childbearing potential (WOCBP). OR\n\nA WOCBP who agrees to follow the contraceptive guidelines in Appendix 5 during the study treatment period and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\nWOCBP must have a negative urine pregnancy test within 72 hours prior to the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic gonadotropin \\[B-hCG\\]) pregnancy test will be required.\n\nThe effects of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells on the developing human fetus are unknown. Radiation therapy is absolutely contraindicated in pregnant women. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.\n\nA female patient who becomes pregnant, or suspects pregnancy while she or her partner is participating in this study, must immediately notify her doctor. Female patients who become pregnant will be taken off study.\n\nMale patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 5 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion. Male patients who father a child or suspect that they have fathered a child must immediately notify their doctor.\n\nPatients must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nPatients must have adequate organ function as defined below within 10 days prior to the start of lymphodepleting chemotherapy:\n\nTable 1. Adequate Organ Function Laboratory Values\n\nSystemic Function Test Laboratory Value Hematologic ANC ≥ 1500\u002FµL Platelets ≥ 100,000\u002FµL Hemoglobin ≥9.0 g\u002FdLa Renal Creatinine ≤ 1.5 x ULNb OR CrCl by Cockcroft-Gault ≥30 mL\u002Fmin for patients with creatinine formula \\> 1.5 x ULNb Hepatic Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\>1.5 x ULN AST and ALT ≤2.5 x ULN (≤5 x ULN for patints with liver metastases) Coagulation PT\u002FINR ≤1.5 x ULN unless patien is receiving anticoagulant aPTT therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT=alanine aminotransferase; ANC=absolute neutrophil count; aPTT=activated partial thromboplastin time; AST=aspartate aminotransferase; CrCl=creatinine clearance; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks of the screening test. Patients may be on a stable dose of erythropoietin (≥ approximately 3 months).\n2. Serum creatinine and CrCl should be interpreted and calculated per institutional standard.\n\n   Left ventricular ejection fraction \\>50%.\n\n   Adequate respiratory reserve defined as dyspnea Grade 0 or 1 and saturated oxygen \\>92% in room air. See Table 2 for a grading scale of dyspnea per the CTCAE v5.0.\n\n   Table 2. Dyspnea grading scale.\n\n   Grade 0 - No shortness of breath Grade 1 - Shortness of breath with moderate exertion Grade 2 - Shortness of breath with minimal exertion; limiting instrumental ADL Grade 3 - Shortness of breath at rest; limiting self-care ADL Grade 4 - Life threatening consequences; urgent intervention indicated Grade 5 - Death\n\n   Prior treatment with TROP2-targeted therapy will be allowed.\n\n   Willing to undergo mandatory blood collections and biopsies as required by the study.\n\n   Willing to sign consent for long-term follow-up on protocol PA17-0483.\n\n   Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\n   Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n   Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\n   Ability to understand and the willingness to sign a written informed consent document.\n\n   Exclusion Criteria:\n   1. Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months post TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n   2. Has received systemic anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter, prior to the start of lymphodepleting chemotherapy. For patients treated with monoclonal antibodies, at least 3 weeks must have elapsed prior to the start of lymphodepleting chemotherapy. Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.\n   3. Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the principal investigator (PI)\u002Fco-PIs. If a patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the start of lymphodepleting chemotherapy.\n   4. If patients receive RT within 2 weeks of the start of lymphodepleting chemotherapy, they must not require corticosteroids, and not have had radiation pneumonitis.\n   5. Has received a live vaccine within 6 weeks prior to TROP2 CAR\u002FIL-15 TGFBR2 KO NK infusion and for at least 24 months post infusion. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n   6. Prior CAR T or NK cell or other genetically modified T or NK cell therapy.\n   7. Has diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent).\n   8. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to patients who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.\n   9. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate if they completed radiation therapy, are clinically stable, and without requirement of steroid treatment for at least 2 weeks prior to study enrollment.\n   10. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n   11. History of interstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD. 12. Active infection requiring systemic therapy.\n\n   13\\. Known human immunodeficiency virus (HIV) infection.\n\n   14\\. Known active or chronic hepatitis B or hepatitis C virus infection.\n\n   15\\. Known history of active tuberculosis (Mycobacterium tuberculosis).\n\n   16\\. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n\n   17\\. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n   18\\. Has had an allogenic tissue\u002Fsolid organ transplant.\n\n   19\\. Clinically significant cardiovascular disease within 12 months prior to the start of lymphodepleting chemotherapy, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular event, or cardiac arrhythmia associated with hemodynamic instability. NOTE: medically controlled arrhythmia would be permitted.\n\n   20\\. Prolongation of corrected QT interval using Fridericia's formula to \\>480 milliseconds.\n\n   21\\. Patients with bleeding or thrombotic disorders or at risk for severe hemorrhage. Patients with known deep vein thrombosis\u002Fpulmonary embolism who are on appropriate anti-coagulation treatment are eligible.\n\n   22\\. Patients with history of ≥Grade 3 stomatitis or mucositis with prior therapy.\n\n   23\\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide and fludarabine or other agents used in study.",{"count":504,"type":22},33,[86],"To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2\u002Finterleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.",[28],"2026-06-22",{"date":463,"type":39},{"date":511,"type":39},"2025-12-19",{"date":513,"type":22},"2029-12-31",{"name":515,"class":73},"M.D. Anderson Cancer Center",{"id":517,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":519,"keywords":520,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":523,"leadSponsor":524,"locationsCount":118},"100590658",{"count":21,"type":22},[26,27,28,29],[31,32,33,34],{"date":392,"type":39},{"date":41,"type":39},{"date":43,"type":22},{"name":45,"class":46},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":57,"phases":534,"briefSummary":535,"conditions":536,"keywords":539,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":47},"100495068","phase-2-preoperative-pembrolizumab-and-chemotherapy-in-resectable-recurrent-hnscc-100495068","NCT05726370","Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC","A Phase 2 Study of Preoperative Pembrolizumab and Chemotherapy Followed by Adjuvant Pembrolizumab in Resectable Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC in a previously irradiated field, defined as \\>50% of the presurgical tumor volume having prior radiation dose of \\>45 Gy as determined by the treating radiation oncologist (including primary sites, such as oral cavity, oropharynx, larynx or hypopharynx carcinoma).\n* Participants must be a candidate for curative intent surgery.\n* Participants must have documented time of ≥ 6 months from completion of prior curative intent treatment for HNSCC (surgery and\u002For radiation therapy with\u002Fwithout platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence or a second primary in a previously irradiated field.\n* Participants must be willing to undergo a mandatory pre-treatment biopsy and willing to provide blood and tissue from the pre-treatment biopsy and at the time of surgery. Exceptions may be made after discussion with sponsor if it is not medically feasible to obtain a pre-treatment biopsy or is in the best interest of the patient. Archival tissue may be collected in this situation. Participants will be offered the opportunity to volunteer for optional biopsies at the time of recurrence of disease.\n* Participants may have any smoking history (no restrictions)\n* Participants may have any Human Papilloma Virus (HPV) status of the tumor. Patients with oropharyngeal cancer are required to undergo HPV testing with p16 immunohistochemistry and\u002For confirmatory HPV PCR or ISH testing\n* Age ≥18 years\n* ECOG performance status 0 or 1 (Karnofsky ≥70%, see Appendix A)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Because pembrolizumab and chemotherapy can be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  * a. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR\n  * b. A WOCBP who agrees to follow the contraceptive guidance in Appendix B during the treatment period and for at least 180 days after the last dose of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Sinonasal, nasopharyngeal or cutaneous primary site of squamous cell carcinoma of the head and neck\n* Has known distant metastatic disease. Those with known brain metastases should be excluded from this clinical trial, because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic\n* Has had chemotherapy or radiotherapy for HNSCC in curative intent setting within 6 months prior to entering the study.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has a history of allergic reactions to agents used in study\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia\n* Has had an allogeneic tissue\u002Fsolid organ transplant\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to study registration (see Appendix B). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because pembrolizumab and chemotherapy agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab and chemotherapy, breastfeeding should be discontinued if the mother is treated on this protocol.",{"count":533,"type":22},28,[87],"This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery.\n\nThe names of the study drugs involved in this research study are:\n\n* pembrolizumab (a type of immunotherapy)\n* docetaxel (a type of chemotherapy)\n* cisplatin (a type of chemotherapy)\n* carboplatin (a type of chemotherapy)",[90,28,537,272,538],"Resectable Head and Neck Squamous Cell Carcinoma","Second Primary Squamous Cell Carcinoma of the Head and Neck",[90,28,537,272,538],"2026-06-21",{"date":489,"type":39},{"date":543,"type":39},"2023-05-20",{"date":545,"type":22},"2030-05-20",{"name":259,"class":73},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":57,"phases":556,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":47},"100580452","photobiomodulation-in-head-and-neck-cancer-related-chronic-lymphedema-100580452","NCT06837480","Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema","Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema","Inclusion Criteria:\n\n\\>18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.\n\nExclusion Criteria:\n\nPatients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:\n\nWomen of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases",{"count":555,"type":22},150,[59],"The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.",[28,559],"Lymphedema of the Head and Neck",[561],"Head and neck cancer, chronic lymphedema, photobiomodulation","2026-06-19",{"date":489,"type":39},{"date":565,"type":39},"2026-01-15",{"date":567,"type":22},"2029-11-30",{"name":569,"class":73},"Abramson Cancer Center at Penn Medicine",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":57,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":586,"locationsCount":118},"100644390","phase-1-camrelizumab-with-famitinib-for-patients-with-rare-head-and-neck-malignancies-100644390","NCT07662681","Camrelizumab With Famitinib for Patients With Rare Head and Neck Malignancies","A Prospective, Multi-Cohort Study of Camrelizumab in Combination With Famitinib for the Treatment of Patients With Rare Head and Neck Malignancies","Inclusion Criteria:\n\n* Age ≥18 years; Histologically or cytologically confirmed unresectable or recurrent\u002Fmetastatic soft tissue sarcoma, malignant melanoma, adenoid cystic carcinoma, or salivary gland carcinoma (non-adenoid cystic carcinoma) with no indication for curative treatment; Salivary gland tumors must be negative for both HER2 and AR, as determined by IHC; ECOG PS of 0-1; At least one measurable lesion according to RECIST v1.1 criteria; No prior PD-1 inhibitor therapy; Received ≤1 prior systemic therapy regimen; Adequate organ function, as defined by the following laboratory values: Organ Laboratory Value Hematology Absolute neutrophil count ≥1500\u002FμL (1.5×10\\^9\u002FL) Platelets ≥100,000\u002FμL (100×10\\^9\u002FL) Hemoglobin ≥9 g\u002FdL (90 g\u002FL) or ≥5.6 mmol\u002FL Renal Creatinine or Creatinine clearance Creatinine ≤1.5×ULN; if creatinine \\>1.5×ULN, then creatinine clearance ≥60 mL\u002Fmin Hepatic Total bilirubin ≤1.5×ULN AST and ALT ≤2.5×ULN, or ≤5×ULN in the presence of liver metastases Coagulation INR or PT ≤1.5×ULN; for patients receiving anticoagulants, PT or PTT must be within the therapeutic range of the anticoagulant being used Female subjects must have a negative pregnancy test within 2 weeks prior to the start of study treatment and must not be breastfeeding. Female subjects must agree to use highly effective contraceptive measures during the study and for 6 months after the last dose of study drug. Male subjects must agree to use highly effective contraceptive measures during the study and for 6 months after the last dose of study drug; Subject voluntarily agrees to participate in the study, provides written informed consent, and is able to comply with the protocol-specified visits and related procedures.\n\nExclusion Criteria:\n\n* Radiotherapy or other local therapy (e.g., surgery) within 2 weeks prior to enrollment, or failure to recover from adverse events of prior therapy (i.e., to ≤Grade 1 or baseline); Participation in a clinical trial within 4 weeks prior to enrollment; Poorly controlled cardiac symptoms or diseases, including: (1) NYHA Class II or higher heart failure or LVEF \\\u003C50% on echocardiography; (2) unstable angina; (3) myocardial infarction within 1 year prior to study treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\>450 ms (males) or QTc \\>470 ms (females) (QTc interval calculated using the Fridericia formula; if QTc is abnormal, three consecutive measurements at 2-minute intervals may be taken and averaged).\n\nHypertension that cannot be controlled to within the normal range with antihypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, based on the average of ≥2 BP readings); use of antihypertensive therapy to achieve these parameters is permitted. History of hypertensive crisis or hypertensive encephalopathy.\n\nPresence of multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea and vomiting, chronic diarrhea, intestinal obstruction, etc.).\n\nThrombotic or embolic events within 6 months prior to study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n\nCurrent interstitial pneumonitis or interstitial lung disease, or a history of interstitial pneumonitis or interstitial lung disease requiring corticosteroid therapy, or other conditions such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-induced pneumonitis, or idiopathic pneumonitis that may interfere with the assessment and management of immune-related pulmonary toxicity, or evidence of active pneumonitis or severely impaired pulmonary function on chest CT at screening. Prior radiation pneumonitis in the radiation field is permitted; active tuberculosis.\n\nInvestigator-assessed life expectancy of less than 3 months, or rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain, etc.); Abnormal coagulation function (INR \\>1.5×ULN, APTT \\>1.5×ULN) or bleeding tendency; Diagnosis of immunodeficiency within 7 days prior to enrollment, or receiving systemic corticosteroid therapy or other forms of immunosuppressive therapy.\n\nDiagnosis of other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or other cured tumors that the investigator considers acceptable for exclusion.\n\nKnown active central nervous system metastases; Tumor invasion of major blood vessels or tumor ulceration with bleeding, as judged by the investigator; Active autoimmune disease requiring systemic therapy within 2 years prior to enrollment; History of allogeneic tissue transplantation or solid organ transplantation; Active infection requiring systemic therapy; Psychiatric illness or substance abuse that would interfere with trial compliance or cooperation; Positive serology for HIV or a history of HIV infection; Active HBV or HCV infection; Receipt of a live vaccine within 30 days prior to the start of the trial. Other factors, such as medical history, that in the investigator's assessment could compromise subject safety or affect trial evaluations.",{"count":268,"type":22},[86,87],"This is a prospective, multicenter, multi-cohort, Phase II clinical trial enrolling patients with unresectable, recurrent, or metastatic soft tissue sarcoma, malignant melanoma, adenoid cystic carcinoma, or salivary gland malignancies (excluding adenoid cystic carcinoma) who have not previously received PD-1 inhibitor therapy. The planned sample size is 10 subjects per cohort, for a total of 40 subjects. Investigators may adjust the cohort sample sizes based on actual enrollment. Potentially eligible subjects will be screened within 4 weeks prior to the first dose to assess their eligibility for study entry. Subjects confirmed by the investigator to meet all inclusion criteria and none of the exclusion criteria will receive the investigational medicinal products as per the study design and undergo efficacy and safety assessments. This trial will consist of three periods: Screening\u002FBaseline Period, Treatment Period, and Follow-up Period. The study procedures include: Screening Period: From the signing of the informed consent form up to 28 days prior to the first dose; Treatment Period: Treatment discontinuation is defined as the cessation of treatment for any reason, such as disease progression or intolerance, or premature withdrawal for any reason; Follow-up Period: Following the subject's last dose, safety follow-up will be initiated to monitor the resolution of adverse events. The first safety follow-up visit will occur 30 ± 7 days after the last study dose (calculated based on the later date of 30 days post the last dose of either camrelizumab or famitinib). Subjects are required to return to the study center for this safety follow-up, regardless of whether they have initiated new antineoplastic therapy. The subsequent two safety visits (60 ± 7 days and 90 ± 7 days after the last dose) may be conducted via telephone. After study discontinuation, survival follow-up will be conducted every 3 months to monitor survival status and subsequent antineoplastic treatments. The dosing regimen is as follows: camrelizumab 200 mg, IV, on Day 1, Q3W; famitinib 10 mg, PO, QD, Q3W, with 21 days constituting one treatment cycle. Study drugs should be administered at approximately the same time each day. If a patient vomits or misses a dose, no replacement dose should be taken on that day, and the next scheduled dose should be taken as usual. Subjects will continue treatment with camrelizumab and famitinib until discontinuation criteria are met. Clinical tumor imaging assessments will be performed every 2 cycles according to RECIST v1.1 (Appendix IV). Additionally, on Day 1 of each treatment cycle, clinically required assessments must be completed, including vital signs, physical examination, complete blood count, urinalysis, fecal occult blood test, hepatic and renal function tests, serum electrolytes, serum proteins, coagulation profile, serum tumor markers, thyroid function, electrocardiogram (ECG), and ECOG performance status score (specific assessments for each visit are detailed in the Schedule of Assessments). Hepatitis virus carriers will also require viral load monitoring every 2 to 4 treatment cycles.",[28],"2026-06-17",{"date":489,"type":39},{"date":149,"type":22},{"date":585,"type":22},"2029-07-01",{"name":587,"class":73},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":595,"enrollmentInfo":596,"targetDuration":4,"studyType":57,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":603,"leadSponsor":604,"locationsCount":118},"100644313","phase-2-efficacy-and-safety-of-paclitaxel-polymeric-micelles-in-patients-with-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-100644313","NCT07662746","Efficacy and Safety of Paclitaxel Polymeric Micelles in Patients With Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma","Efficacy and Safety of Paclitaxel Polymeric Micelles in Patients With Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Exploratory Phase II Clinical Study","Inclusion Criteria:\n\n* Age ≥18 and ≤75 years, male or female; Histologically or cytologically confirmed head and neck squamous cell carcinoma; Prior first-line systemic therapy (including chemotherapy, targeted therapy, and immunotherapy) with disease progression or judged by the clinician to no longer derive clinical benefit; ECOG performance status score of 0-2 and a life expectancy of at least 3 months; At least one measurable lesion on imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1, Appendix 3);\n\nAdequate major organ function, with subjects meeting the following laboratory parameters:\n\nComplete blood count meeting the following criteria (no blood transfusion, blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to the test): WBC ≥3.0×10\\^9\u002FL, ANC ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, hemoglobin ≥90 g\u002FL; Blood biochemistry meeting the following criteria: total bilirubin ≤1.5×ULN, AST, ALT, or ALP ≤2.5×ULN (for subjects with liver metastases, ALT, AST, or ALP ≤5×ULN is permitted; for subjects with bone metastases, ALP ≤10×ULN is permitted); serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula, Appendix 4) ≥50 mL\u002Fmin; Adequate coagulation function, defined as INR ≤1.5×ULN and PT or APTT ≤1.5×ULN; Subjects of childbearing potential must agree to use highly effective contraceptive measures during the trial. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of chemotherapy; Good compliance, able to undergo treatment and follow-up, and willing to comply with the study requirements; voluntary signing of the informed consent form.\n\nExclusion Criteria:\n\n* Known allergy or intolerance to any study treatment or any excipient; Presence of uncontrolled serious medical conditions, such as severe comorbidities including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; Other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery; Requirement for concomitant use of other antineoplastic drugs; Receipt of any other investigational drug or participation in another interventional clinical trial within 30 days prior to screening; History of psychotropic substance abuse with inability to abstain, or presence of psychiatric disorders; Pregnant or breastfeeding women; Patients deemed unsuitable for enrollment by the investigator.","75 Years",{"count":597,"type":22},29,[87],"Paclitaxel polymeric micelles 300 mg\u002Fm², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)",[28],{"date":489,"type":39},{"date":149,"type":22},{"date":585,"type":22},{"name":587,"class":73},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":57,"phases":613,"briefSummary":614,"conditions":615,"keywords":618,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":118},"100624280","phase-1-ph-iii-sodium-thiosulfate-for-otoprotection-during-cisplatin-stop-cis-100624280","NCT07407582","Ph. I\u002FII Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)","Phase I\u002FII Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)","Inclusion Criteria:\n\n* Participants have provided informed consent prior to initiation of any study-specific activities.\n* At least 18 years of age, male or female, at the time of signing the informed consent.\n* ECOG Performance Status 0-1\n* Histologically or cytologically confirmed treatment-naïve cancer.\n* Scheduled to receive an FDA-approved, on-label indication, standard of care systemic cisplatin-based regimen (at least 200 mg\u002Fm2 cumulative dose) for any untreated any solid malignancy deemed by the treating physician\n\nExclusion Criteria:\n\n* Prior cisplatin exposure due to a cancer treatment history\n* Concurrent ototoxic medication unable to be safely discontinued or switched to a non-toxic alternative\n* Planned radiation to the head or neck prior to, during, or within 3 months of completion of cisplatin\n* History of severe hypersensitivity to sulfite, sodium thiosulfate, or any components\n* Baseline serum sodium \\> 145 mmol\u002FL or any grade ≥ 3 electrolyte abnormality\n* Cisplatin infusion duration greater than 6 hours\n* Females during pregnancy or breastfeeding, and childbearing potential, unwilling to use a method of contraception during treatment\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment\n* Subject likely not to be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject's and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.",{"count":7,"type":22},[86,87],"The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.",[616,322,28,617],"Solid Tumor Malignancies","Thoracic Cancer",[619,620,29,621,622,623,624],"Cisplatin","Otoprotectant","Hearing Impairment","Sodium Thiosulfate","Adults","Solid Tumor","2026-06-16",{"date":627,"type":39},"2026-06-18",{"date":629,"type":39},"2026-05-18",{"date":631,"type":22},"2028-04-30",{"name":633,"class":73},"University of Arizona",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":344,"sex":18,"minAge":19,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":57,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":118},"100617407","prehabilitation-protocol-for-head-and-neck-cancer-patients-100617407","NCT07318220","Prehabilitation Protocol for Head and Neck Cancer Patients","Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period","Aim 2 Inclusion Criteria: Implement prehabilitation prescription protocol and evaluate the feasibility and acceptability of the prehabilitation prescription protocol in a sample of HNC patients.\n\n1. Age 18 to 80 years old\n2. Patients with a diagnosis of non-metastatic squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).\n3. Patients with a plan for curative radiation therapy (RT) \u002F chemoradiation therapy (CRT) at SCCC\\* - \\*Patients who underwent surgery for the HNC are still eligible.\n4. Clearance for exercise by the medical team.\n5. Patients who do not have their first treatment scheduled within 3 weeks at the time of recruitment.\n6. An English or Spanish speaker.\n\nAim 2 Exclusion Criteria:\n\n1. A patient with a metastatic cancer.\n2. A patient who cannot complete the baseline assessment and\u002For start prehabilitation by the initiation of RT\u002FCRT.\n3. Any contraindication for diet change or exercising as determined by a physician.\n\n   week for the prior month.\n4. A patient who is not an English or Spanish speaker.\n5. History of dementia or major psychiatric disease which would interfere with study.\n6. History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure\n7. Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.","80 Years",{"count":643,"type":22},60,[59],"The purpose of this research is to help researchers understand the barriers, supports, and preferences for prehabilitation. Prehabilitation in this study means head and neck cancer patients will receive nutritional counseling sessions and attend exercise programs before and during radiotherapy\u002Fchemoradiotherapy treatment.",[28],{"date":581,"type":39},{"date":649,"type":39},"2026-05-01",{"date":651,"type":22},"2027-08-30",{"name":653,"class":73},"University of Miami",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":57,"phases":663,"briefSummary":664,"conditions":665,"keywords":666,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":675,"locationsCount":118},"100642890","a-pilot-study-of-ultra-high-dose-rate-conformalflash-for-reirradiation-of-carcinoma-of-the-head-and-neck-100642890","NCT07644585","A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck","C-FLASH-01","Inclusion Criteria:\n\n1. Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits\n2. Patients ≥ 18 years old\n3. Patients ineligible for or decline upfront surgical resection\n4. Histologically confirmed diagnosis of carcinoma of the head and neck\n5. Prior receipt of at least 45 GyRBE radiotherapy to the head and neck\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or evidence of similar in the electronic medical record\n7. Life expectancy of more than 12 weeks\n8. Ability to understand and the willingness to provide written informed consent and to follow the study procedures\n\nExclusion Criteria:\n\n1. Receipt of prior head and neck radiotherapy within the prior 6 months\n2. Surgical resection of the current disease in the head and neck\n3. More than 3 areas of disease requiring reirradiation\n4. Disease focus exceeding 6.5 cm in greatest dimension\n5. Presence of distant metastatic disease\n6. Involvement of any of the following structures: skin, carotid artery, or mandible\n7. Receipt of concurrent chemotherapy during radiotherapy\n8. Uncontrolled intercurrent illness including medical and psychiatric, and social situations that would limit compliance with study requirements\n9. Enrolled in any other investigational studies that involve administrations of another cancer therapeutic (such as surgery, chemotherapy, immunotherapy) during RT\n10. Pregnant and\u002For breastfeeding",{"count":662,"type":22},10,[59],"This pilot study is designed to evaluate the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) in participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection. ConformalFLASH treatment planning and delivery workflows are comparable to those of conventional Stereotactic Body Radiation Therapy (SBRT), a standard approach for re-irradiation in this population.",[28],[667,668],"Proton Therapy","Ultra-High Dose-Rate","2026-06-11",{"date":671,"type":39},"2026-06-12",{"date":673,"type":22},"2026-08",{"date":215,"type":22},{"name":676,"class":46},"IBA Proton Therapy, Inc.",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":57,"phases":686,"briefSummary":687,"conditions":688,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":118},"100524050","locally-ablative-therapy-in-oligo-progressive-solid-tumors-valorous-100524050","NCT06103669","Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)","VALOROUS","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed genitourinary malignancies:\n\n   1. Cohort A: Breast Malignancy\n   2. Cohort B: Gynecological Malignancy\n   3. Cohort C: Head and Neck Malignancies\n   4. Cohort D: Sarcomas\n   5. Cohort E: Other solid malignancy specified in the protocol\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",{"count":685,"type":22},250,[59],"This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[27,689,28,183,417],"Oligoprogressive",{"date":691,"type":39},"2026-06-15",{"date":693,"type":39},"2023-10-05",{"date":695,"type":22},"2033-12",{"name":697,"class":73},"University of California, Davis"]