[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tongue-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tongue-squamous-cell-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,96,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100609637","phase-1-a-study-evaluating-the-safety-efficacy-and-pharmacokinetics-pk-of-evolve104-in-participants-with-advanced-urothelial-and-squamous-cell-carcinomas-100609637",false,"NCT07217171","A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas","A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas","Key Inclusion Criteria:\n\nParticipants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma.\n\n1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.\n2. The cancer must be measurable by CT scan or MRI.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.\n4. Anticipated life expectancy of at least 3 months.\n5. Adequate organ function, as indicated by standard blood tests.\n6. Able to provide a fresh or archival tumor biopsy.\n7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile.\n\nKey Exclusion Criteria:\n\n1. The participant is a candidate for treatment with a targeted agent known to provide a benefit.\n2. Persistent significant toxicities from prior anticancer therapy.\n3. Brain metastases unless previously treated and stable.\n4. Prior severe or life-threatening immunologic reactions to previous therapies.\n5. Significant medical conditions, including but not limited to:\n\n   * History of clinically significant cardiac disease\n   * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis.\n   * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations.\n   * History of cirrhosis or significant portal hypertension.\n   * Uncontrolled or significant infection.\n   * History of certain other cancers in the past 3 years.\n   * History of arterial thrombosis, stroke and transient ischemic attack within 6 months.\n   * Active or uncontrolled HIV, HBV or HCV infection.\n   * Autoimmune or other condition requiring chronic systemic immunosuppression.","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.",[26,27,28,29,30,31,32,33,34,35,36],"Bladder Cancer","Squamous Cell Carcinoma of the Lung","Esophageal Squamous Cell Carcinoma","Tongue Squamous Cell Carcinoma","Cutaneous Squamous Cell Cancer","Penile Squamous Cell Carcinoma","Anal Squamous Cell Carcinoma","Vulvar Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Vaginal Squamous Cell Carcinoma","Urethral Squamous Cell Carcinoma",[38,39,40,41,42,43,44,45,46],"bladder","lung","esophagus","tongue","penile","anal","vulvar","cervical","vaginal","RECRUITING","2026-07-01",{"date":50,"type":51},"2026-07-02","ACTUAL",{"date":53,"type":51},"2025-11-13",{"date":55,"type":20},"2031-01-29",{"name":57,"class":58},"EvolveImmune United, Inc","INDUSTRY",12,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100388112","phase-2-comparing-sentinel-lymph-node-sln-biopsy-with-standard-neck-dissection-for-patients-with-early-stage-oral-cavity-cancer-100388112","NCT04333537","Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer","Randomized Phase II\u002FIII Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION INCLUSION:\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration\n* Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[ed.\\]) based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 42 days prior to registration\n  * Imaging of head and neck within 42 days prior to registration\n\n    * PET\u002FCT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic quality CT is preferred and highly recommended as part of the PET\u002FCT when possible\n  * Imaging of chest within 42 days prior to registration\n\n    * Chest x-ray, CT chest scan (with or without contrast), or PET\u002FCT (with or without contrast)\n* Surgical assessment within 42 days prior to registration. Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END)\n\n  * Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins\n* Age \\>= 18\n* Zubrod performance status 0-2 within 42 days prior to registration\n* For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* Only patients who are able to read and understand English or French are eligible to participate as the mandatory patient reported NDII tool is only available in these languages\n* PRIOR TO STEP 2 RANDOMIZATION:\n* FDG PET\u002FCT required prior to step 2. Note: FDG PET\u002FCT done prior to step 1 can be submitted for central review\n\n  * PET\u002FCT node negative patients, determined by central read, will proceed to randomization. PET\u002FCT node positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development\n\n    * NOTE: All FDG PET\u002FCT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization)\n* The patient must complete NDII prior to step 2 registration\n\nExclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION EXCLUSION:\n* Definitive clinical or radiologic evidence of regional (cervical) and\u002For distant metastatic disease\n* Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years\n* Diagnosis of head and neck SCC in the oropharynx, nasopharynx, hypopharynx, and larynx\n* Unable or unwilling to complete NDII (baseline only)\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Severe, active co-morbidity that would preclude an elective or completion neck dissection\n* Pregnancy and breast-feeding mothers\n* Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted\n* Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are \\>= 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound (U\u002FS)-guided fine-needle aspiration (FNA) biopsy\n* Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \\[CLL\\]) or other active disease capable of causing lymphadenopathy (e.g., sarcoidosis or untreated mycobacterial infection)\n* Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy\n* Currently participating in another investigational therapeutic trial",{"count":68,"type":20},686,[70,71],"PHASE2","PHASE3","This phase II\u002FIII trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.",[74,75,76,77,78,79,80,81,82,83,29,84],"Buccal Mucosa Squamous Cell Carcinoma","Floor of Mouth Squamous Cell Carcinoma","Gingival Squamous Cell Carcinoma","Hard Palate Squamous Cell Carcinoma","Lip Squamous Cell Carcinoma","Lower Alveolar Ridge Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Retromolar Trigone Squamous Cell Carcinoma","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Upper Alveolar Ridge Squamous Cell Carcinoma","2026-06-22",{"date":87,"type":51},"2026-06-25",{"date":89,"type":51},"2020-09-23",{"date":91,"type":20},"2031-04-27",{"name":93,"class":94},"NRG Oncology","OTHER",107,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100628835","resection-and-defect-repair-of-oral-cancer-aided-by-mixed-reality-technology-100628835","NCT07466810","Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology","Prospective Clinical Study in Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology Based on UE5 Engine","Inclusion Criteria:\n\n1. Definite pathological diagnosis of oral cancer before surgery;\n2. Defects suitable for free flap reconstruction;\n3. Patients have signed the informed consent form and are willing to cooperate with postoperative follow-up.\n\nExclusion Criteria:\n\n\\- Poor general condition, evaluated as unable to tolerate surgical treatment.\n\n-Exclusion Criteria (After Enrollment)\n\nSubjects who have been enrolled in this trial will be excluded if they meet any of the following conditions:\n\n1. Violation of important inclusion criteria;\n2. Subjects did not receive surgical treatment;\n3. No observation data after randomization. Withdrawal Criteria Withdrawal of subjects from the trial refers to cases where enrolled subjects are determined by the investigator to withdraw from the trial due to conditions that make it inappropriate to continue the trial. In accordance with the informed consent form, subjects have the right to withdraw from the trial midway. Subjects who do not explicitly propose to withdraw but stop receiving treatment and tests and are lost to follow-up are also considered \"withdrawn\" (or \"lost to follow-up\"). The reason for withdrawal should be understood and recorded as much as possible, such as: poor subjective curative effect; inability to tolerate certain adverse reactions; inability to continue participating in the clinical study due to personal reasons; economic factors; or lost to follow-up without stating the reason.\n\n(1) Aggravation or deterioration of the condition during the trial that requires emergency measures; (2) Occurrence of certain comorbidities, complications or special physiological changes in subjects during the trial, making it inappropriate to continue participating in the trial; (3) Voluntary withdrawal by the subject.\n\nData Handling of Withdrawn Subjects\n\nRegardless of the reason, the complete clinical data of subjects who withdraw from the trial shall be retained. For all withdrawn subjects, the trial conclusion form and the reason for withdrawal shall be filled in the case report form (CRF). Generally, there are 6 types of reasons: occurrence of adverse events (including adverse drug reactions and allergic reactions), lack of efficacy (deterioration of condition or occurrence of complications), violation of the trial protocol (including poor compliance), lost to follow-up (including voluntary withdrawal by the patient), termination by the sponsor, or others.",{"count":104,"type":20},30,[106],"NA","The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site.\n\nResearchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality \\[MR\\] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group.\n\nThe primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.",[29,109,110,111,112],"Mixed Reality","Virtual Surgical Planning","Free Flap","Oral Cancer",[109,114,115,116,117,111,110,112],"tongue reconstruction","Unreal Engine 5","Glossectomy","Surgical guide","NOT_YET_RECRUITING","2026-03-18",{"date":121,"type":51},"2026-03-20",{"date":123,"type":20},"2026-04-01",{"date":125,"type":20},"2027-10-01",{"name":127,"class":94},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",1,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":128},"100619606","phase-2-lingual-nerve-disruption-to-augment-neoadjuvant-chemoimmunotherapy-in-locally-advanced-tongue-cancer-100619606","NCT07346807","Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer","A Phase II Single-Arm Study of Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer","Inclusion Criteria:\n\n1. Age 18-75 years, male or female.\n2. Histologically or cytologically confirmed primary tongue squamous cell carcinoma (cT3 or cT4).\n3. Patients scheduled to receive 2 cycles of preoperative neoadjuvant chemoimmunotherapy with tirelizumab, cisplatin, and albumin-bound paclitaxel.\n4. Patients planned to undergo surgical resection of tongue cancer following neoadjuvant therapy.\n5. Voluntary participation with signed informed consent, good compliance, and willingness to follow study procedures.\n\nExclusion Criteria:\n\n1. Known distant metastases of the tumor.\n2. History of tongue squamous cell carcinoma or other malignant tumors of the tongue within the past 5 years.\n3. Active infection requiring systemic therapy; non-infectious pneumonia or interstitial lung disease requiring steroid therapy, or current pneumonia\u002Finterstitial lung disease; known hepatitis B infection (HBsAg positive) or active hepatitis C infection (detectable HCV RNA); known HIV infection.\n4. Previous allogeneic tissue or organ transplantation.\n5. Unresolved ≥Grade 2 (CTCAE v5.0) toxicities from prior anticancer treatments, except alopecia.\n6. Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, NYHA class ≥II heart disease within 3 months prior to enrollment).\n7. Active serious clinical infections (\\>Grade 2 NCI-CTCAE v5.0).\n8. Uncontrolled hypertension (treated systolic BP \\>150 mmHg and\u002For diastolic BP \\>90 mmHg) or clinically significant cardiovascular disease, including recent cerebrovascular accident or myocardial infarction (≤6 months), unstable angina, NYHA class ≥II congestive heart failure, or severe arrhythmia not controlled by medication that could affect study treatment.\n9. Laboratory abnormalities:\n\n   Hematology: WBC \\\u003C3,000\u002Fmm³, Hb \\\u003C8 g\u002FdL, platelets \\\u003C80,000\u002Fmm³ Liver function: ALT\u002FAST \\>3× upper limit of normal, bilirubin \\>1.5× ULN Renal function: serum creatinine \\>1.5× ULN, renal failure requiring dialysis Diabetes: poorly controlled (FBG \\>10 mmol\u002FL) Proteinuria: urine protein ≥++ and 24-hour urine protein \\>1.0 g\n10. Pregnant women; breastfeeding women must discontinue breastfeeding to participate.\n11. History of substance abuse or psychiatric disorders that would interfere with study participation.\n12. Participation in another clinical trial within 30 days prior to enrollment.","75 Years",{"count":138,"type":20},69,[70],"The goal of this clinical trial is to evaluate the feasibility and preliminary efficacy of lingual nerve disruption combined with neoadjuvant chemoimmunotherapy in patients with locally advanced tongue squamous cell carcinoma.\n\nThe study aims to learn whether surgical disruption of the lingual nerve can enhance the effectiveness of neoadjuvant chemoimmunotherapy before definitive surgery in adults with locally advanced (cT3\u002FT4) tongue cancer. The main questions it aims to answer are:\n\nCan lingual nerve disruption combined with neoadjuvant chemoimmunotherapy improve tumor response prior to surgery?\n\nIs this combined treatment approach safe and feasible for patients with locally advanced tongue cancer?\n\nThis is a single-arm, phase II clinical trial.\n\nParticipants will:\n\nUndergo tumor biopsy with simultaneous surgical disruption of the affected-side lingual nerve.\n\nReceive neoadjuvant chemoimmunotherapy consisting of tislelizumab, cisplatin, and nab-paclitaxel for two treatment cycles.\n\nUndergo definitive surgical resection of the primary tumor and neck dissection.\n\nAttend scheduled follow-up visits for safety assessments, imaging evaluations, and collection of blood samples for immune monitoring.",[29],"2026-01-08",{"date":144,"type":51},"2026-01-16",{"date":146,"type":20},"2026-01-01",{"date":148,"type":20},"2026-10-31",{"name":150,"class":94},"Shanghai Zhongshan Hospital"]