[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oropharyngeal-squamous-cell-carcinoma-scc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oropharyngeal-squamous-cell-carcinoma-scc":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,61,91,117,142,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":40,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100625084","phase-2-a-single-arm-phase-ii-trial-in-p16-positive-oropharynx-cancer-of-selective-dose-de-escalation-of-nodal-volumes-at-minimal-risk-and-primary-site-disease-saved-100625084",false,"NCT07418034","A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)","SAVED","4.1 Step 1 Registration 4.1.1 Step 1 Inclusion\n\n(Y) 1. Is there pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n\n(Y) 2. Is the patient ≥ 18 years of age?\n\n(Y) 3. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\n(Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):\n\nTORS candidate patients must be:\n\n• cT0-4 and N0, N1, N3\n\nNon-TORS candidate patients must be either:\n\n* cT1-4 N0, N1, N3\n* cT1-3 N2 with \\\u003C 10 pack years\n\n4.1.2 Step 1 Exclusion\n\n(N) 1. Patient who are clinical N2 and have ≥10 pack years smoking history\n\n(N) 2. Patients who are clinical T4N2\n\n(N) 3. Patients with distant metastasis (M1)\n\n4.2 Step 2 Registration 4.2.1 Step 2 inclusion\n\n(Y) 1. Does the patient have pathologically (histologically or cytologically) proven P16+ status?\n\n(Y) 2. Does the patient have appropriate imaging (PET\u002FCT preferred, CT neck with IV contrast and CT chest without contrast as recommended alternative to PET\u002FCT) completed within 90 days of enrollment?\n\n(Y) 3. Does the patient have clinical or pathological M0 staging? (Y) 4. Patients who have undergone TORS must have pathological stage pT1-4 N0, N1 or N3. TORS patients found to be clinical N2 post TORS or have contralteral neck dissection and positive nodes will be excluded.\n\n(Y) 5. Is the patient a candidate for bilateral radiation based on evaluation by ENT, Rad Onc, or Med Onc and review at multi-disciplinary tumor board?\n\n(Y) 6. Non-TORS patients who are cT1-3 N0, N1, N2 and have \\\u003C10 PY must have completed a ctDNA evaluation prior to Step 2 enrollment.\n\n(Y) 7. Non-TORS patients who are cT1-3 N2 must have a positive ctDNA result prior to Step 2 enrollment.\n\n(Y) 8. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n\n(Y) 9. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n\n(Y) 10. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n\n4.2.2 Step 2 Exclusion\n\n(N) 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n\n(N) 2. Does the patient have distant metastasis?\n\n(N) 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low\u002Fintermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n\n(N) 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n\n(N) 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n\n(N) 6. Did the patient have prior cancer-related surgeries of curative intent of the head and neck excluding superficial removal of cutaneous skin malignancies?\n\n(N) 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n\n(N) 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n\n(N) 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?","ALL","18 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care.\n\nStudies have reported that lowering radiation doses for some patients can reduce side effects while still effectively controlling the cancer.\n\nPatients with this type of head and neck cancer typically receive either surgery or radiation as their first treatment.\n\nFor patients who receive surgery first, radiation to the surgical area and nearby neck lymph nodes is often recommended afterward. In these patients, the study will test whether lowering the radiation dose to low-risk lymph nodes on the side of the neck opposite the tumor can reduce side effects while still effectively controlling the cancer (Method A).\n\nFor patients who receive radiation as their first treatment, the study will test one or both of two radiation approaches aimed at reducing both short-term and long-term side effects. These approaches include reduced lymph node radiation (Method A, described above) and a tumor dose reduction approach (Method B), which lowers the radiation dose delivered directly to the tumor.\n\nInformation such as tumor size, the number of cancerous or suspicious lymph nodes, and risk factors like smoking history will be used to determine which patients may be eligible for reduced lymph node radiation (Method A), reduced tumor radiation (Method B), or both. Patients who may qualify for tumor dose reduction (Method B), either alone or combined with Method A, will need an additional blood test called a circulating tumor DNA (ctDNA) test to determine eligibility.\n\nThe ctDNA test measures small amounts of tumor-related DNA in the blood, which are often elevated at the time of diagnosis. Studies have shown that cancer is more likely to return when ctDNA levels remain positive after treatment. This study will evaluate whether ctDNA levels measured before and during treatment can help identify patients who can safely receive lower radiation doses to the tumor (Method B).\n\nOverall, this study aims to safely evaluate two radiation de-escalation approaches in order to lessen short- and long-term side effects while maintaining excellent cancer control.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Head and Neck Cancer","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Oropharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma (OPSCC)","Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma (SCC)","Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Oropharyngeal Squamous Cell Cancer","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","HPV 16 Positive Oropharyngeal Tumors (OPC)",[41,26,42,43,44,45,46,47,48],"Transoral Robotic Surgery (TORS)","Oropharynx Cancer","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","Radiation Therapy","ctDNA","P16 positive","NOT_YET_RECRUITING","2026-02-10",{"date":52,"type":53},"2026-02-18","ACTUAL",{"date":55,"type":20},"2026-05",{"date":57,"type":20},"2033-05",{"name":59,"class":60},"University of Maryland, Baltimore","OTHER",{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":68,"enrollmentInfo":69,"targetDuration":71,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100603241","a-bidirectional-observational-clinical-study-of-naic-in-the-treatment-of-tumor-regression-patterns-in-la-oscc-and-la-opscc-100603241","NCT07133958","A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC","A Bidirectional Observational Clinical Study of Tumor Regression Patterns in Patients With Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy","Inclusion Criteria:\n\n1. Oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma diagnosed as locally advanced (T3-4) according to the AJCC criteria\n2. Their age ranged from 18 to 80 years\n3. There was no history of other malignant tumors or treatment\n4. Adequate blood function: white blood cell count (WBC) ≥3.5×10\\^9\u002FL, platelet count (PLT) ≥75×10\\^9\u002FL; Hemoglobin concentration (HGB) ≥90g\u002FL\n5. Adequate liver function: total bilirubin (TBIL) ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal\n6. \"Adequate renal function: urinary white blood cells \\\u003C 10, red blood cells \\\u003C 10, cast count \\\u003C 5 per high-power field, and creatinine (CRE) ≤ the upper limit of normal.\n7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI and surgical treatment\n8. PS score ≤2\n\nExclusion Criteria:\n\n1. Presence of distant metastasis\n2. Women who are pregnant or lactating\n3. Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons\n4. Receiving investigational treatment in addition to other clinical studies (in the treatment phase of a clinical study)\n5. Accompanied by severe uncontrolled infection or medical illness\n6. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate NACI or surgical treatment\n7. There are factors affecting surgery or anesthesia, such as severe organ dysfunction\n8. Long-term use of immunosuppressive agents after organ transplantation\n9. Patients with a history of other malignant tumors before enrollment","80 Years",{"count":70,"type":20},35,"2 Years","OBSERVATIONAL","A prospective collection of 35 cases was conducted at Zhujiang Hospital of Southern Medical University. Patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC) from April 2023 onward, who received two cycles of neoadjuvant immunochemotherapy (tislelizumab + paclitaxel + cisplatin\u002Fcarboplatin) at our institution, were included. The study analyzed treatment safety, efficacy, tumor regression patterns, 2-year progression-free survival (PFS), and 5-year overall survival (OS) rates.",[75,33],"Oral Squamous Cell Carcinoma (OSCC)",[77,78,79],"Oral squamous cell carcinoma","Oropharyngeal squamous cell carcinoma","neoadjuvant immunochemotherapy","RECRUITING","2025-08-14",{"date":83,"type":53},"2025-08-21",{"date":85,"type":53},"2023-07-11",{"date":87,"type":20},"2027-12-31",{"name":89,"class":60},"Zhujiang Hospital",1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":90},"100582315","phase-2-chemoimmunotherapy-with-or-without-sbrt-before-surgery-for-locally-advanced-oral-and-oropharyngeal-cancer-100582315","NCT06861712","Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer","Neoadjuvant Chemoimmunotherapy With or Without SBRT Followed by Surgery for Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: A Phase II Randomized Trial","Inclusion Criteria:\n\n1. Oral\u002Foropharyngeal squamous cell carcinoma confirmed by histology and\u002For cytology.\n2. Clinical stage: resectable oral\u002Foropharyngeal squamous cell carcinoma stage III-IVa (AJCC 8th edition)\n3. Age: 18-65 years old.\n4. According to the Eastern Cooperative Oncology Group (ECOG) criteria (performance status score of 0 or 1).\n5. Good organ function:\n\n   A. Hematology: WBC ≥ 4000\u002FμL, neutrophil ≥ 2.000\u002FμL, hemoglobin ≥ 9g\u002FdL, platelet ≥ 100000\u002FμL; B. Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 times ULN can be included), AST and ALT ≤ 3 times, and alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3g\u002FdL; C. International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times; D. Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60mL\u002Fmin according to the Cockcroft-Gault formula.\n6. Expected survival ≥ 3 months.\n7. The patient has signed an informed consent form and is willing and able to comply with the study visits, treatment plans, laboratory tests and other study procedures.\n8. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment and must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose (including chemotherapy drugs and Teplizumab).\n9. If the female partner of the male subject is still of childbearing potential, the male subject must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors.\n2. Patients with known or suspected autoimmune diseases, including dementia and epilepsy.\n3. Patients with severe mental illness.\n4. Patients with necrotic lesions and who are assessed by the researchers to be at risk of major bleeding.\n5. Patients with severe heart disease, pulmonary dysfunction, heart function and pulmonary function below grade 3 (including grade 3).\n6. Patients whose laboratory test values do not meet the relevant standards within 7 days before enrollment.\n7. Patients who have received systemic or local glucocorticoid treatment within 4 weeks before enrollment.\n8. Patients with complications that require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects.\n9. Patients with active pulmonary tuberculosis (TB) who are currently receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.\n10. Previous use of anti-toripalimab, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway).\n11. Subjects with any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood and no need for any intervention as adults can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included).\n12. HIV positive.\n13. HBsAg positive and HBVDNA copy number positive (quantitative detection ≥1000cps\u002Fml); positive blood screening for chronic hepatitis C (HCV antibody positive).\n14. Any anti-infection vaccine (such as influenza vaccine, varicella vaccine, etc.) received within 4 weeks before enrollment.\n15. Women of childbearing age with positive pregnancy test and breastfeeding women.","65 Years",{"count":100,"type":20},50,[23],"In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy\\*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.",[75,33,104],"Stereotactic Body Radiation Therapy (SBRT)",[75,33,104,106,107],"Toripalimab","Phase II Clinical Trial","2025-04-22",{"date":110,"type":53},"2025-04-25",{"date":112,"type":20},"2025-05-06",{"date":114,"type":20},"2026-12-31",{"name":116,"class":60},"Sun Yat-sen University",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":4},"100574428","phase-2-phase-ii-clinical-trial-of-de-intensified-therapy-in-human-papilloma-virus-hpv-associated-oropharyngeal-squamous-cell-carcinoma-100574428","NCT06759155","Phase II Clinical Trial of De-Intensified Therapy in Human Papilloma Virus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically confirmed or suspected HPV associated squamous cell carcinoma of the oropharynx.\n* p16 immunohistochemistry is the surrogate marker for HPV positivity and will be scored as positive if there is strong and diffuse nuclear and cytoplasmic staining present in greater than 70% of the tumor specimen. (A negative result excludes the patient from the trial)\n* In the case of equivocal p16, High Risk HPV (HR HPV), In-Situ Hybridization (ISH) \u002F Polymerase Chain Reaction (PCR) may be performed to determine HPV positivity\n* AJCC TNM 7th edition stage T1-T3, N0-N2b (or AJCC TNM 8th edition stage T1-T3 N0-N1) disease.\n* Staging will be based on cross sectional imaging investigations and clinical exam.\n* Patients who initially have an unknown primary but subsequently have a primary site identified on pathology after surgical resection may be included in the study.\n* Multidisciplinary team decision to treat with primary transoral resection and neck dissection.\n* Patients considered fit for surgery and adjuvant therapy.\n* Aged 18 or over.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* HPV negative squamous cell carcinomas of the head and neck\n* T4 and\u002For T1-T3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins.\n* AJCC TNM 7th edition N2c-N3 nodal disease (or AJCC TNM 8th edition N2-N3 nodal disease) or high likelihood of gross extranodal extension.\n* Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.\n* Distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or PET CT.\n* Women who are pregnant or breastfeeding\n* Prior history of radiation to head and neck",{"count":124,"type":20},20,[23],"HPV-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) is a type of cancer that affects parts of the throat, like the tonsils and the base of the tongue. The treatments for OPSCC, which may include surgery, radiation, and chemotherapy, often cause serious side effects, such as loss of taste, dry mouth, and long-term problems with swallowing. These side effects can lower patients' quality of life and make it difficult for them to eat and speak normally.\n\nThis study aims to explore whether using lower doses of radiation after surgery can help improve long-term swallowing function in patients with HPV-positive OPSCC. By doing this, the study team hopes to reduce treatment-related side effects while maintaining good cancer control.",[128,33,129],"OPSCC","HPV Associated Cancers",[131,132],"radiation","de-intensify","2024-12-27",{"date":135,"type":53},"2025-01-06",{"date":137,"type":20},"2025-01",{"date":139,"type":20},"2030-01",{"name":141,"class":60},"University of Vermont Medical Center",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":90},"100572080","phase-2-preoperative-tislelizumab--cetuximab---chemotherapy-followed-by-salvage-surgery-and-adjuvant-tislelizumab--cetuximab-for-resectable-locally-recurrent-oral-and-oropharyngeal-squamous-cell-carcinoma-100572080","NCT06728618","Preoperative Tislelizumab -Cetuximab - Chemotherapy Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma","A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Tislelizumab -Cetuximab - TP(cisplatin and Albumin-paclitaxel) Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma","OSCC","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed locoregionally recurrent oral\u002Foropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils).\n2. Participants must have documented time of ≥ 16 weeks from completion of prior curative intent treatment for OSCC (surgery and\u002For radiation therapy with\u002Fwithout platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence.\n3. Age ranges from 18 to 75 years old\n4. ECOG performance status 0 or 1.\n5. Expected survival ≥ 12 weeks.\n6. The participants are clinically evaluated to be eligible for salvage surgery and must be intended to undergo salvage surgery.\n7. There must be at least one clinically assessable lesion according to the RECIST V1.1 criteria prior to treatment.\n8. The participants may have any human papillomavirus (HPV) status of the tumor. Patients with oropharyngeal cancer need to undergo HPV testing, including p16 immunohistochemistry and\u002For confirmatory HPV polymerase chain reaction (PCR) or in situ hybridization (ISH) testing.\n9. 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, and continue contraception for 12 months after the end of treatment. 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.\n10. Participants must have adequate organ and marrow function as defined below: The function of important organs meets the following requirements: (1) normal bone marrow reserve function, white blood cell (WBC) ≥ 3.0 × 10 \\^ 9\u002FL; Neutrophil count (NEUT) ≥ 1.5 × 10 \\^ 9\u002FL, platelet count (PLT) ≥ 100 × 10 \\^ 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; (2) Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml\u002Fmin (Cockcroft Gault formula); (3) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); AST or ALT levels ≤ 3 times the upper limit of normal (ULN); (4) Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).\n11. The participants voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Has known distant metastasis of the disease.\n2. Has received chemotherapy or radiotherapy for curative treatment of oral\u002Foropharyngeal squamous cell carcinoma within the 16 weeks prior to enrollment in the study.\n3. Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).\n4. Has received live or attenuated vaccines within 30 days prior to the first dose of Tislelizumab, inactivated vaccines are allowed.\n5. Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg\u002Fday of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.\n6. Has an active infection that requires systematic treatment; Has a history of non -infectious pneumonia\u002Finterstitial lung disease requiring steroid treatment, or current pneumonia\u002Finterstitial lung disease; Has a known history of hepatitis B (defined as positive for hepatitis B surface antigen \\[HBsAg\\]) or known history of active hepatitis C virus (defined as detection of HCV RNA \\[qualitative\\]) infection; Has a known history of human immunodeficiency virus (HIV) infection.\n7. Has received allogeneic tissue\u002Fsolid organ transplantation.\n8. Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia.\n9. Has obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, and heart disease grade 2 or above diagnosed according to the New York Heart Association (NYHA) classification criteria within 3 months prior to the enrollment)。\n10. Has severe clinical infection (\\>NCI-CTCAE 5.0 Level 2 infection);\n11. Has uncontrollable hypertension (systolic blood pressure\\>150mmHg and\u002For diastolic blood pressure\\>90mmHg after treatment with antihypertensive drugs) or clinically significant cardiovascular diseases - such as cerebrovascular accidents (≤ 6 months before enrollment), myocardial infarction (≤ 6 months before enrollment), unstable angina, congestive heart failure classified as Grade II or above by the New York Heart Association (NYHA), or severe arrhythmias that cannot be controlled with medication or have potential impact on experimental treatment.\n12. Pregnant women are not allowed to participate. Breast-feeding women who participate in this study should stop breast-feeding.\n13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n14. Has participated in other clinical studies within 30 days prior to enrollment.\n15. Other situations that researchers consider unsuitable for participation in the study.","75 Years",{"count":152,"type":20},28,[23],"The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral\u002Fpharyngeal squamous cell carcinoma. The combination of Tislelizumab，Cetuximab, Cisplatin and Nab-paclitaxel will be given prior to your surgery, while Tislelizumab and Cetuximab will be continued for approximately half a year after surgery.",[75,33,156,157],"Resectable Oral and Oropharyngeal Squamous Cell Carcinoma","Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma","2024-12-08",{"date":160,"type":53},"2024-12-11",{"date":162,"type":20},"2024-12",{"date":164,"type":20},"2028-03",{"name":166,"class":60},"Shanghai Zhongshan Hospital",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":90},"100561395","phase-1-phase-1-clinical-trial-of-flubhpve6e7-immunotherapy-for-hpv16-associated-oropharyngeal-cancer-100561395","NCT06589609","Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer","A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma","Inclusion criteria:\n\n* Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma with locoregional advanced disease including the following stages:\n\n  * T2N2-3, M0\n  * T3N0-3, M0\n  * T4N0-3, M0\n* Primary tumour accessible for biopsy and intratumoural administration\n* No evidence of distant metastatic disease (HPV16-positive secondary tumours are permissible)\n* Karnofsky 100 - 70 (ECOG 0 or 1)\n* Life expectancy of at least 6 months\n* Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator\n* Women of childbearing potential: Negative serum pregnancy test at screening\n* Agree to use a reliable form of contraception until the end of the study treatment period.\n* Provides written informed consent\n\nExclusion criteria:\n\n* Distant metastases\n* Secondary, not HPV16-associated, malignancy\n* History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period\n* Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease\n* Any vaccination within 1 week before day 0\n* Active significant viral infections including influenza, CMV, and EBV within 4 weeks before receiving study treatment\n* Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states\n* Influenza-like illness (ILI) within 4 weeks before day 0\n* Known hypersensitivity to Tamiflu or any of its components\n* Pregnancy, breastfeeding\n* Serious, concomitant disorder, including active systemic infection requiring treatment\n* Proven or suspected systemic lupus erythematosus, thyroiditis, inflammatory bowel disease including Crohn's disease or multiple sclerosis\n* Immunosuppression including any concurrent condition requiring the continued use of systemic steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate), and biologic disease modifying drugs such as TNF-α inhibitors (e.g. infliximab, adalimumab or etanercept). Corticosteroids must be discontinued \\> 4 weeks prior to day 0 of study medication administration. Eye drops or ear drops containing corticosteroids are permissible.\n* Prior major surgery within 4 weeks before day 0\n* Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease (e.g. chronic renal failure; angina, myocardial ischemia or infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias)\n* Participation in another experimental protocol\u002Fuse of investigational drug within two months before day 0\n* Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives\n* Unability to comply with the protocol requirements",{"count":175,"type":20},12,[177],"PHASE1","A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus",[33],[181,182,183,184,185,186],"immunotherapy","Oropharyngal squamous cell carcinoma","HPV-16","Human papilloma virus","cancer","Head and neck cancer","2024-09-06",{"date":189,"type":53},"2024-09-19",{"date":191,"type":53},"2024-08-23",{"date":193,"type":20},"2029-11",{"name":195,"class":196},"BlueSky Immunotherapies GmbH","INDUSTRY"]