[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head--neck-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head--neck-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,43,79,89,117,145,166,192,217,241,264,285,308,330,356,376,414,450,474,494,519,542],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054145","phase-3-a-clinical-study-to-compare-bupizenge-with-lidocaine-for-pain-due-to-oral-mucositis-in-patients-with-head-and-neck-cancer-100054145",false,"NCT07672236","A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.","A Randomized, Open-label, Phase III Trial to Assess the Efficacy and Safety of BupiZenge Compared to Lidocaine for Pain Associated With Oral Mucositis in Head and Neck Cancer","BEAM-Pain","Inclusion Criteria:\n\n* Participant must provide signed written informed consent prior to trial participation and must be willing and able to comply with all requirements and restrictions of the trial.\n* Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing.\n* Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.\n* About to start IMRT with curative intent with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative intended dose of at least 60 Gy and a maximum of 72 Gy. Proton therapy given at equivalent biological doses is allowed.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n* Female participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive measure or practice total sexual abstinence from the time of giving informed consent until at least 24 hours after last dose of IMP.\n\nExclusion Criteria:\n\n* Participation in another investigational interventional clinical trial within 3 months prior to first dosing, or for a longer period if required by local regulations, or within 5 half-lives of the investigational agent taken (whichever is longer). An exception is studies where patients are randomized to different radiotherapy settings, e.g. participation in DAHANCA 35 is allowed.\n* Previous radiation therapy to the head and\u002For neck area.\n* Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.\n* Receiving high-dose (\\> 15 mg per day prednisolone), corticosteroids (for any indication).\n* Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.\n* Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).\n* Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy \\[PEG\\] or nasogastric tube) for any reason.\n* Moderate\u002Fsevere liver or kidney disease defined as:\n\n  1. AST\u002FALT \\> 3 × upper limit of normal (ULN) or bilirubin \\> 1.5 × ULN (unless related to Gilbert's syndrome)\n  2. glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Known diagnosis of epilepsy.\n* Known phenylketonuria (PKU).\n* Pregnancy or breastfeeding.\n* Any condition or circumstance-based on the investigator's assessment-that could increase risk to the participant, confound trial results, or interfere with compliance \u002F participation (including inability or unwillingness to follow trial procedures, or any clinically significant physical or psychiatric condition).","ALL","18 Years","80 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief.\n\nBupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth.\n\nThis study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids.\n\nThe main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy.\n\nThe study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth.\n\nThe study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine.\n\nTreatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.",[28,29],"Head & Neck Cancer","Oral Mucositis","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-07-07",{"date":38,"type":22},"2027-01-31",{"name":40,"class":41},"OncoZenge AB","INDUSTRY",11,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100644619","integrated-early-care-for-head--neck-cancer-100644619","NCT07671573","Integrated Early-CARE for Head & Neck Cancer.","Randomized Multicenter Clinical Trial of Early Integration of Palliative Care With Chemoradiotherapy Versus Chemoradiotherapy Alone in Patients With Locally Advanced Unresectable Head and Neck Cancer.","i-CARE-HN","Inclusion Criteria:\n\nEach patient must fulfil all of the following criteria:\n\n1. Diagnosis of locally advanced (unresectable) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, and hypopharynx, staged according to the TNM AJCC 8th edition, proposed at a multidisciplinary team (MDT) meeting for definitive chemoradiotherapy (CRT) on an outpatient basis;\n2. Age ≥18 years;\n3. ECOG performance status 0-2;\n4. Adequate organ function: haemoglobin ≥9 g\u002FdL; neutrophils ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; creatinine ≤1.5×ULN; bilirubin, AST, ALT, LDH ≤1.5×ULN;\n5. Signed informed consent by the participant.\n\nExclusion Criteria:\n\nEach patient will be excluded if they meet any of the following criteria:\n\n1. ECOG performance status 3-4;\n2. Previous follow-up by specialised palliative care;\n3. Primary tumours of the nasopharynx, oesophagus, lip, or salivary glands;\n4. Metastatic head and neck cancer (oral cavity, oropharynx, larynx, and hypopharynx);\n5. Severe comorbidities: decompensated cardiovascular disease (NYHA class III\u002FIV heart failure, recent myocardial infarction), severe COPD (FEV₁ \\\u003C50% predicted), renal insufficiency (eGFR \\\u003C30 mL\u002Fmin), hepatic insufficiency (Child-Pugh B\u002FC);\n6. Laboratory values: neutrophils \\\u003C1.5×10⁹\u002FL, platelets \\\u003C100×10⁹\u002FL, haemoglobin \\\u003C9 g\u002FdL, creatinine \\>1.5×ULN;\n7. Diagnosis of dementia;\n8. Participation in another clinical trial.",{"count":52,"type":22},64,[54],"NA","In Portugal, approximately 2,424 new cases of head and neck cancer are diagnosed each year, of which 60% are already at an advanced stage, presenting with intense pain and dysphagia (difficulty swallowing). There is also marked social isolation due to communication difficulties, economic hardship, and facial disfigurement (altered facial appearance). As a result, patients frequently face challenges in accessing specialised palliative care services, encountering delays, fragmentation, or a complete absence of such care.\n\nThe i-CARE-HN study is the solution: investigators aim to integrate outpatient palliative care with oncological treatment -namely chemoradiotherapy -at an earlier stage of the disease-when it is still limited to the throat and neck region, without metastasis (spread to other organs). This means multidisciplinary support from the outset of oncological treatment - symptom control, psychological support, and quality of life - without delaying the cure. It is like giving the patient a 'shield' against suffering, enabling them to complete treatment more efficiently.\n\nIn the i-CARE-HN study, early palliative care aims to better manage patients' symptoms (such as pain, difficulty speaking, swallowing, breathing, dry mouth, loss of appetite, and anxiety), to clarify doubts, to support therapeutic decisions, and to strengthen communication between the patient and the team, without replacing the primary oncological treatment. Rather than waiting for symptoms to worsen before seeking help, this support will be provided throughout treatment with chemotherapy and radiotherapy. Through this simultaneous integration of outpatient palliative care into oncological treatment, investigators hope to improve patients' symptoms and quality of life, as well as clinical outcomes: fewer treatment interruptions, improved treatment tolerability, fewer emergency hospitalisations, and greater overall survival. Investigators will want to know how patients are feeling throughout the process, and to that end, will invite them to complete a survey at several points during the study. Responses to the questionnaires are critical to enabling the medical team to rapidly identify which participating patients present with the most significant symptoms and the greatest risk of complications.\n\nThis study plans to recruit 64 patients aged 18 years or older, with a recent diagnosis of locally advanced, inoperable cancer, being followed on an outpatient basis at the IPO de Coimbra, IPO do Porto, and ULS de Coimbra, who will be invited to participate in the study. Should the patient agree to participate, some baseline data will be collected, and patients will subsequently be randomly assigned to one of two groups: one group will receive isolated chemoradiotherapy (standard treatment: cisplatin 100 mg\u002Fm² every 3 weeks- days 1, 22, and 49- and daily radiotherapy 70 Gy in 35 fractions over 7 weeks) and the other group will receive chemoradiotherapy alongside palliative care, on an outpatient basis (access to palliative care consultations). Patients randomised to the standard treatment group (chemoradiotherapy without a structured early palliative care intervention) will not have palliative care appointments systematically scheduled. However, should a referral to palliative care be requested, the patient may be directed to that clinical department.",[28,57,58],"Locally Advanced Head and Neck Cancer","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)",[60,61,62,63,64,65,66],"chemoradiotherapy","Cancer","Palliative care","Locally advanced Head and neck cancer","Squamous Cell Carcinoma of the Head and Neck","Edmonton Symptom Assessment System (ESAS)","Head and neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-25",{"date":70,"type":34},"2026-06-26",{"date":72,"type":22},"2026-10-01",{"date":74,"type":22},"2028-03-31",{"name":76,"class":77},"Portuguese Oncology Institute, Coimbra","OTHER",1,{"id":80,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":26,"conditions":83,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":88,"locationsCount":42},"100644515",{"count":21,"type":22},[25],[28,29],"2026-06-23",{"date":70,"type":34},{"date":68,"type":22},{"date":38,"type":22},{"name":40,"class":41},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":78},"100643752","reproton-hn-prospective-observational-study-on-proton-re-irradiation-for-locoregional-recurrences-of-head-and-neck-tumors-100643752","NCT07635641","REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors","REPROton-HN","Inclusion Criteria:\n\n* ≥ 18 years old\n* ECOG 0-2\n* Pathologically and or radiologically confirmed head and neck cancer recurrence\n* Indication for proton therapy\n* Written informed consent for REPRO-HN according to applicable legal and ethical requirements by the end of radiotherapy treatment\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* ECOG\\>3\n* Life expectancy \\\u003C 3 months\n* Inability to provide informed consent",{"count":97,"type":22},50,"OBSERVATIONAL","Some patients with head and neck cancer may develop a tumor recurrence in an area that has already been treated with radiotherapy. In these situations, surgery is not always possible, and giving radiotherapy again can be challenging because nearby healthy tissues and organs may already have received high radiation doses.\n\nThe REPROton-HN study is evaluating the use of proton therapy for these patients. Proton therapy is a type of radiation treatment that can deliver radiation more precisely to the tumor while reducing exposure to surrounding healthy tissues.\n\nThe aim of the study is to better understand how safe and effective proton therapy is when used as a second course of radiation treatment. Researchers will monitor side effects, tumor control, survival, and patients' quality of life. The results may help improve treatment planning and identify which patients are most likely to benefit from proton therapy in the future.",[28],[102,103,104,105,106,107],"head&neck cancer","re-irradiation","proton-therapy","protontherapy","radiotherapy","cancer","2026-06-03",{"date":110,"type":34},"2026-06-09",{"date":112,"type":34},"2026-05-29",{"date":114,"type":22},"2036-05",{"name":116,"class":77},"Istituto Clinico Humanitas",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":78},"100638659","phase-1-intratumoral-injection-of-recombinant-human-endostatin-adenovirus-eds01-for-the-treatment-of-recurrent-or-metastatic-head-and-neck-tumors-100638659","NCT07625423","Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors","A Phase I Clinical Trial of Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) Combined With Toripalimab for the Treatment of Recurrent or Metastatic Head and Neck Tumors","EDS01 HN","Inclusion Criteria:\n\nAdults aged 18 to 65 years. Histologically or cytologically confirmed recurrent or metastatic head and neck tumor.\n\nPreviously received at least 1 standard platinum-based systemic chemotherapy regimen for recurrent\u002Fmetastatic disease, or had platinum-insensitive or platinum-intolerant disease after prior curative-intent treatment.\n\nNot suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus injection.\n\nAt least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1.\n\nNo chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment.\n\nEstimated life expectancy of at least 12 weeks. ECOG performance status 0 to 1. Male or female participants of childbearing potential must agree to use reliable contraception during treatment and for at least 6 months after treatment.\n\nRecovery of prior treatment-related toxicities to NCI CTCAE grade 1 or baseline, with screening laboratory results within 1 week before enrollment meeting protocol requirements: ANC ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, total bilirubin ≤1.5 × ULN, ALT and AST ≤2 × ULN, and coagulation parameters ≤1.25 × ULN.\n\nWilling and able to provide written informed consent.\n\nExclusion Criteria:\n\nKnown allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection.\n\nReceiving radiotherapy to the study lesion at the same time. Prior anti-angiogenic therapy. Receiving immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes at a dose greater than prednisone 10 mg\u002Fday (or equivalent) within 2 weeks before enrollment.\n\nActive autoimmune disease or history of autoimmune disease. Congenital or acquired immunodeficiency. Risk of major nasopharyngeal hemorrhage or deep nasopharyngeal ulceration. Severe coagulation disorder or bleeding tendency. Severe uncontrolled medical disease or myocardial infarction within 3 months before enrollment.\n\nAcute infection. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","65 Years",{"count":127,"type":22},9,[129],"PHASE1","This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, whose disease has progressed after platinum-based systemic therapy or who are not suitable for further platinum treatment.\n\nA total of 9 participants will be enrolled in 3 planned dose groups of EDS01. EDS01 will be injected directly into an accessible tumor lesion on Days 0 and 7, and toripalimab 240 mg will be administered intravenously on Day 1 of each treatment cycle for up to 4 cycles, unless disease progression or unacceptable toxicity occurs. The study will evaluate treatment-related adverse events as well as preliminary efficacy outcomes, including tumor response, disease control, and time to progression, using clinical assessments, laboratory tests, imaging, and follow-up after treatment.",[28,132],"Nasopharyngeal Cancinoma (NPC)",[134,135,136],"head and neck cancer","nasopharyngeal cancer","recombinant human endostatin adenovirus",{"date":138,"type":34},"2026-06-04",{"date":140,"type":34},"2026-03-27",{"date":142,"type":22},"2028-03-30",{"name":144,"class":77},"West China Hospital",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":78},"100640187","specialist-nurse-led-nursing-management-for-patients-undergoing-head-and-neck-cancer-surgery-100640187","NCT07622381","Specialist Nurse-Led Nursing Management for Patients Undergoing Head and Neck Cancer Surgery","Development and Evaluation of a Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management Model for Patients Undergoing Head and Neck Cancer Surgery: A Prospective Controlled Study","Inclusion Criteria:\n\n* Patients diagnosed with head and neck cancer according to the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Head and Neck Tumors (2023)\n* Patients scheduled to undergo head and neck cancer surgery\n* Age \\>18 years\n* Patients who fully understand the study and voluntarily agree to participate\n\nExclusion Criteria:\n\n* Patients with severe cardiovascular diseases, uncontrolled infections, or other diseases or complications that could affect study participation\n* Patients with an estimated survival time of less than 6 months based on tumor stage and overall health status","70 Years",{"count":154,"type":22},80,[54],"The goal of this clinical trial is to evaluate the effectiveness of a multidisciplinary specialist nurse-led perioperative nursing management model for patients undergoing head and neck cancer surgery. The study aims to improve perioperative recovery, reduce postoperative complications, and enhance the quality of nursing care for patients with head and neck cancer.\n\nThe main questions it aims to answer are:\n\nDoes the multidisciplinary specialist nurse-led nursing management model reduce the incidence of postoperative complications in patients undergoing head and neck cancer surgery? Does the intervention improve nutritional indicators, quality of life, and nursing satisfaction compared with routine perioperative nursing care? Does the intervention reduce length of hospital stay and hospitalization costs?\n\nResearchers will compare patients receiving the multidisciplinary specialist nurse-led perioperative nursing management model with patients receiving routine perioperative nursing care to evaluate the effectiveness of the intervention.\n\nParticipants will:\n\nReceive either routine perioperative nursing care or the multidisciplinary specialist nurse-led nursing management intervention during hospitalization Undergo comprehensive perioperative assessments, including nutritional status, risk of pulmonary complications, swallowing function, voice function, oral health status, and psychological condition Receive individualized multidisciplinary rehabilitation and nursing interventions developed collaboratively by specialist nurses, physicians, dietitians, and psychological counselors Participate in perioperative rehabilitation, health education, and continuous follow-up management during hospitalization Complete assessments of quality of life and nursing satisfaction during the perioperative period",[28],"2026-06-02",{"date":108,"type":34},{"date":161,"type":34},"2025-11-24",{"date":163,"type":22},"2026-09-30",{"name":165,"class":77},"Tianjin Medical University Cancer Institute and Hospital",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":78},"100638524","phase-2-nimotuzumab-combined-with-pd-1-inhibitors-and-chemotherapy-in-the-treatment-of-locally-advanced-head-and-neck-squamous-cell-carcinoma-100638524","NCT07601737","Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age 18 to 75 years inclusive.\n2. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition.\n3. Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. For oropharyngeal carcinoma: mandatory p16 immunohistochemistry (testing within standard of care is acceptable; repeat testing not required). p16 testing is not required for other tumor locations.\n6. Availability of tumor tissue (archived or newly obtained) for PD-L1 testing (prior testing is acceptable; repeat testing not required).\n7. At least one measurable lesion per RECIST 1.1.\n8. Life expectancy ≥ 6 months.\n9. Adequate hematologic function:\n\n   White blood cell count ≥ 4.0 × 10⁹\u002FL Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL\n10. Adequate renal function:\n\n    Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR\n\n    Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin calculated by Cockcroft-Gault formula:\n\n    Female: CrCl (mL\u002Fmin) = (140 - age) × body weight (kg) × 0.85 \u002F (72 × serum creatinine (mg\u002FdL)) Male: CrCl (mL\u002Fmin) = (140 - age) × body weight (kg) × 1.00 \u002F (72 × serum creatinine (mg\u002FdL))\n11. Adequate hepatic function:\n\n    Total bilirubin ≤ 1.5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n12. Female subjects: negative pregnancy test within 2 weeks before first study drug, non-lactating.\n\n    Females: highly effective contraception required during study and for 6 months after last study drug.\n\n    Males: highly effective contraception required during study and for 6 months after last study drug.\n13. Written informed consent obtained prior to any study-specific procedures, and willingness to comply with all study visits and protocol requirements.\n\nExclusion Criteria:\n\n1. Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment.\n2. Participation in another interventional clinical trial within 30 days prior to screening.\n3. In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol.\n4. Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection.\n5. History of other malignancy within the past 5 years (except cured basal cell carcinoma of the skin).\n6. History of primary immunodeficiency disease.\n7. Presence of uncontrolled comorbidities, including heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders, etc.\n8. Known HIV infection, active viral hepatitis, or active tuberculosis.\n9. Underwent major surgery within 90 days prior to the first study drug, or planning major surgery unrelated to this cancer treatment.\n10. Hypersensitivity to any study drug or their components.\n11. Pregnant (confirmed by serum or urine HCG test) or lactating woman; or subject of childbearing potential unwilling or unable to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment (applicable to both males and females).\n12. Investigator considers the subject not suitable for study participation.\n13. Unwilling to participate or unable to provide written informed consent.\n14. Receipt of a live vaccine within 30 days before the first study drug administration.","75 Years",{"count":175,"type":22},182,[177],"PHASE2","This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.",[180,181,28,182],"Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma (HNSCC)","Neoadjuvant Therapy","2026-05-15",{"date":185,"type":34},"2026-05-22",{"date":187,"type":34},"2026-04-20",{"date":189,"type":22},"2030-04-30",{"name":191,"class":77},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":78},"100636031","feasibility-study-on-the-implementation-of-a-supervised-home-based-adapted-physical-activity-program-for-patients-with-head-and-neck-cancer-100636031","NCT07560397","Feasibility Study on the Implementation of a Supervised, Home-based Adapted Physical Activity Program for Patients With Head and Neck Cancer","Feasibility Study on the Implementation of a Supervised, Home-based Adapted Physical Activity Program During the Preoperative Phase for Patients With Head and Neck Cancer","PREPACHIR ORL","Inclusion Criteria:\n\n* surgery requiring the placement of a covering flap)\n* Medical prescription of adapted physical activity\n* A period of more than 2 weeks between the announcement of surgery and the surgery itself\n\nExclusion Criteria:\n\n* Absolute contraindications to physical activity\n* Pregnant or breastfeeding women\n* Patients who, for any reason, are unable to understand the study or comply with the trial requirements (language, psychological, or geographical barriers, etc.)",{"count":201,"type":22},66,[54],"Head and neck cancers are the seventh most common type of cancer worldwide. The standard of care is surgical removal of the tumor, often accompanied by simultaneous reconstruction of the affected structures.\n\nEnhanced post-surgical rehabilitation programs are offered to promote early recovery of functional abilities; they are applicable to all patients and all surgical specialties. Studies have shown a very significant benefit of physical activity prior to surgery in the context of cancers of the digestive or thoracic systems. Multimodal programs that incorporate nutritional and psychosocial factors and include physical exercise have been shown to improve postoperative mobility and physical activity levels in patients with colorectal, gastrointestinal, lung, and prostate cancers.\n\nOur hypothesis is based on the premise that implementing an exercise program during the preoperative period could promote a return to optimal functional capacity, reduce the incidence of postoperative pulmonary complications, and lower overall morbidity. Furthermore, we believe that the proposed support would encourage greater patient involvement in their care journey starting in the preoperative period and raise their awareness of the importance of postoperative mobilization. Early patient involvement would thus help develop their sense of self-efficacy and promote behavioral change toward a more active lifestyle suited to their health status. Consequently, maintaining physical activity after surgery and in the post-cancer period-recognized as a factor in secondary and tertiary prevention-would be encouraged.",[28],[206,207],"Physical activity program","home-based","2026-04-24",{"date":210,"type":34},"2026-05-01",{"date":212,"type":22},"2026-06-01",{"date":214,"type":22},"2028-10-01",{"name":216,"class":77},"Centre Henri Becquerel",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100634324","phase-1-vebectotamab-vedotin-combined-with-pucotelimab-in-the-treatment-of-locally-advanced-laryngeal-carcinoma-100634324","NCT07538206","Vebectotamab Vedotin Combined With Pucotelimab in the Treatment of Locally Advanced Laryngeal Carcinoma","An Exploratory Study of Neoadjuvant Vibecortamab Combined With Putilimab in Locally Advanced Laryngeal Cancer - A Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Aged 18 to 80 years old (inclusive of 18 and 80 years), of either gender.\n2. Histopathologically or cytologically confirmed, and diagnosed as resectable locally advanced laryngeal carcinoma by MRI imaging.3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.4. Male subjects are eligible if they agree to comply with the following standards during treatment and for at least 180 days after the last cycle of chemotherapy:a) Prohibition of sperm donation;AND• Abstain from heterosexual intercourse as a usual and preferred lifestyle (long-term and persistent abstinence) and agree to maintain abstinence;OR• Agree to use contraceptive measures unless confirmed as azoospermic (vasectomy or secondary to medical reasons, see Appendix 5), with details as follows:→ Use a male condom during penile-vaginal intercourse with a reproductive-aged female partner who is not currently pregnant, and the partner uses an additional contraceptive method.Note: Males whose partners are pregnant or breastfeeding must agree to either maintain abstinence from penile-vaginal intercourse at all times or use a male condom for every penile-vaginal penetration.b) Male subjects must also agree to use a male condom during any activity that allows ejaculation with others of any gender.c) Contraceptive methods used by males must comply with regulations regarding contraception in clinical research participation.5.Female subjects are eligible if they are not pregnant or breastfeeding, and meet at least one of the following conditions:(1) Not a woman of childbearing potential (WOCBP);OR(2) If a WOCBP, use a highly effective contraceptive method (annual failure rate \\\u003C1%) with low user dependence, or abstain from heterosexual intercourse as a preferred and regular lifestyle (long-term and persistent abstinence) during the intervention period and for at least 210 days after the last cycle of chemotherapy, and agree not to donate ova (eggs, oocytes) to others or freeze\u002Fstore ova for personal reproductive purposes during this period. Investigators shall evaluate the likelihood of contraceptive method failure (i.e., non-compliance, recent initiation) relative to the first administration of study treatment.a) WOCBP must have a negative result on a highly sensitive urine or serum pregnancy test (urine or serum test selected per regulatory requirements) within 24 hours (urine) or 72 hours (serum) before the first administration of study treatment to be enrolled.Note: If the interval between the screening pregnancy test and the first administration of study intervention exceeds 24 hours (urine) or 72 hours (serum), a repeat pregnancy test (urine or serum) must be performed, and the result must be negative for the subject to start receiving study medication.b) If a urine test is inconclusive (e.g., unclear result), a serum pregnancy test is required. In such cases, subjects with a positive serum pregnancy test result must be excluded.c) Investigators are responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of enrolling women with undetected early pregnancy.d) Contraceptive methods used by females must comply with regulations regarding contraception in clinical research participation;6.Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 within 3 days before the first administration of study intervention.7.Evidence of extranodal extension (ENE) in lymph nodes (confirmed by MRI, CT, or pathology).8.Voluntarily sign the written informed consent form for the study.9.Expected survival time ≥6 months.10.Adequate organ function as indicated by screening laboratory test results.a) Hematological parameters:White blood cell (WBC) count ≥4 × 10⁹\u002FL;Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;Platelet count ≥100 × 10⁹\u002FL;Hemoglobin (Hb) ≥90 g\u002FL;b) Renal function:Serum creatinine ≤1.5 × upper limit of normal (ULN), or creatinine clearance (CrCl) \\>60 mL\u002Fmin (calculated using the Cockcroft-Gault formula):Female: CrCl = \\[(140 - age) × body weight (kg) × 0.85\\] \u002F (72 × Scr \\[mg\u002FdL\\])Male: CrCl = \\[(140 - age) × body weight (kg) × 1.00\\] \u002F (72 × Scr \\[mg\u002FdL\\])c) Hepatic function:Serum total bilirubin ≤1.5 × ULN;Aspartate aminotransferase (AST) ≤2.5 × ULN;Alanine aminotransferase (ALT) ≤2.5 × ULN;d) Coagulation function:International Normalized Ratio (INR) ≤1.5;Prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.11.Good compliance and willingness to cooperate with follow-up procedures.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for advanced (metastatic) or unresectable (locally advanced) laryngeal cancer, except for permitted neoadjuvant\u002Fadjuvant therapy. Neoadjuvant\u002Fadjuvant therapy must have been completed at least 6 months before the diagnosis of advanced and\u002For unresectable disease. Subjects who received prior neoadjuvant\u002Fadjuvant therapy and had R2 pathology after tumor resection are excluded.\n2. Active autoimmune disease requiring systemic therapy (i.e., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic therapy and are permitted.3.Major surgery prior to the initiation of study intervention with inadequate recovery from surgery and\u002For surgical complications.4.Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).5.Prior treatment with EGFR-targeted agents.6.Anti-tumor therapy for advanced tonsillar cancer, including investigational drugs, within 4 weeks before enrollment.7.Unresolved adverse events (AEs) from prior anti-cancer therapy (i.e., AEs \\> Grade 1 or baseline). Subjects with neuropathy ≤ Grade 2 may be eligible based on investigator assessment.8.Radiotherapy within 2 weeks before the start of investigational treatment. Subjects must have recovered from all radiotherapy-related toxicities, be free of corticosteroid use, and have no history of radiation pneumonitis. A 1-week washout period is permitted for palliative radiotherapy (≤2 weeks of radiotherapy) for non-central nervous system (CNS) disease (if deemed safe by the investigator). A 2-week washout period is required for longer radiotherapy courses (\\>2 weeks).9.Administration of live vaccines within 30 days before the first dose of study drug.Note: Live vaccines include, but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines administered by injection are generally inactivated virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not permitted.10.Current or prior participation in a study of an investigational drug, or use of an investigational device within 4 weeks before the first dose of study drug.Note: Subjects who have entered the follow-up phase of an investigational study are eligible to participate in this study if at least 4 weeks have passed since the last dose of the prior investigational drug.11.Diagnosis of immunodeficiency or receipt of long-term systemic corticosteroid therapy (dose exceeding 10 mg prednisone equivalent per day) or any form of immunosuppressive therapy within 7 days before the first dose of study drug.12.History of another invasive malignancy that is progressive or required active treatment within the past 3 years.Note: Subjects with a history of skin basal cell carcinoma, skin squamous cell carcinoma, or carcinoma in situ (e.g., ductal carcinoma in situ of the breast, cervical carcinoma in situ) who have received potentially curative treatment are not excluded.13.Severe hypersensitivity reaction (\\> Grade 3) to toripalimab, nimotuzumab, albumin-bound paclitaxel, carboplatin, and\u002For any of their excipients.14.History of (non-infectious) pneumonitis requiring corticosteroid therapy, or current pneumonitis.15.Active infection requiring systemic therapy.16.Known history of human immunodeficiency virus (HIV) infection.17.Known active tuberculosis (TB; Mycobacterium tuberculosis).18.Severe, poorly controlled concurrent diseases (e.g., heart failure, diabetes mellitus, hypertension, liver failure, renal failure, thyroid disease, psychiatric illness, etc.).19.Major surgery within 30 days before the first dose of investigational drug or planned surgery during the study period.20.Inappropriate for study participation as assessed by the investigator.21.Unwillingness to participate in the study or inability to sign the informed consent form.22.Known history or any evidence of central nervous system (CNS) metastases and\u002For carcinomatous meningitis as assessed by the study site investigator.23.History or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results, prevent full participation in the study (e.g., hearing impairment), or that the investigator believes would not be in the subject's best interest to participate.24.Known psychiatric illness or substance abuse disorder that would interfere with the subject's ability to comply with study requirements.25.History of allogeneic tissue\u002Fsolid organ transplantation.",{"count":225,"type":22},10,[129,177],"This is a prospective, single-arm, Phase II clinical trial designed to evaluate the efficacy and safety of vibecotamab combined with putelimab in the treatment of locally advanced laryngeal carcinoma.",[28],[230,231,232],"neouAdjuvant","pathological complete response, pCR","vibecotamab combined","2026-04-15",{"date":187,"type":34},{"date":236,"type":22},"2026-04-23",{"date":238,"type":22},"2031-04-23",{"name":240,"class":77},"Tang-Du Hospital",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":78},"100627162","phase-3-postoperative-radiotherapy-combined-with-nimotuzumab-followed-by-benmelstobart-in-high-risk-patients-with-head-and-neck-squamous-cell-carcinoma-100627162","NCT07445048","Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age \\> 70 years;② Renal insufficiency (creatinine clearance \\\u003C 50 mL\u002Fmin; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy \\> Grade 1;⑥ Patient refusal of chemotherapy.\n3. Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative\u002Funrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.\n4. Underwent radical surgery with at least one high-risk feature:\n\n   Extracapsular extension (ECE) of lymph node metastasis; Close margin (\\\u003C 1 mm) or positive margin;\n   * 4 metastatic lymph nodes, or multiple perineural invasions.\n5. No evidence of distant metastasis on imaging.\n6. Sufficient tumor tissue available for EGFR and PD-L1 testing; for oropharyngeal cancer, HPV\u002Fp16 testing is required (testing may be waived if results are already available).\n7. Expected survival ≥ 6 months.\n8. ECOG performance status 0-1.\n9. Adequate hematologic function:\n\n   WBC ≥ 3 × 10⁹\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL.\n10. Adequate renal function:Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) \\> 50 mL\u002Fmin (calculated by Cockcroft-Gault formula):\n\n    Female: CrCl = (140 - Age) × Weight (kg) × 0.85 \u002F (72 × Scr (mg\u002FdL)) Male: CrCl = (140 - Age) × Weight (kg) × 1.00 \u002F (72 × Scr (mg\u002FdL))\n11. Adequate hepatic function:\n\n    Total bilirubin ≤ 1.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN.\n12. Women of childbearing potential: negative serum or urine pregnancy test within 14 days before enrollment, and agreement to use effective contraception during the study.Male subjects: use effective contraception from the start of treatment until 180 days after the last study drug administration.\n13. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.\n\nexclusion Criteria:\n\n1. Prior radiotherapy for head and neck cancer before enrollment.\n2. Prior treatment with similar immunological or targeted agents.\n3. Participation in another interventional clinical trial within 30 days prior to screening.\n4. Evidence of distant metastasis.\n5. History of other malignancy within the previous 5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized differentiated thyroid cancer (papillary \u002F follicular), localized prostate cancer, and ductal carcinoma in situ.\n6. Uncontrolled concurrent medical conditions (e.g., heart failure, diabetes mellitus, hypertension, thyroid disease, psychiatric disorders, etc.).\n7. Known HIV infection, active viral hepatitis, or active tuberculosis.\n8. Major surgical procedure within 30 days before the first dose of study medication, or planned major surgery during the study.\n9. Hypersensitivity to any study drug or their components.\n10. Pregnancy (confirmed by serum or urine HCG test) or lactating women; subjects of childbearing potential unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last study treatment.\n11. Subjects considered inappropriate for study participation by the investigator.\n12. Subjects unwilling to participate in the study or unable to provide written informed consent.",{"count":249,"type":22},370,[25],"A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy.\n\nThe primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.",[253,28,254],"Head & Neck Squamous Cell Carcinoma","Postoperative Adjuvant Treatment","2026-04-14",{"date":257,"type":34},"2026-04-17",{"date":259,"type":34},"2026-03-04",{"date":261,"type":22},"2031-03-05",{"name":263,"class":77},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":272,"targetDuration":4,"studyType":23,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":4},"100633813","protein-supplementation-for-radiation--induced-oral-mucositis-in-head-and-neck-cancer-patients-receiving-radiotherapy-100633813","NCT07531563","Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy","Effect of Oral Protein Hydrolysate Supplementation on Radiation-Induced Severe Oral Mucositis and Prealbumin Levels in Patients With Head and Neck Squamous Cell Carcinoma","C-Head-002","Inclusion Criteria:\n\n* Age 18-75 years\n* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx\n* No distant metastases (M0 stage)\n* Planned to receive curative or postoperative radiotherapy (with or without concurrent therapy) with a mean oral cavity dose ≥20 Gy\n* Adequate nutritional intake via oral or nasogastric route\n* Willingness to follow NCCN\u002FMASCC guidelines for oral care during radiotherapy\n* Signed written informed consent\n\nExclusion Criteria:\n\n* PG-SGA score ≥8 (indicating severe nutritional risk)\n* Use of non-guideline-recommended oral care during radiotherapy\n* Use of other protein supplementation products during radiotherapy\n* Known allergy to components of the study product\n* Acute or chronic renal insufficiency\n* Severe hepatic impairment\n* Congestive heart failure requiring fluid restriction\n* Gastrointestinal disorders affecting amino acid absorption (e.g., atrophic gastritis, bowel obstruction, inflammatory bowel disease)\n* Conditions increasing aspiration risk (e.g., abdominal compartment syndrome, gastric emptying disorders)\n* Inborn errors of amino acid metabolism\n* Cognitive impairment, psychiatric illness, or other factors affecting compliance or informed consent",{"count":273,"type":22},504,[54],"This clinical trial aims to evaluate whether oral supplementation with a hydrolyzed whey protein formula (\"TeYiShu\") can reduce the incidence of severe radiation-induced oral mucositis and improve prealbumin levels in patients undergoing radiotherapy for head and neck squamous cell carcinoma (HNSCC). The study will compare the protein supplement to an isocaloric placebo without protein, maintaining equal caloric intake across groups. Participants will receive either the protein supplement or placebo daily throughout the course of radiotherapy. The primary outcomes are the incidence of grade ≥3 oral mucositis, assessed using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria, and changes in serum prealbumin levels. Secondary outcomes include the time to onset and resolution of mucositis, nutritional status changes, adverse events, and quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\\&N35).",[28],"2026-04-12",{"date":233,"type":34},{"date":280,"type":22},"2026-07-01",{"date":282,"type":22},"2027-12-31",{"name":284,"class":77},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":295,"conditions":296,"keywords":297,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":78},"100632025","role-of-the-immune-system-in-preventing-laryngeal-cancer-100632025","NCT07508319","Role of the Immune System in Preventing Laryngeal Cancer","Laryngeal Dysplasia and Progression to Carcinoma: Investigating Genetic and Immune Alterations Predictive of Malignant Transformation","Inclusion Criteria:\n\n* Histopathological diagnosis of laryngeal dysplasia.\n* Age \\>18 years and informed consent.\n\nExclusion Criteria:\n\n* Prior surgical, radiotherapeutic, or oncologic treatments for head and neck regions.\n* Congenital or acquired immunodeficiency disorders.\n* Synchronous malignancies.\n* Immunosuppressive therapy.\n* Age \\\u003C18 years or absence of research consent.","99 Years",{"count":294,"type":22},3,"Laryngeal dysplasia and progression to carcinoma: investigating genetic and immune alterations predictive of malignant transformation",[28],[298],"Laryngeal dysplasia","2026-03-31",{"date":301,"type":34},"2026-04-02",{"date":303,"type":34},"2025-11-19",{"date":305,"type":22},"2026-12-31",{"name":307,"class":77},"European Institute of Oncology",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":328,"locationsCount":78},"100632179","fl-261-imaging-for-cancer-diagnosis-and-staging-100632179","NCT07510321","FL-261 Imaging for Cancer Diagnosis and Staging","Clinical Application of FL-261 Radionuclide Imaging in the Diagnosis and Staging of Malignant Tumors","Inclusion Criteria:\n\n* Ability to provide written informed consent (by the subject or legally authorized representative)\n* Willingness and ability to comply with all study procedures\n* Age ≥18 years, any sex\n* Clinically suspected or histologically confirmed malignancies (e.g., non-small cell lung cancer, colorectal cancer, head and neck cancer), supported by tumor markers, imaging (ultrasound, CT, MRI), or pathology\n* Good general condition\n* Agreement to use existing tissue samples\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Inability to comply with study procedures\n* Acute systemic disease or significant electrolyte imbalance\n* Pregnant or breastfeeding women\n* Any condition deemed unsuitable by the investigator (e.g., known intolerance to c-MET-targeted agents)",{"count":316,"type":22},12,"c-MET is a receptor tyrosine kinase overexpressed in multiple malignancies and associated with tumor progression, therapeutic resistance, and poor prognosis, while showing limited expression in normal tissues, making it an attractive imaging and therapeutic target. Current assessment relies on invasive biopsy and is limited by tumor heterogeneity and sampling bias.\n\nFL-261 is a novel c-MET-targeting ligand with high affinity and specificity, favorable tumor uptake and retention, rapid background clearance, and good preclinical safety. It can be radiolabeled for both diagnostic imaging and potential theranostic applications.\n\nThis first-in-human study will evaluate \\[68Ga\\]Ga-FL-261 PET or \\[111In\\]In-FL-261 SPECT imaging in patients with advanced malignancies, including non-small cell lung cancer, colorectal cancer, and head and neck cancer. The study aims to assess safety, biodistribution, and tumor-targeting capability, and to explore its diagnostic value by correlating imaging findings with histopathological c-MET expression.",[319,320,28,321],"Non-Small Cell Lung Cancer","Colorectal Cancer","Advanced Solid Tumors","2026-03-29",{"date":324,"type":34},"2026-04-03",{"date":326,"type":34},"2025-11-27",{"date":305,"type":22},{"name":329,"class":77},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":78},"100628257","early-phase-1-the-safety-dosimetry-and-efficacy-of-177lu-inn805-in-patients-with-malignant-solid-tumors-100628257","NCT07459283","The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors","Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-INN805 Injection in Patients With Malignant Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 to 75 years old male and female.\n2. Patients with advanced malignant solid tumors who have failed standard treatments.\n3. According to RECIST 1.1, there is at least one measurable lesion.\n4. ECOG performance status 0-1.\n5. Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥90g\u002FL, neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count ( PLT) ≥100×10\\^9\u002FL; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula method\n\nExclusion Criteria:\n\n1. Received anti-tumor therapy within 4 weeks before enrollment.\n2. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.\n3. Have undergone surgery within 4 weeks before enrollment.\n4. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).\n5. Central nervous system metastases with clinical symptoms.\n6. With any situations that the researcher considers inappropriate to participate in this research.",{"count":225,"type":22},[339],"EARLY_PHASE1","This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.",[342,28,343,344,345,346],"Maligant Solid Tumor","Thyroid Cancer","Lung Cancer - Non Small Cell Squamous","Breast Cancer","Sarcoma","2026-03-08",{"date":349,"type":34},"2026-03-10",{"date":351,"type":22},"2026-04",{"date":353,"type":22},"2027-03",{"name":355,"class":41},"FindCure Biosciences (ZhongShan) Co., Ltd.",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":78},"100627445","impact-of-early-response-to-first-line-anti-pd-1-monotherapy-in-patients-with-recurrent-andor-metastatic-rm-head-and-neck-squamous-cell-carcinoma-assessed-by-18f-fdg-petct-100627445","NCT07448727","Impact of Early Response to First-line Anti-PD-1 Monotherapy in Patients With Recurrent and\u002For Metastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma, Assessed by 18F-FDG PET\u002FCT","Prospective Observational Study On The Impact Of Early Response To First-line Anti-PD-1 Therapy In Patients With Recurrent And\u002FOr Metastatic (R\u002FM) Head And Neck Squamous Cell Carcinoma, Assessed By 18F-FDG PET\u002FCT","PEMBRO-PET","Inclusion Criteria:\n\n* Histological diagnosis of recurrent and\u002For metastatic HNSCC, not amenable for curative locoregional treatment (either surgery or radiotherapy), and amenable for first line systemic treatment\n* CPS PD-L1 \\>=1\n\nExclusion Criteria:\n\n* Any controindication to immune checkpoint inhibitors",{"count":365,"type":22},25,"This study aims to evaluate the role of early response assessment by 18F-FDG PET\u002FCT in patients with recurrent and\u002For metastatic (R\u002FM) head and neck squamous cell carcinoma with PD-L1 CPS \\>1 treated with pembrolizumab monotherapy, in accordance with routine clinical practice.",[28,253],"2026-02-28",{"date":259,"type":34},{"date":371,"type":34},"2024-11-20",{"date":373,"type":22},"2027-12",{"name":375,"class":77},"University of Rome Tor Vergata",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":393,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":413},"100615404","phase-1-a-phase-1b2-study-of-the-safety-and-efficacy-of-the-monoclonal-antibody-om-rca-01-in-patients-with-metastatic-tumors-expressing-fibroblast-growth-factor-receptor-1-100615404","NCT07292168","A Phase 1b\u002F2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1","A Phase 1b\u002F2 Study Evaluating the Safety and Preliminary Efficacy of OM-RCA-01, an Anti-FGFR1 Monoclonal Antibody, in Patients With Metastatic Cancers Expressing FGFR1.","TAGNOT","Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form confirming voluntary participation in the study.\n2. Age ≥ 18 years at the time of consent.\n3. Body weight ≥ 50 kg.\n4. Histologically confirmed metastatic solid tumors:\n\n   1. clear-cell renal cell carcinoma;\n   2. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);\n   3. prostate cancer (castration-resistant adenocarcinoma);\n   4. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);\n   5. head and neck tumors (squamous carcinoma, salivary gland cancer).\n5. Immunohistochemical expression of FGFR1 of 2+ or higher.\n6. Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.\n7. Presence of at least one measurable lesion according to RECIST 1.1 criteria.\n8. Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.\n9. ECOG performance status 0 or 1.\n10. Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:\n\n    * Hemoglobin level ≥ 90 g\u002FL\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n    * Platelet count ≥ 100 × 10⁹\u002FL\n    * Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)\n    * Glomerular Filtration Rate (GFR) ≥ 30 mL\u002Fmin\n    * AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)\n    * Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)\n    * Serum calcium ≥ lower limit of normal\n    * Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)\n11. Life expectancy of more than 12 weeks.\n12. Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.\n13. Women capable of childbearing must be using an effective method of contraception.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study.\n2. Presence of central nervous system (CNS) metastases and\u002For medullary carcinomatosis at the time of inclusion.\n\n   Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:\n   * No evidence of new or progressive CNS metastases\n   * No ongoing steroid therapy\n   * Stable mental status sufficient to provide informed consent\n3. History of or current evidence of any condition, therapy, or laboratory abnormality that could:\n\n   * Limit interpretation of study results,\n   * Prevent completion of the study protocol, or\n   * Pose a risk to patient safety or well-being. This includes any serious or unstable general medical, psychiatric, or other conditions potentially jeopardizing safety, informed consent, or compliance.\n4. Any second malignancy within the previous 5 years, except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma of the skin with limited growth, provided these are well controlled.\n5. Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.\n6. Plans to conceive during the study period, current pregnancy, or lactation.\n7. Known HIV-positive status.\n8. Known active hepatitis B or C infection.\n9. Evidence of active bleeding or hemorrhagic diathesis.\n10. Radiation therapy within 14 days prior to inclusion.\n11. Receipt of any anti-tumor treatments including:\n\n    * Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or\n    * Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.\n12. Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.",{"count":385,"type":22},58,[129,177],"One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.\n\nThe goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:\n\n1. What medical problems do participants have when receiving drug OM-RCA-01?\n2. What dose of the drug should patients receive in the next studies?\n3. Does tumor growth slow down in patients receiving OM-RCA-01?\n\nAll patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.",[389,390,391,392,28],"Renal Cell Carcinoma Metastatic","Prostate Cancer Metastatic","Non-small Cell Lung Cancer Metastatic","Breast Cancer Metastatic",[394,395,396,397,398,399,400,401,402,403],"metastatic cancer","resistance","monoclonal antibody","fibroblast growth factor receptor 1","OM-RCA-01","kidney cancer","prostate cancer","head & neck cancer","lung cancer","breast cancer","2026-01-20",{"date":406,"type":34},"2026-01-21",{"date":408,"type":34},"2025-12-02",{"date":410,"type":22},"2027-01-01",{"name":412,"class":77},"Kidney Cancer Research Bureau",5,{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":78},"100619216","phase-1-sl-28-for-advanced-solid-tumours-100619216","NCT07341737","SL-28 for Advanced Solid Tumours","A Phase 1\u002F2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n* Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study\n* Adult males and females ≥18 years of age at screening\n* Life expectancy of at least 3 months\n* Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)\n* Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular\u002Fbiomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate\n* Eligible tumor types include:\n* Head and neck squamous cell carcinoma\n* Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer)\n* Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma)\n* Genitourinary malignancies (bladder, renal cell, prostate cancer)\n* Gynecologic malignancies (ovarian, endometrial cancer)\n* Breast cancer and melanoma\n* Evaluable disease per RECIST v1.1\n* ECOG performance status 0-1 (or up to 2 at PI discretion)\n* Adequate organ function, defined as:\n* Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome)\n* AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)\n* Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault) or eGFR ≥50 mL\u002Fmin (CKD-EPI)\n* Absolute neutrophil count ≥1,000\u002Fmm³\n* Platelet count ≥100,000\u002Fmm³\n* Hemoglobin ≥90 g\u002FL without transfusion within 2 weeks\n* Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)\n\nFemale patients:\n\n-Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose\n\nMale patients:\n\n* Agreement not to donate sperm for 90 days post-dose\n* Agreement to use adequate contraception as applicable\n* Suitable venous access for blood sampling\n* Willingness and ability to comply with study procedures and protocol requirements\n\nExclusion Criteria:\n\n* Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)\n* NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG\n* QTcF \\>470 ms (females) or \\>450 ms (males)\n* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Requirement for systemic corticosteroids or other immunosuppressive therapy that cannot be discontinued ≥14 days prior to dosing\n* Prior therapies within restricted timeframes:\n* Immune checkpoint inhibitors or biologics within 28 days\n* Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days\n* Unapproved investigational drugs within 5 half-lives\n* Nitrosoureas or mitomycin C within 6 weeks\n* Concurrent malignancy within 5 years, except specified low-risk cancers\n* Pregnancy or breastfeeding\n* Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection\n* Inability or unwillingness to comply with protocol procedures\n* History of anaphylaxis or significant allergy interfering with participation\n* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, neurologic, psychiatric, or immunologic disease within 6 months\n* Conditions affecting drug absorption, distribution, metabolism, or excretion\n* Receipt of live vaccines within 28 days prior to screening\n* Participation in another investigational study within 30 days prior to screening",{"count":422,"type":22},60,[129,177],"Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.",[28,426,427,428,429,430,431,432,433,434,435,436,437,438,345,439,440,320],"Pancreas Carcinoma","Pancreas Cancer, Metastatic","Lung Adenocarcinoma","Lung Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Esophageal Cancer","Stomach (Gastric) Cancer","Liver Cancer","Intestinal Cancer","Bladder Cancer","Renal Cancer","Prostate Cancer","Melanoma (Skin Cancer)","Ovarian Cancer","Endometrial Cancer","2026-01-13",{"date":443,"type":34},"2026-01-15",{"date":445,"type":22},"2026-02-01",{"date":447,"type":22},"2027-03-01",{"name":449,"class":41},"Second Life Therapeutics",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":458,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":470,"leadSponsor":472,"locationsCount":78},"100618186","improving-dental-care-for-patients-with-head-and-neck-tumors-100618186","NCT07328347","Improving Dental Care for Patients With Head and Neck Tumors","A Simulation Experiment to Improve Dental Care for Patients With Head and Neck Tumors","OncoDent","Inclusion Criteria:\n\n* Patients aged 18 years or older with head and neck cancer whose health status allows completion of a questionnaire\n* Practicing dentists in Germany registered in the OAK-Verlag address database\n\nExclusion Criteria:\n\n* Lack of consent to participate\n* Insufficient German language skills that prevent completion of the questionnaire",true,{"count":460,"type":22},132,[54],"This prospective survey study investigates knowledge, attitudes, experiences, and practices related to dental care in patients with head and neck cancer among affected patients and dentists. Participants complete an anonymous online questionnaire before and after receiving written, guideline-based information. The study aims to evaluate whether targeted educational materials improve knowledge and perceptions regarding dental care in the context of head and neck cancer treatment.",[464,465,28,466,467],"Oral Health Care","Oral Health Behavior Change","Dentist's Role","Dentist-Patient Relations",{"date":443,"type":34},{"date":441,"type":34},{"date":471,"type":22},"2026-05",{"name":473,"class":77},"University Medical Center Goettingen",{"id":475,"slug":476,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":78},"100620138","phase-2-nimotuzumab-combined-with-toripalimab-and-chemotherapy-for-locally-advanced-tonsillar-cancer-100620138","NCT07353723","Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer","A Pilot Study to Assess Feasibility and Preliminary Efficacy of Neoadjuvant Nimotuzumab, Toripalimab, and Chemotherapy in Locally Advanced Tonsillar Cancer","Inclusion Criteria:\n\n1. Aged 18 to 80 years old (inclusive of 18 and 80 years), of either gender.\n2. Histopathologically or cytologically confirmed, and diagnosed as resectable locally advanced tonsillar squamous cell carcinoma (TSCC) by MRI imaging.\n3. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n4. Male subjects are eligible if they agree to comply with the following standards during treatment and for at least 180 days after the last cycle of chemotherapy:a) Prohibition of sperm donation;AND• Abstain from heterosexual intercourse as a usual and preferred lifestyle (long-term and persistent abstinence) and agree to maintain abstinence;OR• Agree to use contraceptive measures unless confirmed as azoospermic (vasectomy or secondary to medical reasons, see Appendix 5), with details as follows:→ Use a male condom during penile-vaginal intercourse with a reproductive-aged female partner who is not currently pregnant, and the partner uses an additional contraceptive method.Note: Males whose partners are pregnant or breastfeeding must agree to either maintain abstinence from penile-vaginal intercourse at all times or use a male condom for every penile-vaginal penetration.b) Male subjects must also agree to use a male condom during any activity that allows ejaculation with others of any gender.c) Contraceptive methods used by males must comply with regulations regarding contraception in clinical research participation.\n5. Female subjects are eligible if they are not pregnant or breastfeeding, and meet at least one of the following conditions:(1) Not a woman of childbearing potential (WOCBP);OR(2) If a WOCBP, use a highly effective contraceptive method (annual failure rate \\\u003C1%) with low user dependence, or abstain from heterosexual intercourse as a preferred and regular lifestyle (long-term and persistent abstinence) during the intervention period and for at least 210 days after the last cycle of chemotherapy, and agree not to donate ova (eggs, oocytes) to others or freeze\u002Fstore ova for personal reproductive purposes during this period. Investigators shall evaluate the likelihood of contraceptive method failure (i.e., non-compliance, recent initiation) relative to the first administration of study treatment.a) WOCBP must have a negative result on a highly sensitive urine or serum pregnancy test (urine or serum test selected per regulatory requirements) within 24 hours (urine) or 72 hours (serum) before the first administration of study treatment to be enrolled.Note: If the interval between the screening pregnancy test and the first administration of study intervention exceeds 24 hours (urine) or 72 hours (serum), a repeat pregnancy test (urine or serum) must be performed, and the result must be negative for the subject to start receiving study medication.b) If a urine test is inconclusive (e.g., unclear result), a serum pregnancy test is required. In such cases, subjects with a positive serum pregnancy test result must be excluded.c) Investigators are responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of enrolling women with undetected early pregnancy.d) Contraceptive methods used by females must comply with regulations regarding contraception in clinical research participation;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 within 3 days before the first administration of study intervention.\n7. Evidence of extranodal extension (ENE) in lymph nodes (confirmed by MRI, CT, or pathology).\n8. Voluntarily sign the written informed consent form for the study.\n9. Expected survival time ≥6 months.\n10. Adequate organ function as indicated by screening laboratory test results.a) Hematological parameters:White blood cell (WBC) count ≥4 × 10⁹\u002FL;Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;Platelet count ≥100 × 10⁹\u002FL;Hemoglobin (Hb) ≥90 g\u002FL;b) Renal function:Serum creatinine ≤1.5 × upper limit of normal (ULN), or creatinine clearance (CrCl) \\>60 mL\u002Fmin (calculated using the Cockcroft-Gault formula):Female: CrCl = \\[(140 - age) × body weight (kg) × 0.85\\] \u002F (72 × Scr \\[mg\u002FdL\\])Male: CrCl = \\[(140 - age) × body weight (kg) × 1.00\\] \u002F (72 × Scr \\[mg\u002FdL\\])c) Hepatic function:Serum total bilirubin ≤1.5 × ULN;Aspartate aminotransferase (AST) ≤2.5 × ULN;Alanine aminotransferase (ALT) ≤2.5 × ULN;d) Coagulation function:International Normalized Ratio (INR) ≤1.5;Prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n11. Good compliance and willingness to cooperate with follow-up procedures.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for advanced (metastatic) or unresectable (locally advanced) tonsillar cancer, except for permitted neoadjuvant\u002Fadjuvant therapy. Neoadjuvant\u002Fadjuvant therapy must have been completed at least 6 months before the diagnosis of advanced and\u002For unresectable disease. Subjects who received prior neoadjuvant\u002Fadjuvant therapy and had R2 pathology after tumor resection are excluded.\n2. Active autoimmune disease requiring systemic therapy (i.e., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic therapy and are permitted.\n3. Major surgery prior to the initiation of study intervention with inadequate recovery from surgery and\u002For surgical complications.\n4. Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).\n5. Prior treatment with EGFR-targeted agents.\n6. Anti-tumor therapy for advanced tonsillar cancer, including investigational drugs, within 4 weeks before enrollment.\n7. Unresolved adverse events (AEs) from prior anti-cancer therapy (i.e., AEs \\> Grade 1 or baseline). Subjects with neuropathy ≤ Grade 2 may be eligible based on investigator assessment.\n8. Radiotherapy within 2 weeks before the start of investigational treatment. Subjects must have recovered from all radiotherapy-related toxicities, be free of corticosteroid use, and have no history of radiation pneumonitis. A 1-week washout period is permitted for palliative radiotherapy (≤2 weeks of radiotherapy) for non-central nervous system (CNS) disease (if deemed safe by the investigator). A 2-week washout period is required for longer radiotherapy courses (\\>2 weeks).\n9. Administration of live vaccines within 30 days before the first dose of study drug.Note: Live vaccines include, but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines administered by injection are generally inactivated virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not permitted.\n10. Current or prior participation in a study of an investigational drug, or use of an investigational device within 4 weeks before the first dose of study drug.Note: Subjects who have entered the follow-up phase of an investigational study are eligible to participate in this study if at least 4 weeks have passed since the last dose of the prior investigational drug.\n11. Diagnosis of immunodeficiency or receipt of long-term systemic corticosteroid therapy (dose exceeding 10 mg prednisone equivalent per day) or any form of immunosuppressive therapy within 7 days before the first dose of study drug.\n12. History of another invasive malignancy that is progressive or required active treatment within the past 3 years.Note: Subjects with a history of skin basal cell carcinoma, skin squamous cell carcinoma, or carcinoma in situ (e.g., ductal carcinoma in situ of the breast, cervical carcinoma in situ) who have received potentially curative treatment are not excluded.\n13. Severe hypersensitivity reaction (\\> Grade 3) to toripalimab, nimotuzumab, albumin-bound paclitaxel, carboplatin, and\u002For any of their excipients.\n14. History of (non-infectious) pneumonitis requiring corticosteroid therapy, or current pneumonitis.\n15. Active infection requiring systemic therapy.\n16. Known history of human immunodeficiency virus (HIV) infection.\n17. Known active tuberculosis (TB; Mycobacterium tuberculosis).\n18. Severe, poorly controlled concurrent diseases (e.g., heart failure, diabetes mellitus, hypertension, liver failure, renal failure, thyroid disease, psychiatric illness, etc.).\n19. Major surgery within 30 days before the first dose of investigational drug or planned surgery during the study period.\n20. Inappropriate for study participation as assessed by the investigator.\n21. Unwillingness to participate in the study or inability to sign the informed consent form.\n22. Known history or any evidence of central nervous system (CNS) metastases and\u002For carcinomatous meningitis as assessed by the study site investigator.\n23. History or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results, prevent full participation in the study (e.g., hearing impairment), or that the investigator believes would not be in the subject's best interest to participate.\n24. Known psychiatric illness or substance abuse disorder that would interfere with the subject's ability to comply with study requirements.\n25. History of allogeneic tissue\u002Fsolid organ transplantation.",{"count":225,"type":22},[177],"This is a prospective,single-arm,Phase II clinical study to designed to evaluate the efficancy and safety of nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer",[28],[486,230,231],"Nimotuzumab","2026-01-11",{"date":404,"type":34},{"date":490,"type":34},"2025-11-15",{"date":492,"type":22},"2031-11-30",{"name":240,"class":77},{"id":495,"slug":496,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":78},"100618565","phase-3-compare-radiotherapy-plus-nimotuzumab-versus-radiotherapy-alone-in-platinum-ineligible-patients-with-locoregionally-advanced-head-and-neck-squamous-cell-carcinoma-100618565","NCT07333274","Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma","An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)","Inclusion Criteria:\n\n* Eligible subjects must meet all of the following:\n\n  * Age ≥18 years.\n  * Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).\n  * Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \\[T3-4 N0-3 M0, or T1-2 N2-3 M0\\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).\n  * Suitable for definitive radiotherapy with curative intent.\n  * At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:\n* Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;\n* ECOG Performance Status \\>2 (if this criterion is met, the ECOG criterion listed below may be waived);\n* Renal dysfunction: creatinine clearance (CrCl) \\\u003C50 mL\u002Fmin (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);\n* Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);\n* Peripheral neuropathy \\> Grade 1;\n* Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.\n\n  * Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV\u002Fp16 testing if feasible (no need to retest if previously tested).\n  * ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).\n  * At least one measurable lesion per RECIST 1.1.\n  * Expected survival ≥6 months.\n  * Adequate hematologic function: WBC ≥4×10\\^9\u002FL; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n  * Adequate renal function: serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault):\n* Female CrCl = (140 - age) × weight (kg) × 0.85 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n* Male CrCl = (140 - age) × weight (kg) × 1.00 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n\n  * Adequate liver function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.\n  * Voluntary participation: signed written informed consent and ability to comply with visits and procedures.\n\nExclusion Criteria:\n\n* Any of the following excludes enrollment:\n\n  * Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.\n  * Participation in another interventional clinical trial within 30 days prior to screening.\n  * History of other malignancy (except cured basal cell carcinoma of the skin).\n  * History of primary immunodeficiency.\n  * Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).\n  * Known HIV infection, or active viral hepatitis or active tuberculosis.\n  * Major surgery within 90 days before first study treatment, or planned surgery during the study.\n  * Known allergy to nimotuzumab or its excipients.\n  * Deemed unsuitable to participate by the investigator.\n  * Unwilling or unable to sign informed consent.\n  * Receipt of a live vaccine within 30 days before first dose.",{"count":502,"type":22},335,[25],"This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),",[253,28],[486,507,508,509],"Radiotherapy","locoregionally advanced head and neck squamous cell carcinoma","LA-HNSCC","2025-12-30",{"date":512,"type":34},"2026-01-12",{"date":514,"type":22},"2026-01-05",{"date":516,"type":22},"2030-01-05",{"name":518,"class":77},"Shandong Cancer Hospital and Institute",{"id":520,"slug":521,"hasResults":11,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":78},"100616834","phase-2-contrast-enhanced-ultrasound-for-sentinel-node-detection-100616834","NCT07310758","Contrast-enhanced Ultrasound for Sentinel Node Detection","Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer","Inclusion Criteria:\n\n* Aged 18 years or older\n* Patient has been diagnosed with cancer in the skin (melanoma), breast or head \\& neck (including melanoma of head and neck area)\n* In case of a melanoma: it should be located in the limbs or head and neck area\n* Scheduled for a surgical SN procedure at the NKI-AvL\n* Patient provides written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products\n* Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease",{"count":527,"type":22},91,[177,25],"This is a prospective single-center interventional non-inferiority study where subjects are participating for one day for patients 18 years or older with melanoma, breast cancer or head \\& neck cancer (including melanoma of head and neck area) and scheduled for a surgical SN procedure in the NKI-AvL without any contra-indication for Sonazoid contrast agent, such as an allergy to eggs or egg products. The primary objective is to assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Secondary objectives are the specificity of CEUS for intra-operative SN localization, the time required to localize the SNs using CEUS and intraoperative usability of the CEUS-system. The primary endpoint is the sensitivity of the CEUS SN localization method. The conventional gamma probe will be used as ground truth comparison.",[531,345,28],"Melanoma",[533],"contrast-enhanced ultrasound","2025-12-16",{"date":510,"type":34},{"date":537,"type":34},"2025-09-18",{"date":539,"type":22},"2026-09-18",{"name":541,"class":77},"The Netherlands Cancer Institute",{"id":543,"slug":544,"hasResults":11,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":78},"100614897","performance-of-18f-fdg-micro-pet-ct-in-the-assessment-of-surgical-margins-in-head-and-neck-cancer-100614897","NCT07285564","Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer","TEP Margins","Inclusion Criteria:\n\n* Signed informed consent\n* Adult, male or female, aged 18 or over\n* Patient with a malignant tumor of the oral cavity, oropharynx, hypopharynx, larynx, sinuses, or salivary glands, regardless of lymph node status (any N) M0, operable\n* Member or beneficiary of a social security plan\n\nExclusion Criteria:\n\n* Child-Pugh C liver failure\n* Patients under guardianship, conservatorship, or legal protection\n* Patients deprived of their liberty\n* Pregnant or breastfeeding women\n* Hypersensitivity to 18F-FDG or any of its excipients (ethanol or water for injection)\n* Uncontrolled diabetes\n* Moderate to end-stage renal failure, stage IIIB to V (glomerular filtration rate less than 44 mL\u002Fmin\u002F1.73 m²)\n* Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, or geographical issues).",{"count":225,"type":22},[54],"The purpose of this study is to evaluate the diagnostic performance of 18F-FDG micro-PET-CT in malignant Head and neck cancer compared to definitive histological analysis (gold standard).",[28],[554,555,556],"Margins","microPET\u002FCT","specimen",{"date":534,"type":34},{"date":559,"type":34},"2025-11-07",{"date":561,"type":22},"2026-06-15",{"name":216,"class":77}]