[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"la-hnscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:la-hnscc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100647513","phase-2-a-prospective-exploratory-study-of-becotatug-vedotin-plus-putlimab-for-neoadjuvant-therapy-and-adjuvant-radiotherapy-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100647513",false,"NCT07707167","A Prospective, Exploratory Study of Becotatug Vedotin Plus Putlimab for Neoadjuvant Therapy and Adjuvant Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","A Prospective, Exploratory Clinical Study of Becotatug Vedotin Combined With Putlimab as Neoadjuvant Therapy Prior to Surgery and Adjuvant Radiotherapy After Surgery in Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Diagnosis of any malignancy other than gastric cancer within 5 years prior to the first dose, with the exception of adequately treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and\u002For radically resected carcinoma in situ;\n2. Known endoscopic evidence of active bleeding in the target lesion;\n3. Concurrent participation in another interventional clinical study, or receipt of any investigational medicinal product or use of investigational device within 4 weeks prior to the first dose;\n4. Prior exposure to any of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents; agents targeting other stimulatory or co-inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, and CD137); or antibody-drug conjugates (ADCs) with MMAE or MMAF payloads;\n5. Systemic administration of Chinese proprietary medicines with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, and interleukins, except for local administration to control pleural effusion) within 2 weeks prior to the first dose;\n6. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy;\n7. Receipt of systemic corticosteroid therapy (excluding intranasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose; \\*Note: Physiologic doses of corticosteroids (prednisone ≤10 mg\u002Fday or equivalent) are permitted;\\*\n8. History of allogeneic organ transplantation (corneal transplantation excluded) or allogeneic hematopoietic stem cell transplantation;\n9. Known hypersensitivity to pucotenlimab, MRG003, or any of their excipients;\n10. Failure to recover adequately from toxicities and\u002For complications of prior interventions (i.e., to Grade ≤1 or to baseline, excluding fatigue and alopecia) prior to initiation of study treatment;\n11. Known history of human immunodeficiency virus (HIV) infection (HIV-1\u002F2 antibody positive);\n12. Untreated active hepatitis B infection (defined as HBsAg positivity with HBV-DNA copy number above the upper limit of normal of the local laboratory); \\*Note: Subjects with hepatitis B may be enrolled if they meet the following criteria:\\* 1) HBV viral load \\\u003C1,000 copies\u002FmL (200 IU\u002FmL) prior to the first dose; subjects must receive prophylactic anti-HBV therapy throughout the study treatment period to prevent viral reactivation; 2) Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and undetectable HBV viral load are not required to receive prophylactic anti-HBV therapy but require close monitoring for viral reactivation;\n13. Active hepatitis C infection (HCV antibody positive with HCV-RNA level above the lower limit of quantification);\n14. Receipt of a live vaccine within 30 days prior to Cycle 1 Day 1; \\*Note: Inactivated injectable influenza vaccines for seasonal influenza are permitted within 30 days prior to the first dose; intranasal live-attenuated influenza vaccines are not permitted;\\*\n15. Pregnancy or breastfeeding;\n16. Presence of any serious or uncontrolled systemic condition, including but not limited to:\n\n1\\) Resting ECG demonstrating significant, symptomatic, and poorly controlled abnormalities in rhythm, conduction, or morphology, including complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, or chronic heart failure of New York Heart Association (NYHA) Class ≥2; 3) Any arterial thrombosis, embolism, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months prior to enrollment; 4) Inadequately controlled hypertension (systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg); 5) History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose, or currently clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) Active or uncontrolled infection requiring systemic antimicrobial therapy; 8) Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction; 9) Hepatic conditions including cirrhosis, decompensated liver disease, or acute or chronic active hepatitis; 10) Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL); 11) Urinalysis demonstrating urine protein ≥2+ with confirmed 24-hour urine protein \\>1.0 g; 12) Psychiatric disorder that would preclude compliance with study requirements;\n\n17\\. Any medical condition, laboratory abnormality, or concurrent therapy that, in the Investigator's opinion, may interfere with study assessments, compromise subject safety, or render the subject unsuitable for study participation.\n\nExclusion Criteria:\n\n1. Presence of distant metastatic lesions;\n2. History of Grade ≥3 immune-related adverse events or treatment-related adverse events that have not recovered to Grade ≤1;\n3. Receipt of surgery, chemotherapy, targeted small molecule therapy, or radiotherapy for another invasive malignancy within the past 5 years;\n4. Autoimmune disease requiring systemic corticosteroid therapy within the past 3 months, history of clinically significant autoimmune disease, or syndrome requiring systemic corticosteroid therapy;\n5. Active infection requiring systemic treatment;\n6. Prior receipt of any form of anti-tumor therapy for the primary tumor or metastatic lymph nodes, including chemotherapy, radiotherapy, targeted therapy, anti-PD-1 or anti-PD-L1 therapy, or surgery (biopsy excluded);\n7. History of other malignancies;\n8. History of organ transplantation;\n9. History of autoimmune disease, or other conditions requiring long-term systemic corticosteroid or immunosuppressive therapy;\n10. Positive for human immunodeficiency virus (HIV);\n11. Active hepatitis B or hepatitis C infection (HBV DNA or HCV RNA above the upper limit of normal);\n12. Total white blood cell count \\\u003C3.5×10⁹\u002FL, absolute lymphocyte count \\\u003C0.8×10⁹\u002FL, neutrophil count \\\u003C1.5×10⁹\u002FL, platelet count \\\u003C100×10⁹\u002FL, or hemoglobin \\\u003C90 g\u002FL; total bilirubin \\>1.5× upper limit of normal (ULN), transaminases (AST, ALT) \\>3× ULN (\\>5× ULN if hepatic metastases present), serum creatinine \\>1.5× ULN; coagulation abnormalities with international normalized ratio (INR) or prothrombin time (PT) \\>1.5× ULN;\n13. Serious cardiovascular, respiratory, or major immune system comorbidities; including urinary tract obstruction, myocardial infarction, arrhythmia, obstructive or restrictive lung disease, or other conditions that the Investigator considers may increase subject risk;\n14. Pregnant or lactating women;\n15. Refusal to use effective contraception during the treatment period and for 3 months thereafter;\n16. Concurrent participation in another clinical study;\n17. Critically ill patients unable to complete the study assessments;\n18. History of psychiatric disorders (e.g., schizophrenia, mania, anxiety disorder, depression, phobia, etc.) or subjects\u002Fspouses diagnosed with psychiatric illness at the time of study enrollment;\n19. Subjects or spouses with communication barriers or inability to provide normal responses due to altered consciousness, aphasia, intellectual disability, or other causes;\n20. Any other condition that the Investigator considers renders the subject unsuitable for enrollment or may interfere with subject participation or completion of the study.","ALL","18 Years","75 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, exploratory, non-registration, multi-center clinical study to evaluate the efficacy and safety of becotatug vedotin (EGFR-ADC) combined with putlimab and radiotherapy in the perioperative treatment of locally advanced resectable head and neck squamous cell carcinoma (HNSCC).\n\n\\*\\*Neoadjuvant Phase\\*\\* (3-week cycle, 2 cycles):\n\n* Putlimab (HX008): 200 mg, Q3W, D1, IV\n* Becotatug vedotin (MRG003): 2.0 mg\u002Fkg, Q3W, D1, IV\n\n\\*\\*Adjuvant\u002FMaintenance Phase:\\*\\* Surgery within 2-4 weeks post-neoadjuvant; surgical approach at investigator discretion.\n\n\\*\\*Group A (Postoperative pCR):\\*\\*\n\n* Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year\n* Adjuvant RT: 40 Gy\u002F5 weeks\n\n\\*\\*Group B (Postoperative MPR):\\*\\*\n\n* Putlimab (HX008): 200 mg, Q3W, D1, IV, up to 1 year\n* Adjuvant RT: 50 Gy\u002F5 weeks\n\n\\*\\*Group C (Postoperative Partial\u002FNo Response):\\*\\*\n\n* Low-risk (no extracapsular nodal extension \\[ENE\\] and negative margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60 Gy\u002F6 weeks\n* High-risk (ENE and\u002For positive margins): Putlimab 200 mg Q3W (up to 1 year) + RT 60-66 Gy\u002F6-6.6 weeks + Cisplatin 60 mg\u002Fm², Q3W, D1, IV, for 2 cycles\n\nRT timing, field, and fractionation may be adjusted by investigators based on individual disease status.\n\nImaging assessment every 2 cycles (±7 days) until disease recurrence, initiation of new anti-tumor therapy, withdrawal of informed consent, death, or up to 21 cycles, whichever occurs first. Additional imaging may be performed at any time if clinically indicated.",[27],"LA HNSCC",[29,30,31],"Becotatug vedotin","Pucotenlimab","Sequential radiotherapy","NOT_YET_RECRUITING","2026-07-15",{"date":35,"type":36},"2026-07-16","ACTUAL",{"date":38,"type":21},"2026-08-31",{"date":40,"type":21},"2029-01-31",{"name":42,"class":43},"Jiangsu Cancer Institute & Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100591315","phase-2-cetuximab--tislelizumab--chemotherapy-in-the-treatment-of-unresectable-la-hnscc-100591315","NCT06978829","Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC","Cetuximab Combined With Tislelizumab and Chemotherapy in the Treatment of Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;\n2. Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;\n3. No prior treatment for head and neck squamous cell carcinoma;\n4. No prior treatment with cetuximab or PD-(L)1 inhibitors;\n5. At least one measurable lesion according to RECIST v1.1;\n6. No gender restriction, age ≥18;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n8. Expected survival period ≥ 3 months;\n9. Organ function levels meet the following criteria:\n\n   1. Blood routine: Hemoglobin ≥90 g\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥90×10\\^9\u002FL;\n   2. Blood biochemistry: ALT, AST ≤2.5×ULN (≤5×ULN if liver metastasis is present), total serum bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN, serum albumin ≥30 g\u002FL;\n   3. Cardiac function: Left ventricular ejection fraction \\>50% as shown by echocardiography.\n10. Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. Previous anti-tumor treatments received (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);\n2. Known or suspected allergy to any component of cetuximab or PD-(L)1 monoclonal antibodies, as well as to the chemotherapeutic drugs paclitaxel and cisplatin;\n3. Patients with hypertension that cannot be controlled to normal range with antihypertensive medications (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg), patients with coronary heart disease of grade II or above, grade II arrhythmia (including QTc interval prolongation \\>470 ms), and grade I cardiac insufficiency;\n4. History of autoimmune diseases or autoimmune disease history (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), immunodeficiency history, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;\n5. Uncontrolled active hepatitis B (HBV DNA ≥ 1000 IU\u002FmL) or active hepatitis C (positive hepatitis C antibody) patients;\n6. Patients with active tuberculosis (with exposure history or positive tuberculosis test; accompanied by clinical and\u002For imaging manifestations);\n7. Patients who have undergone major surgery within 4 weeks before the first dose or whose wounds have not fully healed;\n8. Patients with a clear tendency to bleed;\n9. Patients with severe complications such as pyloric obstruction, upper gastrointestinal bleeding, gastrointestinal perforation, obstructive jaundice, severe malnutrition, etc.;\n10. Patients who have experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment;\n11. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor is highly likely to invade important blood vessels during treatment, leading to fatal massive bleeding;\n12. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.;\n13. Patients with active brain metastasis;\n14. Patients with other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer);\n15. Pregnant or breastfeeding women;\n16. Patients with severe concomitant diseases that endanger patient safety or affect the completion of the study, as judged by the investigator, and those whom the investigator considers unsuitable for inclusion.",{"count":53,"type":21},42,[24],"This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.",[27],[58,59,27],"Tislelizumab","Cetuximab","RECRUITING","2025-05-12",{"date":63,"type":36},"2025-05-18",{"date":65,"type":36},"2025-03-01",{"date":67,"type":21},"2027-12-31",{"name":69,"class":43},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":44},"100571610","efficacy-and-safety-of-a-third-course-of-neoadjuvant-immunochemotherapy-combined-with-sbrt-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-patients-with-stable-disease-after-two-treatment-courses-a-single-arm-exploratory-study-100571610","NCT06722495","Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients With Stable Disease After Two Treatment Courses: A Single-Arm Exploratory Study","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years on the date of signing the informed consent form, male or female.\n2. Histologically and imaging-confirmed T3-4a or N+M0 stage III-IVb (AJCC 8th) HNSCC, patients have received 2-courses of platinum-based chemotherapy and tirilizumab immunotherapy, and whose efficacy is assessed as Stable Disease (SD).\n3. Life expectancy is at least 3 months.\n4. ECOG PS 0-1。\n5. Haematological analysis： 5.1 Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL without granulocyte colony-stimulating factor in the last 14 days； 5.2 Absolute T-lymphocyte value ≥ 0.5 times the lower limit of normal value； 5.3 Platelets ≥100×10\\^9\u002FL without transfusion or platelet-boosting drugs in the last 14 days； 5.4 Haemoglobin ≥90g\u002FL without transfusion or erythropoietin use in the last 14 days.\n6. Renal function:\n\n   6.1 Creatinine clearance\\* (Ccr) ≥60 mL\u002Fmin; \\*Ccr will be calculated using the Cockcroft-Gault formula: Ccr = (140-age) × body weight (kg) \u002F \\[0.818 (0.85 for males, 0.85 for females) × blood creatinine (SCr, umol\u002FL) \\] or Ccr = (140-age) × body weight (kg)\u002F \\[72 × blood creatinine (SCr, mg\u002FdL) \\]; 6.2 Creatinine ≤ 1.5 × upper limit of normal (ULN)； 6.3 Routine urinalysis suggests urinary protein ≤ +; 6.4 Quantitative 24-hour urine protein \\\u003C1.0g.\n7. Liver function:\n\n   7.1 Serum total bilirubin (TBil) ≤ 1.5 × ULN; 7.2 AST and ALT ≤ 2.5 × ULN, ≤ 5 × ULN for liver metastases, and TBil ≤ 3 × ULN.\n8. Coagulation: international normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n9. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may be enrolled if total T3 (or FT3) and FT4 are within the normal range.\n10. Cardiac enzyme profiles within the normal range (enrolment is also permitted if the investigator's combined judgement is that it is a purely laboratory abnormality of no clinical significance).\n11. Patients must be able to understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any of the antineoplastic therapeutic drug components of this research.\n2. Those who have previously suffered from other malignant tumours and have received radiotherapy.\n3. have uncontrolled clinical symptoms or cardiac disease including, but not limited to, symptomatic congestive heart failure (Grade 2 and above as determined by the New York Heart Association's Functional Class), unstable angina pectoris, acute myocardial ischaemia, and poorly controlled cardiac arrhythmias. Past history of myocarditis and cardiomyopathy.\n4. Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, glucocorticoids, or immunosuppressants). Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.\n5. History of (non-infectious) pneumonia requiring steroids or current pneumonia.\n6. Have active tuberculosis.\n7. History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first dose or current clinically active interstitial lung disease.\n8. Active or uncontrolled infection requiring systemic therapy.\n9. History of human immunodeficiency virus (HIV) infection (e.g., HIV-positive).\n10. Liver disease such as cirrhosis, decompensated liver disease; known active hepatitis B (e.g., hepatitis B surface antigen (HBsAg) positive and HBV-DNA \\> upper limit of normal in the laboratory of the research centre) or active hepatitis C virus infection (e.g., HCV antibody positive and HCV RNA level above the lower limit of detection).\n\n    \\*Note: Hepatitis B subjects meeting the following criteria may also be enrolled: 10.1 HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the study treatment period to avoid viral reactivation; 10.2 In subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is needed.\n11. Have an active bleeding disorder or other history of severe bleeding.\n12. Allogeneic organ transplantation (except corneal transplantation) or allogeneic haematopoietic stem cell transplantation.\n13. Pregnant or breastfeeding, or preparing to become pregnant during the trial period.\n14. Medical, psychological, or social condition that may interfere with the subject's participation in the research or affect the assessment of the results; or other conditions that, in the opinion of the investigator, make enrolment inappropriate, or that, in the opinion of the investigator, present other potential risks that make participation in this research inappropriate.",{"count":77,"type":21},20,[79],"NA","Neoadjuvant immunotherapy before surgery has shown good efficacy and safety in locally advanced HNSCC, particularly with the use of PD-1 inhibitors combined with chemotherapy, where some patients have achieved a high rate of pathological complete response. However, approximately 40% of patients respond poorly to neoadjuvant immunochemotherapy, with prolonged treatment courses failing to significantly improve outcomes, and some patients may even experience disease progression. For these patients, timely surgery or definitive radiotherapy combined with other well-tolerated therapeutic approaches is needed to improve pathological response rates, enhance long-term survival, and preserve organ function.",[82,83,27],"SBRT","Neoadjuvant Immunochemotherapy","2024-12-05",{"date":86,"type":36},"2024-12-09",{"date":88,"type":21},"2024-12-24",{"date":90,"type":21},"2026-12-26",{"name":92,"class":43},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]