[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lei Liu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,74,100],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100550202","phase-2-a-phase-ii-study-of-neoadjuvant-immunotherapy-in-combination-with-chemotherapy-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100550202",false,"NCT06444009","A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck Cancer：A Randomized, Phase II Study","Inclusion Criteria:\n\n1. Males and females； Age：18 to 75 years.\n2. Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC).\n3. Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. No prior treatment for the cancer.\n6. Intention to undergo curative treatment.\n7. Patients with normal organ function and suitable for immunotherapy combined with chemotherapy and surgery:\n\n   Adequate hematologic function (total white blood cell count ≥ 3.0×10\\^9\u002FL, absolute lymphocyte count ≥ 0.8×10\\^9\u002FL, absolute neutrophil count ≥ 1.5×10\\^9\u002FL, platelets ≥ 100×10\\^9\u002FL, hemoglobin ≥ 90g\u002FL); Adequate hepatic function (bilirubin level ≤ 2 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN); Adequate renal function (serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula), urine protein \\\u003C2+ on dipstick or \\\u003C1g in a 24-hour urine collection); Good cardiac function, i.e., normal or clinically insignificant abnormalities on electrocardiogram (ECG), echocardiogram showing a left ventricular ejection fraction (LVEF) ≥50%; Adequate coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; participants on anticoagulation treatment are eligible if the PT is within the therapeutic range of the anticoagulant;\n8. Blood pressure well controlled (defined as systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg) with or without antihypertensive medication, and no change in antihypertensive treatment within 1 week before the first dose of study medication.\n9. Patients with HBV infection capable of having detectable HBV DNA levels (≥10IU\u002FmL or above the limit of quantitation) (manifested as positive for hepatitis B surface antigen (HbsAg) and\u002For hepatitis B core antibody (anti-HBc)) must receive antiviral therapy according to clinical practice at the site before randomization to ensure adequate viral suppression. Patients must maintain antiviral therapy during the study and for 6 months after the last dose of study treatment. Patients who are anti-HBc positive but do not have detectable HBV DNA (\\\u003C10IU\u002FmL or below the limit of quantitation) are not required to receive antiviral therapy unless their HBV DNA levels exceed 10IU\u002FmL or the limit of quantitation during treatment.\n10. Women of childbearing potential (15-49 years old) must have a negative pregnancy test within 7 days before starting treatment; patients of childbearing potential must agree to use effective contraception to ensure they do not become pregnant during the study period and for 3 months after stopping treatment.\n11. Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients who have received any form of anti-tumor treatment previously.\n2. Patients with allergic constitution and congenital immune deficiencies.\n3. Patients who have undergone organ transplantation.\n4. Patients with a history of severe bleeding tendencies or coagulation dysfunction; those who have had clinically significant bleeding symptoms within 1 month prior to the study treatment, including but not limited to gastrointestinal bleeding, hemoptysis; those who have received prolonged anticoagulation treatment within 10 days prior to the study treatment.\n5. Patients who have experienced arteriovenous thrombotic events within 6 months before the study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n6. Patients with active autoimmune diseases or inflammatory diseases, or a history thereof, including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (excluding diverticulosis), systemic lupus erythematosus, sarcoidosis or Wegener's granulomatosis (e.g., granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis). Exceptions to this criterion include patients with vitiligo or alopecia; patients with stable hypothyroidism after hormone replacement therapy (e.g., following Hashimoto's thyroiditis); patients with any chronic skin disease not requiring systemic treatment; inclusion of patients without active disease in the last 5 years is allowed only after consultation with the study physician.\n7. Patients with active infections, including tuberculosis or human immunodeficiency virus (HIV 1\u002F2 antibody positive).\n8. Patients with uncontrollable complications, including but not limited to: persistent or active infections receiving study treatment (except HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, or any psychiatric\u002Fsocial situations that might limit compliance with study requirements, significantly increase the risk of adverse events (AE), or impair the ability of the patient to give written informed consent.\n9. Pregnant or breastfeeding women.\n10. Patients who do not agree to use effective contraception during the treatment period and for 3 months thereafter.\n11. Patients participating in other clinical studies simultaneously.\n12. Patients who are critically ill and unable to complete the investigation.\n13. Patients with a history of other primary malignant tumors, except for the following: Malignant tumors treated with curative intent and no known active disease for ≥5 years prior to study treatment and with a low risk of relapse; adequately treated non-melanoma skin cancer or in-situ melanoma without evidence of disease; adequately treated carcinoma in situ without evidence of disease.\n14. Patients with a history of psychiatric illness (e.g., schizophrenia, mania, anxiety disorder, depression, phobia) or diagnosed with a psychiatric disease at the time of enrollment or their spouses.\n15. Patients or their spouses with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent normal responses.\n16. Patients with other malignant neoplastic diseases.\n17. Patients whom the researcher considers unsuitable for inclusion or whose participation might affect their ability to participate or complete the study for other reasons.","ALL","18 Years","75 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection.\n\nThis proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.",[27],"Head and Neck Squamous Cell Carcinoma",[29,30,31,32],"Locally advanced head and neck squamous cell carcinoma","Neoadjuvant therapy","Immunotherapy","AK112","RECRUITING","2024-11-26",{"date":36,"type":37},"2024-12-02","ACTUAL",{"date":39,"type":37},"2024-07-01",{"date":41,"type":21},"2027-12-01",{"name":43,"class":44},"Lei Liu","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100565245","phase-2-neoadjuvant-chemotherapy--pd-1-inhibitordifferent-radiotherapy-fractionations-for-hrher2--breast-cancer-100565245","NCT06639672","Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+\u002FHER2- Breast Cancer","Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+\u002FHER2- Breast Cancer: A Phase II Study","Inclusion Criteria:\n\n* 1\\. Histologically or cytologically confirmed HR+\u002FHER2- breast cancer\n* 2\\. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）\n* 3\\. ECOG performance status of 0-1;\n* 4\\. Adequate bone marrow function, defined as: Hb ≥ 9.0 g\u002FdL (90 g\u002FL); ANC ≥ 1,500\u002FmcL (1.5 × 10\\^9\u002FL); PLT ≥ 100,000\u002FmcL (100 × 10\\^9\u002FL) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;\n* 5\\. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g\u002FL;\n* 6\\. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;\n* 7\\. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL\u002Fmin calculated using the Cockcroft-Gault formula corrected for body surface area;\n* 8\\. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);\n* 9\\. No severe organic heart disease or arrhythmias;\n* 10\\. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;\n* 11\\. Voluntary signed informed consent by the study participant.\n\nExclusion Criteria:\n\n* 1\\. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.\n* 2\\. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.\n* 3\\. Poorly controlled tumor-related pain.\n* 4\\. Patients participating in other clinical studies simultaneously.\n* 5\\. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* 6\\. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening.\n* 7\\. Active pulmonary tuberculosis.\n* 8\\. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina.\n* 9\\. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period.\n* 10\\. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death , such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.\n* 11\\. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety.\n* 12\\. Patients who have previously received allogeneic stem cell or solid organ transplants.\n* 13\\. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.","FEMALE","65 Years",{"count":56,"type":21},60,[24],"For the hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2-negative (HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine treatments have shown better survival, this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy, with an approximately pCR of 20%. The low immunogenicity result in suboptimal pCR and objective response rates for this group. Therefore, there is an urgent need to explore new, highly effective, and low-toxicity treatment strategies to further improve the efficacy of HR+\u002FHER2- breast cancer. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of chemotherapy combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant treatment of HR+\u002FHER2- breast cancer.",[60],"HR+HER2- Breast Cancer",[62,63,31,64],"HR+\u002FHER2- breast cancer","Neoadjuvant chemotherapy","Radiotherapy","NOT_YET_RECRUITING","2024-10-11",{"date":68,"type":37},"2024-10-15",{"date":70,"type":21},"2024-11-01",{"date":72,"type":21},"2031-05-01",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100556884","phase-2-a-phase-ii-study-of-mrg003-injection-combined-with-pucotenlimab-injection--cisplatin-injection-in-the-neoadjuvant-treatment-locally-advanced-egfr-positive-head-and-neck-squamous-cell-carcinoma-100556884","NCT06530914","A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Sign the informed consent voluntarily and follow the requirements of the program;\n2. Age ≥18 years old, ≤70 years old, gender is not limited;\n3. Physical condition score ECOG 0 or 1;\n4. Histopathology confirmed the diagnosis of head and neck squamous cell carcinoma, and immunohistochemistry confirmed that EGFR expression was positive (defined as weak staining of \\> 10% of tumor cells);\n5. No previous treatment for head and neck squamous cell carcinoma, including drug therapy, radiotherapy, surgery, etc., and the tumors of the subjects assessed by the researchers before admission could be surgically resected;\n6. According to the American Joint Committee on Cancer (AJCC) \u002FTNM Staging System eighth Edition, patients must have the following tumor stages: 1) patients with stage III, IVA, and IVB non-oropharyngeal cancer and patients with HPV-negative oropharyngeal cancer; Or 2) Stage II and III HPV-positive oropharyngeal cancer patients. For patients with oropharyngeal cancer, HPV status should be determined by p16 IHC.\n7. The level of organ function must meet the following requirements:\n\n   * Bone marrow: absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count ≥100×109\u002FL, hemoglobin ≥90 g\u002FL, and no blood transfusion or biological response regulator (such as granulocyte, erythrocyte growth factor, etc.) treatment within 14 days before the first dose;\n   * Liver: total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5×ULN; Serum albumin ≥28 g\u002FL;\n   * Kidney: creatinine clearance (Ccr) ≥50 mL\u002Fmin (according to Cockcroft and Gault formula);\n   * Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN (except those receiving therapeutic anticoagulants);\n   * No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%;\n8. Fertile men and women of childbearing age are willing to take effective contraceptive measures from the signing of informed consent to 6 months after the last administration of the experimental drug; Women of reproductive age include premenopausal women and women within 1 year after menopause. Blood pregnancy test results for women of childbearing age must be negative within ≤7 days before the first trial drug administration.\n\nExclusion Criteria:\n\n1. Tumors originating from nasopharyngeal, paranasal, nasal or salivary glands, thyroid or parathyroid lesions, skin, unknown primary squamous cell carcinoma or non-squamous histology (e.g., mucosal melanoma);\n2. Peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0);\n3. Have received any of the following treatments:\n\n   * Received intravenous antibiotic therapy within 7 days prior to initial dosing;\n   * Investigational drugs that have received other clinical trials within 4 weeks prior to initial dosing;\n   * have received live attenuated vaccine within 4 weeks prior to first administration, and are allowed to receive inactivated seasonal influenza vaccine or approved COVID-19 vaccine without live virus;\n   * Received systemic immunostimulatory drugs (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to initial administration;\n   * Had major surgery (e.g., transabdominal, thoracic, etc., excluding diagnostic puncture, infusion device implantation, or digestive home implantation) within 4 weeks prior to initial dosing, or expected to require major surgery during the study period; Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug that targets T-cell co-stimulation or immune checkpoint pathways;\n4. A history of other primary malignancies within the past 3 years, excluding basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ that has been completely and radically resected;\n5. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident\u002Fstroke\u002Fmyocardial infarction, unstable angina, congestive heart failure (NYHA Class II and above), or severe arrhythmia requiring medication within the first 6 months of enrollment;\n6. Evidence of active infection includes hepatitis B (HBsAg positive with HBV DNA≥2000 IU\u002Fml, excluding hepatitis due to drugs or other causes), hepatitis C (HCV positive with anti-HCV antibody), hepatitis B (HCV positive with HBV DNA≥2000 IU\u002F mL), and hepatitis C (HCV positive with HBV DNA≥2000 IU\u002F mL). HCV RNA results greater than the lower limit of detection) or human immunodeficiency virus (HIV) infection; Uncontrolled active bacterial, other viral, fungal, rickettsial, or parasitic infections, unless treated and resolved prior to administration of the investigational drug;\n7. Loss of more than 10% of body weight in the 4 weeks prior to the first dose (unless appropriate nutritional support measures are taken);\n8. Active gastrointestinal bleeding, or bleeding requiring more than 2 red blood cell transfusions or 4 units of compressed red blood cell transfusions within the first 4 weeks;\n9. Patients with a history of primary immunodeficiency or active autoimmune disease who were taking immunosuppressants or systemic hormone therapy (dose ≥10 mg\u002F day of prednisone or other equivalent hormone) and continued to use it within 2 weeks prior to enrollment; Attention: Patients with type I diabetes, stable hypothyroidism with hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis, vitiligo, or psoriasis that does not require systemic treatment may be enrolled with topical or inhaled corticosteroids, or short-term (≤7 days) corticosteroids for prevention or treatment of non-autoimmune diseases. And infrequent allergic diseases are excluded. ;\n10. A history of grade 3 allergy to any component of MRG003, Ptrelizumab injection, and\u002For cisplatin injection;\n11. Previous history of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.;\n12. History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. After careful evaluation, patients who received autologous hematopoietic stem cell transplantation (HSTC) ≥ 5 years ago and who have normal bone marrow function (independent of transfusion) may be considered for study participation;\n13. Other conditions deemed unsuitable for participation in this clinical trial by the investigator, including but not limited to serious mental illness, central nervous disorder, substance abuse, etc.","70 Years",{"count":82,"type":21},30,[24],"A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.",[86],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[88,30,89,90,91],"Locally Advanced EGFR-positive HNSCC","Antibody-drug conjugate","immunotherapy","chemotherapy","2024-07-30",{"date":94,"type":37},"2024-07-31",{"date":96,"type":21},"2024-08-01",{"date":98,"type":21},"2027-12-31",{"name":43,"class":44},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":121,"locationsCount":4},"100555277","phase-2-a-phase-ii-study-of-anti-egfr-antibody-drug-conjugate-adc-combine-with-cdk46-inhibitors-posterior-line-in-the-treatment-of-recurrentmetastatic-cdkn2a-gene-variant-head-and-neck-squamous-cell-carcinoma-100555277","NCT06509997","A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4\u002F6 Inhibitors Posterior Line in the Treatment of Recurrent\u002FMetastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma","MRG003 Combined With Dalpicicilip Posterior Line in the Treatment of Recurrent\u002FMetastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial","Inclusion Criteria:\n\n1. 18 years old ≤75 years old;\n2. Patients with recurrent or metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx, larynx, etc.) confirmed by histology or cytology, recurrent patients cannot receive local treatment such as surgery or radiotherapy, and have failed to receive PD-1 (L1) inhibitors and\u002For platinum drugs in the past, which can be first-line combination regimens or sequential administration. Progression after receiving PD-1 (L1) inhibitors and\u002For platinum-based drugs;\n3. Receive ≤2 lines of treatment;\n4. ECOG score 0\\~1;\n5. Lack of CDKN2A function;\n6. At least one evaluable lesion according to RECIST (version 1.1) criteria;\n7. Adequate organ function;\n8. The expected survival time is greater than 3 months;\n9. No serious organic heart disease or arrhythmia;\n10. Women of childbearing age (15-49 years) must undergo a pregnancy study within 7 days before starting treatment and the results are negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment;\n11. Obtain the \"informed consent\" voluntarily signed by the patient.\n\nExclusion Criteria:\n\n1. ≥ grade 2 peripheral neuropathy (according to CTCAE 5.0).\n2. Surgery or any other form of systemic or local anti-tumor therapy, including maintenance therapy or radiotherapy for head and neck squamous cell carcinoma (including palliative care, except palliative care for non-target lesions), is expected to be required during the study period.\n3. Systematic chemotherapy was received within 3 weeks before the first administration of the drug, small molecule targeted therapy was received within 2 weeks before the first administration or 5 half-lives (depending on the time), antitumor biotherapy, macromolecule targeted therapy or immunotherapy was received within 4 weeks before the first administration of the drug. Or major surgery (except minor surgery performed within 2 weeks and complete recovery); Radiotherapy was received within 14 days prior to initial administration of the investigational drug (except for central nervous system radiotherapy, which required a washout period of ≥28 days).\n4. Known to have active central nervous system metastasis and\u002For cancerous meningitis. Patients with treated BMS may participate in the study if their condition is stable and they do not:\n\n   * Progressive or new neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headache;\n   * MRI shows evidence of enlargement at least 4 weeks before first dosing and at least 14 days before study drug dosing Corticosteroids are required.\n5. Residual toxic effects (except alopecia, fatigue and grade 2 hypothyroidism) caused by previous antitumor therapy (including immunotherapy, targeted therapy, chemotherapy or radiotherapy) or clinically significant laboratory test outliers higher than grade 1 (CTCAE v5.0).\n6. Uncontrolled or poorly controlled heart disease, including a history of congestive heart failure (CHF) ≥2 (CTCAE v5.0 or New York Heart Association rating), myocardial infarction, unstable angina, ventricular tachycardia or tip twisting ventricular tachycardia, or arrhythmias requiring treatment within the 6 months prior to admission, For example, men with QTcF \\> 450 ms and women with QTcF \\> 470 ms have complete left bundle branch block or third-degree atrioventricular block. QTcF= QT\u002F (RR\\^0.33).\n7. Pulmonary embolism or deep vein thrombosis (except for catheter-derived thrombosis at infusion port or PICC) occurred within 3 months prior to the first administration of the drug.\n8. There is a known prior history of malignancy (except in patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, carcinoma in situ, or papillary carcinoma of the thyroid who have undergone radical surgery), unless the patient has received potentially curable therapy and has been free of disease recurrence for 5 years since starting treatment. Note: The 5-year recurrence-free time requirement does not apply to head and neck squamous cell carcinoma in patients enrolled in this trial.\n9. Any serious or uncontrolled systemic disease, including uncontrolled or poorly controlled hypertension (such as systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg), glycosuria (glycated blood red and egg white (HbA1c) \\>8%), etc.\n10. Patients with a history of active bleeding, clotting disorders, or receiving coumarin anticoagulant therapy.\n11. Known allergic reactions to any component or excipient of MRG003 (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride and polysorbate 80), or grade ≥3 allergic reactions to other prior anti-EGFR drugs (including investigational drugs) or to other monoclonal antibodies.\n12. Known active hepatitis B or C. Active hepatitis B is defined as known HBsAg positive and HBV DNA≥500 IU\u002FmL. Active hepatitis C is defined as a known positive hepatitis C antibody and a known quantitative hepatitis C virus HCV RNA result greater than the lower limit of detection. Other serious liver diseases are present, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH).\n13. Concurrent severe, uncontrolled infection or known human immunodeficiency virus (HIV) (HIV antibody positive) infection, or a diagnosis of acquired immune deficiency syndrome (AIDS); Or uncontrolled autoimmune disease; Have previously received an allogeneic tissue\u002Forgan transplant, stem cell or bone marrow transplant, or have previously received a solid organ transplant.\n14. Active bacterial, viral, fungal, rickettsial, or parasitic infections requiring systemic anti-infective therapy (unless treatment is obtained and resolves prior to administration of the investigational drug).\n15. The live virus vaccine was administered within 30 days prior to the first administration of the investigational drug. Seasonal influenza vaccines or approved COVID-19 vaccines that allow the use of inactivated viruses must be at least one week from the time of first administration.\n16. A history of interstitial pneumonia, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, and symptomatic bronchospasm.\n17. Immunological based treatment for any reason, including long-term use of a systemic steroid equivalent to \\>10 mg\u002F day of prednisone within 7 days before the first administration of the study drug or at any time during study participation. Note: Inhaled or topical steroids or systemic corticosteroids equivalent to ≤10 mg\u002F day of prednisone are permitted, as are short-term corticosteroids equivalent to \\>10 mg\u002F day of prednisone (e.g., prodromal administration before contrast agent administration).\n18. Uncontrolled pleural, abdominal, pelvic or pericardial effusions require drainage ≥ once a month.\n19. Patients who have tested positive for pregnancy or are breastfeeding. Women and men who do not plan to use adequate contraception during treatment and within 180 days after the last treatment.\n20. Any other illness or clinically significant laboratory parameter abnormality, serious medical or psychiatric illness\u002Fcondition, and substance abuse, including alcohol abuse, that the investigator believes could compromise patient safety, study integrity, affect patient participation in the study or interfere with the purpose of the study and analysis of the results.",{"count":82,"type":21},[24],"A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent\u002Fmetastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC). The objective of this study was to evaluate the safety and efficacy of MRG003 combined with the Dalpicicilip posterior line in the treatment of recurrent\u002Fmetastatic CDKN2A gene variant HNSCC.",[27],[112,113,114,89,115],"Recurrent\u002Fmetastatic head and neck squamous cell carcinoma","CDKN2A gene variant","CDK4\u002F6 inhibitor","EGFR inhibitor","2024-07-18",{"date":118,"type":37},"2024-07-19",{"date":96,"type":21},{"date":98,"type":21},{"name":43,"class":44},""]