[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-squamous-cell-carcinomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-squamous-cell-carcinomas":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,65,90,116],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100653701","phase-2-a-study-of-bl-m08d1-in-patients-with-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-and-other-solid-tumors-100653701",false,"NCT07788950","A Study of BL-M08D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the requirements of the protocol;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) and other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions obtained within 3 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction; left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol-specified requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and must be non-lactating; all trial participants (both male and female) must agree to use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;\n15. Participants must be capable of and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures as required by the protocol.\n\nExclusion Criteria:\n\n1. Received chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe cardiac or cerebrovascular disease;\n3. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosed with another malignant tumor within 5 years prior to the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension poorly controlled by antihypertensive medication;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or currently diagnosed with ILD, or grade ≥2 radiation pneumonitis;\n10. Severe impairment of respiratory function;\n11. Active central nervous system (CNS) metastases;\n12. Prior or concurrent central nervous system lesions;\n13. Participants with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;\n14. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n15. Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;\n16. Active infections requiring systemic therapy within 4 weeks prior to the first dose of study drug;\n17. Pleural, peritoneal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of study drug;\n18. Imaging findings suggest tumor invasion or encasement of abdominal, thoracic, or other major vessels;\n19. Received another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n20. Pregnant or breastfeeding women;\n21. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase II study is a clinical trial exploring the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic squamous cell carcinoma of the head and neck and other solid tumors.",[27,28],"Head and Neck Squamous Cell Carcinomas","Solid Tumors","NOT_YET_RECRUITING","2026-08-25",{"date":32,"type":33},"2026-08-27","ACTUAL",{"date":35,"type":21},"2026-09",{"date":37,"type":21},"2028-12",{"name":39,"class":40},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"100552124","phase-1-a-study-of-bl-b16d1-in-patients-with-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-and-other-solid-tumors-100552124","NCT06469008","A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Gender is not limited;\n3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);\n4. Expected survival time ≥3 months;\n5. Patients with pathologically and\u002For cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors who failed or could not receive standard treatment;\n6. Agreed to provide primary tumors or metastases 3 years archive of tumor tissue samples or fresh tissue samples;\n7. Must have at least one accord with RECIST v1.1 define measurable lesions;\n8. ECOG physical status 0 or 1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulating factor therapy within 14 days before screening;\n12. Blood coagulation function: international standardization ratio (INR) 1.5 or less, and the part activated clotting time (APTT) live enzymes ULN 1.5 or less;\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All the patients (no matter male or female) shall be 6 months after the end of the treatment period and adequate precautions.\n\nExclusion Criteria:\n\n1. Antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;\n2. History of severe heart disease;\n3. QT prolongation, complete left bundle branch block, III degree atrioventricular block;\n4. Active autoimmune and inflammatory diseases;\n5. Before the first delivery within 5 years diagnosed as other malignant tumor;\n6. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg);\n7. Patients with poor glycemic control;\n8. Present with grade ≥1 radiation pneumonitis according to the RTOG\u002FEORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;\n9. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n10. There is activity of the central nervous system symptoms;\n11. Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B16D1;\n12. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);\n13. Previous anthracycline-based adjuvant therapy (new), the cumulative dose anthracycline-based drugs \\> 360 mg\u002Fm2;\n14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;\n15. Severe infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;\n16. Patients with massive or symptomatic effusions or poorly controlled effusions;\n17. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);\n18. Had the following ocular diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;\n19. Other circumstances that the investigator deemed inappropriate for participation in the trial.",{"count":50,"type":21},21,[52],"PHASE1","This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of BL-B16D1 in recurrent or metastatic head and neck squamous cell carcinomas and other solid tumors.",[27,55],"Solid Tumor","RECRUITING","2025-09-17",{"date":59,"type":33},"2025-09-18",{"date":61,"type":33},"2024-06-27",{"date":63,"type":21},"2026-07",{"name":39,"class":40},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100483994","phase-3-tislelizumab-combined-with-chemotherapy-followed-by-surgery-versus-up-front-surgery-in-resectable-head-and-neck-squamous-cell-carcinoma-reduction-i-100483994","NCT05582265","Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)","A Phase 3, Prospective，Multicenter, Randomized Open-Label Trial to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Chemotherapy Followed By Surgery Versus Up-Front Surgery as Treatment for Resectable Head And Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\nHave a histologically confirmed diagnosis of HNSCC which is planned for treatment with curative intent including surgical resection: stage III\u002FIVA.\n\nGreater than or equal to 18 and less than 80 years of age at time of study entry.\n\nECOG performance status of 0 or 1. Measurable disease as per RECIST 1.1. Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines.\n\nScreening labs must meet the following criteria and must be obtained within 14 days prior to registration:\n\nAdequate hepatic and renal function as demonstrated by\n\nSerum creatinine \\\u003C 1.5 X ULN or CrCl \\> 40mL\u002Fmin (if using the Cockcroft-Gault formula below):\n\nMales: Creatinine CL (mL\u002Fmin) = (Weight (kg) x (140 - Age))\u002F(72 x serum creatinine (mg\u002FdL)） Females: Creatinine CL (mL\u002Fmin) = (Weight (kg) x (140 - Age))\u002F(72 x serum creatinine (mg\u002FdL))x 0.85 AST\u002FALT ≤ 3 x ULN Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n\nAdequate bone marrow function as demonstrated by:\n\nAbsolute Neutrophil Count \\>1,500\u002FµL Platelets \\> 100 X 103\u002FµL Hemoglobin \\> 9.0 g\u002FdL Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 21 days of study enrollment.\n\nWomen of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; \"women of reproductive potential\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL.\n\nMen of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception.\n\nAbility to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nSubject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nSubjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes. In addition, subjects must consent to allow use of their residual post-operative tissue for research purposes.\n\nExclusion Criteria:\n\nIs currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n\nHas had another known invasive malignancy within the previous 5 years and\u002For has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.\n\nIf subject received major surgery for any other reason, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n\nSubjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n\nHas an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.\n\nActive, known or suspected autoimmune disease. Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger .\n\nHas evidence of interstitial lung disease or active, non-infectious pneumonitis.\n\nHas an active infection requiring systemic therapy. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.\n\nA history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.\n\nHas a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n\nHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\nIs pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.\n\nHas a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1\u002F2 antibodies).\n\nHas known active Hepatitis B or C. Known history of active TB (bacillus tuberculosis ).","80 Years",{"count":74,"type":21},537,[76],"PHASE3","A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.",[27],"2024-05-16",{"date":81,"type":33},"2024-05-17",{"date":83,"type":33},"2022-10-28",{"date":85,"type":21},"2030-10",{"name":87,"class":88},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",3,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":41},"100538974","phase-2-myeloprotection-with-trilaciclib-in-pan-cancer-population-100538974","NCT06297811","Myeloprotection With Trilaciclib in Pan-cancer Population","Efficacy and Safety of Trilaciclib in Myeloprotection During Chemotherapy for Advanced\u002FRecurrent Malignant Solid Tumors - A Phase II Study","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;\n3. Histologically or cytologically confirmed advanced or recurrent solid malignant tumors, including:\n\n   * Unresectable stage III\u002FIV non-small cell lung cancer (NSCLC);\n   * Recurrent or metastatic breast cancer (BC);\n   * Newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IC-IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer without further surgical planning before disease progression; or recurrent platinum-sensitive ovarian cancer (OC);\n   * FIGO stage III-IV or recurrent endometrial cancer (EC), including endometrioid carcinoma and serous or clear cell carcinoma;\n   * FIGO stage IVB (including persistent) or recurrent cervical cancer (CC) (≤ 1 prior platinum-based therapy) not amenable to radical surgery or radiotherapy;\n   * Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (including primary lesions located in the larynx, oropharynx, hypopharynx, oral cavity, undifferentiated or poorly differentiated nasopharyngeal carcinoma, and salivary gland carcinoma), which is not suitable for further surgery or radiotherapy.\n4. At least one measurable lesion according to RECIST version 1.1;\n5. Received up to one prior systemic chemotherapy and no prior paclitaxel plus carboplatin chemotherapy;\n6. Adequate organ function meeting the following criteria: (1) adequate bone marrow function: Hb ≥ 100 g\u002FL (no ESA or blood transfusion within 14 days before the first dose); ANC ≥ 2 × 10\\^9\u002FL (no G-CSF within 14 days before the first dose); platelet count ≥ 100 × 10\\^9\u002FL (no rhTPO, rhIL-11 or platelet transfusion within 14 days before the first dose); (2) adequate liver and kidney function: alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula); (3) adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%;\n7. Life expectancy ≥ 3 months;\n8. Females of childbearing potential agree to practice reliable contraception during the clinical trial and have a negative serum or urine pregnancy test within 7 days prior to dosing;\n9. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. History of myeloid leukemia, myelodysplastic syndrome, or concomitant sickle cell disease;\n2. Symptomatic CNS metastases and\u002For leptomeningeal disease requiring immediate radiation or steroid therapy;\n3. Received surgery or radiotherapy within 4 weeks prior to the first dose of study drug;\n4. Receipt of any investigational drug ≤ 30 days or ≤ 5 half-lives (whichever is longer) prior to the first dose of study drug;\n5. Platinum-resistant OC (refractory to 1 line of platinum-based chemotherapy or recurrent platinum-based chemotherapy within 6 months prior to the first dose of study drug);\n6. Requires concurrent radiotherapy;\n7. Known history of hypersensitivity to the drug components of this protocol;\n8. Pregnant or lactating women;\n9. Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.",{"count":98,"type":21},132,[24],"The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:\n\n* effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy\n* does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type\n\nParticipants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic\u002FPD-X\u002Fanti-HER2 therapy.",[102,103,104,105,106],"Non-Small Cell Lung Cancer","Breast Cancer","Endometrial Cancer","Cervical Cancer","Head And Neck Squamous Cell Carcinomas","2024-02-29",{"date":109,"type":33},"2024-03-07",{"date":111,"type":21},"2024-03-01",{"date":113,"type":21},"2027-12-31",{"name":115,"class":88},"Sun Yat-sen University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100438690","phase-2-a-study-of-toripalimab-as-consolidation-therapy-after-postoperative-chemoradiotherapy-in-hnscc-100438690","NCT04992559","A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC","A Phase II, Open-Label, Single-arm Study of Toripalimab As Consolidation Therapy After Postoperative Radiotherapy or Chemoradiotherapy in Patients With Head and Neck Squamous Cell Carcinomas (HNSCC)","Inclusion Criteria:\n\n* Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma.\n* Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.\n* Greater than or equal to 18 and less than 70 years of age at time of study entry.\n* ECOG performance status of 0 or 1.\n* Measurable disease as per RECIST 1.1.\n* Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:\n\n  1. Adequate hepatic and renal function as demonstrated by\n\n     1. Serum creatinine \\\u003C 1.5 X ULN or CrCl \\> 40mL\u002Fmin (if using the Cockcroft-Gault formula below):\n\n        * Males: Creatinine CL (mL\u002Fmin) = (Weight (kg) x (140 - Age))\u002F(72 x serum creatinine (mg\u002FdL)）\n        * Females: Creatinine CL (mL\u002Fmin) = (Weight (kg) x (140 - Age))\u002F(72 x serum creatinine (mg\u002FdL))x 0.85\n     2. AST\u002FALT ≤ 3 x ULN\n     3. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  2. Adequate bone marrow function as demonstrated by:\n\n     1. Absolute Neutrophil Count \\>1,500\u002FµL\n     2. Platelets \\> 100 X 103\u002FµL\n     3. Hemoglobin \\> 9.0 g\u002FdL\n* Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 7 days of study enrollment.\n* Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 3 months after the last dose of study drugs; \"women of reproductive potential\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL.\n* Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 3 months after the last dose of study drugs; men who are azoospermic do not require contraception.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had another known invasive malignancy within the previous 5 years （With the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid, which has been cured）.\n* If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Active, known or suspected autoimmune disease.\n* Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has received prior therapy with an anti-PD-1 antibody .\n* A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B or C.\n* Known history of active TB ( bacillus tuberculosis ).","70 Years",{"count":125,"type":21},41,[24],"This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).",[27],"2023-04-13",{"date":131,"type":33},"2023-04-14",{"date":133,"type":33},"2021-06-22",{"date":135,"type":21},"2027-05-01",{"name":87,"class":88},2]