[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-cancer-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-cancer-squamous-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,64,92,116,145,173,200,221],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100589797","phase-2-efficacy-and-safety-evaluation-of-vs-101-in-combination-with-chemoradiotherapy-in-patients-with-head-and-neck-cancer-100589797",false,"NCT06959082","Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer","A Multi-center, Randomized, Open-label, Parallel-group, Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination With Chemoradiotherapy (CRT) in Patients With Head and Neck Cancer","Inclusion Criteria:\n\n1. Males or females aged more than 18 years at the time of ICF signing\n2. Diagnosed based on position emission tomography (PET), computed tomography (CT), or magnetic resonance imaging (MRI) with pathologically confirmed (histologic or cytological) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx\n3. Defined by American Joint Committee on Cancer \\[AJCC\\] Guidelines 8th Edition:\n\n   * Oral cavity, hypopharynx, or larynx (independent of p16): Stage III, IVa, IVb per TNM guidelines; or\n   * Oropharyngeal p16 negative disease: Stage III, IVa, IVb per TNM guidelines; or\n   * Oropharyngeal p16 positive disease: Stage III per TNM guidelines\n4. Have measurable disease based on RECIST 1.1\n5. Participants with head and neck cancer who have limited to those receiving definitive CRT without surgical excision\n6. Participants prescribed standard intensity-modulated radiation therapy (IMRT) with a cumulative planned dose of approximately 70 Gy\n7. Participants with Eastern Cooperative Oncology Group (ECOG) Performance Statue (PS) of 0 \\~ 2\n8. Participants with the status of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 Grade 2 if stable and not clinically significant, or lower for acute or chronic adverse reaction at the time of screening\n9. Participants with an expected survival period of at least 20 weeks\n10. Participants who can comply with the requirements of the clinical trial protocol\n11. Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Medical History\n\n   1. Patients with a history of prior radiation to the head and neck region which overlap with the planned radiation fields (or cumulative doses exceed the constraints for organs-at-risk \\[OAR\\]) or with a known susceptibility to radiation.\n   2. Patients with active or uncontrolled or clinically significant medical or psychiatric disorders that, in the investigator's opinion, may interfere with informed consent, adherence, or patient safety. Stable medical or psychiatric conditions under a stable dose regimen are permitted.\n   3. Patients with a history of uncontrolled seizure disorder. Patients with a remote history of a single provoked seizure or well-controlled seizures on stable monotherapy may be eligible.\n   4. Patients who are unable to swallow the study tablet at the screening visit, unless a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube is already in place for clinically indicated reasons and the patient is clinically stable.\n2. Patients who show abnormalities in the following test results at the time of screening:\n\n   1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5 × upper limit of normal (ULN)\n   2. Creatine clearance ≤50 mL\u002Fmin (using Cockcroft-Gault (C-G) formula)\n   3. Absolute neutrophil count (ANC) \\\u003C1,500\u002FµL\n   4. Platelets \\\u003C100,000\u002FµL\n   5. Hemoglobin \\\u003C9 g\u002FdL\n   6. Serum calcium \\>1.5 × ULN\n   7. Total bilirubin \\> 2 × ULN\n   8. Prothrombin time (PT) (International Normalized Ratio \\[INR\\]) \\>1.5 × ULN or activated partial thromboplastin time (aPTT) (sec)\n   9. Positive result for serum tests (hepatitis B or C virus, human immunodeficiency virus \\[HIV\\], rapid plasma reagin \\[RPR\\] test)\n   10. Patients who show significant abnormalities in electrocardiogram (ECG) test results (e.g.,QTcF \\> 450 msec)\n3. Patients who received hypofractionated chemoradiation regimens (\\> 2 Gy per day) Note：If it is established that the abnormal lab values are a consequence of their underlying malignant disease rather than any other co-existing condition, reflect minor variations attributable to individual differences or testing conditions, and is not considered clinically significant, the Principal Investigator (PI) may discuss the case with the Medical Monitor to determine eligibility.\n4. Patients with known hypersensitivity to components or excipients of clinical investigational drugs\n5. Participants with a history of drug addiction within 3 months before ICF signing, unless a Urine drug screen negative result is obtained prior to randomization\n6. Contraindicated Drugs and Treatments:\n\n   1. Participants who have administered strong cytochrome P450 (CYP) 3A4 or CYP2D6 inducers or inhibitors within 14 days of baseline or 5 times the drug's half-life, whichever is longer.\n   2. Participants who received chemotherapy within 14 days of baseline (drugs or treatment known to have anticancer effects such as cytotoxic chemotherapy, antihormonal therapy, and targeted therapy).\n   3. Participants who required intravenous antibiotics, antivirals, or antifungals for active or uncontrolled infection at baseline.\n   4. Participants who have administered benzodiazepines (e.g., lorazepam) that causes clinically significant sedation (stable low dose is permitted).\n   5. Participants who participated in another clinical trial within 4 weeks of the baseline and administered the clinical trial drug\n7. Participants and their spouses (or partners) with childbearing potential who are not using medically acceptable methods of contraception for the duration of the trial and for 14 months (in female participants) and 11 months (in male participants) after the last dose of cisplatin treatment\n8. Participants who, in the judgment of other investigators, are not suitable to participate in the study\"","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.",[26],"Head and Neck Cancer Squamous Cell Carcinoma","RECRUITING","2026-06-17",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2027-06",{"name":37,"class":38},"VSPharmTech Co.,Ltd.","INDUSTRY",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100628108","phase-2-a-study-testing-emactinib-sulfate-with-chemotherapy-and-immunotherapy-before-surgery-for-advanced-head-and-neck-cancer-100628108","NCT07457346","A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer","A Pilot Trial of Neoadjuvant Sulfate Emactinib Plus Chemo-immunotherapy for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck.","Inclusion Criteria:\n\n1. ECOG Performance Status of 0-1.\n2. Histologically and\u002For cytologically confirmed Stage III-IVA head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx).\n3. Classified according to the Asia-Pacific multidisciplinary consensus (Y.Guo et al., Oral Oncol 2024):\n\n   * Cohort A: Resectable\\*\\* (amenable to upfront surgery): T2N2-3M0, T3-4N0-2M0 (AJCC 8th edition).\n   * Cohort B: Potentially Resectable:\\*\\* Cases with relative contraindications to surgery (e.g., cervical lesion directly invading skin, anterior 2\u002F3 tongue tumor extending below the hyoid level, extension to the vallecula) or where surgery would cause significant disfigurement\u002Ffunctional loss, requiring discussion by an MDT (head \\& neck surgery, radiology) to weigh risks vs. non-surgical options.\n   * Cohort C: Unresectable: Tumor extensively invading skull base, extending to nasopharynx\u002Fdeep nasopharyngeal wall, invading\u002Fencasing carotid artery, extending to mediastinal structures, prevertebral fascia, or cervical spine; T3-4 (N0-3) or any N2a-3 (T1-4) M0 (AJCC 8th edition).\n4. Biomarker: Peripheral blood flow cytometry analysis showing that PD-1+TIM-3+CD8+ exhausted T cells account for \\>10% of CD8+ T cells.\n5. Adequate baseline organ function within 14 days prior to enrollment:\n\n   * Hematological: White Blood Cell count (WBC) ≥4000\u002FμL, Absolute Neutrophil Count (ANC) ≥2000\u002FμL, Hemoglobin (HGB) ≥9 g\u002FdL, Platelet count (PLT) ≥100,000\u002FμL.\n   * Renal: Serum creatinine \\\u003C1.5 times the Upper Limit of Normal (ULN) OR Creatinine Clearance (CrCl) \\>60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n   * Hepatic: Total bilirubin ≤1.5x ULN (except subjects with Gilbert's syndrome, who may have total bilirubin \\\u003C3x ULN); Aspartate Aminotransferase (AST) \u002F Alanine Aminotransferase (ALT) ≤3x ULN; Alkaline Phosphatase (ALP) ≤3x ULN; Albumin (ALB) ≥3 g\u002FdL.\n6. Ability to understand and willingness to sign the Informed Consent Form. Subjects must be willing and able to comply with the protocol, including receiving treatments and scheduled visits\u002Fexaminations, including follow-up.\n\nExclusion Criteria:\n\n1. Prior treatment with immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 agents) or JAK inhibitors. History of severe allergic reactions to any component of monoclonal antibodies.\n2. Active autoimmune disease or condition requiring immunosuppressive therapy. Subjects requiring systemic corticosteroids or other immunosuppressive drugs prior to enrollment.\n3. History of other active malignancies or active infections (including tuberculosis and hepatitis); uncontrolled infections (HIV, HBV, HCV).\n4. Severe cardiac or pulmonary dysfunction, including severe cardiac insufficiency (e.g., NYHA Class III or higher) or severe pulmonary dysfunction (e.g., FEV1 \\\u003C50% predicted); history of thrombotic diseases, coagulation disorders (Prothrombin Time (PT) \\>16 seconds, Activated Partial Thromboplastin Time (APTT) \\>53 seconds, Thrombin Time (TT) \\>21 seconds, Fibrinogen (FIB) \\\u003C1.5 g\u002FL), bleeding tendency, or current thrombolytic\u002Fanticoagulant therapy.\n5. Pregnant or lactating women. Subjects unwilling to use effective contraception during the study period.","75 Years",{"count":49,"type":20},76,[23],"The goal of this clinical trial is to evaluate the efficacy and safety of a novel combination therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). The therapy combines the JAK1 inhibitor Sulfamethoxazole, the anti-PD-L1 antibody Adebrelimab, and chemotherapy (Nab-paclitaxel + Cisplatin) as a neoadjuvant treatment (given before surgery). The main questions it aims to answer are:\n\n* For patients with resectable locally advanced HNSCC: Can this combination improve the pathological complete response (pCR) rate (the absence of viable cancer cells in the surgical specimen) compared to current neoadjuvant therapies?\n* For patients with potentially resectable or unresectable locally advanced HNSCC: Can this combination improve the objective response rate (ORR) (the percentage of patients with significant tumor shrinkage), potentially making surgery possible or reducing its scope?\n\nResearchers will also assess secondary outcomes including event-free survival (EFS), overall survival (OS), and the safety profile of the combination.\n\nParticipants will:\n\n* Receive neoadjuvant treatment with the combination of Sulfamethoxazole, Adebrelimab, and chemotherapy. A key feature is the timed sequencing of the JAK inhibitor, which will be started on day 8 of each treatment cycle.\n* Be evaluated for surgery after the neoadjuvant treatment. For those who undergo surgery, the pathological response will be analyzed.\n* Have regular follow-up assessments, including imaging studies (such as CT or MRI scans) and safety monitoring, to evaluate long-term treatment response, survival, and side effects.\n* Provide tissue and\u002For blood samples for exploratory biomarker analysis (e.g., Interferon-Stimulated Gene signature) to help identify patients who benefit most from this treatment.",[26],"2026-03-04",{"date":55,"type":31},"2026-03-09",{"date":57,"type":31},"2026-01-01",{"date":59,"type":20},"2030-08-30",{"name":61,"class":62},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":63},"100622993","phase-1-a-study-of-sh009-injection-in-patients-with-advanced-solid-tumors-100622993","NCT07390838","A Study of SH009 Injection in Patients With Advanced Solid Tumors.","An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n* (1) Age≥18 years old at the time of informed consent, male or female;\n* (2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy;\n* (3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy;\n* (4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analyses;\n* (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;\n* (6) Life expectancy ≥12 weeks;\n* (7) Bone marrow function meets the following criteria: neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 90 × 10\\^9\u002FL (platelet count ≥ 75 × 10\\^9\u002FL in patients with liver cancer); hemoglobin (Hb) ≥ 90 g\u002FL;\n* (8) Liver function meets the following criteria: total bilirubin(TBIL) ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome); aspartate aminotransferase (AST) and alanine and aminotransferase (ALT) ≤ 3 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver cancer or liver metastases);\n* (9) Renal function meets the following criteria: serum creatinine clearance(CLcr) ≥ 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula); urine dipstick test results show that urine protein \\\u003C 2 +, urine protein ≥ 2 + subjects should undergo 24-hour urine collection and urine protein content \\\u003C 1g within 24 hours;\n* (10) Coagulation function meets the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5× ULN;\n* (11) Female subjects of childbearing potential must use effective contraception during the trial and for 6 months after the last dose, and have a negative pregnancy test within 7 days before treatment initiation (except those who are surgically sterilized or postmenopausal). Male subjects must agree to use effective contraception during the trial and for 6 months after the last dose;\n* (12) The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form.\n\nExclusion Criteria:\n\n* (1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47\u002FSIRPα recombinant protein;\n* (2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose;\n* (3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks. Mitomycin or nitrosoureas within 6 weeks. Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer).Chinese\u002Fherbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area;\n* (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period;\n* (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo elective surgery during the trial period;\n* (6) Patients who received systemic glucocorticoids (dexamethasone \\> 10 mg\u002F day or equivalent dose of the same drug) or other immunosuppressive therapy within 14 days before the first administration; except for topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast allergy);\n* (7) Symptomatic brain parenchymal or leptomeningeal metastases, deemed by the investigator as unsuitable for enrollment;\n* (8) Prior immunotherapy with ≥Grade 3 irAE or ≥Grade 2 immune-related myocarditis;\n* (9) Severe or uncontrolled systemic disease, including but not limited to: uncontrolled pleural or peritoneal effusion; uncontrolled diabetes; ventricular arrhythmia requiring intervention; acute coronary syndrome, congestive heart failure, stroke, or other ≥Grade 3 cardiovascular event within 6 months; NYHA Class ≥II or LVEF \\\u003C50%; clinically significant QTcF prolongation or arrhythmia risk (baseline QTcF \\>450 msec for males or \\>470 msec for females); clinically uncontrolled hypertension (SBP \\>160 mmHg and\u002For DBP \\>90 mmHg after treatment) as judged by the investigator. Subjects judged by the investigator as unsuitable due to any such condition;\n* (10) History of pneumonia requiring hormone therapy or interstitial lung disease (including past and current history); active pulmonary infection;\n* (11) Active infection requiring intravenous anti-infective therapy within 1 week prior to study drug administration (fever attributed to the tumor per investigator's judgment is acceptable). History of self-limited infections that have resolved is acceptable;\n* (12) Active Hepatitis B, Hepatitis C, or syphilis infection. Subjects positive for HBeAb or HBsAg are eligible if HBV-DNA ≤200 IU\u002FmL. Subjects positive for HCV-Ab are eligible if HCV-RNA ≤ the upper limit of normal at the research center. Subjects with hepatocellular carcinoma and HBV-DNA ≥2000 IU\u002FmL must receive antiviral\u002Fhepatoprotective therapy first and can only enroll after HBV-DNA decreases to \\\u003C2000 IU\u002FmL;\n* (13) History of primary immunodeficiency, including positive human immunodeficiency virus (HIV) test, or suffering from other acquired, congenital immunodeficiency diseases;\n* (14) History of other malignancies within 5 years prior to the first dose, except for:\n\n  a) Any other invasive malignancy, treated with curative intent, with a disease-free interval \\>3 years and deemed by the investigator not to affect efficacy evaluation for the current tumor. b) Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or other locally cured cancers;\n* (15) History or presence of autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis or high risk (e.g., post-transplant immunosuppression). Exceptions: stable type 1 diabetes on fixed-dose insulin; autoimmune hypothyroidism on hormone replacement only; skin conditions not requiring systemic treatment (e.g., eczema, rash covering\\\u003C10% BSA, psoriasis without ocular symptoms);\n* (16) Arterial thromboembolic events within 6 months prior to the first dose, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose (catheter-related or superficial venous thrombosis is not considered \"serious\"). Receiving thrombolytic or anticoagulant therapy for high thrombotic risk;\n* (17) Subjects who had receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplant);\n* (18) According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss, pigmentation, hypothyroidism stabilized by hormone replacement therapy and peripheral neuropathy (need to recover to ≤ grade 2)). Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the study drug may be allowed after consultation with the medical monitor;\n* (19) Known history of severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies(CTCAE v5.0 Grade ≥3), or any component of the study drug;\n* (20) Known alcohol and\u002For drug dependence, or any other condition deemed by the investigator to affect the safety or compliance of the study treatment, including but not limited to psychiatric disorders;\n* (21) Pregnant or lactating women.",{"count":72,"type":20},150,[74],"PHASE1","Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors",[77,78,26,79,80,81,82],"Liver Cancer (Locally Advanced or Metastatic)","Lung Cancer (NSCLC)","Breast Cancer (Locally Advanced or Metastatic)","Esophageal Cancer","Gastric Cancer (GC)","Solid Tumor Malignancies","2026-01-28",{"date":85,"type":31},"2026-02-05",{"date":87,"type":31},"2025-05-16",{"date":89,"type":20},"2028-12-30",{"name":91,"class":38},"Nanjing Sanhome Pharmaceutical, Co., Ltd.",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":39},"100609469","phase-2-pdt-for-induction-therapy-for-head-and-neck-cancer-100609469","NCT07214987","PDT For Induction Therapy For Head And Neck Cancer","A Phase 2 Study of Toripalimab in Combination With Cisplatin and Docetaxel (PDT) for Induction Therapy in CPS-Positive Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Participants must have a new diagnosis of histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, sinonasal cavities or unknown primary HNSCC.\n* Participants with HPV-independent SCC or HNSCC or other head and neck subsites must have stage III or non-metastatic stage IV at the time of diagnosis. Participants with HPV-associated oropharynx SCC must have stage II or stage III disease.\n* Participants must be determined by the investigator to be candidates for induction systemic therapy due to reasons such as the extent of primary tumor at the time of diagnosis, rate of progression, symptom burden or potential benefit of cytoreduction prior to definitive local therapy.\n* CPS ≥ 1%\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of toripalimab in combination with cisplatin and docetaxel in participants \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status ≤ 1\n* Life expectancy of greater than 12 weeks.\n* Participants must meet the following organ and marrow function as defined below:\n\nHemoglobin ≥8.0 g\u002FdL absolute neutrophil count ≥1500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ 2 institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤ 2 × institutional ULN creatinine ≤ 2 x institutional ULN OR glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73 m2\n\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because immunotherapy agents as well as cisplatin and docetaxel are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of toripalimab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Diagnosis of EBV-associated nasopharynx squamous cell carcinoma\n* Strong clinical suspicion or histologic confirmation of cutaneous squamous cell carcinoma\n* Histology other than squamous cell carcinoma.\n* Proven distant metastases (below the clavicle) by clinical or radiographic measures.\n* Prior radiotherapy to the head and\u002For neck with the exception of radiation for cutaneous malignancies involving radiation fields that do not overlap with areas of current disease involvement.\n* Pre-existing peripheral neuropathy CTCAE grade 2 or higher\n* Participants who are receiving any other investigational agents for this condition.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to toripalimab, cisplatin or docetaxel.\n* An autoimmune condition requiring treatment with systemic corticosteroids within the past 30 days. Long-term steroid replacement for patients with adrenal insufficiency is allowed.\n* Any second malignancy that required antineoplastic therapy in the previous 6 months.\n* Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Pregnant women are excluded from this study because toripalimab, cisplatin and docetaxel have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with toripalimab, cisplatin and docetaxel, breastfeeding should be discontinued if the mother is treated with toripalimab. These potential risks may also apply to other agents used in this study.",{"count":100,"type":20},26,[23],"This research study is being done to assess the safety and tolerability of toripalimab in combination with cisplatin and docetaxel (PDT) induction therapy for patients with CPS-positive locally advanced head and neck squamous cell carcinoma (HNSCC).",[104,26,105],"Squamous Cell Carcinoma","Head and Neck Cancer",[107],"Head and Neck Squamous Cell Carcinoma","NOT_YET_RECRUITING",{"date":110,"type":31},"2026-01-30",{"date":55,"type":20},{"date":113,"type":20},"2029-09-01",{"name":115,"class":62},"Massachusetts General Hospital",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":63},"100618864","stereotactic-post-operative-radiotherapy-for-intraparotid-metastatic-cutaneous-squamous-cell-carcinoma-100618864","NCT07337161","Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma","SPRINT","Inclusion criteria\n\n* Age ≥ 18 years\n* Patient able to provide informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patient is a candidate for curative intent treatment\n* Patient is able to comprehend English adequately to complete patient reported outcome questionnaires\n* Biopsy-confirmed cutaneous SCC\n* Definitive resection of a primary cutaneous tumor within the head and neck\n* Tumor stage T1-T4 (AJCC 8th edition); or tumor stage unknown (T0\u002FTx) with a positive intraparotid, peri-parotid or cervical node that is assumed to be from a head and neck cutaneous SCC by the treating oncologist\n* Nodal stage N1-N3 (AJCC 8th edition)\n* At least 1 indication for adjuvant radiation, including:\n\n  * T3 or T4 tumor stage\n  * Lymphovascular invasion (LVI)\n  * Perineural invasion (PNI)\n  * Positive or close (≤ 3 mm) margin\n  * ≥ 1 positive intraparotid, peri-parotid or cervical lymph node\n  * Multiple local recurrences or multi-focal disease\n* Neoadjuvant or adjuvant immunotherapy is allowed\n\nExclusion criteria\n\n* Definite metastatic disease at diagnosis\n* Pregnant or breastfeeding women\n* Significant health conditions or contraindications to receiving surgery and radiation\n* History of previous head and neck cancer within 5 years, except for localized skin cancers (i.e. no nodal or distant spread)\n* Prior head and neck radiation involving the ipsilateral parotid or neck. However, prior radiation to the index skin cancer that has led to the parotid nodal disease being treated on this trial is allowed, as long as there is no overlap, or inconsequential overlap, in the judgement of the treating oncologist.\n* Indications for contralateral neck radiation (i.e. contralateral or bilateral lymph nodes)\n* Previous invasive malignancy within 5 years, unless controlled with no evidence of disease",{"count":124,"type":20},90,[126],"NA","The purpose of this study is to compare the effectiveness and side effects of stereotactic radiotherapy (5 sessions) against conventional (standard) radiotherapy (20-30 sessions) for the treatment of skin cancer involving the head and neck after surgical resection.\n\nStereotactic radiotherapy works in the same way that conventional (standard) radiotherapy does to kill cancer cells by damaging their genetic material and stopping the cancer cells from making copies of themselves.\n\nThis study will help the study doctors find out if this different approach is the same, better, or worse than the standard of care for your cancer.",[129,26],"Cutaneous",[131,132,133,134,135],"skin","head and neck","radiation","SBRT","SABR","2026-01-06",{"date":138,"type":31},"2026-01-13",{"date":140,"type":31},"2025-10-21",{"date":142,"type":20},"2035-09-01",{"name":144,"class":62},"David Palma",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":63},"100606262","improved-oral-health-in-head-and-neck-cancer-survivors-100606262","NCT07173270","Improved Oral Health in Head and Neck Cancer Survivors","OHHNC","Inclusion Criteria:\n\n* patients (≥ 18 years)\n* diagnosed with HNC\n* scheduled for treatment with curative intent, including RT or CRT with or without surgery\n\nExclusion Criteria:\n\n* severe alcoholism\n* cognitive impairment\n* inability to understand the Swedish language",{"count":153,"type":20},300,[126],"The goal of this clinical trial is to learn if an oral care programme can prevent or reduce late oral side effects in patients with head and neck cancer following treatment. The main questions it aims to answer are:\n\n* Can additional support from hospital dental care for cancer survivors, up to three years after completion of treatment, improve patients' oral health, nutritional status, quality of life, and reduce stress and anxiety compared to standard care?\n* Are there differences in oral health outcomes between younger and older individuals receiving additional support from hospital dental care?\n* Can additional support from hospital dental care for cancer survivors, up to three years after completion of treatment, reduce the duration of sick leave and enhance patients' ability to return to work compared to standard care?\n* Can additional support from hospital dental care for cancer survivors, up to five years after completion of treatment, be cost-effective from a health economic perspective?\n\nResearchers will compare oral care programme to standard care to see if the programme works to improve oral health, reduce oral symptoms and problems, enhance quality of life and lower the economic costs of healthcare\n\nParticipants will:\n\nParticipate in an oral care programme, every three months for three years.",[26,105],[158,159,160,161,162,163],"Head and neck cancer","Nutrition","Oral health","cancer survivors","Quality of Life","healthcare costs","2025-09-08",{"date":166,"type":31},"2025-09-15",{"date":168,"type":20},"2025-09-24",{"date":170,"type":20},"2045-09-23",{"name":172,"class":62},"Uppsala University",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":63},"100604162","phase-2-neoadjuvant-immunochemotherapy-and-postoperative-adjuvant-immunotherapy-for-head-and-neck-squamous-cell-carcinoma-invading-the-skull-base-100604162","NCT07145931","Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base","Tislelizumab Combined With Chemotherapy for Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Therapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base: A Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n* Age 18 to 80 years, regardless of gender;\n* Histologically confirmed squamous cell carcinoma (including gingiva, buccal mucosa, palate, oropharynx, maxillary sinus, or maxilla\u002Fmandible) with radiological evidence of skull base invasion;\n* Measurable tumor lesions (meeting RECIST v1.1 criteria);\n* Treatment-naïve primary T4b-stage patients (N any, per AJCC 8th Edition, 2017);\n* ECOG PS score: 0-1;\n* Medically fit for surgery and chemotherapy, with no surgical contraindications;\n* Women of childbearing potential (18-49 years) must have a negative pregnancy test within 7 days before treatment. Sexually active men and women must agree to use effective contraception during the trial and for 3 months after treatment cessation;\n* Willing to provide written informed consent and comply with scheduled follow-ups, treatments, lab tests, and other study requirements.\n\nExclusion Criteria:\n\n* Previous anti-tumor treatments including chemotherapy, radiotherapy, or immunotherapy; Refusal to sign informed consent;\n* Patients who refuse the study treatment protocol; patients unable to complete treatment as planned; or patients unable to comply with regular follow-up due to psychological, social, familial or geographical reasons;\n* Patients with known allergies to any study medications;\n* Patients with poor systemic conditions unfit for treatment: as determined by routine tests (complete blood count, blood biochemistry, ECG, chest X-ray, etc.). Poor systemic conditions include: hemoglobin \\\u003C60g\u002FL, WBC \\\u003C3.0×10⁹\u002FL, platelets \\\u003C80×10⁹\u002FL, or serum creatinine \\>133μmol\u002FL - such patients may be recommended for conservative treatment;\n* Patients with autoimmune diseases requiring long-term immunosuppressive or corticosteroid therapy;\n* Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing potential);\n* Patients with current or previous malignancies (except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma);\n* Participation in other clinical trials within 30 days prior to enrollment;\n* Other conditions that may compromise patient safety or compliance as assessed by investigators, including: severe comorbidities (including psychiatric disorders), significantly abnormal laboratory results, or other high-risk familial\u002Fsocial factors.","80 Years",{"count":182,"type":20},24,[23],"This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. The primary objectives are to address the following questions:\n\n* What are the objective response rate and pathological response of tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with skull base-invading head and neck squamous cell carcinoma?\n* Can neoadjuvant therapy convert unresectable skull base-invading head and neck squamous cell carcinoma into a resectable condition?\n* Can adjuvant immunotherapy after neoadjuvant therapy prolong patients' recurrence-free survival and overall survival? The researchers will administer neoadjuvant therapy (tislelizumab combined with chemotherapy) and adjuvant immunotherapy to patients with skull base-invading head and neck squamous cell carcinoma and assess the treatment's efficacy and safety.\n\nParticipants will:\n\n* Receive neoadjuvant therapy every 3 weeks (tislelizumab 200mg on Day 1, nab-paclitaxel 260mg\u002Fm² on Day 1, cisplatin 75mg\u002Fm² on Days 1-3) for 3 cycles.\n* Undergo surgical treatment within 3 weeks after completing neoadjuvant therapy.\n* Receive (chemo)radiotherapy 4-6 weeks after surgery.\n* Receive adjuvant immunotherapy (tislelizumab 200mg) every 3 weeks after (chemo)radiotherapy for 8 cycles.",[26,186,187,188],"Skull Base--Cancer","Neoadjuvant Chemoimmunotherapy","Objective Response Rate",[26,186,187,190],"Objective response rate","2025-08-21",{"date":193,"type":31},"2025-08-28",{"date":195,"type":20},"2025-09-20",{"date":197,"type":20},"2029-09-20",{"name":199,"class":62},"Sun Yat-sen University",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":63},"100583478","phase-2-surufatinib-combined-with-envolizumab-as-second-line-treatment-for-recurrentmetastatic-hnscc-100583478","NCT06876844","Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent\u002FMetastatic HNSCC","Phase II Clinical Study on the Combination of Surufatinib and Envolizumab As Second-line Treatment for Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma","HNSCC","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria for enrollment:\n\n  1. Have fully understood the study and voluntarily signed the informed consent form;\n  2. Age: 18-75 years (calculated from the day of informed consent, including the boundary value), both male and female;\n  3. Pathologically or histologically confirmed recurrent\u002Fmetastatic head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)\n  4. Progressive or recurrent\u002Fmetastatic disease following first-line systemic therapy within 6 months of completion of concurrent chemoradiation; (first-line systemic therapy includes platinum-based chemotherapy, cetuximab plus chemotherapy, immune checkpoint inhibitors alone or in combination.)\n  5. Inability to perform salvage surgery as assessed by oral and maxillofacial surgeons or patient refusal of surgical treatment;\n  6. Patients must have at least one measurable lesion (RECIST 1.1);\n  7. ECOG performance status 0-2 score;\n  8. Expected survival ≥ 6 months;\n  9. Vital organs functioning as defined below (no blood components or cell growth factors allowed within 14 days prior to enrollment):\n* Absolute neutrophil count ≥ 1.5 x 10 9\u002FL;\n* Platelets ≥ 90 × 10 9\u002FL ;\n* Hemoglobin ≥ 9 g\u002FdL ;\n* Serum albumin ≥ 3 g\u002FdL ;\n* Bilirubin ≤ 1.5 times ULN ;\n* ALT and AST ≤ 2.5 times ULN ; ( ALT and AST ≤ 5 times ULN if liver metastases );\n* Serum creatinine ≤ 1.5 times ULN ; 10. Female patients of childbearing potential voluntarily used highly effective contraception from screening through the designated time after the last dose of study drug (within 1 month after the last dose of Surufatinib or within 2 months after the last dose of envolizumab, whichever came later) and agreed not to donate ovum (oocytes) for reproductive purposes during this period.\n\nAll female patients will be considered to be of childbearing potential unless they are naturally postmenopausal, have undergone artificial menopause, or have undergone sterilization (eg, hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation). Male patients with sexual partners of childbearing potential who are willing to use condoms during sex from screening through 3 months after the last dose of study drug and should refrain from donating or freezing sperm during this period.\n\nExclusion Criteria:\n\n* Any of the following criteria must be excluded from the study plan:\n\n  1. Received previous treatment with Surufatinib and envolizumab, and 6 months with other anti-angiogenic agents;\n  2. Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy;\n  3. Participated in other domestic clinical trials of drugs not approved or marketed within 4 weeks before enrollment and received the corresponding investigational drug;\n  4. Any major surgery or invasive treatment or operation (except venous catheterization, puncture drainage, etc.) within 4 weeks before enrollment;\n  5. International normalized ratio (INR) \\> 1.5 or activated partial thromboplastin time (APTT) \\> 1.5 × ULN ;\n  6. Clinically significant electrolyte abnormalities as judged by the investigator;\n  7. Patients with current hypertension uncontrolled by medications, defined as systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg ;\n  8. Patients with currently poorly controlled diabetes (fasting plasma glucose concentration ≥ 10 mmol\u002FL after regular treatment);\n  9. Patients with any current disease or condition affecting drug absorption, or patients unable to take oral Surufatinib;\n  10. Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator;\n  11. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding \\> 30 mL with hematemesis, melena, hematochezia within 3 months), hemoptysis (\\> 5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and\u002For transient ischemic attack) within 12 months;\n  12. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment;\n  13. Other malignancies within the last 5 years, except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix;\n  14. Active or uncontrolled serious infection (≥ CTCAE Grade 2 infection);\n  15. Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis \\[known hepatitis B (HBV) carriers must exclude active HBV infection, ie, HBV DNA positive (\\> 1 × 10 4 copies\u002FmL or \\> 2000 IU\u002Fml); Known hepatitis C virus infection (HCV) and HCV RNA positive (\\> 1 × 10 3 copies\u002FmL), or other hepatitis, cirrhosis\\];\n  16. Patients with current central nervous system (CNS) metastasis or previous brain metastasis;\n  17. Unresolved toxicities above CTCAE Grade 1 due to any prior anticancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity of ≤ Grade 2 ;\n  18. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n  19. Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days prior to enrollment;\n  20. Tumor involving skin and\u002For pharyngeal mucosa accompanied by ulceration;\n  21. Patients who have a history of psychiatric drug abuse and cannot quit or have mental disorders;\n  22. Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, would reasonably suspect that the patient has a disease or condition that would make the use of study drug inappropriate (eg, having a seizure and requiring treatment) or would compromise the interpretation of study results or put the patient at high risk.\n  23. Urine routine showed urine protein ≥ 2 + , and 24 hour urine protein \\> 1.0g ;\n  24. Patients with other concomitant diseases that, in the judgment of the investigator, might jeopardize the patient 's safety or might affect the patient' s completion of the study.",{"count":182,"type":20},[23],"This study is a prospective,open-label,single-arm clinical trial to evaluate the efficacy and safety of s Surufatinib combined with envolizumab as second-line treatment of recurrent\u002Fmetastatic head and neck squamous cell carcinoma .\n\nenvolizumab: 300 mg subcutaneously every 3 weeks (Q3W); Surufatinib : 200 mg orally within 1 hour after breakfast, once daily continuously every 3 weeks as a treatment cycle until intolerable toxicity or disease progression. If any ≥ Grade 2 treatment-related adverse event occurs during treatment, the dose may be adjusted to 100 mg according to the investigator 's clinical assessment.\n\nThe study is divided into 3 period: Screening, Treatment, and Follow-up. The treatment period is a 3-week treatment cycle. During the treatment period, tumor assessment will be performed by imaging method every 6 weeks (± 7 days) until disease progression (RECIST 1.1) or death (during treatment) or intolerable toxicity. The tumor treatment and survival status after disease progression should be recorded.\n\nSafety measures included: adverse events, laboratory tests, vital signs, and changes in electrocardiogram and cardiac ultrasound.",[105,26],"2025-03-10",{"date":214,"type":31},"2025-03-14",{"date":216,"type":31},"2024-12-30",{"date":218,"type":20},"2027-09-30",{"name":220,"class":62},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":242,"leadSponsor":244,"locationsCount":63},"100573939","phase-2-bone-marrow-protective-effect-of-trilaciclib-in-postoperative-ccrt-for-la-hnscc-100573939","NCT06752798","Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC","Bone Marrow Protective Effect of Trilaciclib in Postoperative Concurrent Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Phase 2 Clinical Study","CCRT，LA-HNSCC","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be enrolled in this study:\n\n  * Pathologically or histologically confirmed locally advanced squamous cell carcinoma of the head and neck (this study includes cancers of the oral cavity, oropharynx, hypopharynx, and larynx, excluding cancers of the lip and nasopharynx).\n  * Indications for surgery and postoperative chemotherapy plus radiotherapy, and meeting the following conditions:\n* (1) Staging of T1-4N0-3M0, having undergone radical surgery;\n* (2) At least one of the following factors: positive surgical margin, tumor close to the surgical margin, postoperative pathological staging pT3-4 or pN2-3, positive lymph nodes in neck level IV or V, tumor invasion of nerves\u002Fblood vessels\u002Flymphatic vessels.\n\n  * ECOG performance status score of 0-1.\n  * Normal major organ function, meeting the following criteria:\n* (1) Hematology standards (no blood transfusion or blood products within 14 days): a. HB ≥ 90 g\u002FL; b. Neu ≥ 1.5×10\\^9\u002FL; c. PLT ≥ 100×10\\^9\u002FL;\n* (2) Biochemical criteria: a. TBIL \\\u003C 1.5× upper limit of normal (ULN); b. ALT and AST \\\u003C 2.5× ULN; c. Serum Cr ≤ 1.0× ULN or creatinine clearance rate \\> 60 ml\u002Fmin.\n\n  * Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use reliable contraception during the study and for a specified period after the last dose of the study drug.\n  * Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug. For male participants, they must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug or have undergone surgical sterilization.\n  * The subjects voluntarily join this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pathologically confirmed non-squamous cell carcinoma.\n* Patients with recurrence or distant metastasis (M1).\n* Previous chemotherapy for any reason, or prior surgery, radiotherapy, molecular targeted therapy, or immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, etc.) in the head and neck region.\n* Pregnant or breastfeeding women.\n* Previous or concurrent other malignancies.\n* Patients with other uncontrolled serious diseases.\n* Abnormal function of vital organs such as the heart, brain, or lungs: Hypertension that cannot be controlled to normal range with antihypertensive drugs (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90mmHg); Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia, and Grade II heart failure; stroke or cardiovascular events within 6 months prior to enrollment; abnormal coagulation function (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds or APTT \\> 1.5 ULN), with a tendency to bleed or receiving thrombolytic or anticoagulant therapy; clear tendency to bleed; patients with positive proteinuria (urine protein test 2+ or above, or 24-hour urine protein quantification \\> 1.0 g).\n* Active infections requiring systemic treatment, such as tuberculosis.\n* Previous hematopoietic stem cell or bone marrow transplant.\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive).\n* Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are eligible: HBV viral load must be \\\u003C 1000 copies\u002Fml (200 IU\u002Fml) before the first dose, and subjects should receive anti-HBV therapy throughout the study chemotherapy to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary; active HCV infection subjects (HCV antibody positive and HCV-RNA levels above the detection limit).\n* History of substance abuse that cannot be abstained from or mental disorders.\n* Allergy to the study drug or its components.\n* Any other conditions that the investigator judges may affect the conduct of the clinical study and the determination of the study results.\n* Concurrent participation in another therapeutic clinical study.","70 Years",{"count":19,"type":20},[23],"To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery",[26],[235,158,236,237],"Trilaciclib","Adjuvant treatment","chemoradiotherapy","2024-12-29",{"date":240,"type":31},"2024-12-31",{"date":216,"type":20},{"date":243,"type":20},"2025-12-30",{"name":245,"class":62},"Hunan Cancer Hospital"]