[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pd-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pd-1":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,44,73,94,119,143,164,189,224,245,270,292,313,335,359],{"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":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100409784","correlation-vitamin-d-level-to-endocrine-autoimmune-toxicity-due-to-immune-checkpoint-inhibitors-100409784",false,"NCT04615988","Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors","Correlation of Serum Vitamin D Level With the Development of Endocrine Autoimmune Complications During Treatment With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Malignancy which the treating oncologist plans for next treatment to inhibit PD-1or PD-L1 with the immune inhibitor being the only immunotherapy. Twenty-five subjects in a separate cohort will need for eligibility to be planned for treatment with anti-PD1\u002FPD-L1 plus antri-CTLA-4 therapy.\n* Willingness to complete symptom questionnaires\n* Willingness to allow blood draws\n* Ability to provide informed consent\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* History of clinical or subclinical hyperthyroidism or hypothyroidism\n* Hemoglobin \\\u003C 9\n* Inability to come for all study visits.\n* Actively on vitamin D supplementation due to vitamin D deficiency (As part of a multivitamin is not exclusionary)\n* Pregnant or lactating\n* History of hypophysitis","ALL","18 Years",{"count":19,"type":20},17,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to see if the amount of vitamin D in ones blood makes it more or less likely to develop thyroid gland toxicity when being treated with immunotherapy that blocks the activity of proteins called programed death-1(PD-1) or programmed death ligand-1 (PD-L1). Immunotherapy is treatment that makes changes to the immune system to try to fight cancer. Immunotherapy treatments that block the activity of important parts of the immune system called PD-1 and PD-L1 are used to standardly treat many different types of cancer and can cause thyroid toxicity in certain people. In this study the treatment for your cancer is not research treatment but standard of care determined by your oncologist. Blood will be drawn before starting treatment to determine the amount of Vitamin D and also to assess thyroid function. Also questionnaires will be completed before starting treatment and while on treatment to assess symptoms you are experiencing.",[24,25,26],"Thyroid","PD-1","Cancer",[28,29,30],"vitamin D deficiency","immunotherapy with inhibitor of PD-1\u002FL1","immune mediated thyroid toxicity","RECRUITING","2026-03-23",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":35},"2021-06-09",{"date":39,"type":20},"2028-06",{"name":41,"class":42},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"100603052","phase-2-a-single-arm-multicenter-exploratory-clinical-study-of-tace-combined-with-iparomlimab-and-tuvonralimab-injection-ql1706-and-lenvatinib-for-perioperative-treatment-of-resectable-hepatocellular-carcinoma-100603052","NCT07131501","A Single-Arm, Multicenter, Exploratory Clinical Study of TACE Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma","A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n1. Voluntarily participate, sign ICF, demonstrate good expected compliance, and be willing to cooperate with follow-up.\n2. Age 18-75 years, any gender.\n3. HCC diagnosis confirmed by histopathology, cytology, or imaging.\n4. Resectable HCC staged as CNLC IIb-IIIa (excluding Vp3 and Vp4) or CNLC Ib-IIa with high-risk recurrence factors, confirmed by multidisciplinary liver surgery expert panel.\n5. For CNLC Ib-IIa subjects, presence of at least ONE high-risk recurrence factor.\n6. No prior systemic therapy for HCC (chemotherapy, targeted therapy, immunotherapy, etc.). Subjects with prior curative surgery or ablation are eligible only if recurrence occurred \\>2 years post-resection. Subjects with prior other local therapies are excluded.\n7. Child-Pugh class A.\n8. ECOG PS score 0-1.\n9. Expected survival ≥12 months.\n10. Adequate organ function within 7 days prior to study intervention.\n11. For subjects with HBV infection.\n12. Women of childbearing potential: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Negative pregnancy test within 7 days prior to intervention. Not breastfeeding.\n13. Male subjects with WOCBP partners: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Must not donate sperm during this period. Males with pregnant partners must use condoms.\n\nExclusion Criteria:\n\n1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed carcinoma (\\>30% ICC component), or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years or concurrently. Cured localized cancers are eligible.\n2. Current or history of interstitial lung disease\u002Fpneumonitis requiring steroids, or other active lung disease potentially interfering with immune-related pulmonary toxicity evaluation\u002Fmanagement, or active pneumonia\u002Fsevere impaired pulmonary function on screening CT. Active tuberculosis.\n3. Active autoimmune disease or history of autoimmune disease with potential recurrence. Vitiligo, psoriasis, alopecia not requiring systemic therapy, controlled Type I diabetes on insulin, or childhood asthma resolved in adulthood without intervention are eligible. Asthma requiring bronchodilators is excluded.\n4. Systemic immunosuppressive therapy (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to intervention.\n5. Active infection, unexplained fever ≥38.5°C within 1 week prior, or baseline WBC \\>15 × 10⁹\u002FL. Therapeutic antibiotics (IV\u002Foral) within 2 weeks prior (prophylactic IV antibiotics ≤48h duration allowed).\n6. Primary or acquired immunodeficiency.\n7. Live attenuated vaccine within 4 weeks prior to intervention or anticipated need during study or within 60 days after last Iparomlimab and Tuvonralimab Injection dose.\n8. Significant bleeding symptoms or predisposition within 6 months prior. If baseline fecal occult blood positive, repeat test; if still positive, requires gastroscopy.\n9. Known hereditary\u002Facquired bleeding\u002Fthrombotic diathesis. Current therapeutic-dose anticoagulants\u002Fthrombolytics (prophylactic low-dose aspirin allowed).\n10. Arterial thromboembolic events within 6 months prior.\n11. Poorly controlled cardiac disease.\n12. Hypertension uncontrolled by medication (average SBP ≥140 mmHg or DBP ≥90 mmHg on ≥2 readings). History of hypertensive crisis or encephalopathy.\n13. Major vascular disease within 6 months prior.\n14. Serious unhealed wounds, active ulcers, or untreated fractures.\n15. Major surgery within 4 weeks prior or anticipated major surgery during study.\n16. Inability to swallow pills, malabsorption syndrome, or GI condition affecting absorption.\n17. Bowel obstruction or related symptoms\u002Fsigns within 6 months prior requiring parenteral support\u002Ffeeding. Subjects with prior resolved obstruction treated definitively (surgically) may be eligible after assessment.\n18. Strong CYP3A4 inducers within 2 weeks prior or strong CYP3A4 inhibitors within 1 week prior.\n19. Known hypersensitivity to any study drug or excipient.\n20. Participation in another investigational drug study within 4 weeks prior.\n21. Pregnancy or lactation.\n22. Any other condition deemed unsuitable by the investigator.","75 Years",{"count":53,"type":20},48,"INTERVENTIONAL",[56],"PHASE2","This is a single-arm, multicenter, exploratory clinical study evaluating the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection (QL1706) and lenvatinib for perioperative treatment of resectable HCC (CNLC IIb-IIIa excluding Vp3\u002FVp4 or CNLC Ib-IIa with high-risk recurrence factors). Eligible subjects providing written informed consent will receive study treatment. The primary endpoint is MPR rate.",[59,60,61,25,62],"Hepatocellular Carcinoma","Immunotherapy","Preoperative","CTLA-4","NOT_YET_RECRUITING","2025-08-13",{"date":66,"type":35},"2025-08-20",{"date":68,"type":20},"2025-08-11",{"date":70,"type":20},"2029-08-31",{"name":72,"class":42},"The First Affiliated Hospital with Nanjing Medical University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":79,"targetDuration":4,"studyType":54,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100602802","phase-2-a-single-arm-multicenter-exploratory-clinical-study-of-transarterial-chemoembolization-tace-combined-with-iparomlimab-and-tuvonralimab-injection-and-bevacizumab-injection-for-the-treatment-of-unresectable-non-metastatic-hepatocellular-carcinoma-hcc-100602802","NCT07128251","A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n1. Voluntarily participate in the study and provide written informed consent.\n2. Age 18-75 years, inclusive (male or female).\n3. Histologically or cytologically confirmed HCC, or clinically diagnosed HCC according to the \\*Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition)\\*.\n4. Barcelona Clinic Liver Cancer (BCLC) Stage A, B, or C, not amenable to curative treatment (e.g., surgical resection, liver transplantation, or ablation).\n5. At least one measurable lesion according to RECIST v1.1 criteria.\n6. Suitable candidate for Transarterial Chemoembolization (TACE) with no known allergy or contraindication to iodized oil or epirubicin.\n7. Child-Pugh Liver Function Class A.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n9. Life expectancy ≥ 3 months.\n10. Adequate organ and bone marrow function.\n11. If positive for Hepatitis B Virus (HBV) infection, HBV DNA must be \\\u003C 2000 IU\u002FmL (\\\u003C 10,000 copies\u002FmL if only copies\u002FmL units available at the site) and the subject must be willing to receive continuous antiviral therapy throughout the study period. Subjects positive for Hepatitis C Virus (HCV) RNA must receive antiviral therapy according to clinical guidelines.\n12. Subjects with esophageal\u002Fgastric varices must undergo evaluation and appropriate management prior to enrollment.\n13. Women of childbearing potential (WOCBP): Must have a negative serum human chorionic gonadotropin (hCG) test within 7 days prior to initiation of study treatment; must be non-lactating; must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (hysterectomy, bilateral salpingectomy\u002Foophorectomy). Male subjects with female partners of childbearing potential: Must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment; must agree to refrain from sperm donation. Male subjects with pregnant partners must use condoms; no additional contraception is required.\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, mixed hepatocellular cholangiocarcinoma, or cholangiocarcinoma; history of other active malignancies within 5 years or concurrently with HCC. Cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma \\*in situ\\* of the prostate, cervix, or breast) are permitted.\n2. Presence of Vp3 or Vp4 portal vein tumor thrombosis (PVTT), any grade of hepatic vein or inferior vena cava invasion; any grade of bile duct invasion. \\*Note: Vp1 or Vp2 PVTT is permitted.\\*\n3. Presence of extrahepatic spread (EHS).\n4. Intrahepatic lesion(s) with maximum diameter ≥ 10 cm, \\> 10 intrahepatic lesions, or intrahepatic tumor burden ≥ 70% of liver volume, per RECIST v1.1.\n5. Prior systemic anti-cancer therapy for HCC, including molecular targeted agents, cytotoxic chemotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune checkpoint agonists, cellular therapies), or biologic therapy (e.g., cancer vaccines, cytokines, growth factors).\n6. Prior locoregional therapy for HCC, including therapeutic TACE, transarterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE).\n\n1\\) Prior curative surgery or ablation is permitted; one session of prophylactic TACE following curative resection is permitted.\n\n2\\) Prior percutaneous ethanol injection (PEI) or radiotherapy with curative intent is permitted.\n\n7\\. Prior or planned organ transplantation or allogeneic bone marrow transplantation.\n\n8\\. Current interstitial lung disease (ILD)\u002Fpneumonitis, history of ILD\u002Fpneumonitis requiring steroid treatment, or other pulmonary conditions that may interfere with the detection or management of immune-mediated pneumonitis (e.g., pulmonary fibrosis, organizing pneumonia \\[e.g., bronchiolitis obliterans\\], pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonia evidenced by screening chest computed tomography \\[CT\\] scan). Prior radiation pneumonitis within the radiation field is permitted. Active tuberculosis.\n\n9\\. Active autoimmune disease or history of autoimmune disease with potential for recurrence (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects with hypothyroidism stable on hormone replacement are eligible). Conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), controlled Type I diabetes on insulin, or childhood asthma in complete remission without adult intervention are permitted. Asthma requiring bronchodilator therapy is excluded.\n\n10\\. Clinically significant ascites requiring therapeutic paracentesis or drainage (Child-Pugh score \\>2 for ascites; asymptomatic ascites detected only radiographically is permitted); uncontrolled or moderate\u002Flarge pleural effusion or pericardial effusion.\n\n11\\. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg based on ≥2 measurements) despite antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy.\n\n12\\. Clinically significant cardiac disease. 13. History of spontaneous rupture of hepatic tumor(s). 14. History of hepatic encephalopathy. 15. History or presence of central nervous system metastases. 16. Congenital or acquired immunodeficiency (e.g., HIV infection). 17. Thromboembolic event within 3 months prior to treatment (e.g., cerebrovascular accident \\[including transient ischemic attack, cerebral hemorrhage, cerebral infarction\\], deep vein thrombosis, pulmonary embolism).\n\n18\\. History of gastrointestinal (GI) bleeding within 6 months prior to treatment or high risk of GI bleeding (e.g., high-risk or severe esophageal\u002Fgastric varices, active GI ulceration, persistent fecal occult blood positivity). \\*Note: If fecal occult blood positive at baseline, repeat test; if persistently positive, esophagogastroduodenoscopy \\[EGD\\] required; exclusion if EGD shows varices\u002Flesions with bleeding risk.\\* 19. Abdominal fistula, GI perforation, intra-abdominal abscess, or bowel obstruction within 6 months prior to treatment.\n\n20\\. Major surgical procedure within 4 weeks prior to treatment or anticipated during study; unhealed wound, ulcer, or fracture within 4 weeks prior to treatment.\n\n21\\. Coagulopathy or bleeding diathesis (e.g., hemophilia); use of antiplatelet agents (e.g., aspirin \\>325 mg\u002Fday, dipyridamole, ticlopidine, clopidogrel, cilostazol) or anticoagulants (e.g., warfarin, low molecular weight heparin) within 10 days prior to treatment.\n\n22\\. Significant vascular disease within 6 months prior to treatment (e.g., aortic aneurysm requiring surgical repair, recent peripheral arterial thrombosis).\n\n23\\. Severe infection within 4 weeks prior to treatment (e.g., requiring hospitalization for infection, bacteremia, or severe pneumonia complications); therapeutic antibiotics administered orally or intravenously within 2 weeks prior to treatment (prophylactic antibiotics, e.g., for UTI or COPD prevention, are permitted).\n\n24\\. Known hypersensitivity to the active substances or excipients of \\*\\*Iparomlimab and Tuvonralimab Injection\\*\\*, \\*\\*Bevacizumab Injection\\*\\*, or epirubicin; history of severe hypersensitivity to any other monoclonal antibody or anti-angiogenic targeted therapy.\n\n25\\. Use of immunosuppressive agents or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) for immunosuppressive purposes within 2 weeks prior to treatment.\n\n26\\. Administration of live attenuated vaccines within 4 weeks prior to treatment or planned during Iparomlimab and Tuvonralimab Injection treatment or within 60 days after the last dose.\n\n27\\. Treatment with any investigational agent within 4 weeks or 5 half-lives (whichever is longer) prior to treatment initiation.Subjects with any other condition deemed by the investigator to potentially affect study results or lead to premature study termination (e.g., alcoholism, drug abuse, other severe medical\u002Fpsychiatric disorders requiring concomitant therapy, significant laboratory abnormalities, or familial\u002Fsocietal factors compromising subject safety).",{"count":80,"type":20},47,[56],"This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.",[84,60,25,62,85],"Hepatocellular Carcinoma (HCC)","TACE",{"date":87,"type":35},"2025-08-17",{"date":66,"type":20},{"date":90,"type":20},"2029-12-30",{"name":92,"class":93},"Anhui Provincial Hospital","OTHER_GOV",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":101,"targetDuration":4,"studyType":54,"phases":103,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":43},"100599916","phase-2-pd-1-inhibitor-therapy-versus-radiotherapy-in-mpr-patients-with-locally-advanced-hnscc-after-neoadjuvant-immunochemotherapy-hnc-sysu-006-100599916","NCT07090707","PD-1 Inhibitor Therapy Versus Radiotherapy in MPR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy (HNC-SYSU-006)","Prospective Exploratory Phase II Study of PD-1 Inhibitor Therapy Versus Radiotherapy in MPR Patients After Neoadjuvant Immunochemotherapy for Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* In this study, patients with locally advanced head and neck squamous cell carcinoma (AJCC 8th) who underwent standard surgical treatment after neoadjuvant immunochemotherapy and showed MPR in both primary lesions and lymph node pathology were selected. Locally advanced squamous cell carcinoma of head and neck includes: i) T3, N0, M0; 2) T1-T3, N1-N2, M0; 3) T4a, N0-2, M0.\n* No history of other malignant tumors\n* Ages 18-75\n* Normal baseline inspection:\n\n  1. The absolute value of neutrophil granulocyte (ANC) ≥1.5x109\u002FL in the last 14 days without the use of granulocyte colony stimulating factor;\n  2. Platelets ≥100×109\u002FL without blood transfusion in the past 14 days;\n  3. Hemoglobin \\&gt without blood transfusion or use of erythropoietin within the last 14 days; 9g\u002FdL;\n  4. Total bilirubin ≤1.5× upper limit of normal value (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);\n  6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n  7. Good coagulation function, defined as International Standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n  8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range;\n  9. The myocardial enzyme profile was within the normal range (if the researchers comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included);\n  10. For female subjects of childbearing age, a urine or serum pregnancy test should be tested negative within 3 days prior to receiving the first study drug administration (day 1 of Cycle 1). If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;\n  11. If there is a risk of conception, all subjects (male or female) shall use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapeutic drug administration).\n\n  5 Sign informed consent\n\nExclusion Criteria:\n\n* 1 HNSCC is not the initial diagnosis of other malignant tumors or neoadjuvant therapy.\n* Prior to treatment An active autoimmune immune disease requiring systemic therapy (e.g. the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred in the last 2 years. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);\n\nNote: Hepatitis B subjects who meet the following criteria can also be enrolled:\n\n1\\) HBV viral load \\&lt before initial administration; At 1000 copies \u002Fml (200 IU\u002Fml), subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study treatment period 2) For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required\n\n* Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the lower limit);\n* Pregnant or lactating women;\n* The presence of any serious or uncontrolled systemic disease, such as:\n\n  1. The resting electrocardiogram (ECG) presents significant and severely uncontrollable abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, Ⅱ degree or above heart block, ventricular arrhythmia or atrial fibrillation;\n  2. Unstable angina pectoris, congestive heart failure, and NYHA grade ≥ 2 chronic heart failure;\n  3. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;\n  4. Poor blood pressure control (systolic \\> 140 mmHg, diastolic \\> 90 mmHg);\n  5. A history of non-infectious pneumonia requiring glucocorticoid therapy or clinically active interstitial lung disease within 1 year prior to initial administration;\n  6. Active pulmonary tuberculosis;\n  7. There is an active or uncontrolled infection that requires systemic treatment;\n  8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n  11. Urine routine indicated urine protein ≥++, and confirmed 24 hours urine protein quantity \\> 1.0 g;\n  12. Patients with mental disorders and unable to cooperate with treatment;\n* Medical history or evidence of disease that may interfere with test results, prevent subjects from fully participating in the study, abnormal values of treatment or laboratory tests, or other conditions that the investigator considers unsuitable for enrollment. The investigator considers other potential risks unsuitable for participation in the study.",{"count":102,"type":20},50,[56],"Head and neck malignant tumors rank as the sixth most common type of malignancy worldwide, with approximately 90% being squamous cell carcinoma (Head and Neck Squamous Cell Carcinoma, HNSCC). Globally, there are about 650,000 new cases of HNSCC annually, with China contributing approximately 350,000 new cases each year. At initial diagnosis, 60% of patients already present with locally advanced HNSCC, necessitating comprehensive treatment strategies.\n\nIn the first half of the 20th century, radiotherapy was the primary treatment for HNSCC. However, due to its relatively low local control rate (70%), high rate of distant metastasis (20%), and low 5-year overall survival (OS) rate (40%), coupled with significant early and late adverse effects, radiotherapy often brought severe challenges to patients. For instance, 95% of patients developed radiation-induced oral mucositis, nearly all experienced xerostomia, taste disorders, radiation-induced dental caries, restricted mouth opening, swallowing difficulties, aspiration, and other functional impairments. Some patients even suffered severe complications, with 6% developing radiation-induced osteonecrosis of the jaw, and 0.1% experiencing secondary cancers such as radiation-induced sarcoma or squamous cell carcinoma in the head and neck region. Other complications, such as radiation-induced encephalopathy, also posed significant threats to patients' safety and quality of life. As surgical techniques improved towards the end of the 20th century, surgery gradually replaced radiotherapy as the dominant treatment for HNSCC.\n\nOver the past four decades, despite the use of comprehensive treatments based on surgery supplemented by radiotherapy, chemotherapy, and targeted therapy, the 5-year survival rate for locally advanced HNSCC has not significantly improved, remaining around 50%. Recently, with the advent of immunotherapy centered on PD-1 inhibitors, treatment outcomes for HNSCC patients have improved markedly, and the therapeutic landscape is undergoing significant transformation. Concurrently, many studies have focused on neoadjuvant immunotherapy prior to surgery. In locally advanced lung cancer, neoadjuvant chemoimmunotherapy has been proven safe and effective through phase III clinical trials. Similarly, studies on head and neck tumors have shown that neoadjuvant immunotherapy-whether PD-1 monotherapy or in combination with chemotherapy-demonstrates favorable safety and efficacy. However, for patients who respond well to immunochemotherapy and achieve pathological downstaging, how to evaluate the relationship between therapeutic efficacy, staging, and prognosis, as well as how to plan subsequent treatments, remains unclear in existing guidelines. For some patients with locally advanced HNSCC who achieve major pathological response (MPR) or pathological complete response (pCR) after neoadjuvant immunochemotherapy and undergo extensive primary tumor resection and thorough neck lymph node dissection, there is no research to clarify whether postoperative adjuvant radiotherapy based on pretreatment TNM staging is still necessary.\n\nSome studies suggest that for patients with pN1 stage, adjuvant radiotherapy after thorough neck lymph node dissection does not significantly impact local control or long-term survival. Literature indicates that the recurrence rate of cervical lymph nodes in N1-stage head and neck squamous cell carcinoma is approximately 8%, meaning that about 92% of N1-stage patients who receive postoperative radiotherapy to the cervical lymphatic drainage area might be overtreated. For patients who achieve pCR after neoadjuvant immunochemotherapy, continuing radiotherapy in the original region after high-quality surgery further increases the likelihood of overtreatment. For locally advanced HNSCC patients who achieve pCR or MPR in the primary tumor and lymph nodes, whether routine radiotherapy should be administered following high-quality surgical resection and lymph node dissection remains controversial in the academic community.\n\nThis leads to our clinical question: In patients with locally advanced HNSCC who achieve MPR in both the primary tumor and lymph nodes after neoadjuvant immunochemotherapy and undergo standard surgical treatment, can maintenance therapy with PD-1 inhibitors replace adjuvant radiotherapy?\n\nThis study aims to enroll patients who have undergone neoadjuvant immunochemotherapy followed by standard surgical treatment and achieved MPR in both the primary tumor and lymph nodes. Patients will be divided into an experimental group and a control group. The experimental group will receive maintenance therapy with PD-1 inhibitors, while the control group will follow guideline-recommended adjuvant treatments (radiotherapy or concurrent chemoradiotherapy based on platinum compounds) according to tumor classification and staging before neoadjuvant immunochemotherapy. Outcomes such as 2-year",[106,25,107],"HNSCC","Radiotherapy",[106,25,109],"radiotherapy","2025-07-21",{"date":112,"type":35},"2025-07-29",{"date":114,"type":20},"2025-08-01",{"date":116,"type":20},"2031-12-31",{"name":118,"class":42},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":54,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":43},"100595634","phase-1-study-on-the-safety-and-tolerability-of-pd-1-knockout-tumor-infiltrating-t-cells-tils-in-the-treatment-of-advanced-colorectal-cancer-100595634","NCT07035002","Study on the Safety and Tolerability of PD-1 Knockout Tumor-infiltrating T Cells (TILs) in the Treatment of Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Patients with advanced colorectal cancer confirmed by histology or cytology, who were not eligible to standard treatment at this stage.\n* Patients volunteered to receive surgery or biopsy to obtain tumor tissue for TILs preparation.\n* Aged ≥18 and ≤70 years old.\n* At least one tumor lesion that could be evaluated according to RECIST, version 1.1.\n* ECOG score was 0 or 1.\n* Adequate bone marrow and organ function.\n* The expected survival time of the enrolled patients was no less than 6 months.\n\nExclusion Criteria:\n\n* Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling, except the following:\n\n  1. Nitrosourea or mitomycin C within 6 weeks before surgery;\n  2. Oral fluorouracils and small molecule targeted drugs for 1 week before surgery.\n* Received other unmarketed investigational drug or treatment within 4 weeks before sampling;\n* Had undergone major organ surgery (excluding needle biopsy) within 4 weeks before sampling or had significant lesions Trauma, or the need for elective surgery during the trial;\n* Received systemic glucocorticoid (prednisone \\>10mg\u002F day or equivalent dose) or other immunosuppressive therapy within 14 days before sampling; Treatment with topical, ocular, intra-articular, nasal, and inhaled glucocorticoids was excluded. Short-term prophylaxis with glucocorticoids (e.g., to prevent contrast allergy)\n* Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferin, etc., within 14 days before sampling;\n* Administration of live attenuated vaccine within 4 weeks before sampling;\n* The toxicity of previous antineoplastic therapy has not recovered to CTCAE 5.0 grade ≤1 (except for alopecia and other researchers who judged that there was no safety risk);\n* Patients with symptomatic central nervous system or leptomeningeal metastases or other evidence of uncontrolled central nervous system or leptomeningeal metastases as judged by the investigator to be ineligible for enrollment;\n* Patients with active infection within 1 week before sampling and currently requiring systemic anti-infective treatment;\n* A history of immunodeficiency, including positive HIV antibody test;\n* Hepatitis B (HBsAg positive and\u002For hepatitis C (anti-HCV positive) and\u002For treponema pallidum antibody positive;\n* Patients with current interstitial lung disease;\n* Has a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree II-III atrioventricular block, etc.\n  2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose of dose.\n  3. New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) \\\u003C50%, or structural heart disease at high risk as judged by other investigators;\n  4. clinically uncontrolled hypertension.\n* Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid diseases and well-controlled type I diabetes;\n* Received immunotherapy with grade ≥ 3 irAE;\n* Clinically uncontrollable serous cavity effusion, which was judged by the investigator as not suitable for enrollment;\n* Known alcohol or drug dependence;\n* Persons with mental disorders or poor compliance;\n* Pregnant or lactating women;","70 Years",{"count":127,"type":20},29,[129],"PHASE1","TIL from tumor tissue of advanced colorectal cancer patients were cultured, modified and expanded in vitro, and then transfused back to the patients after quality control. The safety and efficacy of the treatment were investigated. The fundamental cause of oncogenesis lies in the accumulation of gene mutations. A large number of gene mutations in tumor cells lead to changes in the encoded amino acid sequence, resulting in the production of tumor-specific proteins. Human T cells recognize tumor-specific peptides (tumor neoantigens) that are presented on the MHC molecules on the surface of tumor cells, leading to T cell enrichment within the tumor. However, due to the immunosuppressive effect of tumors through various ways, the enriched T cells in tumors cannot effectively kill tumor cells. One of the most common examples is that tumors up-regulate the expression of immune checkpoint protein PD-L1, which binds to PD-1 on the surface of T cells and inhibits T cell function. Therefore, in this study, we will obtain tumor tissue via surgery resection or biopsy, and then isolate TIL cells in the tumor under GMP conditions, and further use gene editing technology to knockout PD-1, the obtained gene-edited T cells will have the characteristics of specific recognition of tumor cells, but not sensitive to the immunosuppressive function of tumor cells, so as to achieve the therapeutic effect on tumor patients.",[132,133,25],"Colorectal Cancer (CRC)","Tumor Infiltrating Lymphocytes","2025-06-15",{"date":136,"type":35},"2025-06-24",{"date":138,"type":35},"2024-12-31",{"date":140,"type":20},"2026-12",{"name":142,"class":42},"Ruijin Hospital",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100589388","a-prospective-study-the-impact-of-sleep-disturbances-on-immunotherapy-in-patients-with-lung-cancer-100589388","NCT06953765","A Prospective Study: the Impact of Sleep Disturbances on Immunotherapy in Patients With Lung Cancer","Inclusion Criteria:\n\nDiagnosis of non-small-cell lung cancer (stage II-IV) Age 18 and older Immune checkpoint inhibitor therapy (e.g., nivolumab, pembrolizumab, etc.) is planned.\n\nBe able to understand the study and provide informed consent\n\nExclusion Criteria:\n\nCoexisting serious mental illness (e.g., major depression, anxiety, etc.) Recent chemotherapy or radiotherapy Other serious comorbidities (e.g., heart disease, liver and kidney insufficiency)",{"count":150,"type":20},350,"In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1\u002FPD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Studies have shown that sleep disorders may affect the function of the immune system, thereby affecting tumor progression and treatment response. Therefore, the aim of this study was to evaluate the impact of sleep disturbances on lung cancer patients receiving immunotherapy.",[153,154,25],"Lung Cancer (NSCLC)","Sleep Disorders, Circadian Rhythm","2025-04-29",{"date":157,"type":35},"2025-05-01",{"date":159,"type":20},"2025-06-01",{"date":161,"type":20},"2028-12-30",{"name":163,"class":42},"Shanghai Zhongshan Hospital",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":54,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":43},"100584338","phase-2-fruquintinib-combined-with-pd-1-inhibitor-as-first-line-maintenance-therapy-for-advanced-gastric-cancer-100584338","NCT06888037","Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric Cancer","A Prospective, Multicenter Clinical Study of Fruquintinib Combined With PD-1 Monoclonal Antibody as First-line Maintenance Therapy in Patients With HER-2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Voluntarily signed the informed consent and had good compliance;\n* Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;\n* Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;\n* He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;\n* Patients with disease progression\u002Frelapse occurring more than 6 months after completion of neoadjuvant\u002Fadjuvant therapy;\n* At least one measurable lesion according to RECIST version 1.1;\n* Tumor tissue\u002Fserum samples were tested as microsatellite stable (MSS) or mismatch repair intact (pMMR), HER2 negative;\n* Adequate organ functions:\n\nAbsolute neutrophil count ≥1.5×109\u002FL; Platelet ≥100×109\u002FL; Hemoglobin ≥90g\u002FL; WBC≥3×109\u002FL Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN (If liver metastasis, AST and ALT≤5 XULN)； Serum creatinine (Cr) ≤1.5XULN or serum creatinine clearance ≥50 ml\u002Fmin； Urinary protein ≤2+, or 24-hour urinary protein volume ≤2000mg; Prothrombin time (PT) and partially activated prothrombin time (APTT) ≤1.5×ULN;\n\n• Female or male patients of reproductive age must use effective contraception throughout and for 6 months after treatment.\n\nExclusion Criteria:\n\n* Participated in other drug clinical trials within 4 weeks before enrollment;\n* Have had other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, superficial bladder, carcinoma in situ of the breast, and carcinoma in situ of the cervix ;\n* History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (NCI-CTCAE 5.0), heart failure ≥ grade 2 New York Heart Association (NYHA), transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.\n* Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) and type 2 diabetes uncontrolled by antidiabetic treatment (fasting blood glucose ≥8.9mmol\u002FL);\n* Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis;\n* Type 1 diabetes mellitus, hypothyroidism that can be controlled only with replacement therapy, and skin diseases (e.g., vitiligo, psoriasis) that do not require systemic treatment could be included;\n* Central nervous system (CNS) metastases that are not adequately treated, or the presence of uncontrolled or symptomatic active CNS metastases; Patients with adequately treated CNS metastases and neurologic symptoms that had returned to baseline at least 4 weeks before enrollment (with the exception of residual signs or symptoms related to CNS therapy) were eligible for enrollment; In addition, participants had to discontinue corticosteroids or to be taking a stable or tapering dose of prednisone (or equivalent doses of other corticosteroids) of 10 mg or less per day at least 4 weeks before enrollment;\n* The patients had pleural effusion and ascites that could not be controlled by puncture drainage and other treatments within 14 days before enrollment. Moderate or greater pericardial effusion with clinical symptoms;\n* A live or attenuated live vaccine was administered within 30 days before enrollment;\n* Major surgery had been performed within 28 days before enrollment or minor nonstudy-related surgery had been performed within 7 days before enrollment (with the exception of tumor biopsy and venous-access port placement);\n* Patients with clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment; Patients with gastrointestinal perforation and\u002For gastrointestinal fistula within 6 months before enrollment (except those whose symptoms disappeared after gastric cancer resection for bleeding\u002Fperforation of gastric cancer);\n* Arterial\u002Fvenous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months beforeenrollment;\n* Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral thrombosis) within 6 months before enrollment;\n* Severe, unhealed or open wounds and active ulcers or untreated fractures;\n* Had a history of immediate anaphylaxis;\n* The presence of clinically significant pulmonary fibrosis or interstitial pneumonia as judged by the investigator; Had active lung infection prior to injection and required anti-infective therapy;\n* Active infections included tuberculosis (medical history, investigator's judgment, radiological examination, and local laboratory testing), hepatitis B (hepatitis B surface antigen positive and HBV DNA above the upper limit of the study center's normal range), hepatitis C (HCV antibody positive and HVC RNA positive), HIV (HIV antibody positive), syphilis, etc;\n* Had active gastrointestinal bleeding or hemoptysis;\n* A history of alcohol or psychotropic substance abuse with no withdrawal or a history of mental disorder;\n* Known allergy to the study drug or any of its excipients; Or severe allergic reactions to other monoclonal antibodies;\n* Systemic antibiotic use for ≥ 7 days within 4 weeks before enrollment or unexplained fever \\>38.5°C during screening or before the first dose (fever due to a neoplastic cause, as judged by the investigator, was eligible);\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Unable to take oral medication;\n* The presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.",{"count":172,"type":20},55,[56],"This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.",[176,177,178,179,180,25],"Gastric Adenocarcinoma","GEJ Adenocarcinoma","First-line Therapy","Maintenance Therapy","Fruquintinib","2025-03-20",{"date":183,"type":35},"2025-03-21",{"date":185,"type":20},"2025-03-31",{"date":187,"type":20},"2028-12-31",{"name":142,"class":42},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":223},"100564959","a-prospective-real-world-evidence-study-prowes-for-concordance-rate-of-blood-based-3d-genome-conformation-mapping-episwitch-cirt-to-identify-likelihood-of-response-and-actual-response-rates-to-pd-l-1-checkpoint-inhibitors-across-multiple-oncological-indications-100564959","NCT06635954","A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.","PROWES","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Stage III or IV cancer\n3. Selected by their healthcare provider to receive the Episwitch CiRT® test according to the current evidence-based schedule (per protocol) as part of their standard of practice.\n4. ECOG performance status ≤ 2\n5. Clinically eligible for ICI therapy\n6. Able to read, understand and provide written informed consent.\n7. Willing and able to comply with the study requirements\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding\n2. History of bone marrow or organ transplant\n3. Contra indication for receiving Immune Check Point inhibitor.",{"count":197,"type":20},2000,"The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs) across multiple oncological indications by comparing the results to actual treatment responses for cancer patients.",[26,60,25,200,201],"PD-L1","Immune Checkpoint Therapy",[203,204,205,206,207,208,209,210,211,212,25,200],"immunotherapy","immune checkpoint inhibitor","ICI therapy","ICI","Immune Checkpoint Inhibitor therapy","Episwitch","Episwitch CiRT","Immune Related Adverse Event","IRAE","cancer","2025-03-12",{"date":215,"type":35},"2025-03-17",{"date":217,"type":35},"2024-05-14",{"date":219,"type":20},"2027-05-14",{"name":221,"class":222},"Oxford Biodynamics Inc.","INDUSTRY",3,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":43},"100427003","multi-centre-prospective-non-interventional-study-to-intensively-monitor-the-safety-of-sintilimab-in-clinical-practice-among-chinese-patients-100427003","NCT04840355","Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients","Clinical Study on Multidimensional Prevention of Sintilimab Induced irAEs Based on GEP Pattern Recognition","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years old;\n2. Subjects with histologically or cytologically confirmed are prepared to receive Sintilimab treatment;\n3. Life expectancy of at least 6 months;\n4. Eastern Cooperative Oncology Group (ECOG) PS status≤ 2 or Karnofsky (KPS) ≥ 60;\n5. No prior immune checkpoint inhibitor treatment\n6. Signed written informed consent before any study-related procedure;\n7. Adequate hematopoietic function as defined by an absolute neutrophil count ≥1.5×109 \u002FL, platelet count≥80×109 \u002FL, hemoglobin≥90 g\u002FL\n8. Adequate hepatic function, defined as a total bilirubin level≤1.5 ×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN in subjects without liver metastases, AST and ALT levels ≤5 × ULN in subjects with documented liver metastases;\n9. Adequate renal function, defined as serum creatinine (Cr)≤1.5×ULN or calculated creatinine clearance≥60ml\u002Fmin (Cockcroft-Gault formula);\n10. Serum albumin ≥28g\u002FL;\n11. Thyroid-stimulating hormone (TSH)≤1×ULN (if abnormal,subject with the normal levels of FT3 and FT4 can be enrolled).\n\nExclusion Criteria:\n\n1. Has active autoimmune disease;\n2. Severe heart, lung, brain, kidney, gastrointestinal or systemic diseases;\n3. has interstitial lung disease;\n4. Simultaneous use of drugs that can affect the results of this study;\n5. Treatment may interfere with the results of the study\n6. Allergy or intolerance to the study drug\n7. subject with unconsciousness and psychiatric disorder\n8. Pregnant and lactating women\n9. Subject with poison and alcohol abuse",{"count":232,"type":20},100,"In recent years, immunotherapy has become one of the important treatments for malignant tumors. Among them, PD-1 inhibitors have been widely used in clinical practice, and have shown a significant survival benefits in many patients. However, the incidence of immune-related adverse reactions (irAEs) of PD-1 inhibitors is relatively high, and severe cases can even threaten patients's life. At present, irAEs have become a bottleneck and it is urgent to establish a prevention strategy for the prediction of irAEs. In this study, the investigators intends to use Sintilimab as the research drug. A prospective cohort study was carried out. Part of the sample which was used as a training set would be detected for producing a time-series multi-dimensional data such as differential genes, metabolites and immune factors. Then gene expression programming (GEP) was used to explore the irAEs recognition model. Then, based on this recognition model, internal verification ( part of samples from the center 1 ) and external verification ( part of samples from the center 2 and center 3 samples) are carried out to accurately predict the high-risk population of irAEs and realize the early-stage warning of Sintilimab induced- irAEs.",[235,25],"Immune Related Adverse Events","2024-12-22",{"date":238,"type":35},"2024-12-27",{"date":240,"type":35},"2021-02-26",{"date":242,"type":20},"2025-11-14",{"name":244,"class":42},"Guohui Li",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":43},"100564662","haic-in-combination-with-pd-1-inhibitors-and-lenvatinib-for-intermediate-and-advanced-hcc-after-the-failure-of-systemic-therapy-recommended-by-bclc-100564662","NCT06632093","HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC","Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC","Inclusion Criteria:\n\n1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;\n2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;\n3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;\n4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;\n5. HAIC was performed after the first PD-1 inhibitor\u002F Lenvatinib treatment or before treatment;\n6. Received at least 2 cycles of HAIC；\n7. Has repeated measurable intrahepatic lesions;\n8. Child-Pugh class A or B.\n\nExclusion Criteria:\n\n1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;\n2. With other malignant tumors;\n3. Unable to meet criteria of combination timeframe described above.",{"count":253,"type":20},84,"The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.",[256,257,258,259,25,260],"BCLC Stage B Hepatocellular Carcinoma","BCLC Stage C Hepatocellular Carcinoma","Hepatic Arterial Infusion Chemotherapy","Lenvatinib","Systemic Therapy","2024-10-06",{"date":263,"type":35},"2024-10-08",{"date":265,"type":35},"2024-09-16",{"date":267,"type":20},"2025-12-30",{"name":269,"class":42},"First Hospital of China Medical University",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":54,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":43},"100552951","phase-2-lm-108-antibody-combination-with-sintilimab-for-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100552951","NCT06479759","LM-108 Antibody Combination With Sintilimab for Locally Advanced or Metastatic Non-Small Cell Lung Cancer","A Multicenter Clinical Study of LM-108 Antibody in Combination With Sintilimab for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","ACCLAIM","Inclusion Criteria:\n\n* Obtain written informed consent before implementing any trial-related procedures;\n* Aged \\>= 18 years old;\n* Patients with locally advanced (stage IIIB\u002FIIIC), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not candidates for surgical treatment and cannot undergo curative radiotherapy or chemotherapy according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;\n* Absence of the following gene mutations: EGFR gene, ALK fusion oncogene, ROS1, etc. For other types of gene mutations, patients without approved targeted therapies are allowed to be included;\n* Cohort 1: Patients with non-small cell lung cancer who have developed acquired resistance to PD-1 inhibitors (alone or in combination with another systemic therapy) after being responsive to treatment (for 6 months or more) can participate in this study. Cohort 2: Patients who have not received any systemic anti-tumor treatment for advanced\u002Fmetastatic disease before; for patients who have previously received platinum-based adjuvant chemo\u002Fradiotherapy, neoadjuvant chemo\u002Fradiotherapy, or curative radiotherapy for advanced disease, disease progression occurred more than 6 months after the last treatment, they can participate in this study;\n* The investigator confirms at least one measurable lesion according to RECIST 1.1 criteria;\n* Estimated life expectancy \\>= 3 months;\n* ECOG PS: 0-1 score;\n* Provide archived tumor tissue (including formalin-fixed paraffin-embedded tissue blocks containing tumor \\[preferred\\] or approximately 15 freshly cut unstained tissue sections) for confirmation of immunohistochemistry for PD-L1, CCR8, CCL1, FOXP3, etc. If archived tissue cannot be obtained, subjects must agree to undergo a tumor biopsy during the screening period;\n* Hematological function is sufficient, defined as absolute neutrophil count \\>= 1.5×10\\^9 \u002FL, platelet count \\>= 100×10\\^9 \u002FL, hemoglobin \\>= 90g\u002FL (no history of transfusion within 7 days);\n* Liver function is sufficient, defined as total bilirubin level \\\u003C= 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \\\u003C= 2.5 times ULN for all patients, or for patients with liver metastases, AST and ALT levels \\\u003C= 5 times ULN;\n* Renal function is sufficient, defined as serum creatinine \\\u003C= 1.5 times ULN;\n* Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) \\\u003C= 1.5 times ULN; if the subject is receiving anticoagulant therapy, INR\u002FPT within the range specified by the anticoagulant drug is acceptable;\n* Childbearing-age women must have a negative pregnancy test within 7 days before starting treatment; and reliable contraception measures (such as intrauterine devices, contraceptive pills, and condoms) should be used within 30 days of the start and end of the trial. Childbearing-age male subjects should use condoms for contraception during the trial and for 30 days after the end of the trial;\n* Cooperate with regular follow-up visits and comply with the requirements of the trial.\n\nExclusion Criteria:\n\n* Prior use of CCR8 drugs or other unapproved investigational drugs or treatments;\n* Known history of intolerance to PD-1 inhibitor therapy;\n* Receipt of any approved systemic anti-cancer therapy or systemic immunostimulant treatment within 28 days prior to the start of the study treatment;\n* Use of traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within the first 2 weeks prior to first dosing;\n* History of allergic reactions to any components of the investigational drug;\n* Known presence of brain metastases. Patients judged by the investigator to have stable brain metastases may be enrolled;\n* Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring clinical intervention;\n* Clinically uncontrollable pleural effusion\u002Fascites (patients who do not require fluid drainage or have no significant increase in fluid for 3 days may be enrolled);\n* Tumor compression of vital organs (such as esophagus) with associated symptoms, compression of superior vena cava, or invasion of major mediastinal vessels, heart, etc.;\n* Severe comorbidities such as a history of severe pulmonary or cardiac disease, any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months prior to enrollment;\n* Receipt of systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] drugs) within 2 weeks prior to enrollment. The use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is allowed;\n* History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with autoimmune-related hypothyroidism receiving stable doses of thyroid hormone replacement therapy are eligible to participate in this study. Patients with type 1 diabetes controlled with a stable insulin regimen are eligible to participate in this study;\n* Active systemic infections, including tuberculosis (clinically diagnosed based on clinical history, physical examination, and radiological findings, as well as TB tests performed according to local medical practice), hepatitis B (known positive for HBV surface antigen \\[HBsAg\\], and HBV DNA \\>= 1000 cps\u002Fml or its lower limit of reference), hepatitis C, or human immunodeficiency virus (HIV antibody positive);\n* Known presence of psychiatric disorders or substance abuse that may affect compliance with trial requirements;\n* Recent use of a full therapeutic dose of oral or non-oral anticoagulants or thrombolytic agents. Prophylactic use of anticoagulants is allowed;\n* History, disease, treatment, or laboratory abnormalities that may interfere with trial results, hinder the subject's full participation in the study, or are deemed by the investigator to be not in the subject's best interest to participate in the study.",{"count":102,"type":20},[56],"The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients.",[282,25],"NSCLC","2024-06-24",{"date":285,"type":35},"2024-06-28",{"date":287,"type":35},"2024-01-12",{"date":289,"type":20},"2025-12-12",{"name":291,"class":42},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":299,"targetDuration":4,"studyType":54,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":43},"100526099","phase-2-neoadjuvant-tirellizumab-combined-with-chemotherapy-for-early-oral-squamous-cell-carcinomahnc-sysu-004-100526099","NCT06130332","Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004)","A Single-center Exploratory Clinical Study of Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma (cT1-2N0M0)","Inclusion Criteria:\n\n* Patients with early oral squamous cell carcinoma diagnosed as T1-2N0M0 according to the eighth edition of AJCC classification;\n* No history of other malignant tumors;\n* 18-75 years old;\n* Baseline inspection is normal:\n\n  1. The absolute value of neutrophil (ANC) ≥1.5x109\u002FL in the past 14 days without the use of granulocyte colony-stimulating factor;\n  2. Platelets ≥100×109\u002FL without blood transfusion in the past 14 days;\n  3. In the case of no blood transfusion or use of erythropoietin in the last 14 days, hemoglobin \\> 9g\u002FdL;\n  4. Total bilirubin ≤1.5× upper limit of normal (ULN);\n  5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN (patients with liver metastases allowed ALT or AST ≤5×ULN);\n  6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n  7. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n  8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;\n  9. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to enter the group);\n  10. For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1) and the result is negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;\n  11. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Other malignant tumors are diagnosed, or oral cancer is not the beginning of neoadjuvant therapy;\n* Prior to treatment, an active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within the previous 2 years. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;\n* known allogeneic organ transplantation (other than corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);\n\nNote: Hepatitis B subjects who meet the following criteria can also be enrolled:\n\n1. HBV viral load \\&lt before first dosing; 1000 copies \u002Fml (200 IU\u002Fml), subjects should receive anti-HBV therapy throughout study treatment to avoid viral reactivation;\n2. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required;\n\n   * active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n   * Pregnant or lactating women;\n   * The presence of any serious or uncontrolled systemic disease, such as:\n\n1\\) The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;",{"count":300,"type":20},40,[56],"Surgery is usually the first choice for early-stage oral squamous cell carcinoma (OSCC). However, there is currently a lack of consensus on whether patients with clinically negative cervical lymph nodes (N0) should undergo elective neck dissection (END) at the same time. About 20-30% of cT1-2N0M0 oral cancer patients have occult lymph node metastasis, and existing examination methods cannot accurately predict occult cervical lymph node metastasis. Therefore, most clinical retrospective and prospective studies recommend END for cN0 patients. Previous studies have found that no cancer cells were found in the cervical lymph nodes of 70% of patients after END. This unselective END can cause patients with accessory nerve dysfunction, neck scars, etc., and prolong hospitalization and surgery time. Exploring the treatment model for patients with early-stage oral squamous cell carcinoma is an urgent problem that needs to be solved. This study intends to conduct a study on the neoadjuvant treatment of tislelizumab, carboplatin, and albumin-bound paclitaxel. After neoadjuvant immunotherapy in patients with early-stage oral cancer (T1-2N0M0), the primary tumor is treated with standard surgical treatment. Comparison with A single-center exploratory clinical study of traditional oral cancer radical resection + selective neck lymphadenectomy was conducted to explore its effectiveness through the difference in 2-year disease-free survival (DFS).\n\nThis research plan covers 40 patients with early-stage oral squamous cell carcinoma. They will be randomly divided into tislelizumab, chemotherapy combined with surgery (experimental group) and traditional surgery (control group) in a 1:1 ratio. The patients' tumors will be collected. Tissues, adjacent cancer tissues, whole blood samples, saliva samples, and matrix samples were used to observe the changes in imaging and pathology compared with treatment. At the same time, the clinical information of the patients was collected, such as quality of life indicators such as judgment function, pathological grading, staging, treatment, Spine, serology, imaging, etc., mainly to evaluate the 2-year event-free survival (EFS) between the experimental group and Weather Forecast, and the 3-year overall survival (OS) and patient quality of life between the experimental group and Weather Forecast.",[304,25],"Oral Cancer","2023-11-12",{"date":307,"type":35},"2023-11-14",{"date":309,"type":35},"2023-09-01",{"date":311,"type":20},"2030-08-31",{"name":118,"class":42},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":321,"targetDuration":4,"studyType":54,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":43},"100514607","phase-2-4-courses-vs-2-courses-of-pembrolizumab-combined-with-carboplatin-and-albumin-binding-paclitaxel-of-neoadjuvant-therapy-in-hnscc-100514607","NCT05980702","4 Courses vs 2 Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel of Neoadjuvant Therapy in HNSCC","Safety and Efficacy of Four Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel Versus Two Courses of Neoadjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma (T3 or T4, N0) : An Optimal Efficacy Study (Prospective, Two-arm, Phase II)","HNC-SYSU-002","Inclusion Criteria:\n\n* 18 years of age ≤65 years of age;\n* cytological or histological diagnosis of surgically resectable head and neck squamous cell carcinoma with the following stages: T3 or T4, N0;\n* According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there was at least one radiologically measurable lesion; First-line patients: have not previously received any systemic antitumor therapy for advanced\u002Fmetastatic disease. Patients who had previously received platinum-containing adjuvant\u002Fneoadjuvant chemotherapy, or had received radical chemoradiotherapy for advanced disease, if the interval between disease progression or recurrence and the end of the last chemotherapy drug treatment was at least 6 months, were allowed to be enrolled in this study.\n* ECOG score 0-1;\n* Expected survival time \\> 3 months;\n* Adequate organ function, subject shall meet the following laboratory indicators:\n\n  1. The absolute value of neutrophil granulocyte (ANC) ≥1.5x109\u002FL in the last 14 days without the use of granulocyte colony stimulating factor;\n  2. Platelets ≥100×109\u002FL without blood transfusion in the past 14 days;\n  3. Hemoglobin \\&gt without blood transfusion or use of erythropoietin within the last 14 days; 9g\u002FdL;\n  4. Total bilirubin ≤1.5× upper limit of normal value (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);\n  6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n  7. Good coagulation function, defined as International Standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n  8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range;\n  9. The myocardial enzyme profile was within the normal range (if the researchers comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included);\n  10. For female subjects of childbearing age, a urine or serum pregnancy test should be tested negative within 3 days prior to receiving the first study drug administration (day 1 of Cycle 1). If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;\n  11. If there is a risk of conception, all subjects (male or female) shall use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapeutic drug administration).\n\nExclusion Criteria:\n\n* Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to initial administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and\u002For carcinoma in situ after radical excision);\n* Currently participating in an interventional clinical study, or receiving other investigational drugs or using investigational devices within 4 weeks prior to initial dosing;\n* Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137);\n* Systemic treatment with Chinese patent drugs or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) with indications of anti-head and neck squamous cell carcinoma within 2 weeks before the first administration;\n* An active autoimmune immune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;\n* Was receiving systemic glucocorticoid therapy (excluding nasal, inhalation, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to initial administration; Note: Physiological doses of glucocorticoids (≤10 mg\u002F day of prednisone or equivalent) are permitted;\n* Clinically uncontrollable pleural effusion\u002Fabdominal effusion (patients with no need to drain effusion or no significant increase of effusion after 3 days of stopping drainage could be included in the group);\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Those who are known to be allergic to the active ingredients or excipients of the drug in this study, Pabolizumab, carboplatin and albumin-binding paclitaxel;\n* Has not fully recovered from toxicity and\u002For complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);\n* Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive coupled with a detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled:1) HBV viral load \\&lt before initial administration; At 1000 copies \u002Fml (200 IU\u002Fml), subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study treatment period.2) For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required\n* Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection);\n* Received live vaccine within 30 days prior to initial administration (cycle 1, day 1); Note: Inactivated injectable virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; But live attenuated influenza vaccines administered intranasally are not allowed.\n* Pregnant or lactating women;\n* There is any serious or uncontrolled systemic disease, such as:\n\n  1. The resting electrocardiogram (ECG) presents significant and severely uncontrollable abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, Ⅱ degree or above heart block, ventricular arrhythmia or atrial fibrillation;\n  2. Unstable angina pectoris, congestive heart failure, and NYHA grade ≥ 2 chronic heart failure;\n  3. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;\n  4. Poor blood pressure control (systolic \\> 140 mmHg, diastolic \\> 90 mmHg);\n  5. A history of non-infectious pneumonia requiring glucocorticoid therapy or clinically active interstitial lung disease within 1 year prior to initial administration;\n  6. Active pulmonary tuberculosis;\n  7. There is an active or uncontrolled infection that requires systemic treatment;\n  8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n  11. Urine routine indicated urine protein ≥++, and confirmed 24 hours urine protein quantity \\> 1.0 g;\n  12. Patients with mental disorders and unable to cooperate with treatment;\n* Medical history or evidence of disease that may interfere with test results, prevent participants from participating fully in the study, abnormal values of treatment or laboratory tests, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers other potential risks unsuitable for participation in the study.",{"count":322,"type":20},192,[56],"In this study, 200 patients with resectable head and neck squamous cell carcinoma (T3 or T4, N0) were enrolled and preoperatively combined with pembrolizumab (PD-1 inhibitor), carboplatin, and albumin-binding paclitaxel. The subjects were randomly divided 1:1 into four treatments and two treatments. The imaging and pathological changes of tumor and paracancer tissues before and after treatment were observed. Clinical information, such as pathological grade, stage, treatment, prognosis, serology, imaging, etc., was collected to evaluate the safety and efficacy of 4-course pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with 2-course neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma. This is a prospective, one-arm, phase II clinical study.\n\nMain purpose By calculating pathological complete response (pCR) in the experimental group, we evaluated the efficacy (optimality) of four courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with two courses of neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma (T3 or T4, N0).\n\nAt the same time, this study evaluated the safety of medication, specifically: The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE (version 5.0) during this study and during follow-up, and the occurrence of adverse events in the experimental and control groups will be compared. To evaluate the safety of 4-course Pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with 2-course neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma (T3 or T4, N0).\n\nSecondary Purpose\n\n1. The event-free survival (EFS) of the two groups were compared;\n2. The main pathological response rate (MPR) of the two groups were compared;\n3. pTR of the two groups was compared;\n4. Overall survival (OS) of the two groups was compared;\n5. The radiological responses of the two groups were compared;\n6. The operation delay rate of the two groups was compared; Exploratory purpose For the response of enrolled patients after treatment, group treatment was conducted according to the guidelines, and stratified factors influencing the prognosis and treatment plan of immunotherapy were explored according to stratification. The stratification factors taken into consideration are: P16 status, smoking history, TNM stage, tumor reduction (MPR condition), presence of risk factors (according to the guidelines, risk factors are presence of episopercular invasion, positive incisal margin, proximal incisal margin, pT3 or pT4, pN2 or pN3 lymph nodes located in the IV and V regions of the neck, Nerve invasion, vascular invasion, etc.). The purpose of this study was to stratified risk factors for evaluating the efficacy of pembrolizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma. At the same time, hematological, pathological and fecal indicators collected in the design of the experiment were collected. Correlation analysis was conducted to statistically analyze the relationship between these indicators and the therapeutic effect of the program.",[106,304,25],[106,304,25],"2023-09-04",{"date":329,"type":35},"2023-09-07",{"date":331,"type":35},"2023-04-04",{"date":333,"type":20},"2030-04-03",{"name":118,"class":42},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":54,"phases":346,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":43},"100514608","phase-3-pd-1-inhibitor-therapy-versus-radiotherapy-in-pcr-patients-with-locally-advanced-hnscc-after-neoadjuvant-immunochemotherapy-100514608","NCT05980715","PD-1 Inhibitor Therapy Versus Radiotherapy in pCR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy","A Randomized Controlled, Non-inferior, Phase III Study of PD-1 Inhibitor Therapy Versus Radiotherapy in pCR Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy","HNC-SYSU-003","Inclusion Criteria:\n\n* In this study, patients with locally advanced head and neck squamous cell carcinoma (AJCC 8th) who underwent standard surgical treatment after neoadjuvant immunochemotherapy and showed pCR in both primary lesions and lymph node pathology were selected. Locally advanced squamous cell carcinoma of head and neck includes: i) T3, N0, M0; 2) T1-T3, N1-N2, M0; 3) T4a, N0-2, M0.\n* No history of other malignant tumors\n* Ages 18-65\n* Normal baseline inspection:\n\n  1. The absolute value of neutrophil granulocyte (ANC) ≥1.5x109\u002FL in the last 14 days without the use of granulocyte colony stimulating factor;\n  2. Platelets ≥100×109\u002FL without blood transfusion in the past 14 days;\n  3. Hemoglobin \\&gt without blood transfusion or use of erythropoietin within the last 14 days; 9g\u002FdL;\n  4. Total bilirubin ≤1.5× upper limit of normal value (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);\n  6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n  7. Good coagulation function, defined as International Standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n  8. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range;\n  9. The myocardial enzyme profile was within the normal range (if the researchers comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included);\n  10. For female subjects of childbearing age, a urine or serum pregnancy test should be tested negative within 3 days prior to receiving the first study drug administration (day 1 of Cycle 1). If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;\n  11. If there is a risk of conception, all subjects (male or female) shall use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapeutic drug administration).\n\n  5 Sign informed consent\n\nExclusion Criteria:\n\n* 1 HNSCC is not the initial diagnosis of other malignant tumors or neoadjuvant therapy.\n* Prior to treatment An active autoimmune immune disease requiring systemic therapy (e.g. the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred in the last 2 years. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);\n\nNote: Hepatitis B subjects who meet the following criteria can also be enrolled:\n\n1\\) HBV viral load \\&lt before initial administration; At 1000 copies \u002Fml (200 IU\u002Fml), subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study treatment period 2) For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required\n\n* Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the lower limit);\n* Pregnant or lactating women;\n* The presence of any serious or uncontrolled systemic disease, such as:\n\n  1. The resting electrocardiogram (ECG) presents significant and severely uncontrollable abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, Ⅱ degree or above heart block, ventricular arrhythmia or atrial fibrillation;\n  2. Unstable angina pectoris, congestive heart failure, and NYHA grade ≥ 2 chronic heart failure;\n  3. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;\n  4. Poor blood pressure control (systolic \\> 140 mmHg, diastolic \\> 90 mmHg);\n  5. A history of non-infectious pneumonia requiring glucocorticoid therapy or clinically active interstitial lung disease within 1 year prior to initial administration;\n  6. Active pulmonary tuberculosis;\n  7. There is an active or uncontrolled infection that requires systemic treatment;\n  8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n  11. Urine routine indicated urine protein ≥++, and confirmed 24 hours urine protein quantity \\> 1.0 g;\n  12. Patients with mental disorders and unable to cooperate with treatment;\n* Medical history or evidence of disease that may interfere with test results, prevent subjects from fully participating in the study, abnormal values of treatment or laboratory tests, or other conditions that the investigator considers unsuitable for enrollment. The investigator considers other potential risks unsuitable for participation in the study.","65 Years",{"count":345,"type":20},324,[347],"PHASE3","In patients with locally advanced head and neck squamous cell carcinoma undergoing standard surgical treatment after neoadjuvant immunochemotherapy, can PD-1 inhibitor therapy be used instead of adjuvant radiotherapy for both primary and lymph node pathology? To provide further evidence-based medical evidence for the late precision treatment of HNSCC patients after neoadjuvant immunochemotherapy. Avoid the side effects caused by excessive radiotherapy, especially avoid the occurrence of second primary cancer, radiation osteonecrosis and other diseases.\n\n1. Main study endpoint:\n\n   A randomized controlled, non-inferiority, multicentre Phase III trial was conducted to investigate the difference in 5-year overall survival (OS) between experimental group (Group B) and control group (group A) in patients undergoing standard surgical treatment after neoadjuvant immunochemotherapy for locally advanced HNSCC, with both primary and lymph node pathology revealed by pCR. At the same time, adverse events and safety were evaluated according to NCI-CTCAE 5.0 criteria and RTOG later radiotherapy damage evaluation criteria.\n\n   Safety indicators focused on late radiotherapy toxicity and the incidence of grade 3 and 4 adverse reactions in NCI-CTC AE 5.0 and RTOG. The differences in the incidence of grade 3 and 4 adverse events were compared between the experimental group and the control group.\n2. Secondary study endpoint:\n\nThe differences in 2-year disease-free survival (DFS), regional relapse-free survival (RRFS), distant metastasis free survival (DMFS), safety and adverse events were compared.\n\nSafety evaluation NCI-CTC AE 5.0 standard was used to evaluate the acute safety index of radiotherapy, and RTOG late-stage damage evaluation standard was used to evaluate the late-stage safety index of radiotherapy.\n\n4\\) Exploratory goals The influence of prognostic laboratory indicators, clinical risk factors were analyzed. To explore the factors that influence the efficacy of radiotherapy after pCR immunotherapy.",[106,107,25],[106,109,25],"2023-08-06",{"date":353,"type":35},"2023-08-08",{"date":355,"type":35},"2023-01-01",{"date":357,"type":20},"2030-12-31",{"name":118,"class":42},{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":366,"targetDuration":4,"studyType":54,"phases":368,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":385,"locationsCount":387},"100422294","phase-3-toripalimab-plus-surgery-vs-surgery-alone-for-resectable-recurrent-nasopharyngeal-carcinoma-100422294","NCT04778956","Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma","Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial","Inclusion Criteria:\n\n1. The recurrence time is more than 6 months from the end of radiotherapy.\n2. Histologically confirmed recurrent nasopharyngeal carcinoma.\n3. Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and\u002For nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)\n4. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common\u002Finternal carotid artery involvement. (according to the 8th edition of AJCC staging system)\n5. Given written informed consent.\n\nExclusion Criteria:\n\n1. Karnofsky Performance Status (KPS) ≤70.\n2. Has severe medical disorder, important organ dysfunction, and\u002For a substantial history of mental illness.\n3. Has known subjects with other malignant tumors.\n4. Has participated in other drug trials within 3 months of planned start of study treatment.\n5. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.\n6. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.\n7. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.\n8. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.\n9. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps\u002Fml or hepatitis C virus (HCV) antibody positive.\n10. Has received a live vaccine within 4 weeks of planned start of study treatment.\n11. Pregnancy or breast feeding.\n12. Cannot complete regular follow-up.",{"count":367,"type":20},218,[347],"Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.",[371,25,372],"Nasopharyngeal Carcinoma","Surgery",[374,375,376,377,378],"Nasopharyngeal carcinoma","Recurrent","Salvage surgery","Anti-programmed death-1 antibody","Disease free survival","2021-03-03",{"date":381,"type":35},"2021-03-04",{"date":379,"type":35},{"date":384,"type":20},"2033-03-03",{"name":386,"class":42},"Sun Yat-sen University",7]