[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-treatment":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,66,93,122,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100589830","phase-2-zanzalintinib-for-the-treatment-of-advanced-thyroid-cancer-before-surgery-100589830",false,"NCT06959511","Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery","ZAnzalintinib Neoadjuvant EValuation in Thyroid Oncology (ZANEVO)","Eligibility Criteria\n\n1. Participants with differentiated thyroid cancer, non-RET-mutated medullary thyroid cancer, or poorly differentiated thyroid cancer who present with locoregionally advanced disease, as defined by extrathyroidal and\u002For extra nodal extension, or with advanced recurrent\u002Fresidual invasive\u002Fbulky nodal disease will be enrolled in this trial, regardless of whether distant metastases are present or not.\n2. At least 18 years of age on the day of signing informed consent.\n3. Pathologic findings supporting the clinical impression of papillary thyroid cancer, follicular thyroid cancer, oncocytic thyroid cancer, medullary thyroid carcinoma, and\u002For poorly differentiated thyroid carcinoma. For patients with Bethesda IV or V FNA's (e.g. follicular neoplasm, follicular lesion, Hürthle cell neoplasm, Hürthle cell lesion), if the radiographic context is conclusive for carcinoma of thyroid origin, including significant extrathyroidal extension with invasion of surrounding structures and PET avidity, patients can be enrolled.\n4. Thyroid Neck Group morbidity complexity score of 1 to 4 (moderate, severe, very severe, or unresectable).\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 with no known sudden deterioration 2 weeks prior to the first dose of trial treatment.\n6. Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy (e.g., physiological replacement of mineral corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ Grade 2 hypomagnesemia, ≤ Grade 2 neuropathy are permitted.\n7. Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 28 days before first dose of study treatment:\n\n   1. Absolute neutrophil count (ANC)≥ 1500\u002Fmm3 (≥1.5 GI\u002FL) without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.\n   2. Platelets ≥ 100,000\u002Fmm3 (≥100 GI\u002FL) without transfusion within 2 weeks of screening laboratory sample collection.\n   3. Hemoglobin ≥9 g\u002FdL (≥90 g\u002FL) without transfusion within 2 weeks prior to screening laboratory sample collection.\n   4. International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN).\n   5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For subjects with documented bone metastasis ALP ≤5 x ULN.\n   6. Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert fs disease ≤ 3 x ULN).\n   7. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin ( ≥0.67 mL\u002Fsec) using the Cockcroft Gault equation.\n   8. Urine protein-to-creatinine ratio (UPCR) ≤1 mg\u002Fmg ( ≤113.2 mg\u002Fmmol) creatinine.\n8. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n9. For MD Anderson site only, subjects must be willing to undergo tumor biopsy prior to trial treatment, unless in the opinion of the treating physician, a biopsy is not feasible or safe. For all sites, subjects must be willing to ultimately undergo surgery if their tumor becomes surgically resectable. Subjects retain the right to refuse any research interventions.\n10. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Appendix A) during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods. (1) through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men.\n11. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n\nExclusion Criteria:\n\n1. Medullary thyroid cancer participants with germline RET or known somatic RET mutations.\n2. Prior treatment with zanzalintinib.\n3. Prior treatment with a tyrosine kinase inhibitor.\n4. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n5. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n7. Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel).\n\n   Allowed anticoagulants are the following:\n   1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n   2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n   Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n8. Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n9. The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n   a. Unstable or deteriorating cardiovascular disorders: i. Congestive heart failure New York Heart Association class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes). ii. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment. iii. Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n\n   iv. Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before to first dose of study treatment. Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: Participants who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n10. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n11. Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed. Intratracheal disease is allowed, as long as the endotracheal disease is not associated with major bleeding episodes.\n12. Lesions invading major blood vessel including, but are not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with internal jugular vein involvement or tumor thrombus in the neck are eligible. Additionally, subjects with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior V. cava) may be eligiblefollowing Principal Investigator approval.\n13. Other clinically significant disorders that would preclude safe study participation.\n\n    1. Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n    2. Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness except for subjects meeting all of the following criteria: (1) on stable anti-retroviral therapy; (2) CD4+ T cell count ≥ 200\u002FμL; and (3) an undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: To be eligible, participants taking CYP inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts and viral load are monitored per standard of care by the local health care provider.\n    3. Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n    4. Malabsorption syndrome.\n    5. Uncontrolled symptomatic hyperthyroidism or hypothyroidism.\n    6. Uncontrolled symptomatic hypercalcemia or hypocalcemia.\n    7. Moderate to severe hepatic impairment (Child-Pugh B or C).\n    8. Requirement for hemodialysis or peritoneal dialysis.\n    9. History of solid organ or allogeneic stem cell transplant.\n14. Major surgery (as defined in Appendix B; e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. Fine needle aspiration and core biopsies are allowed on study drug without drug hold.Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\n    Note: Participants with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n15. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n16. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n17. Pregnant or lactating females.\n18. Inability to swallow tablets or ingest a suspension either orally or by nasogastric (NG) or gastrostomy (PEG) tube.\n19. Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n20. Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.\n21. Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participants ability to complete the study.","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To look at the effectiveness of zanzalintinib, followed by surgery, in treating advanced thyroid cancer. The safety of this treatment will also be studied.",[26,27],"Neoadjuvant Treatment","Thyroid Cancer","RECRUITING","2026-06-01",{"date":31,"type":32},"2026-06-03","ACTUAL",{"date":34,"type":32},"2025-07-22",{"date":36,"type":20},"2030-10-01",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100640085","evaluation-of-the-administration-of-artificial-nutrition-by-feeding-jejunostomy-during-neoadjuvant-treatment-on-postoperative-morbidity-in-the-context-of-esophageal-or-stomach-cancer-100640085","NCT07584577","Evaluation of the Administration of Artificial Nutrition by Feeding Jejunostomy During Neoadjuvant Treatment on Postoperative Morbidity in the Context of Esophageal or Stomach Cancer","FREJENO","Inclusion Criteria:\n\n* Patient undergoing surgery for esophageal cancer\n* Malnourished patient at the time of management\n* Receiving neoadjuvant treatment\n\nExclusion Criteria:\n\n* Patient not malnourished at the time of management\n* Patient who did not receive neoadjuvant treatment",{"count":49,"type":20},670,"OBSERVATIONAL","Malnutrition is common at the time of diagnosis of esogastric cancers. However, there are no recommendations regarding preoperative nutritional support (type and duration) or on the impact of refeeding on postoperative morbidity and mortality.",[53,54,55,26],"Esophageal Cancer","Surgery Indication","Malnourished","2026-05-07",{"date":58,"type":32},"2026-05-13",{"date":60,"type":20},"2026-11-01",{"date":62,"type":20},"2026-11-30",{"name":64,"class":39},"University Hospital, Bordeaux",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":65},"100560425","phase-2-adbelimumab-combined-with-chemotherapy-and-apatinib-in-patients-with-resectable-esophageal-squamous-cell-carcinoma-100560425","NCT06576973","Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma","A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Patients age 18 to 75 years old.\n3. Primary resectable, histologically confirmed esophageal squamous cell cancer.\n4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).\n5. ECOG PS 0-1.\n6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist.\n\nExclusion Criteria:\n\n1. With significant cardiovascular disease.\n2. Current treatment with anti-viral therapy or HBV.\n3. Female patients who are pregnant or lactating.\n4. History of malignancy within 5 years prior to screening.\n5. Active or history of autoimmune disease or immune deficiency.\n6. Signs of distant metastases.","75 Years",{"count":75,"type":20},35,[23],"Esophageal cancer is a prevalent digestive tract tumor, with around 400,000 new cases and 300,000 deaths globally each year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma (ESCC) patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate.\n\nTherefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1\u002F PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of ESCC. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect.\n\nThe results of the Phase 1b trial evaluating adbelimumab monotherapy as a neoadjuvant treatment for locally advanced resectable ESCC demonstrated that patients receiving two cycles of neoadjuvant sequential surgery exhibited favorable safety profiles, with no adverse reactions of grade 3 or higher. The trial reported a major pathological response (MPR) rate of 24%, a pathological complete response (pCR) rate of 8%, a 2-year overall survival (OS) rate of 92%, and a 2-year recurrence-free survival (RFS) rate of 100%. The effectiveness of combining adbelizumab with chemotherapy and targeted therapy for locally advanced esophageal cancer is uncertain.\n\nThis study aims to assess the efficacy and safety of using adbelizumab with chemotherapy and apatinib as neoadjuvant therapy for resectable ESCC.",[79,26],"Esophageal Squamous Cell Carcinoma",[81,82,83,79,26],"Adbelimumab","Chemotherapy","Apatinib","2025-11-24",{"date":86,"type":32},"2025-12-02",{"date":88,"type":32},"2024-08-08",{"date":90,"type":20},"2031-12",{"name":92,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":101,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":65},"100587462","impact-of-targeted-nutritional-apport-and-exercise-on-the-modulation-of-metabolic-and-immune-related-gene-expression-signatures-in-early-breast-cancer-ebc-patients-candidate-to-neoadjuvant-therapy-nat-100587462","NCT06928701","Impact of \"Targeted\" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)","A Phase II Randomized Trial to Evaluate the Impact of \"Targeted\" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)","NEOMET","Inclusion Criteria:\n\n* \\- Women (regardless of menopausal status) ≥ 18 years of age\n* Pathologic confirmation of breast cancer by tumor biopsy\n* Immunohistochemical assessment (as per local standards) of ER and PgR status, HER2 status;\n* Stage I-III breast cancer without evidence of distant metastases\n* Being candidate to standard neoadjuvant therapy\n* Having available tumor tissue from breast and\u002For lymph node at baseline\n* Ability to fill a nutritional daily diary\n* Medical clearance for non-agonistic physical activity\n* Written informed consent to study-specific procedures\n\nExclusion Criteria:\n\n* \\- locally advanced or inflammatory or stage IV BC;\n* tumor size \\\u003C 1 cm with negative nodes (pT1a, N0);\n* chronic diseases or orthopedic issues that might interfere with ability to undertake a dietary and physical activity program;\n* personal history of eating disorders.\n* women engaged in agonistic\u002Fvigorous sport activities, not able to be compliant to exercise schedules","FEMALE",{"count":103,"type":20},160,[105],"NA","NEOMET is an exploratory randomized prospective, multicenter study whose primary aim is to explore if metabolomic signatures can be modified by a lifestyle intervention including dietary supplements and physical exercise intervention, in eBC patients candidate to NAT. Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).",[108,26],"Early Breast Cancer",[110,111,112],"treatment response","metabolomics","nutritional intervention","2025-04-07",{"date":115,"type":32},"2025-04-15",{"date":117,"type":32},"2024-09-01",{"date":119,"type":20},"2026-12",{"name":121,"class":39},"University of Eastern Piedmont",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":40},"100465638","phase-2-the-efficacy-and-safety-of-neoadjuvant-low-dose-radiotherapy-combined-with-chemoimmunotherapy-in-locally-advanced-hnscc-100465638","NCT05343325","The Efficacy and Safety of Neoadjuvant Low-dose Radiotherapy Combined With Chemoimmunotherapy in Locally Advanced HNSCC","Neoadjuvant Low-dose Radiotherapy, Tislelizumab, Combined With Albumin-bound Paclitaxel and Cisplatin in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (NeoRTPC02): an Open Label, Single-arm, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system;\n2. Eligible for radical surgery, as judged by surgeons.\n3. Aged ≥ 18 years and ≤ 70 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n5. Life expectancy of more than 6 months.\n6. At least one measurable lesion according to RECIST 1.1.\n7. Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):\n\n   1. Hemoglobin ≥ 90 g\u002FL; absolute neutrophil count ≥ 1.5 × 109\u002FL; and platelet count ≥ 100 × 109\u002FL;\n   2. Serum albumin ≥ 28 g\u002FL;\n   3. Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN;\n   4. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL\u002Fmin;\n   5. Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ).\n\n      43\u002F5000\n   6. Thyroid Stimulating Hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels should be examined, and patients with normal T3 and T4 levels can be screened.\n8. Women of childbearing age should agree to the use of contraception (e.g., intrauterine devices, birth control pills, or condoms) during drug administration and for 3 months thereafter.\n9. Subjects voluntarily join the study and sign an informed consent form, with good compliance.\n\nExclusion Criteria (Patients will be excluded if any of the following criteria is met):\n\n1. Pregnant or lactating women.\n2. A history of allergies to PD-1 inhibitors or any of albumin-bound paclitaxel or cisplatin.\n3. A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.\n4. Uncontrolled cardiac clinical symptoms or diseases, such as :(1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) patients with clinically significant ventricular or ventricular arrhythmias requiring intervention.\n5. Have received any of the following treatments:\n\n   1. Any research drug received prior to the first dose of the current research drug.\n   2. Joined another clinical study at the same time, unless it is an observational (noninterventional) clinical study or an intervention during a follow-up.\n   3. Needed systemic treatment with corticosteroids (more than 10 mg of prednisone or equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergies or nausea and vomiting. In the absence of active autoimmune diseases, inhalation or partial use of steroids and adrenal corticosteroid replacements at doses greater than 10 mg per day of fentanyl equivalent is permitted.\n   4. Live vaccines were administered within 4 weeks prior to the first administration of research drugs.\n   5. Major surgery or severe trauma within four weeks of initial use of the study drug.\n6. Serious infections (greater than grade 2 according to the Common Terminology Criteria for Adverse Events), such as severe pneumonia, bacteremia, and infection comorbidities, which required hospitalization, occurred within 4 weeks prior to the first dose of the study drug; baseline chest imaging examinations indicate the presence of active lung inflammation or symptoms and signs of infection within 2 weeks prior to the first dose of the study drug or indicate the need for oral or intravenous antibiotic treatment (excluding the use of preventive antibiotics).\n7. A history of active autoimmune diseases and syndromes (including, but not limited to, interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo or cured childhood asthma\u002Fallergies that do not require any intervention in adulthood are not excluded.\n8. A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.\n9. Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment.\n10. Active hepatitis B (HBV DNA ≥ 2,000 IU\u002FmL or 10,000 copies\u002FmL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection).\n11. Known history of psychotropic drug abuse, alcoholism and drug use.\n12. Not suitable for inclusion, as judged by the researcher.","70 Years",{"count":131,"type":20},25,[23],"This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.",[135,26],"Head and Neck Squamous Cell Carcinoma",[137,138,139,140],"locally advanced HNSCC","neoadjuvant treatment","low-dose radiotherapy","pathological response rates","2022-12-26",{"date":143,"type":32},"2022-12-29",{"date":145,"type":32},"2022-03-09",{"date":147,"type":20},"2027-03-31",{"name":149,"class":39},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":65},"100384064","phase-3-neo-adjuvant-immunochemotheray-versus-neo-adjuvant-chemotherapy-for-resectable-esophageal-carcinoma-100384064","NCT04280822","Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma","A Phase III, Randomized Controlled Study of Neo-adjuvant Toripalimab (JS001) in Combination With Chemotherapy Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Histologic diagnosis of local advance squamous cell thoracic esophageal carcinoma of Stage (T1N1-3 or T2-3N0-3 M0), (8th Union for International Cancer Control, UICC-TNM).\n2. No metastatic lymph node in cervical by color doppler sonography.\n3. Patients must not have received any prior anticancer therapy of esophageal carcinoma.\n4. Age ranges from 18 to 75 years.\n5. Without operative contraindication.\n6. Absolute white blood cells count ≥4.0×109\u002FL, neutrophil ≥1.5×109\u002FL, platelets ≥100.0×109\u002FL, hemoglobin ≥90g\u002FL, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.\n7. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).\n8. expected R0 resection.\n9. ECOG 0～1.\n10. Patients should agree to use contraceptive measures during the study period and within 6 months of the end of the study. Women must be non-lactation.\n11. Signed informed consent document on file. 10. .\n\nExclusion Criteria:\n\n* 1\\. Multiple primary cancer. 2.Patients with infections disease that require treatment 3.Patients who need continuous hormone treatment 4.unstable angina within 3 months, myocardial infarction within 6 months 5.psychopath 6.Patients with concomitant hemorrhagic disease. 7.Any unexpected reason for patients can't get operation 8.Inability to use gastric conduit after esophagectomy because of a prior surgery.\n\n  9.Pregnant or breast feeding 10.Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.\n\n  11.Bronchial asthma who requires intermittent use of bronchodilators or medical interventions 12.Due to co-existing diseases, the immunosuppressant was used. And the dosage of immunosuppressant was more than 10mg\u002F day orally and more than 2 weeks before enrollment 13.Abnormal coagulation function (PT\\>16s, APTT\\>53s, TT\\>21s, Fib\\\u003C1.5g\u002FL), tendency of bleeding or receiving thrombolysis or anticoagulant therapy 14.Previous or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, lung function severely impaired 15.Autoimmune diseases, immune deficiency, organ transplantation； 16.Hepatitis b\u002Fc patients。",{"count":158,"type":20},400,[160],"PHASE3","The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.",[53,163,26,164],"Surgery","Survival",[166,167],"Neoadjuvant chemotherapy","Neoadjuvant immunochemotherapy","2022-10-02",{"date":170,"type":32},"2022-10-04",{"date":172,"type":32},"2020-04-21",{"date":174,"type":20},"2028-03-02",{"name":176,"class":177},"Henan Cancer Hospital","OTHER_GOV"]