[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-esophageal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-esophageal-squamous-cell-carcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,68,94,119,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100635162","efficacy-and-safety-of-tislelizumab-plus-chemotherapy-as-conversion-therapy-in-unresectable-locally-advanced-escc-100635162",false,"NCT07549100","Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC","Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Written informed consent is obtained prior to any study-related procedures.\n2. Age 18 to 75 years, inclusive; both male and female patients are eligible.\n3. Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma (ESCC) with initially unresectable locally advanced disease, defined as:\n\n   T4b tumors invading adjacent critical structures, including the heart, great vessels, trachea, or other adjacent organs (including liver, pancreas, lung, or spleen); or Multiple-station or bulky lymph node metastases.\n4. No evidence of distant metastasis.\n5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. Estimated life expectancy of ≥6 months.\n8. Adequate organ function, as defined below (without transfusion of blood products or use of hematopoietic growth factors within 14 days prior to assessment):\n\n   Hematologic function: absolute neutrophil count (ANC) ≥1,500\u002Fmm³; platelet count ≥100,000\u002Fmm³; hemoglobin ≥9 g\u002FdL (5.6 mmol\u002FL).\n\n   Renal function: serum creatinine ≤1.5 mg\u002FdL and\u002For creatinine clearance ≥60 mL\u002Fmin.\n\n   Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤1.5 × ULN.\n9. For women of childbearing potential: must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use a medically acceptable method of contraception (e.g., intrauterine device, oral contraceptives, or barrier methods) during the study treatment period and for at least 3 months after the last dose.\n\n   For men with partners of childbearing potential: must agree to use a medically acceptable method of contraception during the study treatment period and for at least 3 months after the last dose.\n10. Willingness to participate in the study, good compliance, and ability to adhere to study procedures, including safety and survival follow-up.\n\nExclusion Criteria:\n\n1. Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer.\n2. Evidence of distant metastasis confirmed by imaging.\n3. History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n4. Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab.\n5. Active autoimmune disease or a history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.\n6. Patients with vitiligo or a history of childhood asthma that has completely resolved and requires no intervention in adulthood may be eligible.\n7. Patients with asthma requiring bronchodilator therapy are not eligible.\n8. Current use of immunosuppressive medications, including systemic corticosteroids or absorbable local steroids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment.\n\n   Clinically significant ascites or pleural effusion requiring therapeutic drainage.\n\n   Uncontrolled or clinically significant cardiovascular disease, including but not limited to:\n\n   New York Heart Association (NYHA) class II or higher heart failure; Unstable angina; Myocardial infarction within 1 year prior to enrollment; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n9. Coagulation abnormalities, defined as: prothrombin time (PT) \\>16 seconds, activated partial thromboplastin time (APTT) \\>43 seconds, thrombin time (TT) \\>21 seconds, or fibrinogen (Fbg) \\>2 g\u002FL; or presence of bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.\n10. Presence of gastrointestinal conditions associated with a high risk of bleeding or perforation within 3 months prior to enrollment, including but not limited to esophageal varices, active gastric or duodenal ulcers, ulcerative colitis, portal hypertension, or unresected tumors with active bleeding; or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg\u002Fm², day 1, every 3 weeks \\[Q3W\\]) plus cisplatin (75 mg\u002Fm²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery.\n\nSecondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.",[25],"Locally Advanced Esophageal Squamous Cell Carcinoma","RECRUITING","2026-04-16",{"date":29,"type":30},"2026-04-23","ACTUAL",{"date":32,"type":30},"2023-05-15",{"date":34,"type":21},"2028-12-31",{"name":36,"class":37},"Shandong Provincial Hospital","OTHER_GOV",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":46,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":38},"100543501","phase-2-a-clinical-study-on-the-efficacy-and-safety-of-paclitaxel-polymeric-micelles-and-cisplatin-combined-with-cadonilimab-as-a-neoadjuvant-therapy-for-locally-advanced-esophageal-squamous-cell-carcinoma-100543501","NCT06356688","A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma","A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-Arm, Single-Center, Prospective Clinical Trial (POINTS Trial)","Inclusion Criteria:\n\n1. Age ≥18 years, ≤75 years, gender is not limited;\n2. Squamous esophageal cancer of thoracic segment confirmed by pathology;\n3. Locally advanced patients with no distant metastasis by imaging, resectable or potentially resectable after discussion among oncology, esophageal surgery, and imaging, and clinical stage cT2-4aN+ or cT3-4aN0, M0, stage II, III, or IVA (AJCC 8th edition cTNM staging);\n4. ECOG PS score of 0-1;\n5. No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy;\n6. Expected survival \\> 6 months;\n7. Adequate baseline organ function: (i) WBC ≥3×10\\^9\u002FL, ANC ≥1.5×10\\^9\u002FL, PLT ≥100×10\\^9\u002FL, Hb ≥9g\u002FdL; (ii) Liver function: TBIL ≤2ULN, AST ≤2.5ULN, ALT ≤2.5ULN; (iii) Renal function: cCr\\>40 ml\u002Fmin, Cr≤1.5 ULN; (iv) Cardiac function: no cardiac disease or coronary artery disease. Cardiac function: no heart disease or coronary heart disease, patients with cardiac function grade 1-2;\n8. Hypertensive patients applying antihypertensive drugs to control blood pressure within the normal range;\n9. Diabetic patients with fasting blood glucose controlled at ≤8mmol\u002FL by hypoglycemic drug treatment;\n10. No other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation, or other diseases that require continuous hormone therapy) that conflict with this protocol;\n11. No history of other malignant tumors;\n12. The patient agrees to participate in this clinical study and signs the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Patients who have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.);\n2. Combination of other incurable malignant tumors (except cured non-malignant skin tumors, cervical cancer in situ, and prostate cancer);\n3. Patient has or anticipates a significant risk of esophageal perforation, fistula, and hemorrhage;\n4. Active autoimmune or immunodeficiency disease, use of immunosuppressants prior to enrollment, and use of immunosuppressant dosage ≥10 mg\u002Fday of oral prednisone for more than 2 weeks;\n5. Clinically significant cardiovascular disease including, but not limited to, severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass grafting surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention, left ventricular ejection fraction \\\u003C50%, or other anticipated inability to tolerate chemoradiotherapy in the 6 months prior to enrollment;\n6. Severe allergies;\n7. Pregnant or lactating women;\n8. Severe mental disorders;\n9. Presence of CTC grade ≥3 peripheral nerve disease;\n10. Abnormal coagulation function (PT \\> 16s, APTT \\> 53s, TT \\> 21s, Fib \\\u003C 1.5g\u002FL), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;\n11. Presence of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severe impairment of lung function, or active tuberculosis within 1 year;\n12. Presence of active hepatitis B or C;\n13. Any other condition that the investigator evaluates to be ineligible for enrollment.",{"count":20,"type":21},"INTERVENTIONAL",[49],"PHASE2","The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1\u002FCTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.",[25,52],"Neoadjuvant Therapy",[54,55,56,57],"cadonilimab","neoadjuvant therapy","esophageal squamous cell carcinoma","Paclitaxel Polymeric Micelles for Injection","2025-08-05",{"date":60,"type":30},"2025-08-08",{"date":62,"type":30},"2025-04-20",{"date":64,"type":21},"2027-10-01",{"name":66,"class":67},"Sun Jing","OTHER",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":47,"phases":76,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":38},"100580944","phase-2-a-phase-ii-study-of-toripalimab-combined-with-sequential-neoadjuvant-chemoradiotherapy-in-patients-with-esophageal-squamous-cell-carcinoma-100580944","NCT06843889","A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1: age 18-75 years old, both sexes; 2: esophageal squamous cell carcinoma confirmed by histopathology; 3: T2-4a, N0-3, M0 (AJCC 8th edition) thoracic esophageal cancer patients, resectable by surgical evaluation; 4: initial treatment patients without anti-tumor therapy; 5: expected survival time ≥6 months; 6: ECOG ≤1; 7: There was no history of esophageal perforation, active esophageal bleeding, and no obvious invasion of trachea or thoracic large vessels.\n\n  8: The function of vital organs meets the following requirements: white blood cell ≥4.0×109\u002Fl, neutrophil ≥1.5×109\u002Fl, platelet ≥100.0×109\u002Fl, hemoglobin ≥90g\u002Fl; Serum albumin ≥2.8g\u002FDl; Total bilirubin ≤1.5 × ULN, ALT\u002FAST\u002F AKP≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance \\> 60 mL\u002Fmin; There were no severe organic diseases.\n\n  9: FEV1 ≥ 0.8L; 10: Patients were informed about the trial details and signed informed consent.\n\nExclusion Criteria:\n\n* 1: known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components; 2: currently participating in and receiving other study treatment; 3: previous systemic therapy for esophageal cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc.\n\n  4: patients with active pulmonary tuberculosis (TB) who were receiving anti-TB treatment or received anti-TB treatment within 1 year before screening; 5: uncontrolled or symptomatic hypercalcemia (\\>1.5mmol\u002FL calcium ion or calcium \\>12mg\u002FdL or corrected serum calcium \\>ULN); 6: clinically uncontrolled active infection, including but not limited to acute pneumonia; 7: uncontrolled major seizures or superior vena cava syndrome; 8: previous or current concomitant other malignant tumors (except non-melanoma basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast\u002Fcervix, superficial bladder, etc., which were treated radically and had no evidence of disease recurrence) 9: Patients with a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia detected by chest CT scan or other moderate to severe lung diseases that seriously affect lung function; 10: known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 11: severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 6 months before enrollment; 12: received systemic immunosuppressive drugs (i.e., corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years before study entry; 13: received live viral vaccine within 4 weeks before study entry; 14: patients with prior allogeneic stem cell or solid organ transplantation; 15: pregnant or lactating women or women with the possibility of pregnancy before the first medication positive pregnancy test, patients with fertility but unwilling to accept contraceptive measures or their sexual partners unwilling to accept contraceptive measures; 16: any other disease or condition of clinical significance that the investigator believes could affect adherence to the protocol (e.g., history of psychosis or substance abuse), preclude benefit from the study, or prevent informed consent (e.g., drug use and substance abuse), or preclude participation in the study (including but not limited to: Abnormal laboratory results, clinical active diverticulitis, intra-abdominal abscess, intestinal obstruction, and peritoneal carcinomatosis).",{"count":75,"type":21},34,[49],"This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy\u002F20F, 2Gy\u002FF); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion. According to the postoperative pathological results, the pathological complete response (pCR) and major response (MPR) were evaluated. The disease-free survival (DFS), overall survival (OS), 1 or 2 years survival rate and adverse reactions were recorded.",[25],[80,81,82,83,84],"Esophageal cancer","Immunotherapy","Neoadjuvant radiotherapy","Neoadjuvant chemotherapy","Efficacy","2025-04-11",{"date":87,"type":30},"2025-04-16",{"date":89,"type":30},"2025-04-03",{"date":91,"type":21},"2028-08-01",{"name":93,"class":67},"Nanfang Hospital, Southern Medical University",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":47,"phases":104,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":38},"100585840","phase-2-optimizing-neoadjuvant-treatment-regimens-for-locally-advanced-esophageal-squamous-cell-carcinoma-100585840","NCT06907602","Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma","Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study","ONTRESCC","Inclusion Criteria:\n\n* male or female\n* Age ≥ 18 years old\n* Pathological confirmation of esophageal squamous cell carcinoma\n* Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET\u002FCT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+\n* No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)\n* Tumor longitudinal diameter ≤ 10cm\n* The tumor did not involve the dentate line\n* ECOG score 0 or 1\n* No hematological diseases, no liver or kidney dysfunction\n* Absolute neutrophil count ≥ 1.5 × 109\u002FL\n* Platelets ≥ 100 × 109\u002FL\n* Hemoglobin ≥ 11g\u002FL\n* ALT ≤ 2 times the upper limit of normal value\n* TBil ≤ 1.5 times the upper limit of normal value\n* Creatinine clearance rate (Cockroft) ≥ 50ml\u002Fmin\n* Obtain informed consent\n\nExclusion Criteria:\n\n* T staging evaluation is T1\u002FT2\n* PET\u002FCT and other evaluations show distant metastasis (M1)\n* Planned pregnancy or patients during pregnancy or lactation\n* History of previous chemotherapy, radiation therapy, or immunotherapy\n* Previous severe coronary heart disease and heart failure (NYHA grade III\u002FIV)\n* Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery\n* Previous autoimmune disease requiring systemic treatment within 2 years\n* Previous immunodeficiency diseases or the need for systemic steroid replacement therapy\n* Previous motor or sensory neurotoxic diseases\n* Previous mental illness\n* Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies\n* Acute infectious diseases requiring systemic treatment\n* Previous HIV, HBV, or HCV infections\n* Previously received stem cell or solid organ transplantation",{"count":103,"type":21},120,[49,105],"PHASE3","Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable.\n\nHowever, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.",[25],[56,109,110],"neoadjuvant chemoimmunotherapy","radiotherapy","2025-03-27",{"date":113,"type":30},"2025-04-02",{"date":115,"type":30},"2024-01-12",{"date":34,"type":21},{"name":118,"class":67},"Peking Union Medical College Hospital",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":47,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100548884","phase-2-neoadjuvant-cadonilimab-combined-with-anlotinib-in-locally-advanced-resectable-esophageal-squamous-cell-carcinoma-100548884","NCT06426797","Neoadjuvant Cadonilimab Combined With Anlotinib in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","Safety and Efficacy of Cadonilimab Combined With Anlotinib in Neoadjuvant Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Single Arm, Phase II Study","Inclusion Criteria:\n\n1. Able to provide written informed consent and understand and agree to comply with the requirements of this study as well as the assessment schedule.\n2. Be at least 18 years of age on the date of signing the ICF.\n3. Histopathologically confirmed esophageal squamous cell carcinoma: the clinical stage is T1-2N1-3M0, T2 (diameter≥3 cm) N0M0 or T3-4aN0-3M0 (stage II-IVA), and the staging should be based on the AJCC 8th edition esophageal cancer staging system.\n4. Patients are asked to provide an archival tumor tissue sample (FFPE tissue block or approximately 15 \\[≥6\\] freshly cut unstained FFPE sections) and a pathology report of this baseline sample. If no archival sample is available or the sample is not available, a biopsy sample is requested at baseline.\n5. Prior to study enrollment, patients are evaluated by thoracic surgeon in charge of surgery to verify that they meet the study requirements for R0 resection with radical curative intent.\n6. Cardiac and pulmonary function is good, and surgical resection for curative purposes is confirmed, and cardiopulmonary function tests and respiratory or cardiology consultation can be completed if necessary.\n7. Measurable disease as assessed by the investigator according to RECIST version 1.1.\n8. Eligible for anlotinib treatment.\n9. ECOG performance status ≤ 2 points.\n10. ≤ 14 days prior to enrollment, the following laboratory test values during the screening period suggest that the patient has good organ function:\n\n    * Patient has not had a blood transfusion or use of growth factor supportive therapy within ≤14 days prior to blood draw, when the following items are tested prior to enrollment:\n\n      * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n      * Platelet ≥ 75×109\u002FL\n      * Hemoglobin ≥ 90 g\u002FL\n    * Glomerular filtration rate (GFR) estimated by the Cooperative Equation for Epidemiology of Chronic Kidney Disease ≥45mL\u002Fmin\u002F1.73 m2.\n    * Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin must be \\\u003C3 ×ULN in patients with Gilbert's syndrome).\n    * AST and ALT≤2.5 ×ULN.\n    * Patients not receiving anticoagulant therapy: International normalized ratio or activated partial prothrombin time ≤ 1.5× ULN.\n11. Females of childbearing potential must be willing to practice highly effective contraception for the duration of the study, and for ≥120 days after the last dose of cadonilimab or anlotinib, whichever occurs later, and have a negative urine or serum pregnancy test result within ≤7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Previous treatment for current esophageal cancer, including chemotherapy or radiotherapy.\n2. Prior receipt of antibodies or drugs targeting immune checkpoint pathways, including but not limited to anti-cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4), anti-PD-1, and anti-PD-L1 therapeutic antibodies.\n3. Patients with non-squamous cell carcinoma.\n4. Presence of locally advanced, unresectable disease, regardless of disease stage and presence or absence of metastases (stage IV).\n5. Active autoimmune disease or history of autoimmune disease that may recur.\n\n   Note: Patients with the following conditions do not need to be excluded and can proceed for further enrollment screening:\n   * Well-controlled type I diabetes\n   * Hypothyroidism (as long as it is treated with hormone replacement therapy alone)\n   * Well-controlled celiac disease\n   * Skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia)\n   * Any other illness that is not expected to recur in the absence of an external trigger\n6. Any active malignancy in the ≤ 2 years prior to enrollment, with the exception of the specific cancers studied in this study and cancers that have recured locally after radical therapy (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ).\n7. Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent\\> 10 mg\u002Fday) or other immunosuppressive medications within ≤14 days prior to enrollment.\n\n   Note: Patients with current or prior use of any of the following steroid regimens do not need to be excluded:\n   * Adrenal replacement steroids (prednisone or equivalent\\> 10 mg\u002Fday)\n   * Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with very low systemic absorption\n   * Short-term (≤7 days) prophylactic use of corticosteroids (e.g., contrast allergy) or for the treatment of non-autoimmune diseases (e.g., delayed-type hypersensitivity reactions caused by contact allergens)\n8. Poorly controlled diabetes mellitus ≤ 14 days prior to enrollment, or abnormal laboratory test results of potassium, sodium, or corrected calcium \\> grade 1 (regardless of standard medical management) or ≥ grade 3 hypoalbuminemia.\n9. Has a history of interstitial lung disease, non-infectious pneumonitis, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc.\n10. Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n11. Known history of HIV virus infection.\n12. Patients with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU\u002FmL, or patients with active hepatitis C virus (HCV) should be excluded.\n\n    Note: Patients with inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \\\u003C 500 IU\u002FmL), and cured hepatitis C patients can be enrolled.\n13. Any major surgical procedure requiring general anesthesia ≤ 28 days prior to enrollment.\n14. Previous allogeneic stem cell transplantation or organ transplantation.\n15. Any of the following cardiovascular risk factors:\n\n    * Cardiogenic chest pain within 28 days prior to enrollment, defined as moderate pain with instrumental limitation of activities of daily living.\n    * Symptomatic pulmonary embolism within 28 days prior to enrollment.\n    * Any history of acute myocardial infarction within 6 months prior to enrollment.\n    * Any history of heart failure consistent with New York Heart Association Classification Class III or IV≤ 6 months prior to enrollment.\n    * Any ≥ grade 2 ventricular arrhythmic event within 6 months prior to enrollment (inclusive).\n    * Any history of cerebrovascular accident within 6 months prior to enrollment.\n    * Hypertension that remains uncontrolled with standard antihypertensive medication within 28 days prior to enrollment.\n    * Syncope or seizures ≤ 28 days prior to enrollment.\n16. History of severe allergic reaction to chimeric or humanized antibodies or fusion proteins.\n17. Received any other chemotherapy, immunotherapy (e.g., interleukin, interferon, thymosin), or any investigational therapy during the study period.\n18. Patients who have not returned to baseline or stable levels of toxic side effects (due to prior antineoplastic therapy) unless the AE is not considered to pose a safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities).\n19. Received a live vaccine ≤ 4 weeks prior to enrollment. Note: Seasonal influenza vaccines are usually inactivated and are therefore permitted. Intranasal vaccination is a live vaccine, so it is not allowed.\n20. Has an underlying medical condition (including laboratory abnormalities) or alcohol\u002Fdrug abuse or dependence that, in the opinion of the investigator, is detrimental to study drug administration or affects the interpretation of drug toxicity or adverse events, or in the judgment of the investigator that the patient's adherence during the study is not adequate that could affect compliance.\n21. Participating in another therapeutic clinical study at the same time.",{"count":127,"type":21},25,[49],"The goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). The main questions it aims to answer are:\n\nWhat level of pathological complete response (pCR) rate can be achieved with this neoadjuvant regimen? Is this neoadjuvant regimen safe enough with acceptable toxicity?\n\nParticipants will:\n\nReceive cadonilimab (10mg\u002FKg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles.\n\nUndertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication.\n\nAccept an follow-up for 2 years after surgery.",[25],[56,132,133],"neoadjuvant immunotherapy","pathological complete response","NOT_YET_RECRUITING","2024-05-19",{"date":137,"type":30},"2024-05-23",{"date":139,"type":21},"2024-05",{"date":141,"type":21},"2027-05",{"name":143,"class":67},"Peking University People's Hospital",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":47,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":38},"100530501","phase-2-consolidation-of-toripalimab-after-chemoradiotherapy-in-elderly-esophageal-cancer-ec-crt-007-100530501","NCT06187597","Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)","Efficacy and Safety of Toripalimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized, Phase II Trial (EC-CRT-007)","EC-CRT-007","Inclusion Criteria:\n\n1. Histologically confirmed squamous cell carcinoma of the esophagus;\n2. Locally advanced, and absence of hematogenous metastasis disease according to UICC TNM version 8;\n3. Not suitable for surgery (either for medical reasons or patient's choice);\n4. Age at diagnosis 70 to 85 years;\n5. No prior cancer therapy;\n6. Estimated life expectancy \\>6 months;\n7. Eastern Cooperative Oncology Group performance status ≤ 2\n8. No history of concomitant or previous malignancy;\n9. The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥4.0×109\u002FL, absolute neutrophil count (ANC) ≥1.5×109\u002FL; b. platelets ≥100×109\u002FL; c. hemoglobin ≥9g\u002FdL; d. serum albumin ≥2.8g\u002FdL; e. total bilirubin ≤1.5×ULN, ALT, AST and\u002For AKP ≤2.5×ULN; f. serum creatinine ≤1.5×ULN or creatinine clearance rate \\>60 mL\u002Fmin;\n10. Ability to understand the study and sign informed consent.\n\nExclusion Criteria:\n\n1. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);\n2. Patients with hematogenous metastasis disease or esophageal fistula at diagnosis;\n3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;\n4. Patients who have a preexisting or coexisting bleeding disorder;\n5. Inability to provide informed consent due to psychological, familial, social and other factors;\n6. Presence of CTC grade ≥2 peripheral neuropathy;\n7. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer\n8. A history of diabetes for more than 10 years and poorly controlled blood glucose levels;\n9. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.\n10. Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;\n11. A history of interstitial lung disease or non-infectious pneumonia;\n12. A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;\n13. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).","70 Years","85 Years",{"count":155,"type":21},140,[49],"Although definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer, elderly patients tolerate intravenous concurrent CRT less well with age and comorbidities. Previous trials have demonstrated that CRT with oral S-1 was tolerable and provided significant survival benefits over radiotherapy alone in elderly patients with esophageal squamous cell carcinoma (ESCC). However, as high as 54% of patients with elderly ESCC experienced locoregional or distant recurrence after CRT. Therefore, a more effective regimen for older patients is needed. Immune checkpoint inhibitors targeting PD-1\u002FPD-L1 have shown substantial clinical benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in locally advanced esophageal cancer. The aim of this study was to evaluate the efficacy and safety of toripalimab (an anti-PD-1 antibody) after concurrent CRT in elderly patients with locally advanced ESCC.",[25],[160,161,81],"Esophageal squamous cell carcinoma","Chemoradiotherapy","2024-03-10",{"date":164,"type":30},"2024-03-12",{"date":166,"type":30},"2024-03-01",{"date":34,"type":21},{"name":169,"class":67},"Sun Yat-sen University"]