[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhigang Li\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,66],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100633260","phase-2-shr-1701-in-combination-with-irinotecan-liposome-ii-for-second-line-treatment-of-escc-after-immunotherapy-100633260",false,"NCT07524374","SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of ESCC After Immunotherapy","The Efficacy, Safety and Feasibility of SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of Esophageal Squamous Cell Carcinoma After Immunotherapy","Inclusion Criteria:\n\n1. Signed written informed consent, voluntarily participating in this study;\n2. Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;\n3. Prior treatment with immunotherapy;\n4. At least one measurable lesion as assessed by RECIST version 1.1;\n5. Age ≥ 18 years, male or female;\n6. ECOG performance status of 0 or 1;\n7. Life expectancy \\> 3 months;\n8. Adequate organ function:\n\n   1. Hematology: Neutrophils ≥ 1.5 × 10\\^9\u002FL, Hemoglobin ≥ 9 g\u002FdL, Platelets ≥ 100 × 10\\^9\u002FL.\n   2. Hepatic function: Bilirubin ≤ 1.5 × the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin ≤ 3 × ULN are eligible); AST and ALT ≤ 2.5 × ULN (if liver metastases are present, AST\u002FALT ≤ 5 × ULN); Alkaline phosphatase ≤ 3 × ULN (if liver or bone metastases are present, ALP ≤ 5 × ULN); Albumin ≥ 3 g\u002FdL.\n   3. Renal function: Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate by Cockcroft-Gault: Creatinine clearance ≥ 60 mL\u002Fmin.\n   4. Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n9. Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, must not be breastfeeding, and must agree to use effective contraception for 6 months after the last dose; for male patients with a partner of childbearing potential, effective contraception must be used for 3 months after the last dose; sperm donation is not permitted during the study;\n10. Patients are well compliant and agree to cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) assessment during screening.\n\n  2\\. Uncontrolled tumor-related pain. 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); patients with an indwelling catheter (e.g., PleurX®) are permitted.\n\n  4\\. History of a malignancy other than esophageal cancer within 5 years prior to enrollment, except for malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival \\> 90%) and those that are expected to be cured after treatment.\n\n  5\\. History of allergy to monoclonal antibodies, liposomal products, or irinotecan.\n\n  6\\. Prior or current receipt of any of the following therapies:\n  1. Use of immunosuppressive medications or systemic corticosteroid therapy for immunosuppressive purposes (dose \\> 10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to the first dose of study drug; inhaled or topical steroids and adrenal corticosteroid replacement at doses \\> 10 mg\u002Fday prednisone or equivalent are permitted in the absence of active autoimmune disease.\n  2. Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of study drug.\n  3. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of study drug.\n\n     7\\. Any active autoimmune disease or a history of autoimmune disease. 8. History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.\n\n     9\\. Presence of poorly controlled cardiac clinical symptoms or diseases. 10. Occurrence of a severe infection within 4 weeks prior to the first dose of study drug.\n\n     11\\. Active pulmonary tuberculosis infection as identified by medical history or CT examination.\n\n     12\\. Active hepatitis B (HBV DNA ≥ 200 IU\u002FmL or ≥ 1000 copies\u002FmL or ≥ the upper limit of normal), or hepatitis C (positive hepatitis C antibody and HCV RNA above the lower limit of quantification of the assay).\n\n     13\\. Pregnant or breastfeeding women. 14. Any other condition judged by the investigator that could lead to forced discontinuation from the study, such as other serious illnesses (including mental illnesses) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, or factors that could affect patient safety or compliance.","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a single-arm, exploratory clinical trial aimed at evaluating the efficacy and safety of SHR-1701 in combination with liposomal irinotecan (II) in patients with esophageal squamous cell carcinoma who have received prior immunotherapy. Eligible patients with esophageal cancer will be treated with SHR-1701 in combination with liposomal irinotecan (II).",[26],"ESCC",[26,28,29,30],"SHR-1701","Retlirafusp alfa","Liposomal Irinotecan (II)","NOT_YET_RECRUITING","2026-04-06",{"date":34,"type":35},"2026-04-13","ACTUAL",{"date":37,"type":20},"2026-03-15",{"date":39,"type":20},"2028-03-30",{"name":41,"class":42},"Zhigang Li","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":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100582329","phase-2-active-surveillance-after-neoadjuvant-adebrelimab-combined-with-chemoradiotherapy-for-resectable-escc-100582329","NCT06861894","Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC","Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Subjects signed the informed consent and volunteered to participate in the study.\n2. Esophageal squamous cell carcinoma confirmed by histology or cytology.\n3. Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).\n4. Expect to have R0 resection\n5. In age from 18 to 75.\n6. ECOG PS: 0\\~1.\n7. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.\n8. No contraindications to surgery.\n9. Has sufficient organ function including (1) Blood routine: NE≥1.5×109\u002FL; PLT≥100×109\u002FL; HGB≥90 g\u002FL (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL\u002Fmin（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN\n10. Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration.\n11. Good compliance, willing to comply with follow-up schedules.\n\nExclusion Criteria:\n\n1. Subjects have received or are receiving any of:\n\n   1. anti-tumor interventions such as radiotherapy, chemotherapy, or other medications.\n   2. immunosuppressants or systemic glucosteroids (prednisone equivalence\\> 10mg\u002Fd) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence\\>10mg\u002Fd) is allowed if no known active autoimmune disease.\n   3. live vaccine within 4 weeks before the first administration.\n   4. major surgery or major injury within 4 weeks before the first administration.\n2. Cancer-related exclusion criteria\n\n   1. other cancers instead of ESCC\n   2. unresectable or metastatic ESCC\n   3. not comply with cⅡ-Ⅲ（cT2N1-2M0 or cT3N0-2M0, AJCC 8th）\n   4. Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, localized prostate cancer received radical surgery and ductal carcinoma in situ that have received radical treatment and do not need other treatment can be included)\n3. Other criteria\n\n   1. Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmia that needs treatment\n   2. Subjects with any known active autoimmune disease\n   3. Pregnant or breastfeeding female\n   4. Presence of allergy or hypersensitivity to investigational medications\n   5. HIV-positive or active hepatitis B (HBsAg positive and HBV-DNA ≥2000 IU\u002Fml or ≥ 104 copies\u002FmL) or active hepatitis C (HCV antibody positive) or active tuberculosis\n   6. Investigators assessed there might be other factors that cause subjects to withdraw.","75 Years",{"count":53,"type":20},164,[23],"In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.",[57],"Esophageal Squamous Cell Carcinoma","2025-05-13",{"date":60,"type":35},"2025-05-15",{"date":62,"type":20},"2025-07",{"date":64,"type":20},"2029-03",{"name":41,"class":42},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100442615","phase-3-camrelizumab-plus-neoadjuvant-chemotherapy-or-chemoradiotherapy-versus-chemoradiotherapy-in-resectable-escc-100442615","NCT05043688","Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.","Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial","Inclusion Criteria:\n\n1. The result of pathological biopsy showed esophageal squamous cell carcinoma;\n2. Have not received systemic or local treatment for esophageal cancer in the past;\n3. Age 18-75 years (including 18 and 75 years old), both male and female;\n4. ECOG score 0-1;\n5. Thoracic esophageal cancer assessed by CT\u002FMRI\u002FPET-CT etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition of AJCC staging;\n6. Those who are expected to achieve R0 resection;\n7. Voluntarily sign an informed consent form before treatment;\n8. Plan to receive surgical treatment after neoadjuvant treatment is completed;\n9. No surgical contraindications;\n10. Normal function of major organs\n11. Female subjects with fertility must undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least 3 months after the last administration Measures (such as intrauterine devices, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last administration;\n12. The subjects have good compliance and can follow up the efficacy and adverse events\u002Freactions according to the requirements of the plan;\n\nExclusion Criteria:\n\n1. There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;\n2. Patients with supraclavicular lymph node metastasis;\n3. Poor nutritional status, BMI \\\u003C18.5 Kg\u002Fm2; if the symptomatic nutritional support is corrected before randomization, the main investigator can continue to consider it after evaluation;\n4. Those who are known to have a history of allergies to the drug components of this program;\n5. Have received or are receiving any of the following treatments in the past:\n\n   1. Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors;\n   2. Immunosuppressive drugs or systemic hormone drugs are being used within 2 weeks before the first use of the study drug to achieve immunosuppressive purposes (dose\\>10mg\u002Fday prednisone or equivalent dose); if there is no active autoimmune disease In the case of inhalation or topical use of steroids and prednisone doses\\> 10 mg\u002Fday or equivalent doses of adrenal cortex hormone replacement are allowed;\n   3. Received a live attenuated vaccine within 4 weeks before using the study drug for the first time;\n   4. Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;\n6. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;\n7. There are clinical symptoms or diseases of the heart that are not well controlled;\n8. Severe infections (CTCAE v5.0\\> level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest activity Pulmonary inflammation, symptoms and signs of infection in the 14 days before the first use of the study drug, or those who require oral or intravenous antibiotic treatment, except for the prophylactic use of antibiotics;\n9. Participated in other drug clinical studies within 4 weeks before randomization;\n10. People who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or have other pulmonary fibrosis that may interfere with the judgment and management of immune-related lung toxicity , Organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects whose CT shows active pneumonia or severe lung dysfunction during the screening period; active tuberculosis;\n11. Patients with any active autoimmune diseases or history of autoimmune diseases with the possibility of recurrence; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, and insulin treatment Patients with controllable type I diabetes or a history of asthma, but who have been completely relieved during childhood without any intervention can be included in the group; patients with asthma who need bronchodilator intervention cannot be included in the group;\n12. There is active hepatitis B (HBV-DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method);\n13. Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, unless malignant tumors with low risk of metastasis or death (5-year survival rate\\> 90%), such as fully treated skin basal cell carcinoma or squamous cell Skin cancer or cervical carcinoma in situ, etc., may be considered for inclusion;\n14. Women who are pregnant or breastfeeding;\n15. According to the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, alcoholism, drug abuse, family or social factors, which may affect the subjects Factors of safety or compliance.",{"count":74,"type":20},426,[76],"PHASE3","The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.",[79],"Resectable Esophageal Squamous Cell Carcinoma","RECRUITING","2024-10-14",{"date":83,"type":35},"2024-10-17",{"date":85,"type":35},"2021-09-01",{"date":87,"type":20},"2030-12-31",{"name":41,"class":42},5,""]