[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-esophageal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-esophageal-squamous-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"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":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100628122","phase-2-efficacy-and-safety-of-neo-crt-plus-serplulimab-nimotuzumab-in-patients-with-locally-advanced-resectable-escc-100628122",false,"NCT07457528","Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC","Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Sign an informed consent form.\n* Age ≥ 18 years, ≤ 75 years, both genders are eligible.\n* Patients with histologically confirmed clinical stage of locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging).\n* ECOG: 0-1.\n* Expected to achieve R0 resection.\n* No prior treatment for the primary esophageal tumor, including drug therapy, surgery, and radiotherapy.\n* No suspicious metastatic lymph nodes in the neck as suggested by neck enhanced CT or neck ultrasound; no systemic metastasis on imaging studies.\n* Measurable lesions according to RECIST 1.1 criteria.\n* Important organ functions meet the following requirements:\n\n  1. Absolute neutrophil count ≥ 1.5×10\\^9, platelets ≥ 80×10\\^9, hemoglobin ≥ 90g\u002FL;\n  2. Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN (for patients with liver metastasis, AST and ALT levels ≤ 5 times ULN);\n  3. Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml\u002Fmin (Cockcroft-Gault formula);\n  4. Serum albumin ≥ 28g\u002FL;\n  5. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);\n  6. Pulmonary function: FEV1\u002FFVC ≥ 70%, FEV1 ≥ 50% of normal value, DLCO (diffusing capacity of the lung for carbon monoxide) measured value to predicted value percentage \\> 80%.\n* Women of childbearing age must agree to use contraception (such as intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the study ends; negative serum or urine pregnancy test within 7 days before study enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the study ends.\n* Must understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Within the past six months, received EGFR monoclonal antibodies or EGFR-TKIs.\n* Participated in other interventional clinical trials within 30 days prior to screening.\n* Have severe comorbidities, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD stage 4 or higher), thyroid dysfunction, mental disorders, diabetes, severe chronic diarrhea (more than 7 bowel movements per day), etc., and those deemed unsuitable for this clinical study by the investigator.\n* Patients with brain metastases with symptoms or symptom control for less than 3 months.\n* History of other malignancies (except for cured in situ cervical cancer or skin basal cell carcinoma, and other malignancies cured for more than 5 years).\n* Presence of active infection or active infectious disease.\n* Multifocal esophageal malignant tumors or presence of esophageal fistula or perforation signs.\n* Imaging shows tumor invasion of important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the subsequent study period, leading to fatal major bleeding.\n* Allergy to the drugs used in this protocol or their components.\n* According to the Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0), peripheral neuropathy or hearing loss of grade ≥2.\n* Pregnant or breastfeeding women.\n* Those with a history of psychiatric drug abuse and unable to quit, or patients with mental disorders.\n* Those deemed unsuitable for this study by the investigator.\n* Those unwilling to participate in this study or unable to sign the informed consent form.","ALL","18 Years","75 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital. Patients will be treated with serplulimab, nimotuzumab plus concurrent chemoradiotherapy (41.4Gy\u002F1.8Gy\u002F23F) . Six to eight weeks after the completion of neoadjuvant chemoradiotherapy, patients who are considered operable by surgeons will undergo radical resection of esophageal cancer. Postoperative pathological assessment includes MPR rate, pCR rate, and pathological response grade, etc. This trial aims to explore the safety and efficacy of adding serplulimab and nimotuzumab to neoadjuvant chemoradiotherapy, with a focus on whether the combined treatment regimen can enhance the efficacy and safety of neoadjuvant chemoradiotherapy.",[27],"Resectable Esophageal Squamous Cell Carcinoma",[29,30,31],"Serplulimab","Nimotuzumab","Esophageal Squamous Cell Carcinoma","RECRUITING","2026-03-09",{"date":35,"type":36},"2026-03-11","ACTUAL",{"date":38,"type":21},"2026-03-12",{"date":40,"type":21},"2027-06-30",{"name":42,"class":43},"Tianjin Medical University Cancer Institute and Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"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":53,"type":21},426,[55],"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.",[27],"2024-10-14",{"date":60,"type":36},"2024-10-17",{"date":62,"type":36},"2021-09-01",{"date":64,"type":21},"2030-12-31",{"name":66,"class":43},"Zhigang Li",5,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100562177","phase-2-study-of-adebrelimab-with-chemotherapy-endoscopy-and-sequential-chemoradiotherapy-in-inoperable-esophageal-cancer-100562177","NCT06599775","Study of Adebrelimab With Chemotherapy, Endoscopy and Sequential Chemoradiotherapy In Inoperable Esophageal Cancer","Prospective, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Chemotherapy, Endoscopic Resection and Sequential Chemoradiotherapy In the Treatment of Inoperable Clinical Staging T1b-2 Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Signed written informed consent to voluntarily enroll in the study\n2. Age 18-75 years\n3. Histologically or cytologically confirmed squamous esophageal cancer of the thoracic segment\n4. Staging of clinical tumor stage T1b-2N0M0 (according to American Joint Committee on Cancer 8th edition) as judged by the investigator\n5. Contraindication to or refusal of oesophagectomy\n6. No prior treatment for oesophageal cancer, including radiotherapy, chemotherapy, or surgery\n7. Have at least one measurable lesion (RECIST 1.1 criteria)\n8. Eastern Cooperative Oncology Group Performance Status score of 0 to 1\n9. No contraindication to radiotherapy\n10. Adequate organ function on laboratory tests within 14 days prior to the first administration of the drug Blood routine: WBC≥3.0×109\u002FL; ANC≥1.5×109\u002FL; PLT≥100×109\u002FL; HGB≥90 g\u002FL Liver function: AST≤2.5×ULN; ALT≤2.5×ULN; TBIL≤1.5×ULN Renal function: Cr≤1.5×ULN or creatinine clearance rate ≥50 mL\u002Fmin Coagulation function: International Normalized Ratio ≤1.5, activated partial thromboplastin time ≤1.5×ULN\n11. Female subjects of childbearing potential must have a negative blood pregnancy test performed within 72 hours prior to the first dose and not be breastfeeding, and must agree to use effective contraception for the duration of the trial and for 2 months after the last administration of adebrelimab or 6 months after the last administration of chemotherapeutic agent, whichever is longer; for female subjects whose partner is a female of childbearing potential Male subjects should be surgically sterilised or agree to use effective contraception for the duration of the trial and for 2 months after the last administration of adebrelimab or 3 months after the last administration of chemotherapeutic agent, whichever is longer; sperm donation is not permitted during the study.\n\nExclusion Criteria:\n\n1. Criteria related to treatment history:\n\n   Any treatment for oesophageal cancer, including surgery, radiotherapy, chemotherapy or other antineoplastic agents Ongoing treatment with immunosuppressive drugs, or systemic hormonal drugs for immunosuppression (doses \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to the first use of study drug; inhaled or topical steroids and adrenal glands at doses \\>10 mg\u002Fday prednisone or equivalent are permitted in the absence of active autoimmune disease Corticosteroid replacement Received live attenuated vaccine within 4 weeks prior to first use of study drug Major surgery or severe trauma within 4 weeks prior to first use of study drug.\n2. Tumour-related criteria Patients with non-squamous oesophageal cancer Staging not consistent with clinical tumor stage T1b\\~2N0M0 Other malignancies diagnosed within 5 years prior to first use of study drug, except cured carcinoma in situ of the uterine cervix, basal or squamous cell skin cancers, limited prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery\n\nOther criteria:\n\nPresence of any active autoimmune disease or history of autoimmune disease (the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has been in complete remission in childhood and does not require any intervention in adulthood are eligible for inclusion; (Subjects with asthma requiring medical intervention with bronchodilators are not eligible for inclusion)\n\nHave a clinical cardiac condition or disease that is not well controlled, such as:\n\n1. New York Heart Association class 2 or higher heart failure;\n2. unstable angina pectoris;\n3. myocardial infarction within 1 year;\n4. clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention Pregnant or breastfeeding women.\n\n   4\\. Laboratory Tests: Subjects serologically positive for HIV Active hepatitis B (HbsAg positive and hepatitis B virus DNA ≥2000 IU\u002Fml or copy number ≥104\u002Fml) or active hepatitis C (HCV antibody positive and HCV-RNA positive with concomitant need for antiviral therapy) Active tuberculosis.\n\n   5\\. Presence of allergies and adverse drug events: Presence of allergy or hypersensitivity to monoclonal antibodies Presence of allergic reaction to albumin-bound paclitaxel, carboplatin\n\n   6\\. Diseases or laboratory abnormalities that, in the opinion of the investigator, may affect the results of the study or are not in the interest of the subject.",{"count":76,"type":21},42,[24],"Evaluating the efficacy and safety of PD-L1 (Programmed Death-L1)antibody combined with endoscopy and radiotherapy for inoperable cT1b-2 (clinical stage tumor 1b-2) esophageal squamous cell carcinoma",[27],"NOT_YET_RECRUITING","2024-09-13",{"date":83,"type":36},"2024-09-19",{"date":85,"type":21},"2024-10",{"date":87,"type":21},"2028-10",{"name":89,"class":43},"Shanghai Zhongshan Hospital"]