[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-small-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-small-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100452572","phase-2-js001-combined-with-tp-as-first-line-treatment-for-unresectable-or-advanced-small-cell-esophageal-carcinoma-100452572",false,"NCT05173246","JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma","JS001 Combined With Nab-paclitaxel and Cisplatin or Carboplatin as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma : a Prospective, Single Arm, Multicenter, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Males and females aged 18-75 years;\n2. Histologically or cytologically confirmed esophageal small cell carcinoma with unresectable locally advanced \u002F recurrent or distant metastasis\n3. Patients who have not received systemic anti-tumor therapy\n4. Patients with recurrence or metastasis more than 6 months after the end of adjuvant or neoadjuvant chemotherapy accompanied by radical surgery or radical chemoradiotherapy;\n5. With at least 1 measurable lesion according to RECIST 1.1 criteria;\n6. ECOG score 0-1;\n7. Expected survival ≥3 months;\n8. Good organ function (without blood transfusion, use of hematopoietic stimulating factors, or transfusion of albumin or blood products within 7 days prior to examination): 1) Platelet (PLT) count ≥75,000 \u002Fmm3; 2) Neutrophil count (ANC) ≥1,500 \u002Fmm3; 3) Hemoglobin (Hb) level ≥9.0 g\u002Fdl; 4) Total bilirubin (TBIL) level ≤1.5×ULN; 5) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 6) Alkaline phosphatase level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 7) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance \\>50 ml\u002Fmin;\n9. Females of child bearing age must have anegative pregnancy test, and have to take contraception measures and for 3 months after the last dose\n10. Able to understand and willing to sign written informed consent form.\n11. Patients who agree to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissue for gene testing.\n\nExclusion Criteria:\n\n1. Known allergy to study drug or excipients, or allergy to similar drugs;\n2. Received anti-tumor cytotoxic drug therapy, biological drug therapy (such as monoclonal antibody), immunotherapy (such as interleukin-2 or interferon) or other research drug therapy within 4 weeks before enrollment.\n3. Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment.\n4. Patients received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases.\n5. Major surgery was performed or not completely recovered from the previous surgery within 4 weeks before enrollment (the definition of major surgery refers to the level 3 and level 4 surgery specified in the administrative measures for clinical application of medical technology implemented on May 1, 2009).\n6. The toxicity of previous anti-tumor therapy has not recovered to CTCAE \\[version 4.03\\] 0-1, except for the following cases: a) lipsotrichia；b) Pigmentation;c) Peripheral neurotoxicity has recovered to \\\u003C CTCAE 2;d) The long-term toxicity caused by radiotherapy could not be recovered according to the judgment of the researchers;\n7. Subjects with clinically symptomatic CNS metastases and\u002For cancerous meningitis. The subjects who have received brain or meningeal metastasis treatment in the past, if the clinical stability has been maintained for at least 2 months, and the systemic hormone treatment has been stopped for more than 4 weeks can be included.\n8. Have or are currently suffering from other malignancies (except for non melanoma basal cell carcinoma of the skin, breast \u002F cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment in the past five years).\n9. Subjects have any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood who have completely remission and do not need any intervention in adulthood can be included; subjects with asthma requiring bronchodilator for medical intervention can not be included).\n10. Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathway).\n11. Subjects with active pulmonary tuberculosis (TB) are receiving antituberculosis treatment or received antituberculosis treatment within one year before screening.\n12. Patients with complications requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effect (dose \\> 10mg \u002F day of prednisone or other therapeutic hormones).\n13. Received any anti infection vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment.\n14. Pregnant or lactating women.\n15. HIV positive.\n16. HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 CPS \u002F ml).\n17. HCV antibody positive.\n18. Researchers believe that it can affect the compliance of the protocol, or affect the subject to sign the informed consent(ICF), or any other disease or condition of clinical significance that is not suitable to participate in this clinical trial.\n19. There are clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.","ALL","18 Years","75 Years",{"count":20,"type":21},43,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our study found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC). Paclitaxel combined with cisplatin or carboplatin is the first-line treatment for ESCC. JS001 is a Chinese anti-PD-1 monoclonal antibody, which has been approved for the treatment of melanoma. This is a prospective, single arm, multicenter, phase II clinical trial of JS001 combined with nab-paclitaxel and cisplatin or carboplatin in the first-line treatment of unresectable or advanced SCCE. Aim to evaluate the safety and efficacy of this regimen in patients with unresectable or advanced SCCE.",[27],"Esophageal Small Cell Carcinoma",[29,30,31,32,33],"JS001","Nab-paclitaxel and","Cisplatin","Carboplatin","Small cell esophageal carcinoma","RECRUITING","2025-07-12",{"date":37,"type":38},"2025-07-16","ACTUAL",{"date":40,"type":38},"2020-11-17",{"date":42,"type":21},"2026-12-31",{"name":44,"class":45},"Sun Yat-sen University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100552836","phase-2-a-study-of-adebrelimab-combined-with-chemoradiotherapy-in-the-treatment-of-esophageal-small-cell-carcinoma-100552836","NCT06478264","A Study of Adebrelimab Combined With Chemoradiotherapy in the Treatment of Esophageal Small Cell Carcinoma","Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in the Treatment of Esophageal Small Cell Carcinoma: a Single-arm, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n* 1\\. Sign a written informed consent to join the study voluntarily;\n* 2\\. Histologically or cytologically confirmed patients with small cell carcinoma of the esophagus staging T1N0M0 but unable to tolerate surgery or refusing surgery and patients staging T2-4N0-3M0 \\[according to AJCC 8th edition TNM criteria\\];\n* 3\\. Age 18-75 years old, male or female;\n* 4\\. ECOG PS 0-1;\n* 5\\. No previous systemic treatment for esophageal small cell carcinoma;\n* 6\\. At least one measurable lesion (according to RECIST1.1 criteria);\n* 7\\. Normal functioning of major organs, including:\n\n  1. Blood routine examination (no blood component, cell growth factor, white enhancer, platelet enhancer, anemia correction drugs are allowed within 14 days before the first use of the study drug) :\n\n     White blood cell count ≥4.0×10\\^9\u002FL\n\n     Neutrophil count ≥1.5×10\\^9\u002FL\n\n     Platelet count ≥80×10\\^9\u002FL\n\n     Hemoglobin ≥90 g\u002FL\n  2. Blood biochemical examination:\n\n     Total bilirubin ≤1.5×ULN\n\n     ALT≤2.5 x ULN, AST≤2.5 x ULN,\n\n     Serum creatinine ≤1.5×ULN, or creatinine clearance ≥50mL\u002Fmin (Cocheroft-Gault formula, see Annex 2)\n  3. Coagulation function:\n\nInternational Standardized ratio (INR) ≤1.5×ULN\n\nActivated partial thromboplastin time (APTT) ≤1.5×ULN\n\n* 8\\. Patients must submit pre-treatment tumor tissue samples during the study period;\n* 9\\. Expected survival ≥12 weeks;\n* 10\\. Fertile female subjects are required to take a serum or urine pregnancy test with a negative result within 72 hours before starting the study drug administration, and to use effective contraception (such as an IUD, contraceptive pill or condom) during the trial period and for at least 3 months after the last drug administration; For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial period and within 3 months after the last dose;\n* 11\\. The subjects had good compliance and cooperated with follow-up visits.\n\nExclusion Criteria:\n\n* 1\\. Esophageal perforation or hematemesis;\n* 2\\. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n* 3\\. Uncontrolled hypercalcemia or symptomatic hypercalcemia;\n* 4\\. Other malignancies diagnosed within 5 years prior to the first use of the investigational drug, except malignancies with a low risk of metastasis or death (5-year survival \\> 90%), such as adequately treated skin basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ, may be considered for inclusion;\n* 5\\. History of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy); Patients with psoriasis or childhood asthma\u002Fallergies in complete remission without any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;\n* 6\\. Previously received immune checkpoint blocking therapy;\n* 7\\. Subjects who required systemic corticosteroids (\\> 10 mg\u002F day effective dose of prednisone) or other immunosuppressive agents within 14 days prior to initial dosing or during the study period. However, in the absence of active autoimmune disease, subjects were allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at a dose ≤10 mg\u002F day of prednisone effectiveness.\n* 8\\. There are clinical symptoms or diseases of heart that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmias that are not well controlled without or after clinical intervention;\n* 9\\. Poor nutritional status, BMI \\\u003C 18.5 Kg\u002Fm\\^2; If it is corrected before enrollment after symptomatic nutritional support, it can continue to be considered for enrollment after evaluation by the principal investigator;\n* 10\\. Adverse events greater than grade 2 caused by treatment received before the first use of the investigatory drug that have not recovered (i.e., become grade 1 or reach baseline level), and adverse events (such as neurotoxicity) that are difficult to recover quickly as determined by the investigator can be included;\n* 11\\. History of allergy to any component of adbelimab, etoposide, cisplatin or carboplatin;\n* 12\\. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;\n* 13\\. Severe infections (CTCAE \\> Grade 2), such as severe pneumonia requiring hospitalization, bacteremia, and infection complications, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of prophylactic antibiotic use;\n* 14\\. Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or had a history of active pulmonary tuberculosis infection within 1 year before enrollment, or had a history of active pulmonary tuberculosis infection more than 1 year ago without formal treatment;\n* 15\\. Hereditary bleeding tendency or blood clotting dysfunction. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months prior to enrollment, such as hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline;\n* 16\\. Active hepatitis B (HBV DNA≥2000 IU\u002FmL or 10\\^4 copies\u002FmL), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the lower limit of assay);\n* 17\\. Pregnant or lactating women;\n* 18\\. The investigator determined that there were other factors that might have led to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, alcohol, substance abuse, family or social factors, and factors that might have affected the safety or adherence of the subjects.",{"count":55,"type":21},40,[24],"To evaluate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of esophageal small cell carcinoma",[27],[27,60,61],"Adebrelimab","chemoradiotherapy","NOT_YET_RECRUITING","2024-06-23",{"date":65,"type":38},"2024-06-27",{"date":67,"type":21},"2024-07-13",{"date":69,"type":21},"2027-07-13",{"name":71,"class":45},"Zhangzhou Municipal Hospital"]