[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"envafolimab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:envafolimab":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100603926","phase-2-envafolimab-combined-with-neoadjuvant-chemotherapy-treat-stage-iib-resectable-osteosarcoma-patients-100603926",false,"NCT07142863","Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients","Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma","Inclusion Criteria:\n\n* Patients voluntarily participate in the study and have good compliance, signing a written informed consent form before enrollment.\n* Age between 12 and 70 years, with no gender restrictions.\n* Patients diagnosed with non-metastatic, resectable osteosarcoma by pathology and clinical physician assessment.\n* Have measurable disease (according to RECIST 1.1 criteria, non-nodal lesions with a CT scan longest diameter ≥10 mm, and nodal lesions with a CT scan shortest diameter ≥15 mm).\n* No prior systemic anti-tumor treatment.\n* ECOG PS score: 0 to 1.\n* Adequate organ function:\n\n  1. Hematological parameters: Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL, Platelet (PLT) ≥70×10\\^9\u002FL, Hemoglobin (HGB) ≥90 g\u002FL.\n  2. Hepatic function: Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; Serum Albumin ≥28 g\u002FL; Alkaline Phosphatase (ALP) ≤5×ULN; patients on routine hepatic protection treatment meeting the above criteria and stable for at least one week after investigator assessment may be included.\n  3. Renal function: Creatinine (Cr) ≤1.5×ULN, or Creatinine clearance rate ≥50 mL\u002Fmin (using the standard Cockcroft-Gault formula).\n  4. Coagulation function: International Normalized Ratio (INR) ≤1.5, Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; if the subject is undergoing anticoagulant therapy, PT and INR within the intended range of the anticoagulant therapy is acceptable.\n\nExclusion Criteria:\n\n* Participants with a history of or concurrent diagnosis of other malignant tumors (except for cured cutaneous basal cell carcinoma and in situ cervical carcinoma).\n* Patients with recurrent postoperative or previously treated osteosarcoma with local or systemic anti-tumor therapy, or with metastasis.\n* Participants who have received the following treatments within 4 weeks prior to study initiation: radiation therapy for tumors, surgical procedures, chemotherapy, immunotherapy, or other investigational drugs.\n* Known allergies to any component of the study medication in participants. Participants with uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA Class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n* Participants with active infections or fever of unknown origin \\>38.5°C (measured in Celsius) during the screening period or before the first dose of study medication (fever due to tumors may be included at the discretion of the investigator).\n* Use of immunosuppressive drugs within 14 days prior to treatment initiation, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., daily dose of prednisone ≤10 mg or equivalent physiological doses of other corticosteroids).\n* History of active autoimmune diseases or a history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary glanditis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; participants with vitiligo or asthma that may be in complete remission in childhood and currently do not require medical intervention, or history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation).\n* Participants who have received live vaccines within 4 weeks prior to study medication or are likely to receive live vaccines during the study period.\n* Participants with a history of substance abuse, alcoholism, or drug addiction.\n* Participants deemed to be excluded from this study by the investigator, such as those with other factors that could potentially lead to premature termination of the study, such as other serious diseases (including psychiatric diseases) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that could affect participant safety, or collection of data and samples.","ALL","12 Years","70 Years",{"count":20,"type":21},23,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.",[27,28,29,30,31],"Osteosarcoma","Neoadjuvant Therapy","Neoadjuvant Chemotherapy","PD-L1 Antibody","Envafolimab","NOT_YET_RECRUITING","2025-08-26",{"date":35,"type":36},"2025-08-27","ACTUAL",{"date":38,"type":21},"2025-08-25",{"date":40,"type":21},"2026-09-30",{"name":42,"class":43},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100469819","phase-2-envafolimab-plus-chemoradiotherapy-for-locally-advanced-npc-a-prospective-single-armed-phase-ii-trial-100469819","NCT05397769","Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.","Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.","Inclusion Criteria:\n\n* ECOG 0-1\n* histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx\n* stage III-IVa （AJCC\u002FUICC 8th ）, untreated NPC patients\n* NE≥ 1.5×10E9\u002FL, HGB ≥ 100g\u002FL and PLT ≥100×10E9\u002FL\n* ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN\n* creatinine\\\u003C1.5×ULN\n\nExclusion Criteria:\n\n* recurrent or metastatic NPC patients\n* histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx\n* already received radiation or chemotherapy\n* pregnant or lactating women, or women of childbearing age without birth control\n* HIV (+)\n* had other cancers before\n* used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before\n* complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose\n* with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included)\n* use of massive dose of glucocorticoids within 4 weeks before enrollment\n* laboratory test values do not meet relevant standards within 7 days before enrollment\n* significantly lower functions of heart, liver, lung, kidney and bone marrow\n* serious or uncontrolled medical diseases or infections\n* participating other clinical trial in the same time\n* HBsAg (+) and HBV DNA \\>1×10E3 copiers \u002FmL\n* HCV (+) unless HCV RNA PCR(-)\n* with any other treatment contraindications","18 Years","65 Years",{"count":55,"type":21},36,[24],"Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy\u002F30-33f, 5d\u002Fw,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.",[59,31,60,61],"Locally Advanced Nasopharyngeal Carcinoma","Induction Chemotherapy","PD-L1","RECRUITING","2022-08-09",{"date":65,"type":36},"2022-08-10",{"date":67,"type":36},"2022-06-08",{"date":69,"type":21},"2026-12-31",{"name":71,"class":43},"Sun Yat-sen University"]