[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anti-pd-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anti-pd-1":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,64],{"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":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100448868","phase-2-neoadjuvant-anti-pd-1-and-tp-versus-tpf-on-pathological-response-in-oscc-100448868",false,"NCT05125055","Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC","Neoadjuvant Toripalimab and Albumin Paclitaxel \u002FCisplatin Versus Docetaxel\u002F Cisplatin\u002F 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age: 18-75 years old\n2. Gender: male and female\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2\n4. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)\n5. Primary tumor with a clinical stage of III\u002FIVA (T1-2\u002FN1-2\u002FM0 or T3-4a\u002FcN0-2\u002FM0, AJCC2018)\n6. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n7. Blood routine: white blood cells (WBCs) \\>3,000\u002Fmm3, hemoglobin \\>8 g\u002FL, platelets \\>80,000\u002Fmm3\n8. Liver function: alanine amino transferase\u002Faspartate amino transferase (ALAT\u002FASAT) \\\u003C2.5 times the upper limit of normal and bilirubin \\\u003C1.5 times the upper limit of normal\n9. Renal function: Serum creatinine \\\u003C1.5 times the upper limit of normal\n10. Coagulation function: INR, PT, APTT\\\u003C1.5 times the upper limit of normal\n11. Signed the informed consent form\n\nExclusion Criteria:\n\n1. Unresolved grade 2 \\[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\\] or higher toxic reactions caused by previous anticancer treatments\n2. Known allergic reaction to any ingredients or excipients of the therapy\n3. Known history of malignancy, unless been cured and no recurrence for 5 years\n4. Known history of radiation to head and neck\n5. Active severe clinical infection (\\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)\n6. Obvious cardiovascular abnormalities \\[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\\]\n7. Patients receiving immunology-based treatment for any reason\n8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy\n9. Pregnant or lactating women\n10. Uncontrollable hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment\n11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue\u002Forgan transplantation, stem cell or bone marrow transplantation, or solid organ transplantation\n12. Participation in other clinical trials within 30 days before enrollment\n13. Other situations that the investigator considers unsuitable with respect to participating in the trial","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel \u002FCisplatin (TTP) with Docetaxel\u002F Cisplatin\u002F 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.",[28,29,30,31],"Oral Squamous Cell Carcinoma","Neoadjvant Therapy","Anti-PD-1","Chemotherapy","RECRUITING","2023-11-21",{"date":35,"type":36},"2023-11-22","ACTUAL",{"date":38,"type":36},"2021-10-01",{"date":40,"type":21},"2026-12-30",{"name":42,"class":43},"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":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":44},"100444624","phase-2-neoadjuvant-personalized-anti-pd-1-and-anti-vegfr-therapy-in-oscc-patients-100444624","NCT05069857","Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients","Neoadjuvant Personalized Anti-PD-1 Therapy With Combination of Anti-VEGFR Therapy in Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Randomized Controlled Phase II Trial","Inclusion Criteria:\n\n1. Age: 18 to 75\n2. Gender: Male and female\n3. ECOG Score: 0-2\n4. Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)\n5. Clinical stage III\u002FIVA (cT1-2\u002FN1-2\u002FM0 or cT3-4a\u002FN0-2 \u002FM0, AJCC 8th)\n6. The combined positive score (CPS score) of PD-L1 expression \\> 10\n7. Has signed informed consent\n\nExclusion Criteria:\n\n1. Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy\n2. Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, ≥ grade 2 heart disease diagnosed according to the NYHA classification criteria within 3 months prior to enrollment)\n3. Active severe clinical infection (\\> NCI-CTCAE Version 5.0 level 2 infection)\n4. Uncontrollable hypertension (systolic blood pressure \\> after antihypertensive medication; 150mmHg and\u002For diastolic blood pressure \\> 90mmHg) or clinically significant (such as activity) cardiovascular disease, such as cerebrovascular accident (≤ 6 months before screening), myocardial infarction (≤ 6 months before screening), unstable angina, congestive heart failure rated class II or above by NYHA, or severe arrhythmias that cannot be controlled or have a potential impact on trial treatment\n5. Blood routine examination: WBC \\\u003C 3,000\u002Fmm3, hemoglobin \\\u003C 8g\u002FL, platelet \\\u003C 80,000\u002Fmm3\n6. Liver function: ALAT\u002FASAT \\> 2.5 times the normal upper limit, bilirubin \\> 1.5 times the normal upper limit\n7. Renal function: serum creatinine \\> 1.5 times the normal upper limit\n8. Has a history of maxillofacial and neck radiotherapy\n9. Pregnant or lactating women\n10. Participation in other clinical studies within 30 days prior to enrollment\n11. Other conditions that the investigator considers inappropriate for participation",{"count":53,"type":21},46,[24],"To evaluate the efficacy of neoadjuvant anti-PD-1 plus anti-VEGFR therapy for patients with locally advanced and resectable oral squamous cell carcinoma, and the CPS\\>10 in the biopsy samples.",[28,29,30,57],"Anti-VEGFR",{"date":35,"type":36},{"date":60,"type":36},"2021-09-01",{"date":62,"type":21},"2028-06-30",{"name":42,"class":43},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":44},"100515946","phase-2-total-neoadjuvant-chemoradiotherapy-plus-anti-pd-1-in-subperitoneal-patients-with-locally-advanced-rectal-cancerpatients-with-locally-advanced-rectal-cancer-a-prospective-single-arm-exploratory-study-100515946","NCT05998122","Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study","Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal High-Risk or Very High-Risk Patients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study","Inclusion Criteria:\n\n1. The patients and their families are able to understand and are willing to participate in this clinical study, and sign an informed consent form.\n2. Age: 18\\~75 years old, no gender limit;\n3. Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as pMMR\u002FMSS.\n4. The initial TNM risk category (from Rectal cancer: ESMO Clinical Practice Guidelines, 2017 edition) is as follows: 1) \"Bad\": cT3c\u002Fd or very low localisation levators threatened, MRF clear; cT3c\u002Fd mid-rectum, cN1-N2 (extranodal), EMVI+, limited cT4aN0; 2) \"Advanced\": cT3 with any MRF involved, any cT4a\u002Fb, lateral node+.\n5. The lower edge of the tumor is located below the peritoneal reflex;\n6. No distant transfer;\n7. ECOG PS score 0-1 within 7 days before the first medication;\n8. Hepatitis B Surface Antigen (HBsAg) (-) and Hepatitis B Core Antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be less than 1000 copies\u002FmL or 200 IU\u002FmL before entering the group.\n9. HCV antibody (-)\n10. The main organ function is normal.\n11. No history of pelvic radiotherapy;\n12. No history of rectal cancer surgery or chemotherapy;\n13. Not accompanied by systemic infections requiring antibiotic treatment;\n14. Heart, lung, liver, and kidney functions can tolerate surgery;\n15. Others, based on the results of previous medical history, vital signs, physical examination or laboratory examination, the research doctor judges that you are suitable for participating in this clinical study.\n\nExclusion Criteria:\n\n1. Recurrent rectal cancer;\n2. Patients who are planning to undergo or have previously received organ or bone marrow transplantation;\n3. Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia formula);\n4. Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) \\\u003C50%;\n5. Human immunodeficiency virus (HIV) infection;\n6. Suffer from active tuberculosis;\n7. Past and present patients with interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc., which may interfere with the detection and treatment of suspected drug-related lung toxicity;\n8. Patients with active or suspicious autoimmune disease, or with a history of that;\n9. Received treatment with live vaccines within 28 days before the first administration; except for inactivated viral vaccines for seasonal influenza;\n10. Have received other antibody\u002Fdrug treatments against immune checkpoints in the past, such as PD-1, PD-L1, CTLA4, etc.;\n11. Known to have a history of severe allergies to any monoclonal antibody or research drug excipients;\n12. In the past 5 years, patients have suffered from malignant tumors whose survival rate is significantly lower than the historical data of our rectal cancer survival rate (properly treated basal cell carcinoma, skin squamous cell carcinoma, small kidney cancer, breast cancer, and papillary thyroid carcinoma are not included here. range);\n13. The patient has had arterial embolism diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.;\n14. Have received other types of anti-tumor or experimental treatments;\n15. The patient is a female during pregnancy or lactation;\n16. The patient has other diseases or abnormal mental states, which may affect the patient's participation in this study;\n17. There are patients who may increase the risk of participating in research and research medication, or other severe, acute and chronic diseases, who are not suitable for clinical research based on the judgment of the investigator.",{"count":72,"type":21},45,[24],"Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.",[76,77,30],"Locally Advanced Rectal Cancer","Total Neoadjuvant Treatment","NOT_YET_RECRUITING","2023-08-11",{"date":81,"type":36},"2023-08-18",{"date":83,"type":21},"2023-09-01",{"date":85,"type":21},"2028-12-31",{"name":87,"class":43},"The First Hospital of Jilin University"]