[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chinese Academy of Medical Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":143},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,73,100,126],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100476445","phase-2-short-course-radiotherapy-followed-by-chemotherapy-and-pd-1-inhibitor-for-locally-advanced-rectal-cancer-100476445",false,"NCT05484024","Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer","Preoperative Short-course Radiotherapy Followed by Chemotherapy With or Without PD-1 Inhibitor for Locally Advanced Rectal Cancer: a Prospective, Multicenter, Randomized Controlled, Phase II\u002FIII Study (STELLAR II Study)","Inclusion Criteria:\n\n* Biopsy proven rectal adenocarcinoma;\n* Distance between tumour and anal verge≤ 10cm;\n* Locally advanced tumour;(8th edition AJCC\u002FUICC staging :cT3-T4N0\u002FcT2-4N+，M0) Cancer Staging must be based on pelvic MRI or Endoscopic ultrasound;\n* Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;\n* Mentally and physically fit for chemotherapy; Adequate blood counts: White blood cell count ≥3.5 x 109\u002FL Haemoglobin levels ≥100g\u002FL Platelet count ≥100 x 109\u002FL Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL)\n\n  ≤1.5× upper normal limit（UNL）\n* No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.\n* No previous pelvic radiation history；\n* Written informed consent;\n\nExclusion Criteria:\n\n* Previous treatment with anti-PD-1\u002FL1 and anti-CTLA-4 or other immune experimental drugs.\n* Severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis)\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia.\n* At risk for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for bowel perforation.\n* history of other malignancies, excluding curable non-melanotic skin cancer and cervix carcinoma in situ；\n* Active infection, heart failure, heart attack within 6 months, unstable angina or unstable arrhythmia.\n* Any condition investigator considered may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable disease.\n* Pregnancy or breast feeding\n* Immunodeficiency disorders including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantation\n* Active hepatitis B virus (HBV) hepatitis (HBV-DNA ≥ 2000 U\u002FmL), hepatitis C virus (HCV) hepatitis, active tuberculosis infection.\n* Oncology vaccination history or any vaccination within 4 weeks prior to the start of treatment.(Note: influenza vaccines are mostly inactivated and therefore allowed, intranasal preparations are usually live attenuated vaccines and therefore not allowed)\n* Concomitant other immune agents, chemotherapeutic agents, other drugs in clinical studies, and long term cortisol application","ALL","18 Years","75 Years",{"count":20,"type":21},588,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This phase II\u002FIII trial studies how well neoadjuvant short-course radiotherapy and chemotherapy with or without PD-1 inhibitors works in treating patients with locally advanced rectal adenocarcinoma. Neoadjuvant short-course radiation therapy followed by two-drug regimen chemotherapy, such as CAPOX, were shown to be non-inferior to standard long-course chemoradiotherapy in our previous STELLAR study. Immune checkpoint inhibitors (ICIs) using monoclonal antibodies, such as PD-1 or PD-L1 inhibitor, show promising efficiency and reliable security in some limited sample prospective or retrospective studies. When treating patients with locally advanced rectal cancer, giving sequential neoadjuvant short-course radiotherapy and chemotherapy with PD-1 inhibitor may work better.",[28,29],"Rectal Neoplasms Malignant","Radiotherapy",[31,32,33,34],"rectal cancer","short-course radiotherapy","total neoadjuvant therapy","PD-1 inhibitor","NOT_YET_RECRUITING","2022-07-29",{"date":38,"type":39},"2022-08-02","ACTUAL",{"date":41,"type":21},"2022-08-06",{"date":43,"type":21},"2030-07-31",{"name":45,"class":46},"Chinese Academy of Medical Sciences","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100461335","adjuvant-albumin-bound-paclitaxel-versus-taxanes-in-breast-cancer-a-real-world-study-100461335","NCT05287308","Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study","Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study","Inclusion Criteria:\n\n1. Female patients aged from 18 to 70 years old;\n2. Histologically confirmed as invasive breast cancer;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins;\n5. AC-T adjuvant chemotherapy is planned after breast cancer surgery;\n6. Participants with HER-2 negative breast cancer at high risk of recurrence who meet any of the following conditions: 1) HR positive, and ≥4 positive lymph nodes or 1-3 positive lymph nodes with other risk of recurrence \\[such as high Ki67 expression (≥20%), T \\> 2 cm, age \\\u003C 35 years, lymphovascular invasion, grade 3 histology\\]; 2) HR negative with positive lymph node or T \\> 2 cm;\n7. LVEF ≥ 50%;\n8. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.\n\nExclusion Criteria:\n\n1. In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \\> 100\u002Fmin in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \\[Mobitz 2\\] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure \\> 180mm Hg or diastolic blood pressure \\> 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;\n2. Participants who have received prior any systematic treatment for breast cancer;\n3. Participants with bilateral invasive breast cancer;\n4. Breast cancer with distant metastasis;\n5. Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0;\n6. Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active peptic ulcer, unstable diabetes;\n7. Previous or current existence of other malignant tumors other than breast cancer;\n8. Severe liver and kidney dysfunction;\n9. The presence of any myelodysplastic and other hematopoietic disorders;\n10. Participants who are known to be allergic to the active or other components of the study treatment;\n11. Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;\n12. Participants who were judged by the investigator to be unsuitable for this study.","FEMALE","70 Years",{"count":58,"type":21},500,[60],"NA","This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.",[63],"Breast Cancer","2022-03-17",{"date":66,"type":39},"2022-03-31",{"date":68,"type":21},"2022-03",{"date":70,"type":21},"2027-09",{"name":45,"class":46},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":72},"100396058","phase-2-adjuvant-chemotherapy-for-triple-negative-breast-cancer-patients-with-residual-disease-after-neoadjuvant-chemotherapy-100396058","NCT04437160","Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy","A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Patients with histologically confirmed invasive adenocarcinoma of the breast.\n* Triple negative breast cancer: hormone receptor negative (ER \\\u003C 10% and PgR \\\u003C 10%) and HER2 negative (IHC 0\u002F1+ or ISH non-amplified), as defined by the local pathology laboratory.\n* Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.\n* Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.\n* Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.\n* Residual invasive disease must be ≥1cm in the breast, and\u002For have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.\n* ECOG Performance Status: 0-1.\n* Patients without severe heart, lung, liver and kidney disease.\n* Adequate hematologic and end-organ function.\n* No more than 6 weeks may elapse between definitive breast surgery and randomization.\n\nExclusion Criteria:\n\n* Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).\n* Previous neoadjuvant chemotherapy with platinum or taxanes alone.\n* Patients have received other adjuvant therapy.\n* Comprehensive medical examinations have revealed distant metastases before randomization.\n* Patients who are not suitable for anthracycline evaluated by investigators.\n* Prior history of other malignancy (except carcinoma in situ).",{"count":81,"type":21},286,[24],"This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.",[85],"Triple Negative Breast Cancer",[87,88,89,90],"Triple negative breast cancer","Neoadjuvant chemotherapy","Residual invasive breast cancer","Adjuvant chemotherapy","RECRUITING","2020-06-16",{"date":94,"type":39},"2020-06-18",{"date":96,"type":39},"2020-02-01",{"date":98,"type":21},"2027-12",{"name":45,"class":46},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":56,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":72},"100341888","phase-3-salvage-chemoradiation-therapy-for-recurrence-after-radical-surgery-or-palliative-surgery-in-esophageal-cancer-patients-100341888","NCT03731442","Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients","Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial","Inclusion Criteria:\n\n* Locoregional recurrence after radical surgery;\n* Positive resection margin (R1\u002FR2) after surgery;\n* Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;\n* Recurrence after adjuvant chemotherapy;\n* No prior therapy after recurrence;\n* Age 16-70 years;\n* KPS\\>70;\n* No history of drug allergy;\n* Sufficient liver and kidney functions;\n* White blood cell count \\> 4.0\\*10\\^9\u002FL.\n\nExclusion Criteria:\n\n* Age\\>70 or \\\u003C16 years;\n* Pregnancy or lactation;\n* History of drug allergy;\n* Declining informed consent;\n* Insufficient liver or kidney functions, or abnormal CBC test;\n* Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.","16 Years",{"count":109,"type":21},300,[25],"Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.",[113],"Esophageal Cancer",[115,116,117],"Salvage therapy","Recurrence","Chemoradiation","2018-12-10",{"date":120,"type":39},"2018-12-12",{"date":122,"type":39},"2018-11-01",{"date":124,"type":21},"2027-10-31",{"name":45,"class":46},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":4,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":142,"locationsCount":4},"100225215","phase-i-study-of-sorafinib-with-folfox4-as-first-line-treatment-in-advancedmetastatic-gastric-cancer-100225215","NCT02209441","Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced\u002FMetastatic Gastric Cancer","Inclusion Criteria:\n\n* age \\>18 years.\n* documented gastric adenocarcinoma via histological or cytological examinations;\n* newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;\n* no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -\n* an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* an expected survival time of at least 3 months;\n* and provision of informed consent by patients prior to commencement of the study.\n\nExclusion Criteria:\n\n* a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;\n* surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;\n* severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy\n* a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;\n* women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 New York Heart Association (NYHA) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection\n* epileptic patients requiring medical treatment (such as corticosteroids or antiepileptic drugs);\n* patients who had received immunotherapy within 4 weeks prior to or throughout the study or had received mitomycin C or nitrourea drugs within 4 weeks previously;\n* allergies or possible allergies to the study medications or other drugs administered during the study;\n* any patient safety or compliance issues that might jeopardize their participation in the study;\n* an inability to swallow oral drugs.","EXPANDED_ACCESS","* To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin\u002Fleucovorin\u002F5-fluorouracil) as first-line treatment for advanced gastric cancer\n* The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level",[135],"Gastric Cancer.",[137],"sorafenib, gastric cancer, FOLFOX4","AVAILABLE","2014-08-04",{"date":141,"type":21},"2014-08-06",{"name":45,"class":46},""]