[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chongqing University Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":481},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,45,65,102,129,152,174,198,224,244,268,291,317,337,363,385,409,431,456],{"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},"100470080","hematopoietic-stem-cell-containing-autologous-blood-reinfusion-for-bone-marrow-protection-in-cervical-cancer-patients-100470080",false,"NCT05401175","Hematopoietic Stem Cell-containing Autologous Blood Reinfusion for Bone Marrow Protection in Cervical Cancer Patients","Stored Hematopoietic Stem Cell-containing Autologous Blood Transfusion Therapy for Bone Marrow Protection in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy","Inclusion Criteria:\n\n1）18-60 years old; 2)there are radiotherapy and chemotherapy indicators for cervical cancer;3)pathological diagnosis of squamous, adenocarcinoma or adenosquamous carcinoma;4)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 5)the expected survival time was more than 3 months; 6)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;7)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;8)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1\\) clinical diagnosis of bone marrow disease;2) imaging or pathological diagnosis of central nervous system or soft meningeal or bone or bone marrow metastases;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with radiochemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection;9)History of gastrointestinal perforation and\u002For fistula, clinical signs or symptoms of intestinal obstruction and\u002For gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhoea), Crohn's disease, ulcerative colitis or chronic diarrhoea within the previous 6 months;10)evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgical intervention.","FEMALE","18 Years","60 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this project is to promote the reconstruction of haematopoietic function after chemoradiotherapy for cervical cancer with the innovative use of autologous haematopoietic containing stem cell blood transfusion support.To explore the effect of stored hemopoietic stem cell support therapy on bone marrow protection after concurrent chemoradiotherapy, in order to promote its clinical application.",[27],"Cervical Cancer",[27,29,30,31],"concurrent chemoradiotherapy","blood stem cells","autologous blood transfusion","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2022-04-13",{"date":40,"type":21},"2029-04",{"name":42,"class":43},"Chongqing University Cancer 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":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":44},"100470079","chemotherapy-supported-by-autologous-hematopoietic-stem-cells-100470079","NCT05401162","Chemotherapy Supported by Autologous Hematopoietic Stem Cells","Conventional Dose Chemotherapy for Ovarian Cancer Supported by Autologous Haematopoietic Stem Cell Transfusion","Inclusion Criteria:\n\n* 18-60 years old;\n* there are chemotherapy indicators for ovarian cancer;\n* ovarian cancer diagnosed by histopathology;\n* recurrent and metastatic ovarian cancer;\n* the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;\n* the expected survival time was more than 3 months;\n* pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;\n* all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;\n* the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations;\n* bone marrow function is good,ability to perform stem cell mobilisation and collection.\n\nExclusion Criteria:\n\n* patients with bone marrow disease;\n* central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;\n* patient has severe cardiac insufficiency;\n* previous history of allogeneic stem cell transplantation or organ transplantation;\n* patients with active bleeding and autoimmune thrombocytopenic purpura;\n* patients with chemotherapy contraindications;\n* positive for human immunodeficiency virus (HIV);\n* acute or chronic active hepatitis B or hepatitis C infection.",{"count":20,"type":21},[24],"The aim of this project is to use autologous haematopoietic stem cell transfusion support to promote the reconstruction of haematopoietic function after chemotherapy for ovarian cancer. To explore the impact of stored haematopoietic stem cell support therapy on bone marrow protection after conventional chemotherapy for ovarian cancer in order to facilitate its clinical application.",[56],"Ovarian Cancer",[56,58,30,31],"Conventional chemotherapy",{"date":35,"type":36},{"date":61,"type":36},"2022-04-15",{"date":63,"type":21},"2029-05",{"name":42,"class":43},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":44},"100634758","phase-2-a-prospective-multicenter-single-arm-phase-ii-exploratory-study-of-serplulimab-combined-with-oncolytic-virus-h101-short-course-radiotherapy-and-xelox-chemotherapy-as-total-neoadjuvant-treatment-for-locally-advanced-ct1-3n0m0-rectal-cancer-100634758","NCT07543848","A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer","A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)","Inclusion Criteria:\n\n\\- Participants must meet all of the following criteria:\n\n1. Age 18 to 80 years, male or female.\n2. Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge.\n3. Clinical stage T1-3N0M0 according to AJCC staging criteria.\n4. Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing.\n5. No prior anti-tumor treatment.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months.\n7. Adequate organ function, including:\n\n   * Absolute neutrophil count ≥1.5 × 10\\^9\u002FL\n   * Platelet count ≥100 × 10\\^9\u002FL\n   * Hemoglobin ≥9 g\u002FdL\n   * Serum albumin ≥3 g\u002FdL\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN)\n   * ALT and AST ≤2 × ULN\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin\n   * INR or PT ≤1.5 × ULN, and aPTT ≤1.5 × ULN\n8. Thyroid function within normal range or adequately controlled.\n9. Negative pregnancy test for women of childbearing potential.\n10. Willingness to use effective contraception during the study and for 12 months after treatment.\n11. Ability to understand and willingness to sign a written informed consent form.\n12. Willingness and ability to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Participants will be excluded if they meet any of the following criteria:\n\n  1. Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma).\n  2. Prior pelvic radiotherapy.\n  3. Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors.\n  4. Known allergy to study drugs or their components.\n  5. History of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma.\n  6. Active autoimmune disease or history of autoimmune disease requiring systemic treatment.\n  7. Immunodeficiency, including HIV infection, or history of organ transplantation.\n  8. History of interstitial lung disease or non-infectious pneumonitis.\n  9. Active tuberculosis infection or history of untreated tuberculosis.\n  10. Active hepatitis B or hepatitis C infection.\n  11. Severe cardiovascular, pulmonary, or renal disease.\n  12. Uncontrolled hypertension despite medication.\n  13. History of substance abuse (alcohol or drugs).\n  14. Active uncontrolled infection.\n  15. Use of systemic immunosuppressive therapy.\n  16. Pregnant or breastfeeding women.\n  17. Any condition that, in the investigator's opinion, may interfere with study participation or safety.","ALL","80 Years",{"count":75,"type":21},20,[77],"PHASE2","This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).\n\nIn this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.\n\nThe primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.\n\nThe results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.",[80,81],"Rectal Neoplasms","Rectal Adenocarcinoma",[83,84,85,86,87,88,89,90,91,92],"Rectal Cancer","Total Neoadjuvant Therapy","Combination Therapy","Serplulimab","PD-1 Inhibitor","Oncolytic Virus H101","XELOX Chemotherapy","Short-course Radiotherapy","Organ Preservation","Clinical Complete Response","NOT_YET_RECRUITING","2026-04-15",{"date":96,"type":36},"2026-04-22",{"date":98,"type":21},"2026-05-01",{"date":100,"type":21},"2028-12-31",{"name":42,"class":43},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":44},"100625681","phase-2-tislelizumab-combined-with-chemotherapy-followed-by-thoracic-consolidation-radiotherapy-in-the-first-line-treatment-of-extensive-stage-small-cell-lung-cancer-100625681","NCT07425795","Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer","A Prospective, Single Arm, Phase II Clinical Study of Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed informed consent;\n* Age 18-75 years;\n* According to the judgment of the investigator, the patient was able to comply with the study protocol;\n* Histologically or cytologically confirmed extensive stage small cell lung cancer (es-sclc) (according to the Veterans Administration lung cancer association \\[valg\\] staging system);\n* No previous systemic treatment for ES-SCLC;\n* With measurable lesions assessed by the investigator according to RECIST version 1.1;\n* ECOG physical status score was 0 or 1;\n* Life expectancy ≥ 3 months;\n* Adequate hematology and end organ function, as defined by the following laboratory findings, which should be obtained within 14 days before the first study treatment: absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002Fl (without granulocyte colony-stimulating factor treatment); Lymphocyte count ≥ 0.5 × 10\\^9\u002Fl (500 \u002F μ L); Platelet count ≥ 100 × 10\\^9\u002Fl (100000 \u002F μ L); Hemoglobin ≥ 90g\u002Fl (9.0g\u002Fdl); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions: Patients with confirmed liver metastasis: AST and alt ≤ 5 × ULN; Patients with confirmed liver or bone metastasis: ALP ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN, with the following exceptions: patients known to have Gilbert syndrome: total bilirubin ≤ 3 × ULN; Creatinine clearance ≥ 60ml\u002Fmin (calculated by Cockcroft Gault formula); Albumin ≥ 25g\u002Fl (2.5g\u002Fdl).\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressive central nervous system (CNS) metastases; ·Patients with CNS lesions who were treated and asymptomatic were eligible for this study if they met all of the following criteria: measurable lesions that met the recistv1.1 definition were outside the CNS; The patient had no history of intracranial hemorrhage or spinal cord hemorrhage; Patients did not receive stereotactic radiotherapy within 7 days before the start of study treatment, whole brain radiotherapy within 14 days before the start of study treatment, or neurosurgical resection within 28 days before the start of study treatment; Patients do not need to continue to receive corticosteroids for CNS disease. Treatment with stable doses of anticonvulsants was allowed. Metastasis was limited to the cerebellum or supratentorial region (i.e., not to the midbrain, pons, medulla oblongata, or spinal cord); There was no evidence of progression between the completion of CNS local therapy and the initiation of study therapy asymptomatic patients with CNS metastases who could be enrolled according to the assessment of other investigators could be enrolled;\n* History of leptomeningeal disease;\n* Poorly controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage (once a month or more frequently);\n* Poorly controlled or symptomatic hypercalcemia (ionized calcium \\>1.5mmol\u002Fl, calcium \\>12mg\u002Fdl or corrected calcium \\>uln);\n* Have active or ever suffered from autoimmune disease or immunodeficiency;\n* Have a history of idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia;\n* Active pulmonary tuberculosis;\n* Untreated chronic hepatitis B patients, chronic hepatitis B virus carriers with HBV DNA ≥ 500 iu\u002Fml (2500 copies \u002Fml), active hepatitis C patients: inactive HBsAg carriers, patients with stable active HBV infection after drug treatment (HBV dna\\\u003C500 iu\u002Fml (2500 copies \u002Fml)) can be enrolled. HBV DNA testing was only performed in patients who tested positive for hepatitis B core antibody (anti HBC antibody). Patients with negative hepatitis C virus (HCV) antibody test at screening, or patients with positive HCV antibody and negative HCV RNA test at screening can be enrolled in the study. HCV RNA testing will only be performed in patients with positive hepatitis C virus (HCV) antibody. Note: Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be treated according to treatment guidelines. Patients treated with antiviral drugs at the time of screening should have been treated for \\>2 weeks before enrollment and continue to be treated for 6 months after termination of study drug treatment.","75 Years",{"count":111,"type":21},36,[77],"This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.",[115],"Extensive Stage Small Cell Lung Cancer (ES-SCLC)",[117,118,119,120],"Extensive stage small cell lung cancer","tislelizumab","thoracic consolidation radiotherapy","first-line treatment","2026-02-20",{"date":123,"type":36},"2026-02-23",{"date":125,"type":36},"2025-10-10",{"date":127,"type":21},"2028-07-31",{"name":42,"class":43},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":44},"100520645","phase-2-envafolimab-combined-with-chemoradiotherapy-and-recombinant-human-endostatin-for-la-npc-100520645","NCT06059261","Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.","A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin in Locally Advanced Nasopharyngeal Carcinoma.","Inclusion Criteria:\n\n1. ECOG score 0-1.\n2. Aged 18-65 years, male or non-pregnant female;\n3. Pathologically confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III) without the need to detect MSI and dMMR status.\n4. high-risk locally advanced stage III-IVA (8th AJCC\u002FUICC staging), i.e., T4N+ or N2-3, or pretreatment EBV-DNA ≥4000 copies\u002Fml, or lymph node extra-envelope invasion grade 3 (invasion of muscle skin, etc.), treatment-naive nasopharyngeal carcinoma patients.\n5. MRI data of nasopharynx and neck before enrollment, and measurable lesions;\n6. Agree to provide a previously stored tumor tissue specimen or biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1 IHC testing.\n7. Agree to undergo EBV antibody and EBV-DNA quantitative testing before receiving treatment.\n8. Hematology: WBC ≥ 4000\u002FμL, neutrophils ≥ 2.000\u002FμL, hemoglobin ≥ 9 g\u002FdL, platelets ≥ 100,000\u002FμL;\n9. Liver function: ALT, AST \\\u003C 1.5 times the upper limit of normal (ULN), total bilirubin \\\u003C 1.5 × ULN;\n10. Renal function: serum creatinine \\\u003C 1.5 × ULN.\n11. Patients have signed the informed consent form and are willing and able to comply with the study plan visits, treatment plan, laboratory tests and other study procedures;\n\nExclusion Criteria:\n\n1. Patients with recurrent nasopharyngeal carcinoma and distant metastasis.\n2. Pathology was keratinizing squamous cell carcinoma (WHO classification type I).\n3. Patients who have undergone radiotherapy or systemic chemotherapy;\n4. Pregnant or lactating women, in the reproductive period without effective contraceptive measures;\n5. HIV positive.\n6. Having had other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);\n7. Patients who have been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.);\n8. Patients need long-term use of immunosuppressive drug therapy, or systemic or local use of immunosuppressive doses of corticosteroids complications;\n9. Patients with immunodeficiency disease, history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood, without any intervention after adulthood can be included; patients with asthma requiring bronchodilators for medical intervention can not be included;\n10. Use of excessive doses of glucocorticoids within 4 weeks.\n11. Laboratory test values within 7 days before enrollment do not meet the relevant criteria;\n12. Patients with significantly low heart, liver, lung, kidney and bone marrow function.\n13. Any other diseases or conditions are contraindications to recombinant human vascular endothelial inhibitors, chemoradiotherapy, immunotherapy (such as active phase of infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);\n14. Any arterial thrombosis, embolism or ischemia within 6 months before inclusion for treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;\n15. Severe, uncontrolled medical illness and infection.\n16. Concurrent use of other investigational drugs or ongoing other clinical trials;\n17. Refusing or unable to sign the informed consent form to participate in the trial.\n18. Personality or mental disorders, no civil capacity or limited civil capacity;\n19. Hepatitis B surface antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000cps\u002Fml.\n20. Patients who tested positive for HCV antibody were included in the study only if they tested negative for HCV RNA by polymerase chain reaction.","65 Years",{"count":138,"type":21},30,[77],"This is a single-center, prospective, single-arm, phase II clinical study, to evaluate the therapeutic efficacy and safety of envafolimab combined with chemoradiotherapy and recombinant human endostatin in patients with locally advanced nasopharyngeal carcinoma.",[142],"Nasopharyngeal Carcinoma",[142],"2026-02-14",{"date":146,"type":36},"2026-02-18",{"date":148,"type":21},"2026-02-09",{"date":150,"type":21},"2027-02-01",{"name":42,"class":43},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":109,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100612159","reducing-radiation-target-volume-for-stage-iib-cervical-cancer-100612159","NCT07249957","Reducing Radiation Target Volume for Stage IIb Cervical Cancer","Reducing Radiation Target Volume in Radical Radiotherapy for Stage IIb Cervical Cancer: A Single-arm Exploratory Study","Inclusion Criteria:\n\n1. The patient voluntarily participated in this study and signed the informed consent form;\n2. Age range: 50 to 75 years old;\n3. Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;\n4. According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size \\\u003C 4 cm);\n5. ECOG score: 0 to 1, with an expected survival of more than 6 months;\n6. Pregnant women must undergo a pregnancy test (serum or urine) 7 days before enrollment, and the result must be negative, and they are willing to use appropriate contraceptive methods during the trial;\n7. According to the investigator's judgment, there are no absolute contraindications to radiotherapy and chemotherapy or surgery, and they can comply with the trial protocol.\n\nExclusion Criteria:\n\n1. Active or uncontrolled severe infections;\n2. Cirrhosis, decompensated liver disease;\n3. History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;\n4. Chronic renal insufficiency and renal failure;\n5. Patients with other malignancies that require treatment and\u002For newly diagnosed within 5 years;\n6. Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification);\n7. Patients who have undergone pelvic artery embolization;\n8. Patients who have received radiotherapy for pelvic malignant tumors in the past;\n9. Patients who have received partial hysterectomy or radical hysterectomy in the past;\n10. Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs;\n11. Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.;\n12. Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form;\n13. Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.","50 Years",{"count":161,"type":21},60,[24],"This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size \\\u003C 4 cm). The patients first received 6 cycles of induction chemotherapy (carboplatin (AUC2) + paclitaxel (80 mg\u002Fm2), q1w), followed by concurrent chemoradiotherapy with a platinum-based regimen. The external beam radiation field only covered the entire uterus (including the primary lesion of the cervix), the bilateral parametrium, and the lesion of the cervix\u002Fvagina extending 3 cm downward. A total of 60 participants are planned to be included in the study.",[165],"Stage IIb Cervical Cancer Radical Radiotherapy","2025-11-18",{"date":168,"type":36},"2025-11-25",{"date":170,"type":21},"2025-11",{"date":172,"type":21},"2029-10",{"name":42,"class":43},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":72,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":44},"100609670","phase-4-ondansetron-orodispersible-film-for-vomiting-prevention-in-pediatric-radiotherapy-100609670","NCT07217600","Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy","Efficacy and Safety of Ondansetron Orodispersible Film in Preventing Vomiting Induced by Moderately Emetogenic Risk Radiotherapy in Pediatric Patients With Malignant Tumors","Inclusion Criteria:\n\n* Children with malignant tumors diagnosed by histopathology\n* Age range: 1-14 years old (calculated from the day of signing the informed consent form)\n* Weight \\>= 8Kg;\n* Lansky functional status (LPS) score \\>= 50 (excluding posterior fossa syndrome)\n* Be planned to undergo upper abdominal or craniospinal radiation therapy, and the upper abdominal irradiation should cover the anatomical area from the upper edge of the 11th thoracic vertebra to the lower edge of the third lumbar vertebra\n* Radiotherapy is administered once daily, and the fractional dose is 1.8Gy, except for 1.5 Gy for whole abdominal radiotherapy\n* The blood routine test must meet the following criteria: ANC \\>= 1.0 × 10\\^9\u002FL (after discontinuation of G-CSF), PLT \\>= 50 × 10\\^9\u002FL (without drug support or transfusion therapy), HGB \\>= 80g\u002FL\n* Biochemical tests must meet the following standards: total bilirubin \\\u003C= 1.5 times ULN (upper limit of normal), ALT \\\u003C= 2.5 times ULN, AST \\\u003C= 2.5 times ULN, alkaline phosphatase ≤ 1.5 times ULN, serum albumin \\>= 2.5 g\u002FdL, BUN and CRE \\\u003C= 1.5 × ULN\n* Expected survival period \\>= 3 months;\n* The guardian of the child understands and signs the informed consent form, has good compliance, and cooperates with follow-up.\n\nExclusion Criteria:\n\n* The nausea and vomiting caused by the surgery have not fully recovered if the subject has undergone a major surgery\n* The patient has symptoms of central nervous system tumors such as cerebral edema and requires intervention with adrenal cortex hormones\n* Participants who have participated in or are currently participating in other clinical studies within 4 weeks prior to the first use of the investigational drug (calculated based on the time of the last use of the investigational drug for those who have entered the follow-up period)\n* Individuals allergic to 5-HT3 receptor antagonists or other excipients\n* Joint use of apomorphine\n* Congenital QT prolongation syndrome\n* Severe gastrointestinal obstruction\n* Other observers who affect the efficacy and adverse reactions\n* Used other 5-HT3 receptor antagonists in the first 3 days of enrollment\n* According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data.","1 Year","14 Years",{"count":161,"type":21},[185],"PHASE4","The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused by moderate emetic risk radiation in children with malignant tumor.",[188,189],"Radiotherapy-induced Nausea and Vomiting (RINV)","Pediatric Cancer","2025-10-16",{"date":192,"type":36},"2025-10-20",{"date":194,"type":36},"2025-03-25",{"date":196,"type":21},"2026-04",{"name":42,"class":43},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":44},"100405119","the-efficacy-of-lymph-node-dissection-for-stage-iiicr-of-cervical-cancercqgog0103-100405119","NCT04555226","The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)","Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer","Inclusion Criteria:\n\n1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma\n2. Cervical cancer stage IIICr (confirmed by CT\u002FMRI\u002FPET\u002FCT) and the short diameter of image-positive lymph node ≥15mm\n3. ECOG score 0\\~1\n4. Expected survival over 6 months\n5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial\n6. No surgical contraindication\n\nExclusion Criteria:\n\n1. Activity or uncontrol severe infection\n2. Active hepatitis B, Liver cirrhosis, Decompensated liver disease\n3. History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease\n4. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressive medications). Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) were not counted as systemic therapies, and subjects were permitted to use these therapies\n5. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n6. Chronic renal insufficiency or renal failure\n7. Has combined with other malignant tumor which diagnosed within 5 years and\u002For needed to be treated\n8. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure\n9. Has had an allogenic tissue\u002Fsolid organ transplant\n10. A history of pelvic artery embolization\n11. A history of pelvic radiotherapy\n12. A history of partial hysterectomy or radical hysterectomy\n13. A history of immunotherapy or undergoing immunotherapy\n14. A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and\u002For any excipients\n15. During the treatment for complications, the drugs which lead to serious liver and\u002For kidney function impairment need to be used, such as tuberculosis","70 Years",{"count":207,"type":21},452,[24],"This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and\u002For OS with lymph node dissection before CCRT when compared to CCRT.",[27],[212,213,214,215],"Stage IIICr of cervical cancer","Lymph node dissection","Chemoradiation","PFS","2025-08-25",{"date":218,"type":36},"2025-09-02",{"date":220,"type":36},"2021-01-11",{"date":222,"type":21},"2032-08",{"name":42,"class":43},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":205,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":4},"100591548","phase-2-a-single-arm-exploratory-study-of-enlansibumab-sequentially-combined-with-concurrent-chemoradiotherapy-for-locally-advanced-cervical-cancer-100591548","NCT06981858","A Single-Arm Exploratory Study of Enlansibumab Sequentially Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","Inclusion criteria:\n\n1. Female, aged 18-70 years (including boundary values);\n2. Diagnosed histologically as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 3.2018 FIGO stage IIB-IVA; Assess lymph node involvement based on one of the following criteria:\n\n   * Lymph node involvement confirmed by histology and biopsy;\n   * MRI or CT shows one or more positive pelvic\u002Fabdominal aortic lymph nodes with a minimum diameter of ≥ 15mm;\n   * PET\u002FCT or PET\u002FMR display one or more positive pelvic\u002Fabdominal aortic lymph nodes with SUVmax ≥ 2.5 and higher than the background value in surrounding normal tissues.\n\nAccording to the evaluation criteria for solid tumor efficacy version 1.1 (RECIST v1.1), having at least one measurable lesion; 5.ECOG PS 0-1； 6. According to the researcher's judgment, those with an expected survival period of ≥ 3 months; 7. The subjects can provide tumor tissue sections to determine whether formalin fixed paraffin embedded tumor histopathological samples or fresh tumor histopathological samples can be used for PD-L1 expression and other immune indicators detection; 8. Have sufficient organ function and meet the following laboratory examination standards:\n\n1. Blood routine (no blood transfusion within 14 days, no use of hematopoietic stimulating factors, and no use of other drugs to correct blood cell count): White blood cell count (WBC) ≥ 3000\u002Fmm3; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; platelet count (PLT) ≥ 90 × 109\u002FL; hemoglobin (HGB) ≥ 9g\u002FdL;\n2. Blood biochemistry: creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), if\\>1.5 × ULN, creatinine clearance rate must be ≥ 60mL\u002Fmin, calculated using the Cockcroft Gault formula; Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n3. Thyroid function: Thyroid stimulating hormone (TSH) ≤ ULN; If there are abnormalities, additional tests should be conducted on T3 and T4, and their levels should be normal; 9. Women of childbearing age who have a negative pregnancy test and are not breastfeeding, and have fertility, must receive effective medical contraception measures (from signing the informed consent form to within 6 months after the last study administration); 10. Participants must agree to collect blood samples, paraffin embedded (FFPE) tumor tissue specimens or sections, and fresh tumor tissue specimens for relevant research.\n\n11\\. The subjects voluntarily participated in this study, had good compliance with the planned treatment and follow-up, understood the research process of this study, and voluntarily signed an informed consent form.\n\nExclusion criteria:\n\n1. There are distant metastatic diseases present;\n2. Have received any previous anti-tumor treatment, including but not limited to surgery (excluding biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);\n3. Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies;\n4. Active malignant tumor within 3 years before the first administration, excluding cervical cancer studied in this trial and any locally curable tumor that has received radical treatment (such as excised basal cell or squamous cell skin cancer, superficial bladder cancer cancer or cured carcinoma in situ, such as breast carcinoma in situ);\n5. Suffering from active autoimmune diseases, or having a history of autoimmune diseases within 2 years before enrollment, and still requiring systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators;\n6. Suffering from primary immunodeficiency disease or having a medical history;\n7. Individuals who have received immunosuppressive therapy (such as cyclosporine) or require systemic steroid therapy (such as\\>20 mg\u002Fday prednisone or equivalent) within the 14 days prior to enrollment, except for those who receive local corticosteroid therapy via nasal spray, inhalation, or other routes;\n8. Individuals who are HIV Ab positive or have active syphilis infection; Hepatitis B virus surface antigen (HBsAg) is positive, and the detection value of hepatitis B virus is\\>500IU\u002Fml or 2500 copies\u002FmL; Hepatitis C antibody (HCV Ab) is positive, and the hepatitis C virus RNA quantification is greater than the upper limit of the normal value of the detection unit. (Note: For those with positive hepatitis B virus surface antigen (HBsAg), antiviral treatment is recommended before the first use of the study drug, and nucleoside analogs such as entecavir and tenofovir dipivoxil are recommended. )\n9. Active bacterial, fungal, or viral infections (defined as requiring intravenous injection of antibacterial, antifungal, or antiviral drugs for treatment) within 14 days prior to enrollment. For individuals who have no clinical manifestations of active infection before the first medication and receive prophylactic treatment for infection, they may be considered for inclusion;\n10. Active tuberculosis or medical history;\n11. Have experienced severe cardiovascular disease within the 6 months prior to enrollment, including but not limited to: stable angina pectoris with functional classification of III-IV; Unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; Severe arrhythmia requiring medication treatment (if ventricular rate can be controlled, asymptomatic atrial fibrillation subjects are allowed to be included); Serious arterial\u002Fvenous thrombotic events (such as cerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism);\n12. Suffering from uncontrollable hypertension;\n13. Have previously suffered from interstitial lung disease or non infectious pneumonia requiring glucocorticoid treatment;\n14. There is clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stent placement, as determined by researchers; Within 28 days prior to enrollment or planned to receive live or attenuated vaccine treatment during the study period;\n\n16\\. Known recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Have a history of severe allergic reactions and uncontrolled allergic asthma to all components of monoclonal antibody preparations; 18. There are contraindications or severe allergic reactions to any component of cisplatin; 19. Individuals who have participated in other clinical trials and used the investigational drug within 28 days prior to enrollment; 20. Participants who may have poor compliance with the research procedures and requirements, as determined by the researchers, such as those with a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current mental disorders, and substance abuse; 21. Individuals with a clear history of neurological or mental disorders or drug abuse who are unable to quit or have a history of drug use; 22. There are situations where other researchers have determined that it is not suitable to participate in this experiment.",{"count":231,"type":21},34,[77],"This is a prospective , single - arm clinical study , aiming to evaluate the efficacy and safety of Enlansibumab sequential concurrent chemoradiotherapy in locally advanced cervical cancer. Patients will first receive one cycle of Enlansibumab monotherapy (360 mg, 60 - min IV infusion on day 1, every 3 weeks). After one treatment cycle (3 weeks), they'll undergo imaging assessment. Then, they'll have Enlansibumab (360 mg, 60 - min IV infusion on day 1, every 3 weeks for two cycles) combined with concurrent chemoradiotherapy. Chemotherapy involves cisplatin (40 mg\u002Fm²) or carboplatin (AUC2) via IV infusion, weekly (±7 days), with five planned cycles. Investigators may add a sixth platinum - based chemotherapy cycle if needed. Radiotherapy comprises EBRT and BT and must be completed within eight weeks of treatment initiation. The total prescription dose of EBRT combined with BT should have an EQD2 of ≥8000 cGy, with adjustments based on tumor regression. After concurrent chemoradiotherapy, treatment ends. An imaging assessment occurs around seven days (±3 days) later. Then, the follow - up phase begins, including final, safety, and survival follow - ups, continuing until patients are lost to follow-up, the follow-up ends, or they die.",[235],"LOCALLY ADVANCED CERVICAL CANCERS","2025-05-13",{"date":238,"type":36},"2025-05-21",{"date":240,"type":21},"2025-05-15",{"date":242,"type":21},"2029-02-01",{"name":42,"class":43},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":44},"100492108","phase-2-study-of-cadonilimab-combined-with-radiotherapy-in-the-treatment-of-locally-advanced-cervical-cancer-100492108","NCT05687851","Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer","A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign written informed consent.\n2. Women aged ≥18 years at the time of study entry.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.\n4. Life expectancy ≥12 weeks.\n5. Intolerance to chemotherapy regimens.\n6. Histologically confirmed cervical cancer.\n\n   1. Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix;\n   2. Not receiving systemic anti-tumour therapy (including but not limited to radiotherapy, targeted therapy and immunotherapy, etc; concurrent chemotherapy is not included. Note: Removal or biopsy of pelvic lymph nodes or para-aortic lymph nodes for the purpose of clinical staging is allowed).\n   3. Locally advanced cervical cancer（LACC）: The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3\u002FIIA2, IIB-IVA.\n7. At least one measurable tumor lesion according to RECIST v1.1 criteria.\n8. Available archived tumor tissue samples or recent biopsies.\n9. Adequate organ function.\n10. For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy)\n\nExclusion Criteria:\n\n1. Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc).\n2. Evidence of distant metastases.\n3. Have received total hysterectomy.\n4. Subject with other active malignancies within 2 years prior enter the study.\n5. Subject who cannot receive brachytherapy.\n6. Active or prior documented autoimmune disease that may relapse.\n7. History of interstitial lung disease or noninfectious pneumonitis.\n8. Subject with the clinically significant cardio-cerebrovascular disease.\n9. History of severe hypersensitivity reactions to other mAbs.\n10. Prior allogeneic stem cell transplantation or organ transplantation.\n11. Subjects who require systemic treatment with glucocorticoid (\\>10 mg\u002Fday of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior enter the study.\n12. Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.\n13. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).\n14. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results.",{"count":252,"type":21},33,[77],"Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.\n\nThis is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.",[256],"Locally Advanced Cervical Cancer",[258,259],"Local advanced cervical cancer","Concurrent chemoradiotherapy","2024-09-08",{"date":262,"type":36},"2024-09-19",{"date":264,"type":36},"2022-12-29",{"date":266,"type":21},"2026-12",{"name":42,"class":43},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":109,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":44},"100553090","efficacy-and-safety-of-almonertinib-combined-with-stereotactic-body-radiotherapy-sbrt-in-the-treatment-of-non-small-cell-lung-cancer-with-egfr-sensitive-mutation-a-single-arm-open-label-clinical-trial-100553090","NCT06481566","Efficacy and Safety of Almonertinib Combined With Stereotactic Body Radiotherapy (SBRT) in the Treatment of Non-small Cell Lung Cancer With EGFR Sensitive Mutation: a Single-arm, Open-label Clinical Trial","Inclusion Criteria:\n\n1. Aged 18 years or older (including 18 years) and less than 75 years (including 75 years).\n2. Subjects with histologically or cytologically confirmed unresectable NSCLC and stage IIIB-IV tumours (as determined by the International Association for the Study of Lung Cancer (IASLC) Manual of Thoracic Tumour Staging, 8th edition). Oligometastatic lesions (≤5) in the brain on head-enhanced MRI were eligible for enrolment, and at least 1 lesion in the brain could be accurately measured at baseline, with the longest diameter at baseline ≥5 mm. Measurements were made by MRI (layer thickness 1.5 mm).\n3. Have not received any systemic therapy after diagnosis of NSCLC or have not progressed with 1-2 cycles of chemotherapy.\n4. Tumour tissue samples or blood samples diagnosed with NSCLC are tested and confirmed to have an EGFR-sensitive mutation (including exon 19 deletion or L858R, either alone or coexisting with mutations in other EGFR loci). Tumour tissue is recommended if the tumour tissue is accessible; if the tumour tissue is inaccessible or the patient is not amenable to tissue biopsy, blood samples will be sent to test EGFR mutation.\n5. Patients with an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1 and no deterioration in the previous 2 weeks, with a minimum expected survival of 12 weeks.\n6. At least 1 tumour lesion in the patient's lungs can be accurately measured at baseline with a longest diameter of ≥10 mm at baseline (in the case of lymph nodes, a short diameter of ≥15 mm is required). The measurement method of choice is suitable for accurate repeat measurements, either computed tomography (CT) or magnetic resonance imaging (MRI). Only 1 measurable lesion is accepted as a target lesion if it is present, subject to baseline evaluation of the tumour lesion at least 14 days after diagnostic biopsy. And the primary residual lung lesion is suitable for SBRT after targeted therapy.\n7. Women of childbearing potential are required to use adequate contraception and should not be breastfeeding from screening until 3 months after discontinuation of study treatment. Negative pregnancy test prior to initiation of dosing or no risk of pregnancy as evidenced by meeting one of the following criteria:\n\n   1. Postmenopausal defined as amenorrhoea for at least 12 months after age greater than 50 years and cessation of all exogenous hormone replacement therapy;\n   2. Women younger than 50 years of age may also be considered postmenopausal if they have had amenorrhoea for 12 months or more after cessation of all exogenous hormone therapy and have luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels in the range of laboratory postmenopausal reference values.\n   3. Previous irreversible sterilisation including hysterectomy, bilateral oophorectomy or bilateral salpingo-oophorectomy, with the exception of bilateral tubal ligation.\n8. Barrier contraception (i.e., condoms) should be used by male patients from screening until 3 months after discontinuation of study treatment.\n9. Subjects participate voluntarily and sign a written informed consent form.\n\nExclusion Criteria:\n\nSubjects will not be enrolled in the study if they fulfil any of the following criteria:\n\n1. Patients with postoperative recurrence.\n2. Non-primary patients who have received any of the following prior treatments:\n\n   1. prior use of any EGFR tyrosine kinase inhibitor (EGFR-TKI);\n   2. prior radiotherapy for any lung cancer;\n   3. patient has undergone major surgery within 4 weeks prior to the first dose of study drug;\n   4. use of a strong inhibitor of CYP3A4, an inducer, or a drug with a narrow therapeutic window that is a CYP3A4-sensitive substrate within 7 days prior to the first dose of study drug.\n3. Patients with other malignancies that require standardised treatment or major surgery within 2 years of the first dose of study treatment.\n4. Patients who are amenable to surgical resection.\n5. Patients with progression within 3 months of targeted therapy.\n6. Patients with unrelieved residual toxicity from prior therapy greater than CTCAE grade 1 at the time of initiation of study treatment, with the exception of alopecia and grade 2 neurotoxicity from prior chemotherapy.\n7. Patients with uncontrolled pleural effusion and\u002For pericardial effusion.\n8. Have any serious or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding prone constitution or active infection as judged by the investigator. Exclusion of chronic diseases is not required.\n9. Refractory nausea, vomiting or chronic gastrointestinal disorders, inability to swallow study medication or a history of extensive bowel resection that may interfere with adequate absorption of almonertinib.\n10. Cardiac findings consistent with any of the following:\n\n    1. resting electrocardiogram (ECG) examination yielding a corrected QT interval (QTc) \\> 470 msec, applying the Fridericia formula for QT interval correction (QTcF);\n    2. resting ECG suggests the presence of a variety of clinically significant rhythmic, conduction, or ECG morphological abnormalities (e.g., complete left bundle-branch block, third-degree atrioventricular conduction).\n    3. presence of any factor that increases the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained death in an immediate family member under the age of 40 years or any combination of medications that prolong the QT interval;\n    4. left ventricular ejection fraction (LVEF) ≤40%.\n11. History of interstitial lung disease or any evidence of clinically active interstitial lung disease.\n12. Inadequate bone marrow reserve or organ function at the following laboratory limits:\n\n    1. Absolute neutrophil count \\\u003C 1.5 x 10\\^9 \u002F L;\n    2. Platelet count \\\u003C 100 x 10\\^9 \u002F L;\n    3. Haemoglobin \\\u003C 90 g\u002FL (\\\u003C 9 g\u002FdL);\n    4. Alanine aminotransferase \\> 2.5 times the upper limit of normal (ULN);\n    5. Aspartate aminotransferase \\> 2.5 x ULN;\n    6. Total bilirubin \\> 1.5 x ULN; or presence of Gilbert's syndrome (unconjugated hyperbilirubinemia);\n    7. Creatinine \\> 1.5 x ULN and creatinine clearance \\\u003C 50 mL\u002Fmin (calculated by the Cockcroft - Gault formula); confirmation of creatinine clearance is required only if creatinine \\> 1.5 x ULN.\n13. Women who are breastfeeding or who have had a positive blood or urine pregnancy test result within 3 days prior to the first dose of study treatment.\n14. History of hypersensitivity to any active or inactive ingredient of almonertinib or to a drug with a similar chemical structure to almonertinib or an analogue of almonertinib.\n15. Any serious or uncontrolled ocular pathology that, in the judgement of the physician, may increase the risk to the patient's safety.\n16. Patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study.\n17. Patients who, in the judgement of the investigator, have any condition that jeopardises patient safety or interferes with the assessment of the study.",{"count":138,"type":21},[24],"The goal of this clinical trial is to learn if first-line Almonertinib plus upfront stereotactic ablative body radiotherapy (SABR) works to treat EGFR-mutated advanced non-small cell lung cancer. The main questions it aims to answer are:\n\nDoes first-line Almonertinib plus upfront stereotactic ablative body radiotherapy to residual primary lung lesions prolong the progression-free survival of EGFR-mutated advanced non-small cell lung cancer.\n\nParticipants will:\n\nTake first-line Almonertinib for 2-4 months, then deliver SABR to residual primary lung lesions, after that go on Almonertinib maintenance treatment； Visit the hospital once every 3 months for checkups and tests； Keep a diary of their symptoms ；",[278],"Non-small Cell Lung Cancer",[280,281,282],"Non-small cell lung cancer","Stereotactic Ablative Body Radiotherapy","EGFR-TKI","2024-08-30",{"date":285,"type":36},"2024-09-04",{"date":287,"type":36},"2024-06-21",{"date":289,"type":21},"2026-06-30",{"name":42,"class":43},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},"100426228","phase-2-the-efficacy-of-camrelizumab-plus-stereotactic-body-radiotherapy-in-rm-npc-100426228","NCT04830267","The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R\u002FM NPC","A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Signed Written Informed Consent\n2. Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines.\n3. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations.\n4. Target Population:\n\n   Males and females ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Histologically confirmed metastatic or recurrent nasopharyngeal carcinoma.\n5. Subjects must have at least two lesions:\n\n   At least one lesion must be safely amenable to irradiation. This can be a lesion that was previously irradiated as long as prior radiation was at least 6 months prior to projected first fraction of SBRT and as long as reirradiation dose constraints are being met.\n\n   A separate, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria.\n6. The peripheral blood EBV DNA copy number can be obtained.\n7. Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization.\n8. Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses \\>10mg\u002Fday prednisone or equivalent) must be discontinued at least 14 days prior to Camrelizumab administration.\n9. Screening laboratory values must meet the following criteria (using CTCAE v4.0) and should be obtained within 28 days prior to randomization:\n\n   WBC ≥ 2 K\u002Fmicroliter Neutrophils ≥ 1.5 K\u002Fmicroliter Platelets ≥ 100 K\u002Fmicroliter Hemoglobin ≥ 9.0 g\u002Fdeciliter Serum Creatinine ≤ 1.5 x ULN or creatinine clearance \\> 40ml\u002Fmin using the Cockcroft-Gault formula.\n\n   Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg\u002FdL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg\u002FdL AST\u002FALT ≤ 3 x ULN Total bilirubin \\\u003C1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin \\\u003C3.0 mg\u002Fdeciliter).\n\n   Subjects must have a resting baseline O2 saturation by pulse oximetry of \\>=92% at rest.\n10. Reproductive Status:\n\nWomen of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 28 days prior to randomization.\n\nWomen must not be breastfeeding Women of childbearing potential must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment with Camrelizumab plus 5 half- lives plus 30 days for a total of 23 weeks post treatment completion.\n\nMen who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving Camrelizumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.\n\nWomen who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.\n\nAzoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements. However, they still must have a pregnancy test.\n\nExclusion Criteria:\n\n1. Target Disease Exceptions:\n\n   Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed. Subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment.\n2. Medical History and Concurrent Diseases:\n\n   Any medical disorder that, in the opinion of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study results.\n\n   Prior active malignancy within the previous 3 years except for locally curable cancers such as basal or squamous skin cancer, superficial bladder, low risk prostate cancer, breast, or cervix cancer. If other prior malignancy was active within prior 3 years, enrollment requires approval of a principal investigator.\n\n   Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration should be excluded. Inhaled or topical steroids and adrenal replacement doses \\>10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n3. Physical and Laboratory Test Findings:\n\n   Positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid indicating acute or chronic infection.\n\n   Known history of testing positive for HIV or known AIDS. Any grade 4 laboratory abnormalities. Allergies and Adverse Drug Reaction History of allergy to Camrelizumab components History of severe hypersensitivity reaction to any monoclonal antibody.\n4. Prohibited or Restricted Treatments:\n\nThe following medications are prohibited during the study:\n\nImmunosuppressive agents (except to treat a drug-related adverse event). Systemic corticosteroids \\> 10 mg daily prednisone equivalent save for exclusion outlined in the below paragraphs.\n\nAny concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational agents for treatment of cancer.",{"count":299,"type":21},39,[77],"Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.",[142],[304,305,306,307],"Camrelizumab","Stereotactic body radiotherapy","R\u002FM NPC","Best overall response","2024-03-26",{"date":310,"type":36},"2024-03-28",{"date":312,"type":36},"2021-03-01",{"date":314,"type":21},"2026-08-01",{"name":42,"class":43},3,{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":44},"100528925","nbi-combined-with-mri-to-guide-ctv-optimization-in-eccentric-nasopharyngeal-carcinoma-100528925","NCT06167109","NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma","Endoscopic NBI Combined With MRI to Guide the Optimization of Clinical Target Volume Delineation in Eccentric Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Males and females ≥18 years of age;\n2. ECOG Performance Status 0,1 or 2;\n3. Pathologically diagnosed as nasopharyngeal carcinoma;\n4. Pretreatment nasopharynx and neck MRI imaging;\n5. Nasopharyngeal suspected lesions were examined by NBI endoscopy;\n6. Meeting the definition of eccentric NPC with ipsilateral (affected side) staging of T1-4 and contralateral (healthy side) staging of T0;\n7. Patients evaluated without contraindications to radiotherapy;\n8. Voluntary participation in clinical research, and signed informed consent.\n\nExclusion Criteria:\n\n1. Patients who did not successfully undergo all three examinations (MRI, NBI, and endoscopic biopsy);\n2. Other rare pathological types, such as adenocarcinoma;\n3. Patients with tumor invasion of the clivus;\n4. Patients whose contralateral retropharyngeal lymph nodes met the diagnostic criteria;\n5. Invasion of paranasal sinuses (except simple sphenoid invasion).",{"count":161,"type":21},[24],"This is a prospective, single-center clinical trial in eccentric nasopharyngeal carcinoma (NPC) patients. The aim of this study is to evaluate the efficacy and safety of NBI combined with MRI-guided optimized CTV compared with conventional CTV, and to compare the radiotherapy-related adverse events and quality of life between the two groups.",[328],"Nasopharyngeal Carcinoma by AJCC V8 Stage","2023-12-04",{"date":331,"type":36},"2023-12-12",{"date":333,"type":36},"2023-10-20",{"date":335,"type":21},"2026-10",{"name":42,"class":43},{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":205,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":44},"100496872","the-efficacy-of-salvage-surgery-in-patients-with-residual-tumor-after-concurrent-chemoradiation-for-locally-advanced-cervical-cancer-100496872","NCT05749887","The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.","Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.","Inclusion Criteria:\n\n1. Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma.\n2. Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy).\n3. After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET \u002FCT showed that SUVmax of the residual lesions in the cervical and\u002For pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment.\n4. ECOG score:0 \\~ 1.\n5. The expected survival time\\>6 months;\n6. There is no absolute contraindication of surgery and the patients with good compliance.\n\nExclusion Criteria:\n\n1. The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.\n2. PET \u002FCT and\u002For pathological indicates that there is a distant metastasis including para-aortic lymph nodes.\n3. Other malignancies were diagnosed within five years or needed treatments.\n4. History of important organ transplantation.\n5. History of immune disease who need to take immunosuppressive drugs.\n6. History of serious mental illness and brain functional disorder.\n7. Drug abuse or drug use history.\n8. Participants in other clinical trials at the same time.\n9. Those who are unable or unwilling to accept surgical treatment\u002Fsign informed consent\u002Fcomply with research requirements.\n10. Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.\n11. Patients who cannot understand the research regimen and refuse to sign the informed consent form.\n12. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.",{"count":345,"type":21},188,[24],"This is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy.",[27],[350,351,352,353,354],"Locally advanced cervical cancer","chemoradiotherapy","redsidual tumor","salvage sugery","OS","2023-10-06",{"date":357,"type":36},"2023-10-10",{"date":359,"type":36},"2023-08-25",{"date":361,"type":21},"2032-12-31",{"name":42,"class":43},{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":384,"locationsCount":44},"100468308","comparing-the-efficacy-of-surgery-staging-and-image-staging-of-locally-advanced-cervical-cancer-100468308","NCT05378087","Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer","Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study.\n2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma\n3. Stage (FIGO2018): IB3, IIA2, IIB-IVA;\n4. ECOG score: 0 \\~ 1;\n5. The expected survival \\>6 months;\n6. The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.\n\nExclusion Criteria:\n\n1. Activity or uncontrol severe infection;\n2. Liver cirrhosis or other decompensated liver disease;\n3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;\n4. Chronic renal insufficiency or renal failure;\n5. Other malignancies were diagnosed within five years or needed treatments;\n6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);\n7. The CT\u002FMRI\u002FPET\u002FCT show that the para-aortic lymph nodes are positive;\n8. A history of pelvic artery embolization;\n9. A history of pelvic radiotherapy;\n10. A history of partial hysterectomy or radical hysterectomy;\n11. A history of severe allergic reaction to platinum drugs;\n12. The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;\n13. Patients who cannot understand the research regimen and refuse to sign the informed consent form;\n14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.",{"count":371,"type":21},1956,[24],"The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.",[256],[376,377,350,215],"surgery staging","image staging","2023-08-29",{"date":380,"type":36},"2023-08-31",{"date":382,"type":36},"2022-06-27",{"date":361,"type":21},{"name":42,"class":43},{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":408,"locationsCount":44},"100393962","the-efficacy-of-adjuvant-chemotherapy-in-locally-advanced-cervical-cancer-100393962","NCT04409860","The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer","Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer","CQGOG0102","Inclusion Criteria:\n\n1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma\n2. Complete CCRT(Radiation Does: A point 85Gy(+\u002F-10%)，B点50Gy(+\u002F-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))\n3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).\n4. ECOG\\\u003C2\n5. Expected survival is longer than six months\n6. Hb≥70g\u002FL、WBC≥3.5×109\u002F L 、ANC≥1.5×109\u002FL、PLT≥80×109\u002FL\n7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN\n8. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial\n\nExclusion Criteria:\n\n1. Activity or uncontrol severe infection\n2. Liver cirrhosis, Decompensated liver disease\n3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease\n4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure\n5. Have suffered or combined with other malignant tumor\n6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure\n7. A history targeted therapy or pelvic artery embolization\n8. Artery-enous thrombosis within 6 months\n9. Patients with autoimmune diseases\n10. Complications, need to be treatment with drugs which may lead to liver or kidney injury\n11. Patients with disease progression after chemoradiation",{"count":394,"type":21},120,[24],"The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.",[27],[399,400,401],"Locally adcanced","CCRT","Adjuvant chemotherapy","2023-04-08",{"date":404,"type":36},"2023-04-11",{"date":406,"type":36},"2020-05-26",{"date":40,"type":21},{"name":42,"class":43},{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":44},"100500685","phase-2-study-of-chemoradiotherapy-with-envafolimab-for-the-treatment-of-locally-advanced-cervical-cancer-100500685","NCT05799469","Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer","A Single-arm Exploratory Clinical Study of Envafolimab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;\n* Female aged 18-75 years (at the time of signing the informed consent);\n* ECOG score of 0-1 within 7 days prior to first study intervention dose;\n* Expectation of life ≥ 12 weeks;\n* Locally advanced squamous cell carcinoma , adenocarcinoma or adenosquamous -carcinoma of the cervix confirmed by pathological histological or clinical diagnosis according to cervical cancer F IGO stage (2018 version) as I B3 , IIA2 , IIB , I II-IVA stage ;\n* Pathological specimens (≥ 18 eligible tissue sections) may be provided for biomarker testing;\n* No prior surgery for cervical cancer (excluding staging surgery), radiotherapy, chemotherapy, systemic therapy (including investigational agents), or immunotherapy ;\n* At least 1 measurable cervical lesion or metastatic lymph node meeting RECIST1.1 target lesion criteria by CT scan or MRI within 28 days prior to treatment;\n* Adequate major organ function meeting the following criteria:\n\n  1. Hematology (need not be transfused within 14 days and hematopoietic stimulating factor drugs within 7 days without correction testing): hemoglobin (Hb) ≥ 90 g\u002FL; absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; platelets (PLT) ≥ 80 × 109\u002FL;\n  2. Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum total bilirubin (TBIL) ≤ 1.5 × ULN (in subjects with Gilbert 's syndrome, ≤ 3 × ULN); serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n  3. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;\n  4. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;\n  5. Thyroid function is normal，defined as thyroid stimulating hormone (TSH) within normal limits. If baseline TSH is out of normal range, subjects with total T3 (or FT3) and FT4 within normal range can also be enrolled;\n  6. Adequate organ function as judged clinically appropriate for the study by the physician.\n* Subjects of childbearing potential must use adequate contraception during this study and for 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating.\n\nExclusion Criteria:\n\n* Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;\n* Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;\n* Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 5.0 \\[CTCAE 5.0\\]);\n* Subjects with any severe and\u002For uncontrolled disease. Including:\n\n  1. Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);\n  2. Patients with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms) and ≥ Grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification);\n  3. Active or uncontrolled serious infection (≥ CTCAE Grade 2 infection);\n  4. Cirrhosis, active hepatitis \\* ; \\* active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA test value more than the upper limit of normal; hepatitis C reference: HCV antibody positive, and HCV viral titer test value more than the upper limit of normal) ; patients with previous HBV infection or cured HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and the absence of HBsAg) are eligible; among patients with positive HCV antibody, patients can participate in this study only when HCV RNA is negative by polymerase chain reaction (PCR); Note: subjects with positive HBsAg or positive anti-HBc or hepatitis C，who are eligible for inclusion need continuous antiviral treatment to prevent virus activation ;\n  5. Previous (non infectious) pneumonia\u002Finterstitial lung disease still requires steroid treatment or currently has (non infectious) lung disease;\n  6. Active syphilis;\n  7. Patients with renal failure requiring hemodialysis or peritoneal dialysis;\n  8. Patients with a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n* Poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL);\n* Urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein \\> 1.0g;\n* Patients who received major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment; or had wounds or fractures that were not healed for a long time;\n* Severe arterial\u002Fvenous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism within 6 months before the start of study treatment;\n* Patients who have a history of psychotropic substance abuse and cannot quit or have mental disorders;\n* Study treatment related:\n\n  1. History of live vaccination 28 days prior to start of study treatment or planned live vaccination during the study;\n  2. Patients who have experienced severe hypersensitivity reactions after using monoclonal antibodies;\n  3. Active autoimmune disease requiring systemic therapy (eg, use of therapeutic drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to start of study treatment, with the exception of alternative therapies (eg, thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency);\n  4. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (prednisone at a dose \\> 10 mg\u002Fday or other equivalent efficacy physiological dose hormone) and continued to use within 2 weeks before the first study dose;\n  5. Patients with a history of active tuberculosis;\n* Participating or participating in other clinical investigators;\n* Patients who are unable to comply with the trial protocol or cooperate with follow-up according to the investigator 's judgment;\n* Patients with a history of severe allergy;\n* Known hypersensitivity to active ingredients or excipients of the study drug, such as envafolimab and cisplatin;\n* Subjects who have concomitant diseases that, in the investigator 's judgment, would seriously jeopardize the subject' s safety or affect the completion of the study, or who are considered unsuitable for enrollment for other reasons.",{"count":111,"type":21},[77],"This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.",[256],[27,421,259,422],"Local advanced","Immune checkpoint inhibitors","2023-04-03",{"date":425,"type":36},"2023-04-05",{"date":427,"type":21},"2023-05-01",{"date":429,"type":21},"2027-12-31",{"name":42,"class":43},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":447,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":44},"100500245","early-intervention-to-prevent-lower-limb-lymphedema-of-gynecological-malignancy-100500245","NCT05793749","Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy","Early Intervention to Prevent Gynecological Malignant Tumors Clinical Study of Lymphedema of the Lower Limbs in Patients With Radiotherapy After Lymphadenectomy","Inclusion Criteria:\n\n1.Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed consent form.\n\n2.18 to 60 years old. 3.Eastern Cooperative Oncology Group（ECOG) score less than 2. 4.Expected survival time greater than 3 years. 5.Hemoglobin(Hb) greater than or equal to 70 g\u002FL, white blood cells (WBC)greater than or equal to 3.5 × 109 \u002FL, neutrophils(ANC)greater than or equal to 1.5 × 109 \u002FL, platelets (PLT)greater than or equal to 80 × 109 \u002FL.\n\n6.serum alamine aminotransferase(ALT) and glutamic oxalacetic transaminase(AST) less than 2 times the normal value and creatinine less than 1.5 times the normal value, albumin greater than or equal to 35g\u002FL.\n\n7.Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and be willing to use an appropriate method of contraception for the duration of the trial.\n\n8.Ability to comply with the trial protocol, as judged by the investigator.\n\nExclusion Criteria:\n\n1. Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed;\n2. Acute infection of any kind;\n3. Patients with lower extremity edema;\n4. pregnancy, menstrual period;\n5. Recent major abdominal surgery (determined by the investigator);\n6. Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis;\n7. Liver fibrosis;\n8. Abdominal aortic aneurysm;\n9. acute phlebitis;\n10. Severe arterial obstructive disease, arterial ulcer, ABPI (ankle-brachial blood pressure index) greater than 1.3 and less than 0.5;\n11. Severe peripheral neuropathy;\n12. Poor control of hypertension, poor control of stroke and diabetes, and severe bronchial asthma;\n13. Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent;\n14. Those with concomitant diseases or other special circumstances that seriously endanger the patient's safety or affect the patient's completion of the study.",{"count":439,"type":21},400,[24],"This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients.\n\n1. Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy;\n2. Random grouping (A:B=3:1): A. Prophylactic lymphoedema treatment; B. Standard care group;\n3. Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery. All patients were randomly divided into an intervention group and a nonintervention group. The intervention group received preventive lymphedema treatment twice a week. 10 times, and the interval between the two treatments was not less than 48 hours and not more than 2 weeks. The intervention measures included four parts: manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings. In the nonintervention group, knowledge education and telephone follow-up were routinely conducted.\n4. All patients were evaluated for edema, lymphedema symptoms and quality of life 1 day before radiotherapy, every Friday during radiotherapy and every 3 months thereafter. Bioelectrical impedance measurement and leg diameter measurement were used to evaluate edema, the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) was used to evaluate lymphedema symptoms, and the EORTC Quality of Life Scale (QLQ-C30) was used to evaluate quality of life. followed up to 2 years after the end of lymphedema prophylaxis.",[443,444,445,446],"Uterine Cervical Neoplasms","Endometrial Neoplasms","Lymphedema","Treatment Effectiveness",[445,444,443,446],"2023-03-20",{"date":450,"type":36},"2023-03-31",{"date":452,"type":21},"2023-04-01",{"date":454,"type":21},"2026-07-29",{"name":42,"class":43},{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":468,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":44},"100481607","phase-2-fluzoparib-combined-with-bevacizumab-in-psroc-previously-treated-with-parpi-100481607","NCT05551208","Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi","A Prospective, Single-arm, Multicenter Phase Ⅱ Clinical Study of Fluzoparib Combined With Bevacizumab in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi","Inclusion Criteria:\n\n1. Ovarian cancer patients with histopathological type: low\u002Fhigh grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery.\n2. The patient had at least one measurable lesion according to the RECIST V1.1 criteria.\n3. The time from the last cycle of chemotherapy to relapse\u002Fprogression should be more than 6 months.\n4. ECOG score 0\\~1,age 18\\~75 years old\n5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial\n6. CBC Hb≥90g\u002FL, ANC≥1.5×109\u002FL, PLT≥100×109\u002FL,\n7. Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN#\n\nExclusion Criteria:\n\n1. Had used bevacizumab within 6 months of enrollment\n2. Has combined with other malignant tumor which diagnosed within 5 years and\u002For needed to be treated. The patients had untreated CNS metastases.\n3. The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction.\n4. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure\n5. Activity or uncontrol severe infection",{"count":464,"type":21},42,[77],"There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.",[56],[469,470,471,472],"PARP inhibitor","Fluzoparib","Bevacizumab","Platinum - sensitive recurrent EOC","2022-09-19",{"date":475,"type":36},"2022-09-22",{"date":477,"type":36},"2022-08-15",{"date":479,"type":21},"2029-08-30",{"name":42,"class":43},""]