[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gestational-trophoblastic-neoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gestational-trophoblastic-neoplasia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,72,94,120,149,176,197,215],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100339727","phase-3-study-of-hysteroscopic-repeat-curettage-as-the-first-line-treatment-in-low-risk-postmolar-gestational-trophoblastic-neoplasia-100339727",false,"NCT03703271","Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia","A Non-Inferiority Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia","Inclusion Criteria:\n\n* low-risk postmolar gestational trophoblastic neoplasia (GTN)\n* World Health Organization(WHO) risk score≤4\n* Age≤60 years; female, Chinese women\n* Initial treatment\n* Performance status: Karnofsky score≥60\n* Laboratory tests: WBC≥3.5×10(9)\u002FL, ANC≥1.5×10(9)\u002FL, PLT≥80×10(9)\u002FL, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,blood urea nitrogen, Cr≤ normal\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with unconfirmed diagnosis of GTN\n* Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)\n* WHO risk score ≥5分\n* The diameter of a single metastatic lesion in the lung was ≥2cm\n* The number of lung CT metastases was≥ 5\n* With severe or uncontrolled internal disease, unable to receive chemotherapy\n* Concurrently participating in other clinical trials\n* Unable or unwilling to sign informed consents\n* Unable or unwilling to abide by protocol","FEMALE","12 Years","60 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Study of hysteroscopic repeat curettage as the first-line treatment in low-risk postmolar gestational trophoblastic neoplasia compared with the MTX single drug chemotherapy",[27],"Gestational Trophoblastic Neoplasia",[29,27,30,31,32],"postmolar","hysteroscopic","repeat curettage","methotrexate","RECRUITING","2026-06-28",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2019-03-01",{"date":41,"type":21},"2026-12-31",{"name":43,"class":44},"Women's Hospital School Of Medicine Zhejiang University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100346042","study-of-different-therapeutic-strategies-in-hydatidiform-mole-with-lung-nodule-100346042","NCT03785574","Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule","Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial","Inclusion criteria\n\nEligible patients have to meet all of the following criteria:\n\n1. Pathologically confirmed HM.\n2. The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).\n3. The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.\n4. The patients are willing to compliant with the study protocol and be followed up at regular intervals.\n5. The patients agree to sign an informed consent form.\n\nExclusion criteria\n\n1. The patients with a previous history of lung nodules.\n2. The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.\n3. The patients have undergone prophylactic hysterectomy or chemotherapy.\n4. Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.\n5. Patients have immunosuppressive diseases or take immunosuppressants.\n6. Patients are participating in other clinical trials at same time.\n7. Patients were unable or unwilling to provide written informed consent.",{"count":54,"type":21},30,[56],"NA","The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). Lung nodule \\\u003C1.0cm will directly treated as group C",[59,27],"Hydatidiform Mole",[61,62,63],"Pulmonary Nodule","Chemotherapy","Chorionic Gonadotrophin","2026-03-13",{"date":66,"type":37},"2026-03-16",{"date":68,"type":37},"2018-12-24",{"date":70,"type":21},"2030-09-01",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":18,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":45},"100449946","phase-2-camrelizumab-plus-apatinib-in-patients-with-high-risk-gestational-trophoblastic-neoplasia-100449946","NCT05139095","Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia","Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia: a Cohort, Open-label, Phase 2 Trial","Inclusion Criteria:\n\n1. Woman aged 18-60 years;\n2. Previously untreated patients with ultra high-risk GTN（Cohort A） or high-risk chemo-refractory or relapsed GTN (Cohort B);\n3. No previous chemotherapy or radiotherapy for ultra high-risk GTN（Cohort A）and have previously received two or more lines of combination chemotherapies for high-risk chemo-refractory or relapsed GTN (Cohort B);\n4. Patients with ultra high-risk GTN (FIGO stages I-III: score ≥13 and stage IV) according to the International Federation of Gynecology and Obstetrics (FIGO) 2000 staging and risk factor scoring system（Cohort A）and patients with a prognostic score ≥7 (Cohort B);\n5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n6. Patients with abnormal serum hCG level (≥5 IU\u002FL);\n7. Expected survival ≥ 4 months;\n8. The function of vital organs meets the following requirements:\n\n   hemoglobin ≥90 g\u002FL, absolute neutrophil count ≥1·5×109\u002FL, platelets ≥100×109\u002FL; creatinine ≤1·5 × upper limit of normal (ULN), urea nitrogen ≤2·5×ULN; total bilirubin ≤ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, albumin ≥25 g\u002FL; thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and T4 can also be acceptable).\n9. Female patients of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (e.g., intrauterine device, contraceptive or condom) during the study period and within 6 months of the last study drug administration.\n10. The patient should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form.\n\nExclusion Criteria:\n\n1. Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other immunotherapy), anti-angiogenic small-molecule tyrosine kinase inhibitors (such as pazopanib, sorafenib, or regorafenib), or anti-angiogenic monoclonal antibodies (such as bevacizumab); live vaccines injected within 4 weeks before the first dose of study drug; other clinical trials of antitumour drugs within 4 weeks before the first dose of study drug;\n2. Other malignancies in the past 3 years;\n3. Immunosuppressive drugs used within 14 days prior to the first dose of camrelizumab; any active autoimmune disease or a history of autoimmune disease;\n4. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal drug therapy);\n5. Grade II or higher myocardial ischemia, myocardial infarction or poorly controlled arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac color Doppler ultrasound evidence of left ventricular ejection fraction \\\u003C50%; myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or abnormal active conduction system occurring within 6 months before enrolment;\n6. Abnormal coagulation (international normalised ratio \\>1·5×ULN or prothrombin time \\>ULN+4 seconds or activated partial thromboplastin time \\>1·5×ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy;\n7. Severe infections within 4 weeks prior to the first dose of study drug (e.g., need of intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever (\\>38·5°C) during screening or the first dose of study drug;\n8. With a history of psychotropic drug abuse and are unable to withdraw the psychotropic drug, or have mental disorders;\n9. Major surgery performed within 4 weeks before the first dose of study drug, or open wounds or fractures;\n10. Obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, or sinus or perforation of empty organs within 6 months;\n11. Routine urine test indicating urinary protein ++ or more, or confirmed urinary protein ≥1·0 g within 24 hours;\n12. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome, active hepatitis B (HBV DNA \\>500 IU\u002FmL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of the analysis method) or co-infection with hepatitis B and hepatitis C;\n13. Other reasons as judged by the investigator.","18 Years",{"count":20,"type":21},[82],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of camrelizumab and apatinib as combination therapy in patients with ultra high-risk (Cohort A) and high-risk chemo-refractory or relapsed (Cohort B) gestational trophoblastic neoplasia (GTN). Eligible patients will receive camrelizumab plus apatinib plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.",[27],"2026-02-03",{"date":87,"type":37},"2026-02-05",{"date":89,"type":37},"2022-01-27",{"date":91,"type":21},"2027-01-01",{"name":93,"class":44},"Peking Union Medical College Hospital",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100618569","uterine-artery-doppler-flow-velocimetry-parameters-for-predicting-the-occurrence-of-persistent-gestational-trophoblastic-neoplasia-after-evacuation-of-complete-hydatiform-mole-100618569","NCT07333326","Uterine Artery Doppler Flow Velocimetry Parameters for Predicting the Occurrence of Persistent Gestational Trophoblastic Neoplasia After Evacuation of Complete Hydatiform Mole","Uterine Artery Doppler Flow Velocimetry Parameters for Predicting the Occurrence of Persistent Gestational Trophoblastic Neoplasia After Evacuation of Complete Hydatiform Mole ( a Prospective Cohort Study)","Inclusion Criteria:\n\n* Patients with confirmed diagnosis of complete hydatiform mole.\n* Hemodynamically stable patient .\n* No contraindication for anesthetic materials used for the evacuation .\n* Acceptance of possible prolonged follow up , repeated uterine artery doppler ultrasound ,repeated HCG tests\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study.\n* Patient with incomplete hydatiform mole .\n* Patients who were lost during the follow-up period after this procedure.\n* Contraindication for anesthetic materials used for the evacuation .","45 Years",{"count":103,"type":21},175,"OBSERVATIONAL","This Prospective study will be conducted To copare uterine blood flow using Doppler ultrasound before and after evacuation of hydatiform mole between female patients with remissions and those with development of post-molar persistent gestational trophoblastic neoplasia to detect accuracy,efficacy,predictive value and acceptability of uterine artery doppler in predicting gestional trophoblastic neoplasia .",[27,107],"Complete Hydatiform Mole",[109],"Gestational trophoblastic neoplasia","NOT_YET_RECRUITING","2025-12-30",{"date":113,"type":37},"2026-01-12",{"date":115,"type":21},"2026-01-10",{"date":117,"type":21},"2027-02-10",{"name":119,"class":44},"Minia University",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":45},"100529120","the-psychological-impact-of-gtn-on-women-who-have-completed-chemotherapy-treatment-100529120","NCT06169644","The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment","PI-GTN","Inclusion Criteria:\n\n* Treated with chemotherapy for a GTN diagnosis\n* Completed treatment between 6 weeks and 24 months\n* Are able to provide informed consent\n* Have no cognitive impairment as judged by the treating clinician\n\nExclusion Criteria:\n\n* Treatment received less than 6 weeks ago\n* Treatment received more than 24 months ago\n* Non-English speaking","16 Years","55 Years",{"count":130,"type":21},20,"A cross-sectional retrospective study of a sample of 20 women who completed single agent or multi agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi structured telephone interview. A patient sample of 20 is proposed for the study. These are all the patients who meet the inclusion criteria below and are thus eligible for the study. These patients will be contacted via telephone by the principal investigator to inform them of the study and invite participation. A proposed sample size of 20 is sufficient to generate data to address the central questions and furthermore, this sample size is adequate because the intention is to gain insight into the experiences of patients' perceptions about their psychological experiences.\n\nObjectives:\n\n* Gaining insight into the emotional impact of GTN post treatment\n* Ascertaining if health professionals are providing adequate psychological support\n* Identifying sources of support that patients accessed post completion of treatment\n* Identifying potential areas of improvement in the follow up support for future patients\n\nCriteria for inclusion:\n\n* Treated with chemotherapy for a GTN diagnosis\n* Completed treatment between 6 weeks and 24 months\n* Are able to provide informed consent\n* Have no cognitive impairment as judged by the treating clinician\n\nCriteria for exclusion\n\n* Treatment received less than 6 weeks ago\n* Treatment received more than 24 months ago\n* Non-English speaking\n\nOutcome measures are not appropriate in this qualitative study. However outputs from this study include increasing knowledge and insight into:\n\n* patients' experiences of their psychological experiences post chemotherapy\n* patients' perspective of the support received after their treatment\n* potential areas of improvements in care",[27],[134,135,136,137,138,139],"Gestational","Trophoblastic","Disease","Neoplasia","GTD","GTN","2025-02-20",{"date":142,"type":37},"2025-02-21",{"date":144,"type":37},"2024-05-15",{"date":146,"type":21},"2025-12-31",{"name":148,"class":44},"Sheffield Teaching Hospitals NHS Foundation Trust",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":18,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":45},"100518294","toripalimab-plus-actinomycin-d-as-fist-line-treatment-for-gtn-with-figo-score-5-6-100518294","NCT06028672","Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6","Efficacy and Safety of Actinomycin-D With or Without Toripalimab as Fist-Line Treatment in Patients With Gestational Trophoblastic Neoplasia With FIGO Score 5-6: A Multicenter, Open-label, Randomized Controlled Trial","TA56","Inclusion Criteria:\n\nDiagnosed as GTN: There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN: The plateau of β-hCG (±10%) lasts for four measurements over a period of 3 weeks or longer (days 1, 7, 14, 21). There is a rise (\\>10%) in β-hCG for three consecutive weekly measurements over at least a period of 2 weeks or more (days 1, 7, 14). GTN after nonmolar pregnancy: There is a rise after decease, or a plateau of β-hCG 4 weeks after abortion, ectopic pregnancy, or term delivery. Pregnancy residue or new pregnancy have been ruled out.\n\nPatients with a FIGO score of 5-6. Signed informed consent. No previous immunotherapy, chemotherapy, or radiotherapy. Woman aged 18-60 years. Expected survival ≥ 6 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days before first dose.\n\nThe function of vital organs meets the following requirements: hemoglobin ≥90 g\u002FL, absolute neutrophil count ≥1·5×109\u002FL, platelets ≥100×109\u002FL; creatinine ≤1·5 × upper limit of normal (ULN), urea nitrogen ≤2·5×ULN; total bilirubin ≤1.5×ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, INR, PT or APTT ≤1.5×ULN, thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and T4 can also be acceptable).\n\nExclusion Criteria:\n\nHistologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT).\n\nHistologically confirmed primary choriocarcinoma. Other malignancies in the past 3 years. Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy. Live vaccines injected within 30 days before the first dose of study drug; Systemic immune stimulant agent (such as a bacterial or viral vaccine, colony-stimulating factors, interferon, interleukin, and combined vaccine) was used 6 weeks before administration or within the 5 half-lives of the drug, whichever is shorter.\n\nPrevious treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, PD-L2, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other immunotherapy).\n\nKnown hypersensitivity or allergy to actinomycin-D, toripalimab or any of their excipients.\n\nAny active autoimmune disease requiring systemic treatment during the past 2 years.\n\nHistory or current status of non-infectious pneumonia requiring steroid treatment.\n\nReceiving steroid hormones (prednisone dose \\> 10mg\u002F day) or other immunosuppressants within 14 days before enrollment, excluding those on hormone replacement therapy.\n\nActive infection that requires systemic treatment. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome, active hepatitis B, hepatitis C.\n\nHistory of psychotropic drug abuse and are unable to withdraw the psychotropic drug, or have mental disorders.\n\nGrade II or higher myocardial ischemia, myocardial infarction or poorly controlled arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac color Doppler ultrasound evidence of left ventricular ejection fraction \\\u003C50%; myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or abnormal active conduction system occurring within 6 months before enrolment.\n\nUncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal drug therapy).\n\nAbnormal coagulation (international normalized ratio \\>1·5×ULN or prothrombin time \\>ULN+4 seconds or activated partial thromboplastin time \\>1·5×ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.\n\nHistory of cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 3 months before enrolment.\n\nObvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, or sinus or perforation of empty organs within 6 months.\n\nA history of allogeneic stem cell transplantation or organ transplantation. Other reasons as judged by the investigator.",{"count":158,"type":21},40,[56],"Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a higher complete response rate than actinomycin-D alone.\n\nWhether an equally high cure rate can be achieved by multi-drug chemotherapy as second-line treatment in patients who have failed fist-line treatment with toripalimab plus actinomycin-D.\n\nParticipants will be allocated into two groups. Those in experimental group will receive toripalimab plus actinomycin-D, while those in control group will receive actinomycin-D alone. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be completed after 3 consolidation cycles.",[27],[27,163,164,165,166,167],"International Federation of Gynecology and Obstetrics","Toripalimab","Actinomycin-D","Efficacy","Safety","2025-02-03",{"date":170,"type":37},"2025-02-06",{"date":172,"type":37},"2023-09-12",{"date":174,"type":21},"2025-08",{"name":93,"class":44},{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":18,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":45},"100517685","phase-2-toripalimab-plus-actinomycin-d-as-fist-line-treatment-for-gtn-with-figo-score-7-100517685","NCT06020755","Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7","Efficacy and Safety of Toripalimab Plus Actinomycin-D As Fist-Line Treatment in Patients with Gestational Trophoblastic Neoplasia with FIGO Score 7: a Single-Arm, Multicenter, Phase II Trial","TA7","Inclusion Criteria:\n\n1. Diagnosed as GTN:\n\n   There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN: The plateau of β-hCG (±10%) lasts for four measurements over a period of 3 weeks or longer (days 1, 7, 14, 21). There is a rise (\\>10%) in β-hCG for three consecutive weekly measurements over at least a period of 2 weeks or more (days 1, 7, 14).\n\n   GTN after nonmolar pregnancy: There is a rise after decease, or a plateau of β-hCG 4 weeks after abortion, ectopic pregnancy, or term delivery. Pregnancy residue or new pregnancy have been ruled out.\n2. Patients with a FIGO score of 7.\n3. Signed informed consent.\n4. No previous immunotherapy, chemotherapy, or radiotherapy.\n5. Woman aged 18-60 years.\n6. Expected survival ≥ 6 months.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days before first dose.\n8. The function of vital organs meets the following requirements:\n\nhemoglobin ≥90 g\u002FL, absolute neutrophil count ≥1·5×109\u002FL, platelets ≥100×109\u002FL; creatinine ≤1·5 × upper limit of normal (ULN), urea nitrogen ≤2·5×ULN; total bilirubin ≤1.5×ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, INR, PT or APTT ≤1.5×ULN, thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and T4 can also be acceptable).\n\nExclusion Criteria:\n\n1. Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT).\n2. Histologically confirmed primary choriocarcinoma.\n3. Other malignancies in the past 3 years.\n4. Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy.\n5. Live vaccines injected within 30 days before the first dose of study drug;\n6. Systemic immune stimulant agent (such as a bacterial or viral vaccine, colony-stimulating factors, interferon, interleukin, and combined vaccine) was used 6 weeks before administration or within the 5 half-lives of the drug, whichever is shorter.\n7. Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, PD-L2, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other immunotherapy).\n8. Known hypersensitivity or allergy to actinomycin-D, toripalimab or any of their excipients.\n9. Any active autoimmune disease requiring systemic treatment during the past 2 years.\n10. History or current status of non-infectious pneumonia requiring steroid treatment.\n11. Receiving steroid hormones (prednisone dose \\> 10mg\u002F day) or other immunosuppressants within 14 days before enrollment, excluding those on hormone replacement therapy.\n12. Active infection that requires systemic treatment.\n13. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome, active hepatitis B, hepatitis C.\n14. History of psychotropic drug abuse and are unable to withdraw the psychotropic drug, or have mental disorders.\n15. Grade II or higher myocardial ischemia, myocardial infarction or poorly controlled arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac color Doppler ultrasound evidence of left ventricular ejection fraction \\\u003C50%; myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or abnormal active conduction system occurring within 6 months before enrolment.\n16. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal drug therapy).\n17. Abnormal coagulation (international normalized ratio \\>1·5×ULN or prothrombin time \\>ULN+4 seconds or activated partial thromboplastin time \\>1·5×ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.\n18. History of cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 3 months before enrolment.\n19. Obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, or sinus or perforation of empty organs within 6 months.\n20. A history of allogeneic stem cell transplantation or organ transplantation.\n21. Other reasons as judged by the investigator.",{"count":185,"type":21},17,[82],"The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia with FIGO score 7. The main questions it aims to answer are:\n\n* Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a high complete response rate.\n* Whether an equally high cure rate can be achieved by multi-drug chemotherapy as second-line treatment in patients who have failed fist-line treatment with toripalimab plus actinomycin-D.\n\nParticipants will receive toripalimab plus actinomycin-D. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be completed after 4 consolidation cycles.",[27],[27,163,164,165,166,167],"2024-12-27",{"date":192,"type":37},"2024-12-31",{"date":194,"type":21},"2024-12",{"date":174,"type":21},{"name":93,"class":44},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":45},"100568440","clinical-specialty-queue-for-gestational-trophoblastic-neoplasia-100568440","NCT06681259","Clinical Specialty Queue For Gestational Trophoblastic Neoplasia","Inclusion Criteria:\n\n* ① Age ≥ 18 years old; ② Patients clinically diagnosed with GTN (including invasive cases) Molar pregnancy, choriocarcinoma, PSTT, ETT); ③ Complete informed consent for enrollment.\n\nExclusion Criteria:\n\n* ① Having mental illness or cognitive impairment, unable to cooperate in completing the investigation with Patients with concurrent malignant tumors; ③ Participants with severe missing follow-up data.",{"count":204,"type":21},1000,"The aim of this study is to establish a bidirectional cohort study of GTN specific diseases, including 1020 retrospective cases Queue and 1000 prospective cohorts. Based on the clinical collaboration system for gynecological tumors in multiple tertiary hospitals across the country, establish unified criteria for case inclusion and exclusion, and establish a multi center clinical queue for GTN; Collect baseline information of GTN patients, such as age, reproductive history, environmental and social information, genetic related information, physical examination, physicochemical, imaging, and pathological information; Collect biological specimens such as blood\u002Ftissue from patients; Collect information related to the diagnosis, treatment plan, human chorionic gonadotropin (hCG) levels, and toxic side effects of patients during the diagnosis and treatment period; After the end of treatment, follow-up blood hCG levels, imaging, fertility status, as well as recurrence and metastasis status, are conducted to track prognosis, thus building a clinical diagnosis and treatment information database, forming a standardized follow-up system for GTN, identifying high-risk factors for GTN chemotherapy resistance, constructing a precise evaluation model for GTN resistance, and providing high-level evidence-based medicine for effectively improving the initial treatment efficacy of GTN.",[27],"2024-11-07",{"date":209,"type":37},"2024-11-12",{"date":211,"type":21},"2024-11-04",{"date":213,"type":21},"2029-11-04",{"name":43,"class":44},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":45},"100488071","phase-2-a-feasibility-window-study-of-pembrolizumab-prior-to-second-evacuation-for-post-molar-gestational-trophoblastic-neoplasia-100488071","NCT05635344","A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia","Inclusion Criteria:\n\n1. Written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule.\n2. Age ≥18yrs\n3. Postmolar GTN defined as recurrence or persistence of histologically confirmed CHM after primary surgical evacuation with no intervening treatment.\n4. Postmolar GTN defined as plateau or rising human chorionic gonadotropin (hCG). Plateaued hCG is defined as four or more equivalent values of hCG over at least 3 weeks. Rising hCG is defined as two consecutive rises in hCG of 10% or greater over at least 2 weeks.\n5. hCG under 20,000 IU\u002FL\n6. Low risk disease as defined by the Federation of Obstetrics and Gynecology (FIGO) 2000 risk scoring criteria (score of 6 or less)\n7. No metastatic disease on chest X-ray.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n9. Disease present within the uterine cavity not within 5mm of the serosal surface.\n10. Adequate bone marrow reserve or organ function as defined by any one of the following parameters:\n\n    * Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002FL;\n    * Platelet count ≥ 100 x 10\\^9 \u002FL;\n    * Haemoglobin ≥ 9.0 g\u002FdL (may have been blood transfused)\n    * Creatinine clearance ≥ 30 ml\u002Fmin (Cockcroft-Gault formula)\n    * Serum bilirubin ≤ 1.5 x ULN\n    * AST\u002FALT ≤ 2.5 X ULN\n11. All patients must agree to a highly effective method of contraception, or to complete abstinence\\* for 1 year following second evacuation. This is standard practice following second evacuation of GTN because hCG levels rise in pregnancy thus masking a potential cancer recurrence\n\nExclusion Criteria:\n\n1. Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, patients who have had any evidence of the other cancer present within the last 2 years or patients whose previous cancer treatment contraindicates this protocol therapy.\n2. Patients with histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage.\n3. Pregnant women.\n4. Uncontrolled vaginal bleeding.\n5. Administration of live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. History of immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n8. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n9. History of Human Immunodeficiency Virus (HIV) infection.\n10. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n11. History of active TB (Bacillus Tuberculosis).\n12. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. History of allogenic tissue\u002Fsolid organ transplant.",{"count":130,"type":21},[82],"Gestational Trophoblastic Diseases (GTD) are a variety of rare, pregnancy related cell multiplication disorders of cells of the placenta which can range from pre-cancerous growths to more serious lesions that can spread to nearby tissues that can cause serious health issues.\n\nMost patients that develop GTD are diagnosed at the precancerous stage early in pregnancy and undergo surgical removal of the disease from the uterus. Around 15% of patients are not cured by surgical removal alone and need to undergo further treatment with chemotherapy or further surgery; of which roughly one-third of patients are cured with a second round of surgery alone.\n\nAnti-cancer treatment with chemotherapy carries many short- and long-term side effects that can negatively affect a person's quality of living. Finding less harmful anticancer therapies that can be paired with surgery is therefore of great benefit to patients with recurrent GTD.\n\nAn alternative is to pair surgery with another class of anticancer treatments, known as immunotherapies. Immunotherapy aims to encourage the bodies natural defences to fight the cancer cells.\n\nPembrolizumab, an immunotherapeutic agent which works by preventing cancer cells from hiding from the immune system; has been proven to be an extremely safe form of anticancer therapy and is an attractive alternative to more toxic chemotherapeutic agents.\n\nThe RESOLVE study aims to determine how feasible it is to deliver pre-surgical pembrolizumab to patients and determine if this is a desirable alternative; potentially leading to a larger more definitive study.\n\n20 patients will be recruited onto the study and will be evenly split into two arms:\n\n* 10 patients to receive second evacuation alone\n* 10 patients to receive single dose of Pembrolizumab followed by surgery All patients that take part in the study will be recruited from Charing Cross Hospital and will be followed up for a year after the date of their surgery.",[225,27,226],"Gestational Trophoblastic Disease","Gestational Trophoblastic Tumor, Recurrent","2024-04-15",{"date":229,"type":37},"2024-04-17",{"date":231,"type":37},"2024-02-14",{"date":233,"type":21},"2026-08-01",{"name":235,"class":44},"Imperial College London"]