[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gynecological-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gynecological-malignancies":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,70,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100509557","immunotherapy-related-crp-kinetics-in-metastatic-gynecological-malignancies-100509557",false,"NCT05914974","Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven metastatic gynecological malignancies irrespective of therapy line\n* patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group\n* planned ICI therapy in combination with palliative chemotherapy in the experimental group\n* patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group\n* written informed consent into ICK-Gyn\n\nExclusion Criteria:\n\n* missing indication for ICI therapy in the experimental group\n* any ICI therapy before inclusion into the trial\n* patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)","FEMALE","18 Years",{"count":19,"type":20},120,"ESTIMATED","OBSERVATIONAL","ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).",[24,25,26,27,28],"Gynecological Malignancies","Cervical Cancer","Endometrial Cancer","Ovarian Cancer","Vulvar Cancer","RECRUITING","2026-02-09",{"date":32,"type":33},"2026-02-10","ACTUAL",{"date":35,"type":33},"2023-09-11",{"date":37,"type":20},"2035-04",{"name":39,"class":40},"University Hospital Tuebingen","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100526185","phase-1-a-study-of-bl-m07d1-in-patients-with-her2-expressing-recurrent-or-metastatic-gynecologic-malignancies-100526185","NCT06131450","A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Female;\n3. Age: ≥18 years old and ≤75 years old;\n4. Expected survival time ≥3 months;\n5. patients with recurrent or metastatic HER2-positive\u002Flow-expression gynecologic malignancies who have failed or are intolerant to standard treatment or who currently have no standard treatment;\n6. The histopathology of gynecological malignant tumors should meet the following conditions: HER2 positive; Low expression of HER2;\n7. Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;\n8. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n9. ECOG score 0 or 1;\n10. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;\n11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n12. No blood transfusion, use of any cell growth factors and\u002For platelet-raising drugs were allowed within 14 days before screening, and the organ function level had to be acceptable;\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n14. albumin ≥30 g\u002FL;\n15. Women who are likely to give birth must have negative serum\u002Furine pregnancy within 7 days before treatment and must be non-lactating; All enrolled patients should have adequate contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;\n2. had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;\n3. had a history of serious cardiovascular and cerebrovascular diseases;\n4. active autoimmune or inflammatory diseases;\n5. Patients with other malignant tumors within 5 years before the first administration, except cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer and prostate\u002Fcervix\u002Fbreast cancer in situ;\n6. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening;\n7. patients with massive or symptomatic effusions or poorly controlled effusions;\n8. Hypertension poorly controlled by antihypertensive drugs (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg);\n9. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;\n10. patients with central nervous system (CNS) metastases and\u002For carcinomatous meningitis (meningeal metastases);\n11. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1;\n12. patients received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n13. HIVAb positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n14. active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.;\n15. had participated in another clinical trial within 4 weeks before the first dose;\n16. pregnant or lactating women;\n17. The investigator did not consider it appropriate to apply other criteria for participation in the trial.","75 Years",{"count":51,"type":20},138,"INTERVENTIONAL",[54,55],"PHASE1","PHASE2","This study is a single-arm, open, multicenter, non-randomized phase Ib\u002FII clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.",[24],[59],"HER2 expression","2025-09-25",{"date":62,"type":33},"2025-09-26",{"date":64,"type":33},"2024-02-29",{"date":66,"type":20},"2027-12",{"name":68,"class":69},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":77,"targetDuration":4,"studyType":52,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":41},"100587331","phase-1-9mw2821-combined-with-other-antitumor-drugs-in-patients-with-advanced-gynecological-tumors-100587331","NCT06926998","9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors","An Open-Label, Multicenter Phase Ib\u002Fll Clinical Study Evaluating the Safety and Efficacy of 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n2. Female subjects aged 18 to 75 years (including 18 and 75 years).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histopathological diagnosed of advanced gynecological tumors.\n5. Subjects must submit tumor tissues for test.\n6. Life expectancy of ≥ 12 weeks.\n7. Subjects must have measurable disease according to RECIST (version 1.1).\n8. Adequate organ functions.\n9. Sexually active fertile subjects must agree to use methods of contraception during the study and at least 180 days after termination of study therapy.\n10. Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. History of another malignancy within 3 years before the first dose of study drug.\n2. Patients with ongoing clinically significant toxicities related to prior treatment.\n3. Presence of Grade ≥ 2 peripheral neuropathy.\n4. Exclusion of prior diseases and prior treatments as specified in the protocol.\n5. Comorbidities: a. Hemoglobin A1C ≥ 8%; b. Ocular diseases or symptoms present prior to the first dose of study medication; c. Severe respiratory diseases; d. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study medication; e. Active autoimmune diseases within 2 years prior to the first dose of study medication, or a history of autoimmune diseases with potential for recurrence; f. Active infections; g. Severe arterial or venous thromboembolic events.\n6. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to the first dose of medication.\n7. Subjects with central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n8. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated drainage procedures.\n9. Prior Treatments: a. Major surgical procedures within 28 days prior to the first dose of study medication; b. Administration of other investigational drugs or experimental medical devices within 28 days prior to the first dose of study medication; c. Use of P-glycoprotein inhibitors or inducers, or potent CYP3A4 inhibitors within 14 days prior to the first dose of study medication; d. Receipt of live vaccines within 28 days prior to the first dose of study medication or planned administration of any live vaccine during the study period; e. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;.\n10. Subjects with a history of drug abuse or psychiatric disorders, or suspected allergy, intolerance, or severe infusion reactions to the investigational drug or any of its components.\n11. Pregnant or lactating women.\n12. Not suitable to receive study treatment for other conditions as per investigator.",{"count":78,"type":20},260,[54,55],"To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.",[24],"NOT_YET_RECRUITING","2025-04-08",{"date":85,"type":33},"2025-04-15",{"date":85,"type":20},{"date":88,"type":20},"2027-05-01",{"name":90,"class":69},"Mabwell (Shanghai) Bioscience Co., Ltd.",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":16,"minAge":17,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":41},"100527689","an-observational-study-of-menopausal-symptom-in-patients-with-gynecological-malignancy-after-oophorectomy-100527689","NCT06151028","An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy","An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)","Inclusion Criteria:\n\n* Premenopausal women with gynecological malignancies aged 18-55 years old;\n\n  * Tumor types include endometrial cancer, cervical cancer, epithelial ovarian cancer;\n\n    * All patients received standard stage operation and treatment;\n\n      * Patients with bilateral ovaries resection; ⑤Voluntarily participate in this study, willing to sign informed consent, and have long-term follow-up conditions.\n\nExclusion Criteria:\n\n* Menopause (women over 40 years of age stop menstruation for 12 months, excluding pregnancy and other diseases that may cause amenorrhea can be clinically diagnosed as menopause); Or AMH \\\u003C 0.2ng\u002Fml (China Menopause Management and Menopause Hormone Therapy Guidelines 2023 edition); Or FSH\\> 40 mIU\u002Fml after two checks within one month;\n\n  * Other tumors were combined within 2 years and were still in radiotherapy, chemotherapy or hormone therapy;\n\n    * Diagnosis of immunodeficiency disease or active hepatitis B, C, active tuberculosis; ④Serious organic diseases of the organs, etc., can not cooperate with the study follow-up; ⑤Long-term use of hormonal drugs for rheumatic system diseases, such as glucocorticoids;\n\n      * Patients who have previously received pelvic or abdominal radiotherapy; ⑦ ECOG score ≥3 points; ⑧The patient did not sign informed consent or was unwilling to accept follow-up interviews.",true,"55 Years",{"count":101,"type":20},490,"Through long-term dynamic monitoring of gynecologic malignant tumor patients undergoing early menopause after ovaries resection in our center, we explored the changes in menopausal symptoms and bone health status of this population, and studied the effects of platinum combined chemotherapy drugs on menopausal symptoms and bone loss in gynecologic malignant tumor patients. To find the optimal time point and effective regimen for MHT in gynecologic malignancies undergoing surgical menopause, and to provide guidance for osteoporosis screening and prevention strategies in women with gynecologic cancer.",[24,104,105],"Menopausal Symptoms","Bone Loss","2024-03-06",{"date":108,"type":33},"2024-03-07",{"date":110,"type":33},"2023-12-01",{"date":112,"type":20},"2033-12-31",{"name":114,"class":115},"Anhui Provincial Hospital","OTHER_GOV"]