[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gynecological-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gynecological-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,88],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100652869","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-gynecological-tumors-and-other-solid-tumors-100652869",false,"NCT07778862","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gynecological Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Gynecological Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic gynecological tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test being negative, and they must not be lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion;\n15. Trial participants must be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, or other treatments within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive drug therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior occurrence of ≥ Grade 3 toxicity related to anti-angiogenic therapy when receiving such therapy previously;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Poorly controlled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe respiratory impairment;\n13. Active central nervous system metastases;\n14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n18. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n19. Imaging findings indicating tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;\n20. Trial participants with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or breastfeeding women;\n24. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic gynecological tumors and other solid tumors.",[27,28],"Gynecological Tumors","Solid Tumors","NOT_YET_RECRUITING","2026-08-18",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":21},"2026-09",{"date":37,"type":21},"2028-12",{"name":39,"class":40},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":66,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100612907","gut-microbiome-in-gynecological-cancer-patients-with-pelvic-toxicity-controls-versus-ozone-treatment-microzoginetox-100612907","NCT07259681","Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)","Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.","MicrOGineTox","Inclusion Criteria for all patients (Cases and Controls):\n\n1. Adult women (\\>=18 years).\n2. Diagnosed with gynecological tumors (any location and stage).\n3. Previously treated with radiotherapy and\u002For chemotherapy.\n4. Must accept and sign the specific informed consent for this study.\n\n   Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):\n5. Must present chronic TPIRQT with \\>= 3 months of duration after habitual symptomatic treatment.\n6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.\n\nExclusion Criteria for all patients (Cases and Controls):\n\n1. Not meeting all inclusion criteria.\n2. Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.\n3. Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.\n4. Unwillingness or inability to provide written informed consent for study participation.","FEMALE",{"count":52,"type":21},38,"4 Months","OBSERVATIONAL","Patients treated for gynecological tumors with radiotherapy (RT) and\u002For chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.",[57,58,59,27,60,61,62,63,64,65],"Pelvic Toxicity","Radiation Toxicity","Chemotherapy Toxicity","Radiation Proctitis","Radiation Cystitis","Vaginal Mucositis","Vulvar Mucositis","Quality of Life","Dysbiosis",[67,68,69,70,71,72,73,74,75,76,65],"Gut microbiota","Ozone","Ozone therapy","Gynecological tumors","Radiotherapy","Chemotherapy","Side effects","Actinic proctitis","Actinic cystitis","Quality of life","2025-12-16",{"date":79,"type":33},"2025-12-22",{"date":81,"type":21},"2026-01-15",{"date":83,"type":21},"2028-03-31",{"name":85,"class":86},"Bernardino Clavo, MD, PhD","OTHER",2,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100577431","phase-2-a-clinical-trial-of-tqb2102-for-injection-in-gynecological-tumors-with-recurrentmetastatic-advanced-100577431","NCT06798207","A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent\u002FMetastatic Advanced","A Phase 2 Clinical Trial of TQB2102 for Injection in the Treatment of Patients With Recurrent\u002FMetastatic Advanced Gynecological Tumors to Evaluate the Safety and Efficacy","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study, sign informed consent and have good compliance.\n* The age is ≥ 18 years old (subject to the date of signing the informed consent); Female ; eastern cooperative oncology group (ECOG ) score 0-1 ; estimated survival time ≥ 3 months ;\n* Histologically confirmed, unresectable recurrent \u002F metastatic advanced gynecologic tumors;\n* The HER2 expression status (IHC 3+, 2+, 1+ or 0) is confirmed in the tumor tissue, and the subjects with completely negative IHC 0 staining are excluded.\n* Previous chemotherapy with platinum-based drugs was unsuccessful.\n* There is at least one measurable lesion according to the RECIST 1.1 criteria; women of childbearing potential need to meet the following conditions: the serum\u002Furine pregnancy test result is negative before the first administration; they agree to adopt highly effective contraceptive measures (with an annual failure rate of less than 1%) throughout the study period. Women of childbearing potential are defined as premenopausal women who have not had a record of tubal ligation or hysterectomy, or women who have been postmenopausal for no more than 1 year.\n\nExclusion Criteria:\n\n* Other malignant tumors occurred within the past 5 years before treatment or currently suffered simultaneously.\n* Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment, excluding alopecia.\n* Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before the start of treatment.\n* Long-term unhealed wounds or fractures.\n* Subjects with a history of interstitial lung disease\u002Fpneumonia ( non-infectious type ) that required steroid drug intervention treatment in the past, or currently accompanied by interstitial lung disease\u002Fpneumonia, or those with suspected interstitial lung disease\u002Fpneumonia indicated by screening imaging and cannot be excluded.\n* Subjects with moderate to severe pulmonary dysfunction\u002Fdisease within 3 months before the first administration.\n* Arterial\u002Fdeep vein thrombosis events occurred within 6 months before treatment, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism.\n* Subjects with any severe and\u002For uncontrolled diseases.\n* Patients with local recurrence suitable for surgery or radiotherapy.\n* Those with disease progression after receiving chemotherapy drugs of topoisomerase I inhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors in the previous first-line treatment.\n* Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5 half-lives before the first administration in this study.\n* Received treatment with Chinese patent medicines with clear anti-tumor indications in the drug instructions approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration in this study.\n* Serosal effusion that requires repeated drainage to relieve clinical symptoms, or those who received serosal effusion drainage for treatment purposes within 2 weeks before treatment.\n* Patients with clinically significant tumor bleeding or perforation within 1 month before the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, or patients with bleeding or coagulation disorders who are using warfarin, aspirin, or other antiplatelet aggregation drugs.\n* Subjects with known central nervous system metastasis and\u002For carcinomatous meningitis, with diffuse dissemination. Subjects with a history of brain metastasis may be considered for inclusion if clinically stable.\n* Severe bone damage and spinal cord compression caused by tumor bone metastasis, including weight-bearing bone pathological fractures that occurred within 6 months or are likely to occur in the near future, poorly controlled severe bone pain, etc.\n* Those allergic to macromolecular drug components or allergic to any research drug, any component or excipient in the drug.\n* Received live attenuated vaccines within 4 weeks before treatment.\n* Active autoimmune diseases that required systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first administration.\n* Received systemic glucocorticoid treatment or any other form of immunosuppressive therapy or diagnosed with immunodeficiency within 2 weeks before treatment.",{"count":96,"type":21},170,[98],"PHASE2","TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in recurrent\u002Fmetastatic advanced gynecological tumors.",[27],"RECRUITING","2025-07-16",{"date":104,"type":33},"2025-07-18",{"date":106,"type":33},"2025-03-13",{"date":108,"type":21},"2026-11",{"name":110,"class":40},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",31]