[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605865":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":10,"responsibleParty":26,"collaborators":10,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":10,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":42,"studyType":43,"phases":10,"briefSummary":44,"conditions":45,"keywords":49,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":10},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Sacituzumab Group",null,"The patient received 5 mg\u002Fkg of Sacituzumab per two weeks.",[13],{"name":14,"affiliation":5,"role":15},"Jing Li, Doctor","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Yanan Lu, master","CONTACT","+8615868090553","luyn3@mail2.sysu.edu.cn",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Jing Li, doctor","+8615915893493","lijing228@mail.sysu.edu.cn",{"type":15,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jing Li","professor","100605865","efficacy-and-safety-of-sacituzumab-in-patients-with-occc-after-immunotherapy-progression-100605865",false,"NCT07168083","Efficacy and Safety of Sacituzumab in Patients With OCCC After Immunotherapy Progression","The Efficacy and Safety of Sacituzumab in Patients With Ovarian Clear Cell Carcinoma After the Progression of Immunotherapy: A Prospective Real-world Study","Inclusion Criteria:\n\n* Histologically diagnosed ovarian clear cell carcinoma\n* Patients who have progressed on imaging assessment after receiving immunotherapy, including anti-PD-1, PD-L1, and PD-1\u002FPD-L1+CTLA4, and subsequently received Sacituzumab.\n* At least one measurable lesion as assessed by RECIST, version 1.1.\n* Life expectancy ≥ 12 months.\n* Normal renal an liver function, no myelosuppression.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score (PS score) 0-1.\n* Participants must have recovered from all toxicities resulting from previous treatment (recovery to \\\u003C grade 1 or protocol-specified inclusion criteria, based on a CTCAE 5.0 assessment), excluding alopecia.\n* Participants must be willing to participate in the study, be compliant, sign the informed consent form, and be able to adhere to protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n* Receipt of more than two lines of therapy after progression on immunotherapy.\n* Previous use of irinotecan or ADCs containing topoisomerase I inhibitors.\n* Presence or history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment\n* Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal disease that prevents delayed corneal healing.\n* Concomitant incomplete or complete intestinal obstruction, intestinal fistula of any grade, hydronephrosis that cannot be resolved with a ureteral stent, inflammatory bowel disease or brain metastases.\n* Organ transplant recipient.\n* ≥ Grade 3 venous embolism\n* Active infectious disease of any grade, including tuberculosis.\n* Previous history of pelvic or abdominal radiation therapy to any site.\n* Concurrent with other types of malignant tumors.\n* Mental status abnormalities.\n* Pregnant or lactating women; or patients of childbearing potential (male or female) who are unable to use effective medical contraception during the study period and for 6 months after the end of dosing.\n* Any other condition deemed inappropriate for participation in this study by the investigator.","FEMALE","18 Years","70 Years",{"count":40,"type":41},22,"ESTIMATED","2 Years","OBSERVATIONAL","Ovarian clear cell carcinoma (OCCC) is a relatively rare but highly malignant epithelial ovarian cancer, accounting for 5%-10% of all ovarian cancers. The incidence of this tumor has significant racial disparity, with the highest incidence in Asians, accounting for 25% of ovarian cancer patients, while in European and American ovarian cancer patients, it only accounts for 4.8%. Due to the unique biological behavior of OCCC, it responds poorly to traditional platinum-based chemotherapy regimens, and the prognosis of patients with advanced and recurrent disease is extremely poor.\n\nOCCC has low sensitivity to platinum-based chemotherapy, especially in recurrent or persistent disease, and the objective response rate (ORR) of chemotherapy is usually less than 10%. Although immunotherapy has shown good results in OCCC, 60% of patients still cannot shrink their tumors after using combination regimens, and 50% of patients will still progress after 6.9 months of treatment. The question of how to treat OCCC after progression on immunotherapy remains a pressing issue. Sacituzumab (SKB264) is an antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen 2 (Trop-2) monoclonal antibody conjugated to T030. In the KL264-I-01 study (which included patients with OCCC) in patients with recurrent ovarian cancer, single-agent Sacituzumab achieved an objective response rate of 40%, superior to conventional chemotherapy, with manageable toxicity. OCCC patients who progress on immunotherapy face a dilemma of limited treatment options. Based on this current situation and the potential activity of Sacituzumab the investigators propose Sacituzumab as an option for patients with OCCC after immunotherapy progression.",[46,47,48],"Ovarian Cancer","Antibody-drug Conjugates","Clear Cell Adenocarcinoma of Ovary",[50,51],"Ovarian Clear Cell Carcinoma","antibody-drug conjugate","NOT_YET_RECRUITING","2025-09-10",{"date":55,"type":56},"2025-09-11","ACTUAL",{"date":58,"type":41},"2026-09-01",{"date":60,"type":41},"2029-08-31",{"name":5,"class":6}]