Status:
NOT_YET_RECRUITING
Efficacy and Safety of Sacituzumab in Patients With OCCC After Immunotherapy Progression
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Ovarian Cancer
Antibody-drug Conjugates
Eligibility:
FEMALE
18-70 years
Brief Summary
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 racia...
Detailed Description
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 racia...
Eligibility Criteria
Inclusion
- Histologically diagnosed ovarian clear cell carcinoma
- Patients who have progressed on imaging assessment after receiving immunotherapy, including anti-PD-1, PD-L1, and PD-1/PD-L1+CTLA4, and subsequently received Sacituzumab.
- At least one measurable lesion as assessed by RECIST, version 1.1.
- Life expectancy ≥ 12 months.
- Normal renal an liver function, no myelosuppression.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score (PS score) 0-1.
- Participants must have recovered from all toxicities resulting from previous treatment (recovery to \< grade 1 or protocol-specified inclusion criteria, based on a CTCAE 5.0 assessment), excluding alopecia.
- 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.
Exclusion
- Receipt of more than two lines of therapy after progression on immunotherapy.
- Previous use of irinotecan or ADCs containing topoisomerase I inhibitors.
- Presence or history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that prevents delayed corneal healing.
- 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.
- Organ transplant recipient.
- ≥ Grade 3 venous embolism
- Active infectious disease of any grade, including tuberculosis.
- Previous history of pelvic or abdominal radiation therapy to any site.
- Concurrent with other types of malignant tumors.
- Mental status abnormalities.
- 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.
- Any other condition deemed inappropriate for participation in this study by the investigator.
Key Trial Info
Start Date :
September 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT07168083
Start Date
September 1 2026
End Date
August 31 2029
Last Update
September 11 2025
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