Last updated: December 25, 2022
Sponsor: Yonsei University
Overall Status: Active - Recruiting
Phase
2
Condition
Ovarian Cysts
Fallopian Tube Cancer
Pelvic Cancer
Treatment
N/AClinical Study ID
NCT05665023
4-2021-1776
Ages > 19 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with recurrent, metastatic, or unresectable ovarian cancer, fallopian tubecancer, or primary peritoneal cancer diagnosed cytologically or histologically asmucinous cancer. *Subjects who are metastatic (stage IV) or mucinous ovarian cancer that cannot besurgically resected at diagnosis may have undergone cytoreductive surgery prior tosystemic chemotherapy. It is appropriate for participation in this study if there areresidual lesions after surgery and other selection criteria are met.
- Mucous tumors of gastrointestinal origin should be excluded by prior upper and lowerintestinal endoscopy and pathologic immunohistochemical staining (CEA, SATB2, etc.).
- Patients who have not received previous systemic chemotherapy for recurrent,metastatic, or unresectable ovarian, fallopian tube, or primary peritoneal cancer, orwho have failed second-line or less systemic chemotherapy. However, immunotherapyalone (eg, anti-PD-1 or anti-PD-L1 immunotherapy) is not included in previouschemotherapy. *Platinum susceptibility does not affect the selection/exclusion criteria for thistrial.
- Informed consent
- Age more than 19 years old
- Patients with measurable lesions according to RECIST v1.1.
- ECOG Performance score 0-2
- Patients with adequate organ function
- Women of childbearing potential must either have a negative pregnancy test on a urineor serological test or consent to the use of an appropriate contraceptive method.
Exclusion
Exclusion Criteria:
- Patients who have previously received systemic chemotherapy, including oxaliplatin oririnotecan. *Previous treatment with bevacizumab is acceptable.
- Pregnant or breastfeeding women
- Patients who received chemotherapy, targeted small-molecule agents, or radiotherapywithin 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 orlower or baseline level) from a previously administered drug-induced adverse event.
- Active central nervous system (CNS) metastases and/or carcinoma meningitis.
- Patients with known aggravation within the past 3 years or other malignant tumorsrequiring aggressive treatment.
- Patients with moderate acute or chronic medical conditions or abnormal findings onexamination, which are judged to affect the results of this study
- Infected with Human Immunodeficiency Virus (HIV) (HIV-1/2 antibody) infection oractive hepatitis B (HBsAg positive and HBV DNA ≥100 copies/ml) or hepatitis C (anti-HCV antibody positive and HCV RNA detected) being)
- Clinically significant heart disease.
Study Design
Total Participants: 37
Study Start date:
October 28, 2022
Estimated Completion Date:
February 01, 2025
Study Description
Connect with a study center
Yonsei University Health System, Severance Hospital
Seoul,
Korea, Republic ofActive - Recruiting


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