进行中(不再招募) NCT06486441

Sacituzumab Govitecan对比医师选择治疗用于接受铂类化疗及免疫治疗后子宫内膜癌参与者的研究(ASCENT-GYN-01/GOG-3104/ENGOT-en26)

宫颈癌/妇科肿瘤肉瘤Phase IIIPD-L1

本临床研究旨在探讨研究药物sacituzumab govitecan(SG)在曾接受铂类化疗及免疫治疗的子宫内膜癌参与者中的疗效,并与医师选择治疗(TPC)进行比较。 本研究的主要目标是评估SG对比TPC在无进展生存期(PFS)方面的效果,由盲法独立中央审查(BICR)进行评估,以及o

适应症:Endometrial Cancer

入组条件

纳入标准

  • Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
  • Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately.
  • Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
  • Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Adequate organ function

排除标准

  • Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.
  • Participants who are candidates for curative-intent therapy at the time of study enrollment.
  • Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
  • Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
  • Have an active second malignancy.
  • Have an active serious infection requiring systemic antimicrobial therapy.
  • Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.
  • Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。