進行中(不再收案) NCT06486441

Sacituzumab Govitecan對比醫師選擇治療用於接受鉑類化療及免疫治療後子宮內膜癌參與者的研究(ASCENT-GYN-01/GOG-3104/ENGOT-en26)

子宮頸癌/婦癌肉瘤Phase IIIPD-L1

本臨床研究旨在探討研究藥物sacituzumab govitecan(SG)在曾接受鉑類化療及免疫治療的子宮內膜癌參與者中的療效,並與醫師選擇治療(TPC)進行比較。 本研究的主要目標是評估SG對比TPC在無惡化存活期(PFS)方面的效果,由盲法獨立中央審查(BICR)進行評估,以及o

適應症:Endometrial Cancer

收案條件

納入條件

  • 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

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。