進行中(不再收案) NCT04269200

Durvalumab 聯合或不聯合 Olaparib 作為晚期及復發性子宮內膜癌第一線治療後的維持治療

子宮頸癌/婦癌肉瘤Phase IIIIII 期IV 期PD-L1

一項研究,評估 durvalumab 聯合鉑類化療(paclitaxel + carboplatin)後接續 durvalumab 維持治療聯合或不聯合 olaparib,用於新診斷晚期或復發性子宮內膜癌患者的療效與安全性。

適應症:Endometrial Neoplasms

收案條件

納入條件

  • Age ≥18 years at the time of screening and female.
  • Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
  • Patient must have endometrial cancer in one of the following categories:
  • Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
  • Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
  • Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
  • Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse
  • FPPE tumor sample must be available for MMR evaluation.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.

排除條件

  • History of leptomeningeal carcinomatosis.
  • Brain metastases or spinal cord compression.
  • Prior treatment with PARP inhibitors.
  • Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.

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。