招募中 NCT07022535

晚期卵巢癌中間減瘤手術的個人化時機

卵巢癌Phase IIIII 期IV 期

約70%的上皮性卵巢癌患者確診時已屬晚期。當無法進行初次最佳手術時,新輔助化療後進行中間減瘤手術是其中一種治療選擇。然而,對於手術的最佳時機並無共識。CA125是卵巢癌中眾所周知的腫瘤標記。

適應症:Ovarian Cancer、Fallopian Tube Cancer、Peritoneal Cancer

收案條件

納入條件

  • Patients must be at least 18 years old.
  • Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.
  • Patients who are competent to give informed consent.
  • Patients who have stage III-IV histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer not amenable for primary debulking surgery (PDS).
  • Patients who are planned for neoadjuvant chemotherapy (NACT) using platinum-based chemotherapy +/- bevacizumab or biosimilar. Those who are receiving NACT before interval debulking surgery (IDS) are also eligible.
  • Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).
  • Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS.
  • Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.
  • Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.

排除條件

  • Patients who have borderline malignancy, or non-epithelial ovarian cancer like germ cell or sex cord tumor, or metastatic diseases from other origins like Krukenberg's tumor
  • Patients who are eligible for PDS
  • Patients who are not fit for PDS because of medical morbidities or refusal of operation
  • Patients who have already started NACT outside the study centres, except those who have just had one cycle within 21 days and the baseline CA125 is available.
  • Patients who are pregnant

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。