招募中 NCT07022535

晚期卵巢癌中间减瘤手术的个人化时机

卵巢癌Phase IIIII 期IV 期

约70%的上皮性卵巢癌患者确诊时已属晚期。当无法进行初次最佳手术时,新辅助化疗后进行中间减瘤手术是其中一种治疗选择。然而,对于手术的最佳时机并无共识。CA125是卵巢癌中众所周知的肿瘤标志物。

适应症:Ovarian Cancer、Fallopian Tube Cancer、Peritoneal Cancer

入组条件

纳入标准

  • 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.

排除标准

  • 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

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。