招募中 NCT07023484

晚期卵巢癌中间减瘤手术的个人化时机

卵巢癌神经内分泌肿瘤Phase IIIII 期IV 期BRCA1/2HRD

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、Primary Peritoneal Carcinoma

入组条件

纳入标准

  • Patients aged 18 years old or older
  • Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment
  • Patients who can sign the informed consent
  • Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS
  • Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis.
  • Patients who are planned for neoadjuvant chemotherapy (NACT) using 3-weekly carboplatin and paclitaxel. Those who have received one cycle of NACT may be eligible if the CA125 schedule of the study group can be matched.
  • Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal)
  • Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT
  • Patients with adequate hematologic, liver and renal functions for chemotherapy
  • Patients who agree to receive adjuvant chemotherapy after IDS. The total number of NACT and adjuvant chemotherapy should be four or above, up to maximum of 9 cycles.
  • Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.
  • Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test.

排除标准

  • Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins
  • Patients with mucinous and neuroendocrine histology
  • Patients with history of other malignancies within five years
  • Patients who are eligible for primary debulking surgery (PDS)
  • Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone
  • Patients who are not fit for PDS because of medical morbidities or refusal of operation
  • Patients who have already started NACT outside the study centers, except those who have received only one cycle within 7 days and the baseline CA125 value within 3 days of NACT (normal cut-off 35 U/ml) is available
  • Patients who participate in other interventional studies
  • Patients who are pregnant or breastfeeding
  • Patients who have contraindications to platinum-based chemotherapy
  • Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.

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。