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PDS Versus NACT-IDS in AI-Selected Advanced Epithelial Ovarian Cancer

2026年11月10日 更新者：Shanghai Gynecologic Oncology Group

Artificial Intelligence -Assisted Randomized Phase II/III Trial of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer

This multicenter, open-label, randomized phase II/III trial will compare primary debulking surgery (PDS) with neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) in patients with newly diagnosed stage IIIC or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who are recommended for PDS by the MERITS clinical decision tool and are clinically eligible for either treatment strategy.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The optimal timing of cytoreductive surgery in advanced epithelial ovarian cancer remains uncertain. Earlier randomized trials did not clearly identify which patients benefit from PDS rather than NACT-IDS. Using data from 489 participants in the SUNNY trial, the Multi-Endpoint RMST Ensemble for Individualized Treatment Selection (MERITS) model was developed and internally evaluated in the previous SUNNY-AI trial (NCT06839157). The model uses seven pretreatment clinical variable groups: BRCA status, TNM stage, Eastern Cooperative Oncology Group performance status, histologic type, tumor burden, presence of omental metastasis, and age (≤65 vs >65 years). In internal cross-validation, MERITS recommended PDS for 78.1% of patients and achieved a concordance index of 0.63. The current study will prospectively evaluate the clinical utility of feature-based selection and determine whether PDS improves overall survival in the selected population.

All participants must be recommended for PDS by MERITS and judged clinically suitable for both PDS and NACT-IDS. A 20-participant randomized pioneer study will first assess feasibility and early safety. Formal phase II enrollment may begin if major protocol deviations are observed in no more than 4 of 20 participants, 30-day grade ≥3 postoperative complications in no more than 6, 30-day postoperative deaths in no more than 1, at least 18 undergo the planned debulking procedure, and all operated participants have ascertainable 30-day safety outcomes.

The randomized phase II will enroll 100 participants. Phase II will be assessed after the 100th participant has completed 18 months of follow-up and surgical safety data have been verified. The phase II decision is exploratory and does not establish confirmatory noninferiority. The phase III will enroll 414 participants. The final phase III analysis will be performed after at least 247 deaths and at least 60 months of follow-up for the last phase III participant. Overall survival will be compared using a stratified log-rank test, with a stratified Cox model estimating the hazard ratio for PDS versus NACT-IDS and its two-sided 95% confidence interval. Stratification factors are TNM stage, cPCI tumor burden, and BRCA status. PDS will be considered superior only if the estimated hazard ratio is <1 and the two-sided stratified log-rank P value is <0.05.

研究类型

介入性

注册 (估计的)

534

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国
        • Zhongshan Hospital Fudan University
        • 接触：
        • 接触：
          • Libing Xiang, MD, PhD
          • 电话号码：02164041990
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • Zhejiang cancer hospital
        • 接触：
          • Jianqing Zhu, MD
          • 电话号码：86 571 8822222
          • 邮箱：zjq-hz@126.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 79年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female, aged ≥18 and <80 years.
  • Newly diagnosed, pathologically confirmed stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma. Diagnostic surgery, core-needle biopsy, or a pleural/ascitic fluid cell block may be used for confirmation as specified in the protocol.
  • PET-CT based TNM clinical stage and cPCI tumor burden determined by multidisciplinary assessment.
  • Eastern Cooperative Oncology Group performance status 0-2.
  • Frailty index <0.15.
  • Known BRCA1/2 status.
  • MERITS recommendation for PDS and clinical eligibility for both randomized treatment strategies.
  • Adequate bone marrow, renal, hepatic, and nutritional function to undergo chemotherapy and surgery: white blood cell count >3,000/µL; absolute neutrophil count ≥1,500/µL; platelets ≥100,000/µL; hemoglobin ≥9 g/dL; serum creatinine <1.25 × upper limit of normal or creatinine clearance ≥60 mL/min; total bilirubin <1.25 × upper limit of normal; ALT and AST <2.5 × upper limit of normal; and serum albumin >3.5 g/dL.
  • Ability and willingness to comply with protocol treatment and scheduled follow-up.
  • Written informed consent.

Exclusion Criteria:

  • Low-grade ovarian carcinoma, mucinous ovarian carcinoma, or clear cell carcinoma.
  • Non-epithelial ovarian malignancy or borderline ovarian tumor.
  • Prior neoadjuvant chemotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapy for the current disease.
  • Concurrent or uncontrolled malignancy diagnosed within the previous 5 years.
  • Severe systemic disease precluding surgery, including poorly controlled diabetes or hypertension, chronic obstructive pulmonary disease, implanted cardiac pacemaker with clinically relevant comorbidity, moderately reduced cardiac ejection fraction, end-stage renal disease, myocardial infarction, cerebrovascular accident, uncontrolled infection, coagulation disorder, or another condition judged to make surgery or chemotherapy unsafe.
  • Inability to complete the planned treatment course or follow-up.
  • Religious, psychological, or other circumstances that could interfere with informed consent, protocol adherence, or follow-up.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Primary Debulking Surgery

Maximal-effort cytoreductive surgery will be completed within 3 weeks after pathologic diagnosis, followed by 6 cycles of first-line chemotherapy. The interval from surgery to the first postoperative chemotherapy cycle should not exceed 8 weeks unless medically necessary.
程序：Upfront cytoreductive surgery

Upfront cytoreductive surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5

药品：Platinum-based chemotherapy

Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5
有源比较器：Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery

Participants will receive 3 cycles of neoadjuvant chemotherapy, undergo interval debulking surgery with maximal-effort cytoreduction, and then receive 3 additional cycles of chemotherapy. The interval from surgery to the first postoperative chemotherapy cycle should not exceed 8 weeks unless medically necessary.
药品：Platinum-based chemotherapy

Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5

程序：Interval debulking surgery

3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall survival
大体时间：60 months since randomization

Time from randomization to death from any cause; participants alive will be censored at the last date known alive.
60 months since randomization

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival
大体时间：60 months since randomization

Time from randomization to first disease progression or death from any cause, whichever occurs first.
60 months since randomization
Postoperative complications within 30 days after surgery
大体时间：Through 30 days after the planned debulking procedure

The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery, graded using CTCAE version 5.03
Through 30 days after the planned debulking procedure
Quality of life assessments
大体时间：At baseline, 6 months, 12 months, and 5 years after randomization.

Quality of life measured with EORTC QLQ-C30
At baseline, 6 months, 12 months, and 5 years after randomization.
Pattern of first relapse
大体时间：60 months since randomization

The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.
60 months since randomization
The rate of 3-year progression-free survival
大体时间：36 months since randomization

The rate of the patients without progression or recurrence or death at 3 years.
36 months since randomization
The rate of 5-year progression-free survival
大体时间：60 months since randomization

The rate of the patients without progression or recurrence or death at 5 years.
60 months since randomization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Gynecologic Oncology Group

合作者

Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月31日

初级完成 (估计的)

2037年2月28日

研究完成 (估计的)

2037年2月28日

研究注册日期

首次提交

2026年11月6日

首先提交符合 QC 标准的

2026年11月10日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • OV-AI

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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