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Recruiting Phase 2

Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

NCT07023484 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-05-22
Last updated
2025-07-02

Condition(s) studied

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Investigational drug(s) / intervention(s)

KELIMCarboplatin plus PaclitaxelAll Carboplatin trials (592) →All Paclitaxel trials (423) →Interval debulking surgery

KELIM: (i) Patients with KELIM =\>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. (ii) Patients with KELIM \<1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery

Carboplatin plus Paclitaxel: Neoadjuvant chemotherapy

Interval debulking surgery: Interval debulking surgery

Study summary

About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients and compare this with the standard clinical practice.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged 18 years old or older 2. Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment 3. Patients who can sign the informed consent 4. Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS 5. Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis. 6. 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. 7. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal) 8. Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT 9. Patients with adequate hematologic, liver and renal functions for chemotherapy 10. 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. 11. Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment. 12. Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test. Exclusion Criteria: 1. Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins 2. Patients with mucinous and neuroendocrine histology 3. Patients with history of other malignancies within five years 4. Patients who are eligible for primary debulking surgery (PDS) 5. Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone 6. Patients who are not fit for PDS because of medical morbidities or refusal of operation 7. 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 8. Patients who participate in other interventional studies 9. Patients who are pregnant or breastfeeding 10. Patients who have contraindications to platinum-based chemotherapy 11. Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.

Primary outcome measure(s)

  • Complete resection (CC0) rate — up to 24 weeks from randomisation
    The likelihood of CC0 in patients who undergo IDS when KELIM reaches \>=1
  • 12-month progression-free survival (PFS) rate by RECIST criteria — up to 24 months from randomisation
    PFS is defined as the time from the date of randomization until the date of progressive disease or death (whichever comes first).

Trial sites (6)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou China Not Yet Recruiting
The University of Hong Kong - Shenzhen Hospital Shenzhen China Not Yet Recruiting
Pamela Youde Nethersole Eastern HospitalPamela Y Chai Wan Hong Kong Not Yet Recruiting
Queen Mary Hospital, Department of Clinical Oncology Hong Kong Hong Kong Not Yet Recruiting
The University of Hong Kong, Department of Obstetrics and Gynaecology Hong Kong Hong Kong Recruiting
United Christian Hospital Kwun Tong Hong Kong Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07023484 on ClinicalTrials.gov ↗ ← All trials in China