Personalized Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Multicenter Randomized Phase II Non-inferiority Trial

Launched by THE UNIVERSITY OF HONG KONG · Jun 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to decide the best timing for surgery in women with advanced ovarian or fallopian tube cancer. Usually, when surgery can’t be done right away, patients receive chemotherapy first to shrink the tumor, followed by surgery to remove as much cancer as possible. This study wants to see if using a blood test called CA125, which shows how well chemotherapy is working, can help doctors personalize the timing of surgery for each patient, and if this approach works as well as the standard method.

Women aged 18 or older with advanced ovarian or fallopian tube cancer who are planning to have chemotherapy followed by surgery may be eligible to join. To participate, patients need to have a certain level of CA125 in their blood and be healthy enough for chemotherapy and surgery. Those who join will have their CA125 levels closely monitored during treatment to guide the timing of their surgery. The study is currently recruiting patients and aims to find out if this personalized approach is safe and effective, potentially helping doctors better plan treatment for women with these cancers.

Gender

FEMALE

Eligibility criteria

• 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 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 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 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 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 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.