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Taking people in Hong KongPhase 2

Timing of surgery after chemotherapy for advanced ovarian cancer, guided by KELIM test

Tests a KELIM test to time surgery after chemotherapy in advanced ovarian cancer.

Key facts

Who runs it
The University of Hong Kong
Where
Chai Wan, Hong Kong, and Kwun Tong, Hong KongSee the 4 sitesAlso in 1 other country, 2 sites
Trial code
Registry title
Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Status
Recruiting
Phase
Phase 2
People taking part
126 people, planned
Started
22 May 2025
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • KELIM
  • Carboplatin plus Paclitaxel
  • Interval debulking surgery
Record updated
2 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 or older with advanced (stage III-IV) ovarian, fallopian tube or primary peritoneal cancer who cannot have surgery first and are planned for chemotherapy before surgery.

Age
18 years or older
Sex
Female
Disease stage
Stage III-IV epithelial ovarian, fallopian tube or primary peritoneal cancer that cannot be treated with surgery first. Mucinous and neuroendocrine types cannot join.
Earlier treatment
Planned for 3-weekly carboplatin and paclitaxel before surgery. Those who had one cycle may join if the CA125 schedule of the study can be followed. Those who started chemotherapy elsewhere otherwise cannot join.
Biomarker or test result
CA125 level at the start at least 2x the upper limit of normal. A BRCA test (germline and/or somatic) or an HRD test is needed.

Main reasons for not taking part

  • Borderline tumours, germ cell or sex cord tumours, or cancer that spread from another organ
  • Another cancer within the last five years
  • Able to have surgery first, or not fit for it because of other illnesses or refusal
  • Pregnant or breastfeeding
  • Active tuberculosis, a positive HIV test or known AIDS

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients who are eligible for primary debulking surgery (PDS)
  • 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 have contraindications to platinum-based chemotherapy
  • Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins
  • Patients with history of other malignancies within five years
  • Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded
  • Patients with mucinous and neuroendocrine histology
  • 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 participate in other interventional studies
  • Patients who are pregnant or breastfeeding

Where in Hong Kong

Also in 1 other country, 2 sites

  • Pamela Youde Nethersole Eastern HospitalPamela YChai Wan, Hong KongContact: Sung Inda Soong, MBChB, FRCRNot yet recruiting
  • Queen Mary Hospital, Department of Clinical OncologyHong Kong, Hong KongContact: Steven Siu, MBBS, FRCRNot yet recruiting
  • The University of Hong Kong, Department of Obstetrics and GynaecologyHong Kong, Hong KongContact: Lesley Lau, MPhilTaking people
  • United Christian HospitalKwun Tong, Hong KongContact: Victoria Chai, MBBS, FHKCOGNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Standard clinical practiceExisting treatment, for comparison

    Participants will follow the standard practice and receive 3-6 cycles of neoadjuvant chemotherapy, followed by radiological assessment and interval debulking surgery.

    Treatment: Carboplatin plus Paclitaxel and Interval debulking surgery

  • Personalised managementTreatment being tested

    Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.

    Treatment: KELIM, Carboplatin plus Paclitaxel, and Interval debulking surgery

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Personalized Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Multicenter Randomized Phase II Non-inferiority Trial (PRESELECT-I Trial)
Plain-language title
Timing of surgery after chemotherapy for advanced ovarian cancer, guided by KELIM testGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 July 2025