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Ovarian CancerPhase 2PRESELECT-0NCT07022535

Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

A Phase 2 study testing KELIM, Carboplatin plus Paclitaxel and Interval debulking surgery in people with Ovarian Cancer and Fallopian Tube Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
KELIM, Carboplatin plus Paclitaxel and Interval debulking surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteHong Kong
Study dates
28 May 2024to 31 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be at least 18 years old.
  • Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1.
  • Patients who are competent to give informed consent.
  • Patients who have stage III-IV histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer not amenable for primary debulking surgery (PDS).
  • Patients who are planned for neoadjuvant chemotherapy (NACT) using platinum-based chemotherapy +/- bevacizumab or biosimilar. Those who are receiving NACT before interval debulking surgery (IDS) are also eligible.
  • Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).
Show all 9Show fewer
  • Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS.
  • Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.
  • Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.

Who cannot join

  • Patients who have borderline malignancy, or non-epithelial ovarian cancer like germ cell or sex cord tumor, or metastatic diseases from other origins like Krukenberg's tumor
  • Patients who are eligible for PDS
  • Patients who are not fit for PDS because of medical morbidities or refusal of operation
  • Patients who have already started NACT outside the study centres, except those who have just had one cycle within 21 days and the baseline CA125 is available.
  • Patients who are pregnant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lesley Lau, MPhil contact

+852 22554265

lsk382@hku.hk

Iris Tang contact

+852 22554265

iristwk@hku.hk

Hong Kong1 site, 1 recruiting

  • The University of Hong Kong

    Hong Kong

    Lesley Lau, MPhil, +852 22554265, lsk382@hku.hk

    Iris Tang, +852 22554265, iristwk@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study

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.

Read the detailed description

Recruited patients will have additional CA125 at 4th (before administration of chemotherapy), and 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined. Patients with KELIM =>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. 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

Being tested
KELIM, Carboplatin plus Paclitaxel, Interval debulking surgery
Keywords
advanced, ovarian cancer, neoadjuvant chemotherapy, interval debulking surgery, KELIM, CA 125
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KELIMDiagnostic test

    (i) Patients with KELIM >=1 will receive radiological assessment and undergo interval 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 PaclitaxelDrug

    Chemotherapy as neaodjuvant chemotherapy

  • Interval debulking surgeryProcedure or surgery

    Also called cytoreductive surgery

    Interval debulking surgery

Study groups in NCT07022535
Study groupRoleWhat they receive
Personalised managementExperimentalPatients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.
Receives: Diagnostic Test: KELIM; Drug: Carboplatin plus Paclitaxel; Procedure: Interval debulking surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete resection (CC0) rate

    The likelihood of CC0 in patients who undergo IDS when KELIM reaches 1 or above

    Measured: Up to 24 months

  2. Sensitivity of KELIM in predicting CC0

    The sensitivity of KELIM in predicting CC0

    Measured: Up to 24 weeks

Secondary outcomes (3)

  1. Time required to achieve KELIM >=1

    The time required for KELIM to reach >=1 in EOC patients receiving NACT

    Measured: Up to 24 weeks

  2. Complication rates of treatment

    The complication rates of surgery based on the Clavien-Dindo classification and chemotherapy based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

    Measured: Up to 1 year

  3. Quality-of-life scale

    Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start28 May 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pilot study, single-arm
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07022535
Sponsor's protocol ID
UW 24-304
Other IDs
HKUCTR-3091
Acronym
PRESELECT-0
Status last verified
Jun 2025
First submitted
6 Jun 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patients' disease course based on this novel management algorithm

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KELIM, Carboplatin plus Paclitaxel and Interval debulking surgery in people with Ovarian Cancer and Fallopian Tube Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lesley Lau, MPhil (+852 22554265, lsk382@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete resection (CC0) rate (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07022535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

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