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Ovarian CancerPhase 2Preselect-1NCT07023484

Personalized 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 6 sites in 2 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

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
126 participants
Where
6 sitesin 2 countries
Study dates
22 May 2025to 31 Dec 2028
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 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.
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  • 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 join

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

Trial locations and contacts

6 sites in 2 countries. 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

6 sites in 2 countries

Hong Kong4 sites, 4 recruiting

  • Pamela Youde Nethersole Eastern HospitalPamela Y

    Chai Wan

    Sung Inda Soong, MBChB, FRCR, +852 97194300, soongs@ha.org.hk

    Sung Inda Soong, MBChB, FRCR

    Not yet recruiting

  • Queen Mary Hospital, Department of Clinical Oncology

    Hong Kong

    Steven Siu, MBBS, FRCR, +852 22554202, siuwk@ha.org.hk

    Steven Siu, MBBS, FRCR

    Not yet recruiting

  • The University of Hong Kong, Department of Obstetrics and Gynaecology

    Hong Kong

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

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

    Recruiting

  • United Christian Hospital

    Kwun Tong

    Victoria Chai, MBBS, FHKCOG, +852 52156667, cyk095a@ha.org.hk

    Victoria Chai, MBBS, FHKCOG

    Not yet recruiting

Other trials in Hong Kong

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Ting Deng, MD, PhD, +86-13798182430, dengting@sysucc.org.cn

    Jihong Liu, MD

    Not yet recruiting

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen

    Rain Diao, +86 913333-5173, diaowy@hku-szh.org

    Li Zhang, MD

    Not yet recruiting

Other trials in China

About this study

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)

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.

Read the detailed description

Recruited patients will be randomised into two groups. The control group will receive treatment according to the standard clinical practice. The investigation group will have an additional CA125 at the 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined using online tool. 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, fallopian tube cancer, primary peritoneal cancer, neoadjuvant chemotherapy, interval debulking surgery, kelim
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 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 PaclitaxelDrug

    Neoadjuvant chemotherapy

  • Interval debulking surgeryProcedure or surgery

    Interval debulking surgery

Study groups in NCT07023484
Study groupRoleWhat they receive
Standard clinical practiceActive comparatorParticipants will follow the standard practice and receive 3-6 cycles of neoadjuvant chemotherapy, followed by radiological assessment and interval debulking surgery.
Receives: Drug: Carboplatin plus Paclitaxel; Procedure: Interval debulking surgery
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

    Measured: up to 24 weeks from randomisation

  2. 12-month progression-free survival (PFS) rate by RECIST criteria

    PFS is defined as the time from the date of randomization until the date of progressive disease or death (whichever comes first).

    Measured: up to 24 months from randomisation

Secondary outcomes (5)

  1. Chemotherapy response score (CRS)

    CRS of omentum removed during interval debulking surgery CRS 1, there is no or minimal tumor response; CRS 2, there is appreciable tumor response amidst viable tumor; CRS 3, there is complete or near complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups or nodules up to 2 mm

    Measured: up to 24 weeks from randomisation

  2. Progression-free survival (PFS) by RECIST criteria

    PFS is defined as the time from the date of randomization until the date of progressive disease or death (whichever comes first).

    Measured: up to 5 years from randomisation

  3. Overall survival (OS)

    OS is defined as the time from the date of randomization until death due to any cause.

    Measured: Up to 5 years from randomisation

  4. Incidence of adverse events

    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 from randomisation

  5. 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 from randomisation

Timeline

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

  1. First posted17 Jun 2025
  2. Study start22 May 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (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
Randomised
Intervention model
Parallel groups
Model description
non-inferiority randomised trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07023484
Sponsor's protocol ID
UW 24-746
Other IDs
HKUCTR-3092
Acronym
Preselect-1
Status last verified
Jun 2025
First submitted
7 Jun 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 6 sites in 2 countries.

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 12 inclusion and 11 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 6 sites in Hong Kong, China. 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 weeks from randomisation). 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 NCT07023484.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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