Early access
Sign in
Taking people in Hong KongPhase 2

Testing a KELIM-guided timing for surgery after chemotherapy in advanced ovarian cancer

Tests when to schedule surgery after chemotherapy in adults with advanced ovarian cancer.

Key facts

Who runs it
The University of Hong Kong
Where
Hong Kong, Hong KongSee the site
Trial code
Registry title
Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
Status
Recruiting
Phase
Phase 2
People taking part
18 people, planned
Started
28 May 2024
Planned end
31 Dec 2025
Type of study
Interventional
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 with advanced ovarian, fallopian tube or peritoneal cancer who cannot have surgery first and will get chemotherapy before surgery. The timing of the surgery is based on CA125 blood test changes.

Age
18 years or older
Sex
Women only
Disease stage
Stage III-IV epithelial ovarian, fallopian tube or primary peritoneal cancer, confirmed by tissue or cell tests, that cannot be treated with surgery first
Earlier treatment
Platinum-based chemotherapy (with or without bevacizumab or a biosimilar) is planned before surgery. People who have had just one cycle within 21 days, with a baseline CA125 available, can also join.
Biomarker or test result
CA125 level measurable at the start, at least 2x the upper limit of normal

Main reasons for not taking part

  • Borderline tumour, non-epithelial ovarian cancer (such as germ cell or sex cord tumour) or cancer that spread from another organ
  • Able to have surgery first
  • Not fit for surgery first because of other illnesses, or refuses surgery
  • Already started chemotherapy outside the study centres, except one cycle within 21 days with a baseline CA125
  • Pregnant

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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)
  • 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 take part

  • 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

Where in Hong Kong

  • The University of Hong KongHong Kong, Hong KongContact: Lesley Lau, MPhilTaking people

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.

The group in the trial

  • 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
Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study
Plain-language title
Testing a KELIM-guided timing for surgery after chemotherapy in advanced ovarian cancerGenerated 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