NCT07022535 Personalised Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
| NCT ID | NCT07022535 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Hong Kong |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 18 participants in total. It began in 2024-05-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients must be at least 18 years old. 2. Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-1. 3. Patients who are competent to give informed consent. 4. 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). 5. 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. 6. Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal). 7. 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. 8. Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice. 9. Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above. Exclusion Criteria: 1. 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 2. Patients who are eligible for PDS 3. Patients who are not fit for PDS because of medical morbidities or refusal of operation 4. 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. 5. Patients who are pregnant
Contact & Investigator
Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT07022535 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07022535 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07022535 currently recruiting?
Yes, NCT07022535 is actively recruiting participants. Contact the research team at lsk382@hku.hk for enrollment information.
Where is the NCT07022535 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07022535 clinical trial?
NCT07022535 is sponsored by The University of Hong Kong. The principal investigator is Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG at The University of Hong Kong. The trial plans to enroll 18 participants.
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