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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT07355010
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who have chosen to take part voluntarily and have signed a consent form.
- People aged 18 or older (from the date the consent form is signed).
- People who have been newly diagnosed (confirmed by a tissue sample) with high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; or ovarian endometrioid cancer of grade II or higher; or a mixed tumour that contains a high-grade serous or grade II or higher endometrioid component.
- People whose cancer is classified as stage III or IV under the FIGO 2014 staging system.
- People who have at least one tumour that can be measured by CT or MRI scan.
- People whose doctors have assessed that complete surgical removal of the tumour (called R0 resection) is not possible, or that surgery cannot be safely tolerated — based on specific scoring systems or medical reasons such as very high body weight, multiple long-term health conditions, poor nutrition, significant fluid build-up, a recent blood clot, poor general physical condition, or other reasons identified by the doctor.
- People with a physical performance status score of 0, 1, or 2 on the ECOG scale (a measure of how well a person can carry out daily activities).
- People who have been tested by a specialist laboratory and confirmed to have normal (wild-type) BRCA1 and BRCA2 genes in their inherited (germline) DNA.
- People whose blood test results show their bone marrow, liver, and kidney are working well enough — including adequate white blood cell, platelet, and red blood cell levels, as well as normal protein, liver enzyme, and kidney function values (without receiving blood products or growth factor injections in the 14 days before treatment starts).
- People who are capable of becoming pregnant must have a negative blood pregnancy test within one week before the first dose, must not be breastfeeding, and must agree to use effective contraception during the trial and for six months after the last dose — and must tell the research team immediately if pregnancy is suspected or confirmed.
- People who are willing to complete quality-of-life questionnaires during treatment and follow-up, and who agree that the results may be used for research purposes.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have had, or currently have, another cancer that has not been fully treated within the past five years — though certain cancers may be considered exceptions, such as treated thyroid cancer, skin basal cell carcinoma, cancer limited to one spot (carcinoma in situ), or breast cancer that was fully treated and has not returned for more than three years.
- People who have cancer that has spread to the brain or the lining of the brain and has not been treated — though people who previously received treatment for brain or meningeal metastases, have been stable for at least one month confirmed by imaging, have stopped steroid medication for more than two weeks, and have no symptoms may still be considered (confirm with trial site).
- People who have previously been treated with PARP inhibitors, anti-angiogenic drugs (drugs that block blood vessel growth in tumours), or drugs targeting PD-L1 or TGF-β.
- People who cannot swallow tablets normally, or who have a digestive system problem that the doctor believes would affect how the body absorbs the medicine.
- People who have had a bowel blockage or a hole in the digestive tract (gastrointestinal perforation) within the past 3 months.
- People with poorly controlled heart conditions, including moderate or severe heart failure (NYHA grade 2 or above), unstable chest pain (angina), a heart attack within the past year, certain abnormal heart rhythms requiring treatment, or an abnormal heart electrical reading (QTc greater than 470ms).
- People who have had a significant bleeding event (grade 2 or above) within 4 weeks before the first dose — such as gastrointestinal bleeding or a bleeding stomach ulcer — or who have a persistently positive stool blood test at the start of the trial (confirm with trial site regarding follow-up testing requirements).
- People who have received a platelet or red blood cell transfusion within 14 days before treatment starts.
- People who have active ulcers, wounds that have not healed, or fractures that have not healed.
- People who have an active infection or an unexplained fever above 38.5°C during the screening period or before the first dose.
- People who have a condition that weakens the immune system (such as HIV infection), or who have active hepatitis B or hepatitis C based on specific blood test results.
- People who have received radiotherapy, chemotherapy, hormone therapy, or targeted therapy within 4 weeks before the first dose (or within 5 half-lives for oral targeted drugs), or who still have side effects from previous treatment rated above grade 1 (except hair loss).
- People who have had a serious blood clot event (grade 3 or higher) — such as a stroke, brain bleed, deep vein clot, or pulmonary embolism — within 6 months before the first dose.
- People who have a history of inherited or acquired bleeding or clotting disorders, such as haemophilia or platelet disorders.
- People who may need to receive other cancer treatments during the study period.
- People with high blood pressure that has not been well controlled with medication (systolic blood pressure of 140 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher).
- People who are pregnant, breastfeeding, or planning to become pregnant during the study treatment period.
- People who, in the doctor's judgement, have other factors that could make it unsafe or impractical to continue in the study — such as serious other illnesses (including mental health conditions), severely abnormal test results, or personal or social circumstances that could affect safety or data collection.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Qinglei Gao
Registry
ClinicalTrials.gov
Start date
30 December 2025
Est. completion
30 December 2028
Primary endpoints
objective response rate，ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.