Ovarian CancerPhase 2NCT07401654
The Efficacy and Safety of Paclitaxel Monotherapy Versus Paclitaxel-Carboplatin Combination as Neoadjuvant Chemotherapy in Advanced Ovarian Cancer With High PARK2 Expression
A Phase 2 study testing Paclitaxel and Paclitaxel + Carboplatin in people with Ovarian Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Platinum-based neoadjuvant chemotherapy (NACT) followed by interval debulking surgery is a crucial treatment paradigm for advanced ovarian cancer. It can reduce tumor burden, increase the rate of R0 resection, and decrease surgical complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Paclitaxel and Paclitaxel + Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 31 Dec 2027
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-75 years.
- Histologically confirmed FIGO Stage III-IV high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer via laparotomy, laparoscopy, or core needle biopsy.
- Presence of at least one measurable lesion on CT/MRI, meeting at least one of the following conditions:
- Failure to achieve R0 cytoreduction (Fagotti score ≥ 8 or upper abdominal CT score ≥ 3).
- Presence of factors indicating surgical intolerance (meeting ≥1 item): Age ≥75 years; BMI ≥40; Chronic underlying diseases; Malnutrition or hypoalbuminemia; Moderate to large volume ascites; Newly diagnosed venous thromboembolism; ECOG performance status >2.
- High expression of the PARK2 gene in both tumor tissue and blood (Spatial Imaging [SI] score in tumor tissue ≥ 7).
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- Expected survival time > 12 weeks.
- ECOG performance status of 0-2.
- Adequate organ function meeting the following criteria:
- Bone Marrow Function: Absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L); Platelet count ≥ 100,000/mm³ (100 × 10⁹/L); Hemoglobin ≥ 10 g/dL (100 g/L).
- Liver Function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Direct bilirubin ≤ 1 × ULN; AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present).
- Renal Function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
- For women of childbearing potential:
- Negative pregnancy test within 1 week prior to enrollment.
- Agreement to use effective non-hormonal contraception (e.g., barrier method/intrauterine device) during the study period.
- Not currently breastfeeding.
- Recovery from prior chemotherapy-related toxicities to ≤ Grade 1 per CTCAE (or baseline level), except for stable sensory neuropathy or alopecia (which may be ≤ Grade 2).
- Willingness to provide tissue and blood samples during the treatment period.
- Ability to understand and voluntarily comply with the study protocol requirements, including:
- Adherence to the prescribed treatment schedule.
- Completion of required laboratory tests and imaging assessments per protocol.
- Participation in the planned follow-up procedures.
- Willingness to complete quality of life questionnaire assessments.
Who cannot join
- Individuals involved in the planning or conduct of this study.
- Patients concurrently participating in other clinical trials, using other investigational drugs, or receiving neoadjuvant therapies (chemotherapy/radiotherapy/immunotherapy/traditional Chinese medicine therapy).
- Known hypersensitivity or allergy to paclitaxel or carboplatin.
- Patients with dysphagia or gastrointestinal disorders that could affect drug absorption, distribution, metabolism, or excretion (ADME).
- Active symptomatic brain metastases requiring surgery, radiation, and/or corticosteroid therapy, or patients with clinical signs of spinal cord compression.
- Major surgery within 3 weeks prior to study initiation without full recovery.
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- Previous or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or other primary malignancies (except for adequately treated basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix).
- Diseases or conditions associated with a high risk of toxicity, including:
- HIV infection, active hepatitis B or C.
- Severe cardiovascular diseases (e.g., refractory ventricular arrhythmia, myocardial infarction within the past 3 months).
- Uncontrolled grand mal seizures, unstable spinal cord compression, or superior vena cava syndrome.
- Psychiatric illness that would impair the patient's ability to provide informed consent.
- Uncontrolled hypertension or any other condition deemed by the investigator to be unsuitable for study participation.
- Prior medical history or existing clinical conditions that may interfere with the interpretation of study results or patient compliance.
- Transfusion of platelets or red blood cells within 3 days prior to the start of study drug administration.
- Unresolved clinical toxicities ≥ Grade 2 (except for neuralgia, lymphopenia, and skin depigmentation).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploratory Study on the Efficacy and Safety of Paclitaxel Monotherapy Versus Paclitaxel-Carboplatin Combination as Neoadjuvant Chemotherapy in Advanced Ovarian Cancer With High PARK2 Expression
Platinum-based neoadjuvant chemotherapy (NACT) followed by interval debulking surgery is a crucial treatment paradigm for advanced ovarian cancer. It can reduce tumor burden, increase the rate of R0 resection, and decrease surgical complications. The combination of paclitaxel and carboplatin is the standard NACT regimen for ovarian cancer; however, it has limitations: 1) The myelotoxicity of platinum agents may disrupt treatment continuity, and 2) Platinum-based NACT often induces the earlier development of platinum resistance. Therefore, there is a need to explore novel regimens that, while maintaining therapeutic efficacy, can reduce drug exposure and toxicity, delay platinum exposure, and postpone the onset of platinum resistance.
Previous research has revealed that PARK2 can degrade phosphorylated BCL2, thereby enhancing sensitivity to paclitaxel. We established a PARK2-based molecular classification and found that 57% of advanced ovarian cancer cases exhibit high PARK2 expression. Furthermore, ovarian cancers with high PARK2 expression are highly sensitive to paclitaxel. In these patients, a platinum-free paclitaxel regimen demonstrated superior progression-free survival compared to paclitaxel-platinum combination therapy. Based on these findings, we hypothesize that for PARK2-high advanced ovarian cancer, neoadjuvant chemotherapy with single-agent paclitaxel could reduce toxicity and delay premature platinum exposure while achieving efficacy comparable to the standard doublet regimen.
To test this scientific hypothesis, our team plans to conduct an exploratory clinical study. We will enroll patients with advanced, treatment-naive, surgically unresectable, PARK2-high ovarian cancer and randomize them into two cohorts: one receiving neoadjuvant single-agent paclitaxel and the other receiving neoadjuvant paclitaxel plus carboplatin. The study aims to evaluate the efficacy and safety of single-agent paclitaxel NACT in this specific patient population.
- Conditions
- Ovarian Cancer
- Being tested
- Paclitaxel, Paclitaxel + Carboplatin
- Keywords
- Ovarian Cancer, Neoadjuvant chemotherapy, Paclitaxel, Carboplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Paclitaxel 175mg/m2 administered intravenously, repeated every 21 days, for 3 to 4 cycles
Paclitaxel + CarboplatinDrug
Paclitaxel 175mg/m2 intravenous infusion; followed by carboplatin AUC 5~6 intravenous infusion; repeated every 21 days, for 3~4 courses.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Experimental | Paclitaxel 175mg/m2 intravenous infusion, repeated every 21 days, for 3 to 4 courses Receives: Drug: Paclitaxel |
| Paclitaxel + Carboplatin | Active comparator | Paclitaxel 175mg/m2 intravenous infusion; followed by carboplatin AUC 5~6 intravenous infusion; repeated every 21 days, for 3~4 courses Receives: Drug: Paclitaxel + Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a chemotherapy reaction score of 3 (CRS3)
Measured: Perioperative/Periprocedural
Incidence of grade 3-4 neutropenia
Measured: During the 2-year follow-up period, from the start of randomization to the patient's withdrawal from the study
Secondary outcomes (9)
Satisfactory tumor reduction rate
Measured: Perioperative/Periprocedural
R0 resection rate
Measured: Perioperative/Periprocedural
Surgical complexity
The measurement that will be used to assess this outcome measure is the Aletti Surgical Complexity Score (SCS), also known as the Surgical Complexity Scoring System for advanced ovarian cancer. This validated scoring system quantifies the complexity of cytoreductive surgery by assigning a weighted point value to specific surgical procedures performed within three anatomical compartments (upper abdomen, mid abdomen, and pelvis). Procedures such as bowel resection, diaphragmatic surgery, splenectomy, and extensive peritonectomy contribute to a total score, which categorizes the surgical effort as low, intermediate, or high complexity.
Measured: Perioperative/Periprocedural
Progression-free survival (PFS)
Measured: During the 2-year follow-up period, the time elapsed from the start of randomization to disease progression or death
Objective response rate (ORR)
Measured: During the 2-year follow-up period, from patient randomization to the tumor volume reduction reaching 30%
Incidence of platinum resistance in first recurrence
Measured: After the treatment, the disease recurred within 6 months
Overall survival (OS)
Measured: During the 2-year follow-up period, the time elapsed from randomization to death
Quality of Life (QoL)
Quality of Life, measured by the European Organisation for Research and Treatment of Life Questionnaire-Core 30 (EORTC QLQ-C30), version 3.0 (score range: 0-100; higher scores in global health status/functional scales indicate better quality of life, whereas higher scores in symptom scales indicate worse symptoms) and the ovarian cancer-specific module 28-item (QLQ-OV28) questionnaire. Data will be collected via paper-based questionnaires before treatment initiation and during treatment, and via paper-based questionnaires or telephone interviews during the survival follow-up period. The assessment will be terminated upon patient death, withdrawal of informed consent, or upon disease recurrence or metastasis (regardless of whether the randomly assigned treatment is discontinued).
Measured: During the 2-year follow-up period, from the beginning of randomization to the end of the study
Incidence of treatment-related adverse events (TRAEs)
Measured: During the 2-year follow-up period, from the time of randomization to the time when the patient was discharged from the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401654
- Sponsor's protocol ID
- SYSKY-2025-929-01
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy and Safety of Paclitaxel Monotherapy Versus Paclitaxel-Carboplatin Combination as Neoadjuvant Chemotherapy in Advanced Ovarian Cancer With High PARK2 Expression
- ClinicalTrials.gov ID
- NCT07401654
- Acronym / sponsor ID
- SYSKY-2025-929-01
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Neoadjuvant chemotherapy, Paclitaxel, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platinum-based neoadjuvant chemotherapy (NACT) followed by interval debulking surgery is a crucial treatment paradigm for advanced ovarian cancer. It can reduce tumor burden, increase the rate of R0 resection, and decrease surgical complications. The combination of paclitaxel and carboplatin is the standard NACT regimen for ovarian cancer; however, it has limitations: 1) The myelotoxicity of platinum agents may disrupt treatment continuity, and 2) Platinum-based NACT often induces the earlier development of platinum resistance. Therefore, there is a need to explore novel regimens that, while maintaining therapeutic efficacy, can reduce drug exposure and toxicity, delay platinum exposure, and postpone the onset of platinum resistance.
Previous research has revealed that PARK2 can degrade phosphorylated BCL2, thereby enhancing sensitivity to paclitaxel. We established a PARK2-based molecular classification and found that 57% of advanced ovarian cancer cases exhibit high PARK2 expression. Furthermore, ovarian cancers with high PARK2 expression are highly sensitive to paclitaxel. In these patients, a platinum-free paclitaxel regimen demonstrated superior progression-free survival compared to paclitaxel-platinum combination therapy. Based on these findings, we hypothesize that for PARK2-high advanced ovarian cancer, neoadjuvant chemotherapy with single-agent paclitaxel could reduce toxicity and delay premature platinum exposure while achieving efficacy comparable to the standard doublet regimen.
To test this scientific hypothesis, our team plans to conduct an exploratory clinical study. We will enroll patients with advanced, treatment-naive, surgically unresectable, PARK2-high ovarian cancer and randomize them into two cohorts: one receiving neoadjuvant single-agent paclitaxel and the other receiving neoadjuvant paclitaxel plus carboplatin. The study aims to evaluate the efficacy and safety of single-agent paclitaxel NACT in this specific patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Experimental | Drug: PaclitaxelPaclitaxel 175mg/m2 intravenous infusion, repeated every 21 days, for 3 to 4 courses |
| Paclitaxel + Carboplatin | Active comparator | Drug: Paclitaxel + CarboplatinPaclitaxel 175mg/m2 intravenous infusion; followed by carboplatin AUC 5~6 intravenous infusion; repeated every 21 days, for 3~4 courses |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Female patients aged 18-75 years.
- Histologically confirmed FIGO Stage III-IV high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer via laparotomy, laparoscopy, or core needle biopsy.
- Presence of at least one measurable lesion on CT/MRI, meeting at least one of the following conditions:
- High expression of the PARK2 gene in both tumor tissue and blood (Spatial Imaging [SI] score in tumor tissue ≥ 7).
- Expected survival time > 12 weeks.
Key exclusion criteria (16 listed)
- Individuals involved in the planning or conduct of this study.
- Patients concurrently participating in other clinical trials, using other investigational drugs, or receiving neoadjuvant therapies (chemotherapy/radiotherapy/immunotherapy/traditional Chinese medicine therapy).
- Known hypersensitivity or allergy to paclitaxel or carboplatin.
- Patients with dysphagia or gastrointestinal disorders that could affect drug absorption, distribution, metabolism, or excretion (ADME).
- Active symptomatic brain metastases requiring surgery, radiation, and/or corticosteroid therapy, or patients with clinical signs of spinal cord compression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelPaclitaxel 175mg/m2 administered intravenously, repeated every 21 days, for 3 to 4 cycles | Drug | Paclitaxel |
| Paclitaxel + CarboplatinPaclitaxel 175mg/m2 intravenous infusion; followed by carboplatin AUC 5~6 intravenous infusion; repeated every 21 days, for 3~4 courses. | Drug | Paclitaxel + Carboplatin |
Primary outcome
The proportion of patients with a chemotherapy reaction score of 3 (CRS3)
Time frame: Perioperative/Periprocedural
Incidence of grade 3-4 neutropenia
Time frame: During the 2-year follow-up period, from the start of randomization to the patient's withdrawal from the study
9 secondary outcomes
Satisfactory tumor reduction rate
Time frame: Perioperative/Periprocedural
R0 resection rate
Time frame: Perioperative/Periprocedural
Surgical complexity
Time frame: Perioperative/Periprocedural
Progression-free survival (PFS)
Time frame: During the 2-year follow-up period, the time elapsed from the start of randomization to disease progression or death
Objective response rate (ORR)
Time frame: During the 2-year follow-up period, from patient randomization to the tumor volume reduction reaching 30%
Incidence of platinum resistance in first recurrence
Time frame: After the treatment, the disease recurred within 6 months
Overall survival (OS)
Time frame: During the 2-year follow-up period, the time elapsed from randomization to death
Quality of Life (QoL)
Time frame: During the 2-year follow-up period, from the beginning of randomization to the end of the study
Incidence of treatment-related adverse events (TRAEs)
Time frame: During the 2-year follow-up period, from the time of randomization to the time when the patient was discharged from the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Paclitaxel + Carboplatin in people with Ovarian Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 23 inclusion and 16 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Huaiwu Lu, Ph.D (008618688395806, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with a chemotherapy reaction score of 3 (CRS3) (time frame: Perioperative/Periprocedural). 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?
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 10 Feb 2026.