NCT07401654

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
19mo left

Started Jan 2026

Shorter than P25 for phase_2 ovarian-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

January 14, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 14, 2026

Last Update Submit

February 3, 2026

Conditions

Ovarian Cancer

Keywords

Ovarian CancerNeoadjuvant chemotherapyPaclitaxelCarboplatin

Outcome Measures

Primary Outcomes (2)

  • The proportion of patients with a chemotherapy reaction score of 3 (CRS3)

    Perioperative/Periprocedural

  • Incidence of grade 3-4 neutropenia

    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

    Perioperative/Periprocedural

  • R0 resection rate

    Perioperative/Periprocedural

  • Surgical complexity

    Perioperative/Periprocedural

  • Progression-free survival (PFS)

    During the 2-year follow-up period, the time elapsed from the start of randomization to disease progression or death

  • Objective response rate (ORR)

    During the 2-year follow-up period, from patient randomization to the tumor volume reduction reaching 30%

  • +4 more secondary outcomes

Study Arms (2)

Paclitaxel

EXPERIMENTAL

Paclitaxel 175mg/m2 intravenous infusion, repeated every 21 days, for 3 to 4 courses

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

Drug: Paclitaxel + Carboplatin

Interventions

PaclitaxelDRUG

Paclitaxel 175mg/m2 administered intravenously, repeated every 21 days, for 3 to 4 cycles

Paclitaxel
Paclitaxel + CarboplatinDRUG

Paclitaxel 175mg/m2 intravenous infusion; followed by carboplatin AUC 5\~6 intravenous infusion; repeated every 21 days, for 3\~4 courses.

Paclitaxel + Carboplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.
  • +8 more criteria

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

PaclitaxelCP protocol

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Huaiwu Lu, Ph.D

CONTACT

008618688395806luhuaiwu@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

February 10, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 10, 2026

Record last verified: 2026-01