NCT07572409

Brief Summary

The aim of this study is to investigate the efficacy and safety of enucleation of enlarged CPLNs in patients with advanced ovarian cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
49mo left

Started Jul 2026

Typical duration for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

April 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

April 30, 2026

Last Update Submit

May 6, 2026

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • RFS

    From the date of surgery until radiological confirmation of recurrence (RECIST 1.1) or death from any cause;

    experimental group 17.2 month

  • Recurrence-free survival (RFS)

    From the date of surgery until radiological confirmation of recurrence (RECIST 1.1) or death from any cause;

    9-17 month

Study Arms (1)

Study population

OTHER
Procedure: CPLN resection

Interventions

CPLN resectionPROCEDURE

Diaphragmatic angle lymph node dissection

Study population

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, where imaging indicates enlarged CPLNs (short axis ≥ 5 mm and/or PET-CT positive) and the short axis is ≤ 1 cm; 2. Residual intra-abdominal tumour measuring ≤ 1 cm following cytoreductive surgery; 3. Women aged 18-70 years who are not pregnant or breastfeeding; 4. ECOG performance status of 0 or 1; 5. Adequate organ function: white blood cell count ≥2.5×10⁹/L and neutrophil count ≥1.5×10⁹/L, haemoglobin ≥ 90 g/L, platelets ≥ 100 × 10⁹/L; serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; serum creatinine ≤ 1.5 times the normal value, creatinine clearance ≥ 60 ml/min; 6. Expected survival ≥ 6 months; 7. The patient fully understands this study, consents to CPLN resection, voluntarily participates in this clinical trial and has signed the informed consent form.

You may not qualify if:

  • \. Stage I or II epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; 2. Residual intra-abdominal tumour \> 1 cm following cytoreductive surgery; 3. Imaging showing CPLNs with a short axis \> 1 cm; 4. Imaging evidence of mediastinal lymph node metastasis outside the CPLNs; 5. Presence of other active malignant tumours within the past 5 years. Excludes locally cured tumours (e.g. basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or in situ breast cancer); 6. Concurrent presence of other severe, uncontrollable medical conditions (including atrial fibrillation, angina pectoris, heart failure, ejection fraction \<50%, uncontrolled hypertension, renal insufficiency, or uncontrolled infections); 7. Any unstable condition or circumstance that may compromise patient safety or compliance; 8. Currently receiving treatment with other anticancer drugs; 9. Refusal to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first hospital of JILIN UNIVERSITY

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

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

Central Study Contacts

Li XIAOSEN

CONTACT

+8618343116682xiaosen4019@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 7, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

May 7, 2026

Record last verified: 2026-04

Locations

CN(1)