NCT05236686Recruiting
Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
A Prospective, Multi-center, Single-Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Hepato-celiac Lymphadenectomy in the Treatment of Advanced and Recurrent Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 28 Jan 2022
- Start date
- 15 Feb 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Diseases
- Ovarian cancer
- NCT number
- NCT05236686
What you commit to
- Study type: Interventional
- Planned participants: 94
- From 15 Feb 2022 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infeasible complete resection according to preoperative evaluation
- Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy.
- Progression after neoadjuvant chemotherapy in primary settings.
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
Other illness
- Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
- Mucinous ovarian cancer.
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
- Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Other
- Low-grade carcinoma.
- Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.
Who the study is looking for
- Age ≥18 years to ≤ 75 years.
- Pathologic confirmed stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (EOC, PPC, FTC) or platinum sensitive, relapsed EOC, PPC or FTC (no more than 4 lines of therapy)
- Hepato-celiac lymph nodes metastases diagnosed by imaging before surgery and enlarged palpable lymph nodes by surgical findings
- Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation
- 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings
- Platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more.
- ASA score of 1 to 2
- ECOG performance status of 0 to 2
- Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
- White blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- Serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockcroft-Gault formula or to local lab measurement
- Serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL
- Comply with the study protocol and follow-up.
- Written informed consent.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.