Epithelial Ovarian CancerNCT05236686
Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
A study testing Hepato-celiac lymphadenectomy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Hepato-celiac lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2022to Dec 2025
- Phase
- Interventional
- 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
- 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.
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- 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.
Who cannot join
- Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
- Low-grade carcinoma.
- Mucinous ovarian cancer.
- Infeasible complete resection according to preoperative evaluation
- Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.
- Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy.
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- Progression after neoadjuvant chemotherapy in primary settings.
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
- Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Libing Xiang, 862164041990 ext. 2801, xiang.libing@zs-hospital.sh.cn
Libing Xiang
About this study
Official title: 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
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.
Read the detailed description
This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).
- Being tested
- Hepato-celiac lymphadenectomy
- Keywords
- Ovarian Cancer, Surgery, Lymph Node Metastasis, Hepato-celiac Lymphadenectomy
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepato-celiac lymphadenectomyProcedure or surgery
Hepato-celiac lymphadenectomy in the treatment of epithelial ovarian cancer, with a maximum cytoreduction, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).
| Study group | Role | What they receive |
|---|---|---|
| Hepato-celiac lymphadenectomy | Experimental | This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy). Receives: Procedure: Hepato-celiac lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-years Non-Progression Rate
The proportion of patients without disease progression or death at 2 years after entry into the study.
Measured: Participants will be followed up to 2 years after randomization
Secondary outcomes (8)
Progression free survival
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Measured: Participants will be followed up to 24 months after randomization
Overall survival
The time from date of randomization until the date of death from any cause or last follow-up
Measured: Participants will be followed up to 60 months after randomization
Objective response rate
The proportion of patients who achieved complete response (CR) or partial response (PR)
Measured: Participants will be followed up to 24 months after randomization
Disease control rate
The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD)
Measured: Participants will be followed up to 24 months after randomization
Post-operative complications
Postoperative 30-day, 60-day and 90-day complications
Measured: Participants will be followed up to 90 days after randomization
Quality of life assessments (QLQ-C30)
Assessment of potential impact of first line treatment on functionality and well-being in patients by the EORTC core quality of life questionnaire (QLQ-C30, version 3.0).
Measured: Baseline; 6 months, 12 months and 24 months after randomization
Quality of life assessments (FACT-Q)
Assessment of potential impact of first line treatment on functionality and well-being in patients by functional assessment of cancer therapy-ovary (FACT-O, version 4).
Measured: Baseline; 6 months, 12 months and 24 months after randomization
Patterns of subsequent recurrence
The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc.
Measured: Participants will be followed up to 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start15 Feb 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Rongyu Zang, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236686
- Sponsor's protocol ID
- zsfud-GynOncol-005
- Status last verified
- Nov 2025
- First submitted
- 28 Jan 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05236686
- Acronym / sponsor ID
- zsfud-GynOncol-005
- Keywords
- Ovarian Cancer, Surgery, Lymph Node Metastasis, Hepato-celiac Lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Collaborators
- Fudan University
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Feb 2022 (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.
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.
Detailed description
This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepato-celiac lymphadenectomy | Experimental | Procedure: Hepato-celiac lymphadenectomyThis single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
- Low-grade carcinoma.
- Mucinous ovarian cancer.
- Infeasible complete resection according to preoperative evaluation
- Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.
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 |
|---|---|---|
| Hepato-celiac lymphadenectomyHepato-celiac lymphadenectomy in the treatment of epithelial ovarian cancer, with a maximum cytoreduction, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy). | Procedure or surgery | Hepato-celiac lymphadenectomy |
Primary outcome
2-years Non-Progression Rate
Time frame: Participants will be followed up to 2 years after randomization
The proportion of patients without disease progression or death at 2 years after entry into the study.
8 secondary outcomes
Progression free survival
Time frame: Participants will be followed up to 24 months after randomization
Overall survival
Time frame: Participants will be followed up to 60 months after randomization
Objective response rate
Time frame: Participants will be followed up to 24 months after randomization
Disease control rate
Time frame: Participants will be followed up to 24 months after randomization
Post-operative complications
Time frame: Participants will be followed up to 90 days after randomization
Quality of life assessments (QLQ-C30)
Time frame: Baseline; 6 months, 12 months and 24 months after randomization
Quality of life assessments (FACT-Q)
Time frame: Baseline; 6 months, 12 months and 24 months after randomization
Patterns of subsequent recurrence
Time frame: Participants will be followed up to 24 months after randomization
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Rongyu Zang study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepato-celiac lymphadenectomy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 1 site in China.
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 14 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Libing Xiang (862164041990 ext. 2801, xiang.libing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-years Non-Progression Rate (time frame: Participants will be followed up to 2 years after randomization). 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 19 Nov 2025.