Ovarian CancerPhase 3NCT07544030
A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Advanced Epithelial Ovarian Cancer
A Phase 3 study testing PIPAC in people with Ovarian Cancer, run by tongweihua at 1 site in China.
Trial summary
Evaluation Compared with traditional NACT, whether PIPAC can increase the incidence of CRS3 determines the rationality of choosing PIPAC. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- PIPAC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 10 Nov 2027
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high-grade serous adenocarcinoma (HGSOC) with FIGO stage IIIC-IVA.
- Age between 18 and 70.
- Patients were evaluated with Fagotti score and MD Anderson score. MD Anderson score was consistent with Fagotti score ≥ 8, which was evaluated as high tumor load, because the initial curative resection could not achieve R0 resection and NACT was selected; or patients could not tolerate the initial surgery due to severe complications and NACT was selected.
- Normal renal function (blood creatinine: 58-96 μmol/L).
- No bone marrow suppression (HBG ≥ 110 g/L, white blood cell count ≥ 4.0×109/L, neutropenia Granulocyte count greater than or equal to 2.0x109/L and platelet count greater than or equal to 100x109/L).
- Normal liver function (bilirubin 3.4-22.2 μmol/L, ALT 7-40 U/L, AST 13-35 U/L, AST/ALT≤ 1.5）。
- World Health Organization Performance status score (WHO score) 0-2 points.
Who cannot join
- 1) Patients with other malignancies or have received any form of chemotherapy, radiotherapy and targeted therapy for this disease in other hospitals.
- 2) Diagnose complete intestinal obstruction. 3) Subjects who rely entirely on parenteral nutrition. 4) Subjects with decompensated ascites; 5) Subjects with severe abdominal infection (peritonitis); 6) Subjects with extensive adhesions in the abdominal cavity; 7) Subjects who underwent tumor debulking surgery and gastrointestinal resection reconstruction simultaneously; 8) Subjects with portal vein thrombosis; 9) Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart Functional insufficiency, ejection fraction less than 50%, difficult to control hypertension, etc.); 10) Allergy to chemotherapy drugs in the past; 11) Patients with serious cardiopulmonary, liver and kidney, blood system or mental illness and drug abuse; 12) Expected life is less than 12 weeks. 13) Patients who have participated or are currently participating in other clinical trials within 3 months; 14）Other conditions that the researchers judged the patient to be unsuitable for inclusion.
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
The First Hospital of Jilin University
Changchun, Jilin, 130000
Zhentong Wei Medic, 15804300686, zhentongwei2009@163.com
About this study
Evaluation Compared with traditional NACT, whether PIPAC can increase the incidence of CRS3 determines the rationality of choosing PIPAC.
- Conditions
- Ovarian Cancer
- Being tested
- PIPAC
- Keywords
- Ovarian Cancer, PIPAC
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPACProcedure or surgery
This is a randomized, controlled, open, and parallel design clinical study aimed at evaluating the efficacy and safety of PIPAC. Sixty patients with stage IIIC-IVA high-grade serous ovarian cancer (HGSOC) were randomly assigned to either the traditional NACT or PIPAC group for treatment, and the incidence of CRS3 was then assessed. This study is exploratory, and statistical analysis will be conducted after all cases have been treated and followed up, providing a basis for future clinical studies.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The treatment group received PIPAC plus intravenous NACT (paclitaxel or docetaxel plus two cycles of carboplatin) Receives: Procedure: PIPAC |
| control group | No intervention | The control group received intravenous NACT (paclitaxel or docetaxel plus carboplatin for three cycles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can PIPAC increase the incidence of CRS3
The primary objective of this study is to evaluate whether PIPAC can increase the incidence of CRS3 compared to traditional NACT, thereby determining the rationale for choosing PIPAC. The main evaluation metric is derived from the CRS scoring system. According to the ICCR guidelines, the CRS score is obtained through pathological analysis of the peritoneal tissue collected during IDS.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start10 Nov 2025
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Nov 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- tongweihua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, tongweihua, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544030
- Sponsor's protocol ID
- 25K213-001
- Status last verified
- Nov 2025
- First submitted
- 21 Mar 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Advanced Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07544030
- Acronym / sponsor ID
- 25K213-001
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, PIPAC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- tongweihuaUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 22 Apr 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.
Evaluation Compared with traditional NACT, whether PIPAC can increase the incidence of CRS3 determines the rationality of choosing PIPAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: PIPACThe treatment group received PIPAC plus intravenous NACT (paclitaxel or docetaxel plus two cycles of carboplatin) |
| control group | No intervention | –The control group received intravenous NACT (paclitaxel or docetaxel plus carboplatin for three cycles) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with high-grade serous adenocarcinoma (HGSOC) with FIGO stage IIIC-IVA.
- Age between 18 and 70.
- Patients were evaluated with Fagotti score and MD Anderson score. MD Anderson score was consistent with Fagotti score ≥ 8, which was evaluated as high tumor load, because the initial curative resection could not achieve R0 resection and NACT was selected; or patients could not tolerate the initial surgery due to severe complications and NACT was selected.
- Normal renal function (blood creatinine: 58-96 μmol/L).
- No bone marrow suppression (HBG ≥ 110 g/L, white blood cell count ≥ 4.0×109/L, neutropenia Granulocyte count greater than or equal to 2.0x109/L and platelet count greater than or equal to 100x109/L).
Key exclusion criteria (2 listed)
- 1) Patients with other malignancies or have received any form of chemotherapy, radiotherapy and targeted therapy for this disease in other hospitals.
- 2) Diagnose complete intestinal obstruction. 3) Subjects who rely entirely on parenteral nutrition. 4) Subjects with decompensated ascites; 5) Subjects with severe abdominal infection (peritonitis); 6) Subjects with extensive adhesions in the abdominal cavity; 7) Subjects who underwent tumor debulking surgery and gastrointestinal resection reconstruction simultaneously; 8) Subjects with portal vein thrombosis; 9) Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart Functional insufficiency, ejection fraction less than 50%, difficult to control hypertension, etc.); 10) Allergy to chemotherapy drugs in the past; 11) Patients with serious cardiopulmonary, liver and kidney, blood system or mental illness and drug abuse; 12) Expected life is less than 12 weeks. 13) Patients who have participated or are currently participating in other clinical trials within 3 months; 14）Other conditions that the researchers judged the patient to be unsuitable for inclusion.
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 |
|---|---|---|
| PIPACThis is a randomized, controlled, open, and parallel design clinical study aimed at evaluating the efficacy and safety of PIPAC. Sixty patients with stage IIIC-IVA high-grade serous ovarian cancer (HGSOC) were randomly assigned to either the traditional NACT or PIPAC group for treatment, and the incidence of CRS3 was then assessed. This study is exploratory, and statistical analysis will be conducted after all cases have been treated and followed up, providing a basis for future clinical studies. | Procedure or surgery | experimental group |
Primary outcome
Can PIPAC increase the incidence of CRS3
Time frame: Two years
The primary objective of this study is to evaluate whether PIPAC can increase the incidence of CRS3 compared to traditional NACT, thereby determining the rationale for choosing PIPAC. The main evaluation metric is derived from the CRS scoring system. According to the ICCR guidelines, the CRS score is obtained through pathological analysis of the peritoneal tissue collected during IDS.
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 11 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PIPAC in people with Ovarian Cancer, run by tongweihua 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 7 inclusion and 2 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 11 May 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaosen Li Li (18343116682, xiaosensen@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can PIPAC increase the incidence of CRS3 (time frame: Two years). 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 11 May 2026.