Ovarian CancerPhase 2NCT06544460
Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients
A Phase 2 study testing Secondary cytoreduction and Hyperthermic intraperitoneal chemotherapy in people with Ovarian Cancer, run by Fudan University at 1 site in China.
Trial summary
At present, the treatment of recurrent ovarian cancer after PARP inhibitor therapy is quite challenging, and there is no research on the application of hyperthermic intraperitoneal chemotherapy(HIPEC) for the above-mentioned patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Secondary cytoreduction and Hyperthermic intraperitoneal chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to 31 Dec 2026
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- Maintain treatment with PARP inhibitors before recurrence;
- The imaging assessment is suitable, and the patient agrees to undergo further cytoreductive surgery;
- The outcome of recurrent surgery is R0 or R1 resection;
- Sign the informed consent form;
- Age≥18 years old;
Who cannot join
- Patients with ovarian cancer excluded by pathological or clinical diagnosis;
- Inappropriate imaging evaluation or physical intolerance for surgical patients;
- Isolated lymph node recurrence
- Patients who undergo unsatisfactory tumor reduction surgery (R2 resection) due to recurrence;
- Patients who are unwilling to participate in the clinical trial.
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
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer Patients With PARP Inhibitors Resistance: a Phase II Clinical Study
At present, the treatment of recurrent ovarian cancer after PARP inhibitor therapy is quite challenging, and there is no research on the application of hyperthermic intraperitoneal chemotherapy(HIPEC) for the above-mentioned patients. Therefore, this study aims to explore the safety and efficacy of secondary cytoreduction combined with hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer after maintenance therapy with PARP inhibitors through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the treatment options for ovarian cancer patients in the era of PARP inhibitors, thereby improving the overall treatment level and prognosis of ovarian cancer.
Read the detailed description
- Overall design This is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for recurrent ovarian cancer after maintenance therapy with PARP inhibitors.
- Sample size calculation This clinical trial aims to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for the maintenance treatment of recurrent ovarian cancer with PARP inhibitors. The median progression-free survival of patients who received maintenance therapy with PARP inhibitors in our center is 11 months. It is expected that HIPEC can reduce the risk of recurrence by 30%. After 1 year of enrollment and 2 years of follow-up, the alpha value is 0.05. Considering the participants who withdrew from the study midway or dropped out due to loss to follow-up, this study intends to include 94 participants.
- Methods Using the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument, after the surgical operation is completed, four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively. Connect all pipelines and preheat the instrument before starting treatment. The treatment temperature is controlled at 43 ℃± 0.1 ℃, the treatment time is 90 minutes, and the circulation pump flow rate is 400-600ml/min. Within 48 hours after the surgery, cisplatin 75mg/㎡ was added to 3000ml of physiological saline for intraperitoneal hot infusion.
- Data statistics Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
- Conditions
- Ovarian Cancer
- Being tested
- Secondary cytoreduction, Hyperthermic intraperitoneal chemotherapy
- Keywords
- ovarian cancer, hyperthermic intraperitoneal chemotherapy, secondary cytoreduction
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary cytoreductionProcedure or surgery
Repeated tumor cell reduction surgery for recurrent ovarian cancer patients
Hyperthermic intraperitoneal chemotherapyDrug
Using the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument, after the surgical operation is completed, four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively. Connect all pipelines and preheat the instrument before starting treatment. The treatment temperature is controlled at 43 ℃± 0.1 ℃, the treatment time is 90 minutes, and the circulation pump flow rate is 400-600ml/min. Within 48 hours after the surgery, cisplatin 75mg/㎡ was added to 3000ml of physiological saline for intraperitoneal hot infusion. Through the comprehensive effects of circulation flushing, hyperthermia, chemotherapy, and thermochemotherapy sensitization, it kills and removes residual cancer cells or small lesions in the abdominal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Ovarian Cancer After PARPi Therapy | Experimental | After treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery. Receives: Procedure: Secondary cytoreduction; Drug: Hyperthermic intraperitoneal chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: Two years
Secondary outcomes (1)
OS
Overall Survival
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 posted9 Aug 2024
- Study start31 Aug 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Wu MD [zzhong], Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544460
- Sponsor's protocol ID
- OCR-HIPEC-2024
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer Patients With PARP Inhibitors Resistance: a Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06544460
- Acronym / sponsor ID
- OCR-HIPEC-2024
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, hyperthermic intraperitoneal chemotherapy, secondary cytoreduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
At present, the treatment of recurrent ovarian cancer after PARP inhibitor therapy is quite challenging, and there is no research on the application of hyperthermic intraperitoneal chemotherapy(HIPEC) for the above-mentioned patients. Therefore, this study aims to explore the safety and efficacy of secondary cytoreduction combined with hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer after maintenance therapy with PARP inhibitors through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the treatment options for ovarian cancer patients in the era of PARP inhibitors, thereby improving the overall treatment level and prognosis of ovarian cancer.
Detailed description
- Overall design This is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for recurrent ovarian cancer after maintenance therapy with PARP inhibitors.
- Sample size calculation This clinical trial aims to evaluate the safety and efficacy of decellularization combined with intraperitoneal hyperthermic perfusion for the maintenance treatment of recurrent ovarian cancer with PARP inhibitors. The median progression-free survival of patients who received maintenance therapy with PARP inhibitors in our center is 11 months. It is expected that HIPEC can reduce the risk of recurrence by 30%. After 1 year of enrollment and 2 years of follow-up, the alpha value is 0.05. Considering the participants who withdrew from the study midway or dropped out due to loss to follow-up, this study intends to include 94 participants.
- Methods Using the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument, after the surgical operation is completed, four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively. Connect all pipelines and preheat the instrument before starting treatment. The treatment temperature is controlled at 43 ℃± 0.1 ℃, the treatment time is 90 minutes, and the circulation pump flow rate is 400-600ml/min. Within 48 hours after the surgery, cisplatin 75mg/㎡ was added to 3000ml of physiological saline for intraperitoneal hot infusion.
- Data statistics Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent Ovarian Cancer After PARPi Therapy | Experimental | Procedure: Secondary cytoreduction, Drug: Hyperthermic intraperitoneal chemotherapyAfter treated with PARP inhibitors, patients have recurrent ovarian cancer and need a surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with previously diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- Maintain treatment with PARP inhibitors before recurrence;
- The imaging assessment is suitable, and the patient agrees to undergo further cytoreductive surgery;
- The outcome of recurrent surgery is R0 or R1 resection;
- Sign the informed consent form;
Key exclusion criteria (5 listed)
- Patients with ovarian cancer excluded by pathological or clinical diagnosis;
- Inappropriate imaging evaluation or physical intolerance for surgical patients;
- Isolated lymph node recurrence
- Patients who undergo unsatisfactory tumor reduction surgery (R2 resection) due to recurrence;
- Patients who are unwilling to participate in the clinical trial.
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 |
|---|---|---|
| Secondary cytoreductionRepeated tumor cell reduction surgery for recurrent ovarian cancer patients | Procedure or surgery | Recurrent Ovarian Cancer After PARPi Therapy |
| Hyperthermic intraperitoneal chemotherapyUsing the BR-TQR-I intraperitoneal hyperthermic perfusion chemotherapy instrument, after the surgical operation is completed, four drainage tubes are placed in the left and right upper abdomen and lower abdomen respectively. Connect all pipelines and preheat the instrument before starting treatment. The treatment temperature is controlled at 43 ℃± 0.1 ℃, the treatment time is 90 minutes, and the circulation pump flow rate is 400-600ml/min. Within 48 hours after the surgery, cisplatin 75mg/㎡ was added to 3000ml of physiological saline for intraperitoneal hot infusion. Through the comprehensive effects of circulation flushing, hyperthermia, chemotherapy, and thermochemotherapy sensitization, it kills and removes residual cancer cells or small lesions in the abdominal cavity. | Drug | Recurrent Ovarian Cancer After PARPi Therapy |
Primary outcome
PFS
Time frame: Two years
Progression free survival
1 secondary outcome
OS
Time frame: Two years
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 9 Aug 2024.
- 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 2 study testing Secondary cytoreduction and Hyperthermic intraperitoneal chemotherapy in people with Ovarian Cancer, run by Fudan University 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Aug 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hao Wen (+86-021-64175590 ext. 81000, wenhao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (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 9 Aug 2024.