Metastatic Ovarian CarcinomaPhase 1PIPACOVANCT04811703
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
A Phase 1 study testing Combined PIPAC / IV chemotherapy treatment in people with Metastatic Ovarian Carcinoma and Peritoneal Carcinomatosis, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Ovarian Carcinoma, Peritoneal Carcinomatosis, Stage III Ovarian Cancer
- What is being tested?
- Combined PIPAC / IV chemotherapy treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesFrance
- Study dates
- 30 Jul 2021to Jan 2029
- Phase
- Phase 1
- 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 and ≤ 75 years;
- ECOG Performance Status 0-2;
- Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three cycles of carboplatin-paclitaxel that does not correspond to disease progression but is insufficient to allow complete cytoreductive surgery, as assessed by the investigators after multidisciplinary tumor board discussion and validation;
- Adequate hematological function:
- Absolute neutrophil count > 1,500/mm³ (or 1.5 × 10⁹/L);
- Hemoglobin ≥ 9.0 g/dL;
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- Platelet count > 100 × 10⁹/L;
- Adequate renal and hepatic function:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or estimated glomerular filtration rate ≥ 60 mL/min/1.73 m² (CKD-EPI equation);
- Total bilirubin ≤ 1.5 × ULN;
- AST and ALT ≤ 1.5 × ULN (≤ 5 × ULN in patients with liver metastases);
- No unstable medical conditions, including myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer disease, or any condition that could be worsened by the study treatment or impair compliance, as judged by the investigator;
- Written informed consent obtained prior to any study-specific procedures;
- Patient affiliated with a national health insurance system.
Who cannot join
- Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;
- Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel disease;
- Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;
- Contraindication to PIPAC procedures, including:
- Known hypersensitivity to cisplatin or other platinum compounds;
- Known hypersensitivity to doxorubicin or other anthracyclines or anthracenediones;
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- Cardiac disease with myocardial insufficiency;
- Uncontrolled coronary artery disease;
- Known hypersensitivity to sodium thiosulfate, sulfites, or any of its excipients;
- Administration of a live attenuated vaccine within 3 months prior to study treatment initiation or planned during the study;
- Pregnant or breastfeeding women;
- Individuals deprived of liberty, under guardianship, or subject to legal protection measures;
- Participation in another interventional research study with an ongoing exclusion period at inclusion, or in a study that could interfere with the results of the present study, as judged by the investigator;
- Inability to comply with study follow-up for geographical, social, or psychological reasons, as judged by the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Hôpital Claude Huriez - Chirurgie générale et digestive
Lille
Clarisse EVENO, MD, Clarisse.EVENO@CHRU-LILLE.FR
Clarisse EVENO, MD
- Recruiting
Hôpital Claude Huriez - Oncologie médicale
Lille
Anne PLOQUIN, MD, anne.ploquin@CHRU-LILLE.FR
Anne PLOQUIN, MD
- Recruiting
Hôpital de la Croix-Rousse
Lyon
Solene DE-TALHOUET, MD, 04 26 73 26 12 ext. +33, solene.de-talhouet@chu-lyon.fr
Solene DE-TALHOUET, MD
- Recruiting
Hôpital Lyon Sud - Chirurgie Digestive et Oncologique
Pierre-Bénite, 69495
Naoual BAKRIN, MD, 04 78 86 23 71, naoual.bakrin@chu-lyon.fr
Justine ARQUILLIERE, MD
- Recruiting
Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique
Pierre-Bénite
Naoual BAKRIN, MD, naoual.bakrin@chu-lyon.fr
Witold GERTYCH, MD
- Recruiting
Hôpital Lyon Sud - Oncologie Médicale
Pierre-Bénite
Naoual BAKRIN, MD, naoual.bakrin@chu-lyon.fr
Benoit YOU, MD
About this study
Official title: Phase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum
Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks).
Since the 7th amendment of the study, sodium thiosulfate as nephrtoxicity prevention has been administered concurrently with each PIPAC chemotherapy
Read more
The primary objective of the study is to determine the maximum tolerated dose (MDT).
During cycle 1, limiting dose toxicity must be collected as soon as it is known.
Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1.
The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial.
Secondary objectives are :
- to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy
- to describe the pharmacokinetic of the PIPAC chemotherapy
- to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment
- and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous).
Following the addition of sodium thiosulfate to the treatment regimen, an exploratory objective was added to assess its nephroprotective effects At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized..
In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.
- Conditions
- Metastatic Ovarian Carcinoma, Peritoneal Carcinomatosis, Stage III Ovarian Cancer, Stage III Fallopian Tube Cancer, Metastatic Malignant Neoplasm in the Peritoneum, Stage IIb Ovarian Cancer
- Being tested
- Combined PIPAC / IV chemotherapy treatment
- Keywords
- Dose escalation, Phase I study, Intravenous Chemotherapy, Intraperitoneal chemotherapy, PIPAC, RP2D, cytoreductive surgery, Ovarian epithelial cancer, peritoneal cancer, doxorubicin, cisplatin, CA-125 antigen, pharmacokinetic, Sodium thiosulfate
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined PIPAC / IV chemotherapy treatmentDrug
Addition of cisplatin-doxorubicin PIPAC sessions to carboplatin-paclitaxel systemic Chemotherapy Auxiliary treatment : Since amendment n°7,, sodium thiosufate thiosulfate as nephrtoxicity prevention during each PIPAC sessions
| Study group | Role | What they receive |
|---|---|---|
| Combined PIPAC / IV chemotherapy treatment | Experimental | Patients will undergo 3 cycles of combined chemotherapy consisting of PIPAC (cisplatin-doxorubicin, escalating doses) and systemic chemotherapy (paclitaxel-carboplatin, standard doses). The first patient will receive the lowest dose (doxorubicin 2.1 mg/m², cisplatin 10.5 mg/m²). Subsequent patients will receive the dose recommended by the CRM algorithm in the absence of dose-limiting toxicity. Eleven dose levels are planned, with escalation factors between 1 and 3. The maximum dose is doxorubicin 6.3 mg/m² and cisplatin 31.5 mg/m². Since amendment n°7, sodium thiosulfate 25% is administered with each PIPAC: 9 g/m² over 20 min concurrently with cisplatin at H0, then 12 g/m² over 6 h starting at H1. Intravenous chemotherapy doses are defined according to standard practice and previous treatments. Cycles last 28 days (PIPAC Day 1, systemic chemotherapy Day 8) and are repeated every 4 weeks for up to 3 cycles unless unacceptable toxicity occurs. Receives: Drug: Combined PIPAC / IV chemotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
Dose-limiting toxicities (DLTs) will be defined as any event occurring during the first treatment cycle and considered by the investigator as possibly related to treatment, according to NCI CTCAE v5.0. DLTs include: Grade 4 neutropenia (absolute neutrophil count <500/mm³ [0.5 × 10⁹/L]) lasting ≥7 consecutive days; Grade ≥3 neutropenia (absolute neutrophil count <1000/mm³ [1 × 10⁹/L]) associated with a temperature ≥38.5°C; Grade 4 thrombocytopenia (<25,000/mm³ platelets [25 × 10⁹/L]) or Grade 3 thrombocytopenia (<50,000/mm³ [50 × 10⁹/L]) associated with bleeding; Grade ≥3 non-hematological toxicity despite adequate medical intervention, excluding non-life-threatening toxicities such as alopecia or asymptomatic hypophosphatemia; and Grade ≥2 acute kidney injury according to the 2024 KDIGO classification, defined as at least a twofold increase in serum creatinine compared with baseline.
Measured: First cycle of combined chemotherapy = day 1 up to day 28 of the first cycle
Secondary outcomes (8)
Rate of complete surgical resection
Assessed during cytoreductive surgery by the Completeness Cytoreduction (CC) score after the 3 cycles of combined chemotherapy.
Complete cytoreduction refers to a CC-0 or CC-1 score whereas a CC-2 or 3 score is classified as incomplete ; CC-0 score indicates no evidence of macroscopic disease after cytoreduction, a CC-1 score indicates persisting microscopic disease (tumour nodules are < 2.5 mm), a CC-2 score indicates persisting macroscopic disease (residual tumour nodules between 2.5 mm and 2.5 cm) and finally a CC-3 score indicates tumour nodules > 2.5 cm or a confluence of unresected tumour.
Measured: During cytoreductive surgery performed at the end of cycle 3 of combined chemotherapy (each cycle is 28 days), and at a maximum of 12 weeks after the third cycle of PIPAC
Proportion of complete, partial or stabilized tumor response
Assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) criteria version 1.1, on thoracic abdominal pelvic imaging (scanner or MRI in case of contraindication).
Measured: After completing chemotherapy treatment, at 4 to 5 weeks after the third cycle of post PIPAC (each cycle is 28 days)
Peritoneal cancer index (PCI) evolution
PCI index will be evaluated under videosurveillance during laparoscopy. PCI is determined according to Sugarbaker, based on lesion size and distribution. Using a pictorial of the abdomen, each location of a 13 point list receives a peritoneal cancer grade ranging from 0 to 3. The counts for all 13 locations are then summarized as PCI.
Measured: At day 1 of the beginning of each cycle during PIPAC procedure, at 4 to 5 weeks post PIPAC cycle 3 (each cycle is 28 days) and during post-treatment laparoscopy and/or during cytoreductive surgery (12 weeks max post PIPAC cycle 3)]
Area under the curve (AUC) for plasma concentration of DOXORUBICIN and CISPLATIN
The plasma biodisponibility of the PIPAC doxorubicin and CISPLATIN (total and ultrafilterable platinum) chemotherapeutic compound will be assessed by reporting the Area under the plasma concentration- time curve.
Measured: During day 1 of the first cycle of PIPAC chemotherapy (at 0, 30 minute, 1 hour, 2 hours, 4 hours, 6 hours, 7/8 hours and 24 hours post PIPAC for the both chemotherapeutic compound and 48 hours only for DOXORUBICIN), each cycle being 28 days.
Change in CA-125 concentration
CA-125 evolution profile will be monitored during chemotherapy and before surgery of reevaluation at post-treatment visit. Then, mathematical modeling of CA-125 elimination rate KELIM will be calculated from individual CA-125 levels.
Measured: Pharmacokinetic blood samples for each cycle, each cycle being 28 days (at day 1 for PIPAC chemotherapy; at day 8 for systemic chemotherapy) and before post-treatment laparoscopy at 4-5 weeks after the third PIPAC)
Rates of adverse events and operative complications
Adverse events according to the NCI CTCAE v5.0 classification (including toxicities) and per- and post-operative complications according to the Clavien-Dindo classification.
Measured: Up to 8 months after inclusion
Evaluation of sodium thiosulfate-associated nephroprotection during PIPAC procedures : Change in serum creatinine levels
Serum creatinine levels will be measured before each treatment (PIPAC or intravenous chemotherapy) and after each PIPAC procedure.
Measured: From baseline to after each PIPAC procedure, assessed at the end of each treatment cycle (each cycle defined as 28 days), for up to 3 cycles
Evaluation of sodium thiosulfate-associated nephroprotection during PIPAC procedures : Change in estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) will be measured before each treatment (PIPAC or intravenous chemotherapy) and after each PIPAC procedure.
Measured: From baseline to after each PIPAC procedure, assessed at the end of each treatment cycle (each cycle defined as 28 days), for up to 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start30 Jul 2021
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine ARQUILLIERE, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811703
- Sponsor's protocol ID
- 69HCL20_0920
- Other IDs
- 2024-515996-37-00
- Acronym
- PIPACOVA
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum
- ClinicalTrials.gov ID
- NCT04811703
- Acronym / sponsor ID
- PIPACOVA / 69HCL20_0920
- Conditions
- Metastatic Ovarian Carcinoma, Peritoneal Carcinomatosis, Stage III Ovarian Cancer, Stage III Fallopian Tube Cancer, Metastatic Malignant Neoplasm in the Peritoneum, Stage IIb Ovarian Cancer
- Keywords
- Dose escalation, Phase I study, Intravenous Chemotherapy, Intraperitoneal chemotherapy, PIPAC, RP2D, cytoreductive surgery, Ovarian epithelial cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 23 Mar 2021 (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.
Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks).
Since the 7th amendment of the study, sodium thiosulfate as nephrtoxicity prevention has been administered concurrently with each PIPAC chemotherapy
The primary objective of the study is to determine the maximum tolerated dose (MDT).
During cycle 1, limiting dose toxicity must be collected as soon as it is known.
Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1.
The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial.
Secondary objectives are :
- to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy
- to describe the pharmacokinetic of the PIPAC chemotherapy
- to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment
- and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous).
Following the addition of sodium thiosulfate to the treatment regimen, an exploratory objective was added to assess its nephroprotective effects At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized..
In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined PIPAC / IV chemotherapy treatment | Experimental | Drug: Combined PIPAC / IV chemotherapy treatmentPatients will undergo 3 cycles of combined chemotherapy consisting of PIPAC (cisplatin-doxorubicin, escalating doses) and systemic chemotherapy (paclitaxel-carboplatin, standard doses). The first patient will receive the lowest dose (doxorubicin 2.1 mg/m², cisplatin 10.5 mg/m²). Subsequent patients will receive the dose recommended by the CRM algorithm in the absence of dose-limiting toxicity. Eleven dose levels are planned, with escalation factors between 1 and 3. The maximum dose is doxorubicin 6.3 mg/m² and cisplatin 31.5 mg/m². Since amendment n°7, sodium thiosulfate 25% is administered with each PIPAC: 9 g/m² over 20 min concurrently with cisplatin at H0, then 12 g/m² over 6 h starting at H1. Intravenous chemotherapy doses are defined according to standard practice and previous treatments. Cycles last 28 days (PIPAC Day 1, systemic chemotherapy Day 8) and are repeated every 4 weeks for up to 3 cycles unless unacceptable toxicity occurs. |
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 and ≤ 75 years;
- ECOG Performance Status 0-2;
- Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three cycles of carboplatin-paclitaxel that does not correspond to disease progression but is insufficient to allow complete cytoreductive surgery, as assessed by the investigators after multidisciplinary tumor board discussion and validation;
- Adequate hematological function:
- Adequate renal and hepatic function:
Key exclusion criteria (14 listed)
- Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;
- Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel disease;
- Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;
- Contraindication to PIPAC procedures, including:
- Known hypersensitivity to sodium thiosulfate, sulfites, or any of its excipients;
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 |
|---|---|---|
| Combined PIPAC / IV chemotherapy treatmentAddition of cisplatin-doxorubicin PIPAC sessions to carboplatin-paclitaxel systemic Chemotherapy Auxiliary treatment : Since amendment n°7,, sodium thiosufate thiosulfate as nephrtoxicity prevention during each PIPAC sessions | Drug | Combined PIPAC / IV chemotherapy treatment |
Primary outcome
Dose-limiting toxicities
Time frame: First cycle of combined chemotherapy = day 1 up to day 28 of the first cycle
Dose-limiting toxicities (DLTs) will be defined as any event occurring during the first treatment cycle and considered by the investigator as possibly related to treatment, according to NCI CTCAE v5.0. DLTs include: Grade 4 neutropenia (absolute neutrophil count <500/mm³ [0.5 × 10⁹/L]) lasting ≥7 consecutive days; Grade ≥3 neutropenia (absolute neutrophil count <1000/mm³ [1 × 10⁹/L]) associated with a temperature ≥38.5°C; Grade 4 thrombocytopenia (<25,000/mm³ platelets [25 × 10⁹/L]) or Grade 3 thrombocytopenia (<50,000/mm³ [50 × 10⁹/L]) associated with bleeding; Grade ≥3 non-hematological toxicity despite adequate medical intervention, excluding non-life-threatening toxicities such as alopecia or asymptomatic hypophosphatemia; and Grade ≥2 acute kidney injury according to the 2024 KDIGO classification, defined as at least a twofold increase in serum creatinine compared with baseline.
8 secondary outcomes
Rate of complete surgical resection
Time frame: During cytoreductive surgery performed at the end of cycle 3 of combined chemotherapy (each cycle is 28 days), and at a maximum of 12 weeks after the third cycle of PIPAC
Proportion of complete, partial or stabilized tumor response
Time frame: After completing chemotherapy treatment, at 4 to 5 weeks after the third cycle of post PIPAC (each cycle is 28 days)
Peritoneal cancer index (PCI) evolution
Time frame: At day 1 of the beginning of each cycle during PIPAC procedure, at 4 to 5 weeks post PIPAC cycle 3 (each cycle is 28 days) and during post-treatment laparoscopy and/or during cytoreductive surgery (12 weeks max post PIPAC cycle 3)]
Area under the curve (AUC) for plasma concentration of DOXORUBICIN and CISPLATIN
Time frame: During day 1 of the first cycle of PIPAC chemotherapy (at 0, 30 minute, 1 hour, 2 hours, 4 hours, 6 hours, 7/8 hours and 24 hours post PIPAC for the both chemotherapeutic compound and 48 hours only for DOXORUBICIN), each cycle being 28 days.
Change in CA-125 concentration
Time frame: Pharmacokinetic blood samples for each cycle, each cycle being 28 days (at day 1 for PIPAC chemotherapy; at day 8 for systemic chemotherapy) and before post-treatment laparoscopy at 4-5 weeks after the third PIPAC)
Rates of adverse events and operative complications
Time frame: Up to 8 months after inclusion
Evaluation of sodium thiosulfate-associated nephroprotection during PIPAC procedures : Change in serum creatinine levels
Time frame: From baseline to after each PIPAC procedure, assessed at the end of each treatment cycle (each cycle defined as 28 days), for up to 3 cycles
Evaluation of sodium thiosulfate-associated nephroprotection during PIPAC procedures : Change in estimated glomerular filtration rate (eGFR)
Time frame: From baseline to after each PIPAC procedure, assessed at the end of each treatment cycle (each cycle defined as 28 days), for up to 3 cycles
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 6 Oct 2026.
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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.
Justine ARQUILLIERE, MD principal investigator
Hospices Civils de Lyon
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combined PIPAC / IV chemotherapy treatment in people with Metastatic Ovarian Carcinoma and Peritoneal Carcinomatosis, run by Hospices Civils de Lyon at 6 sites in France.
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 14 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Justine ARQUILLIERE, MD (04 78 86 23 71 ext. +33, justine.arquilliere@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (time frame: First cycle of combined chemotherapy = day 1 up to day 28 of the first cycle). 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 6 Oct 2026.