Gastric CancerNCT05644249
PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer
A study testing Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy in people with Gastric Cancer and Peritoneal Carcinomatosis, run by Vilnius University at 2 sites in Lithuania.
Trial summary
Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Peritoneal Carcinomatosis
- What is being tested?
- Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesLithuania
- Study dates
- 1 Dec 2022to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;
- Age≥18;
- ECOG≤1;
- Patient willing to participate;
- Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.
Who cannot join
- Extra-abdominal metastases;
- Siewert I type gastroesophageal junction cancer;
- Mechanical bowel obstruction;
- Allergy to study drugs;
- History of previous intraperitoneal chemotherapy;
- Pregnancy of refusal for birth-control at least 6 months post-study treatment
Trial locations and contacts
2 sites in 1 country.
Lithuania2 sites
Nationa Cancer Institute
Vilnius, Vilniaus, 08406
Vilnius University hospital Santaros Klinikos
Vilnius, Vilniaus, 08661
About this study
Official title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases: Open-label, Single-arm, Multi-center Feasibility Study
Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.
Read the detailed description
This open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants. Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings. In case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. All patients will be followed up for 24 months.
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Being tested
- Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy
- Keywords
- Gastric cancer, Peritoneal carcinomatosis, PIPAC, FOLFOX, Bidirectional
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapyDrug
Also called PIPAC
Each course of combined treatment will start with PIPAC (a pressurized aerosol containing cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 diluted in NaCl 0.9% applied through the nebulizer inside the abdominal cavity during laparoscopy). Fourteen days afterward 2 cycles of systemic FOLFOX chemotherapy will be applied within 28 days. The interval between combined treatment courses will be 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental treatment | Experimental | Each patient will be scheduled for 3 courses of combined treatment: in total 3 PIPAC with cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 and 6 cycles of FOLFOX systemic chemotherapy. Receives: Drug: Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response according to RECIST v 1.1 after second PIPAC
Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after second PIPAC procedure
Measured: Day 7 after second PIPAC procedure (an average of 8 weeks after start of the study)
Secondary outcomes (10)
Objective tumor response according to RECIST v 1.1
Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after third PIPAC procedure
Measured: Day 7 after third PIPAC procedure (an average of 15 weeks after start of the study)
Compliance to treatment
Proportion of patients able to receive all anticipated treatment (3 PIPACs and 6 cycles of FOLFOX)
Measured: Through study completion, an average of 28 months
Postoperative complication assessed by Clavien-Dindo score
The number of patients with postoperative complications, defined and graded according to Clavien-Dindo classification
Measured: Through study completion, an average of 28 months
Peritoneal carcinomatosis index and histological regression according to peritoneal regression grading score (PRGS).
A pathologist blinded to clinical outcomes will evaluate histological tumor response using the Peritoneal Regression Grading Score (PRGS): 1-Complete regression without cancer cells; 2-higher response with prevalence of regressive phenomena and only a few residual cancer cells - PRGS; 3-minor response with prevalence of residual cancer cells and poor regressive phenomena; 4-no response to therapy without regressive phenomena.
A patient will be considered a responder if any reduction in the PRGS during subsequent biopsies will be recorded.
Measured: Through study completion, an average of 28 months
Ascites volume
The volume of ascites recorded at every PIPAC procedure.
Measured: Through study completion, an average of 28 months
Tumor markers
Ca19-9, carcinoembryonic antigen (CEA), Ca72-4 plasma levels measured at different time points.
Measured: Through study completion, an average of 28 months
Quality of life by EORTC questionnaires
Quality of life by EORTC questionnaires measured at different time points.
Measured: Through study completion, an average of 28 months
Overall survival
Time from start of the treatment to death
Measured: From treatment start to death, assessed up to 24 months
Progression-free survival
Time from start of the treatment to progression of the disease
Measured: From treatment start to death, assessed up to 24 months
Adverse events of chemotherapy drugs
The number of patients with toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 during the study period
Measured: Through study completion, an average of 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Martynas Luksta, Vilnius University
- Investigators
- Skaiste Tulyte, MD, Principal investigator, Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644249
- Sponsor's protocol ID
- V1
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luksta M, Bausys A, Bickaite K, Rackauskas R, Paskonis M, Luksaite-Lukste R, Ranceva A, Stulpinas R, Brasiuniene B, Baltruskeviciene E, Lachej N, Sabaliauskaite R, Bausys R, Tulyte S, Strupas K. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study. BMC Cancer. 2023 Oct 25;23(1):1032. doi: 10.1186/s12885-023-11549-z.
PubMed 37875869
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases: Open-label, Single-arm, Multi-center Feasibility Study
- ClinicalTrials.gov ID
- NCT05644249
- Acronym / sponsor ID
- V1
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Keywords
- Gastric cancer, Peritoneal carcinomatosis, PIPAC, FOLFOX, Bidirectional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos, National Cancer Institute (NCI)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Dec 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.
Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.
Detailed description
This open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants. Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings. In case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. All patients will be followed up for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental treatment | Experimental | Drug: Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapyEach patient will be scheduled for 3 courses of combined treatment: in total 3 PIPAC with cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 and 6 cycles of FOLFOX systemic chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;
- Age≥18;
- ECOG≤1;
- Patient willing to participate;
- Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.
Key exclusion criteria (6 listed)
- Extra-abdominal metastases;
- Siewert I type gastroesophageal junction cancer;
- Mechanical bowel obstruction;
- Allergy to study drugs;
- History of previous intraperitoneal chemotherapy;
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 Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapyAlso: PIPACEach course of combined treatment will start with PIPAC (a pressurized aerosol containing cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 diluted in NaCl 0.9% applied through the nebulizer inside the abdominal cavity during laparoscopy). Fourteen days afterward 2 cycles of systemic FOLFOX chemotherapy will be applied within 28 days. The interval between combined treatment courses will be 14 days. | Drug | Experimental treatment |
Primary outcome
Objective tumor response according to RECIST v 1.1 after second PIPAC
Time frame: Day 7 after second PIPAC procedure (an average of 8 weeks after start of the study)
Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after second PIPAC procedure
10 secondary outcomes
Objective tumor response according to RECIST v 1.1
Time frame: Day 7 after third PIPAC procedure (an average of 15 weeks after start of the study)
Compliance to treatment
Time frame: Through study completion, an average of 28 months
Postoperative complication assessed by Clavien-Dindo score
Time frame: Through study completion, an average of 28 months
Peritoneal carcinomatosis index and histological regression according to peritoneal regression grading score (PRGS).
Time frame: Through study completion, an average of 28 months
Ascites volume
Time frame: Through study completion, an average of 28 months
Tumor markers
Time frame: Through study completion, an average of 28 months
Quality of life by EORTC questionnaires
Time frame: Through study completion, an average of 28 months
Overall survival
Time frame: From treatment start to death, assessed up to 24 months
Progression-free survival
Time frame: From treatment start to death, assessed up to 24 months
Adverse events of chemotherapy drugs
Time frame: Through study completion, an average of 28 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 37875869Luksta M, Bausys A, Bickaite K, Rackauskas R, Paskonis M, Luksaite-Lukste R, Ranceva A, Stulpinas R, Brasiuniene B, Baltruskeviciene E, Lachej N, Sabaliauskaite R, Bausys R, Tulyte S, Strupas K. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study. BMC Cancer. 2023 Oct 25;23(1):1032. doi: 10.1186/s12885-023-11549-z.
- 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. This study is not recruiting at the moment.
Skaiste Tulyte, MD principal investigator
Vilnius University Hospital Santaros Klinikos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy in people with Gastric Cancer and Peritoneal Carcinomatosis, run by Vilnius University at 2 sites in Lithuania.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response according to RECIST v 1.1 after second PIPAC (time frame: Day 7 after second PIPAC procedure (an average of 8 weeks after start of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644249, which also lists 1 linked publication.
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 24 Sep 2025.