Gastric Cancer Peritoneal MetastasesPhase 3IPa-GastricNCT07304271
Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis
A Phase 3 study testing Intraperitoneal Paclitaxel and Standard systemic therapy in people with Gastric Cancer Peritoneal Metastases, run by Magnus Nilsson at 7 sites in 3 countries.
Trial summary
The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Peritoneal Metastases
- What is being tested?
- Intraperitoneal Paclitaxel and Standard systemic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 5 Nov 2025to 31 Jan 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
- Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
- Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.
- Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy.
- Adequate hematology assessment and serum chemistry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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- Age of at least 18 years
- Life expectancy of at least three months
- Assurance that adequate anti-reproductive measures will be taken during study interventions when applicable
Who cannot join
- Comorbidity that does not allow treatment with ST or IP paclitaxel
- Confirmed or suspected severe abdominal adhesions
- Severe coagulation disorder which precludes surgical interventions
- Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases
- Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term
- Peritoneal recurrence of gastric cancer diagnosed within 6 months after curative intent surgery
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- Previously received more than 2 cycles of palliative-intent systemic chemotherapy (with the specific exception of cytology positive patients without manifest peritoneal metastases) for the current gastric cancer (up to 2 cycles of first line chemotherapy is allowed). Perioperative chemotherapy within previous curative context is allowed
- Another malignancy that can affect survival within the next three years
- Known or suspected allergies against any product included in the trial interventions
- DYPD deficiency
- Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding
- Active sex-life without use of secure contraceptive method.
- If the investigator considers the patient inappropriate for participation in the study for any other reason
- Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Sweden5 sites, 5 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg, 413 46
Mia Johansson, MD, PhD, +46313421000, mia.i.johansson@vgregion.se
Mia Johansson, MD, PhD
- Not yet recruiting
Skane University Hospital
Lund, SE-222 42
Karolina Granfelt Boman, MD, PhD, +46-46-17 10 00, Karolina.GranfeltBoman@skane.se
Karolina Granfelt Boman, MD, PhD
- Not yet recruiting
Örebro University Hospital
Örebro, SE-701 85
Ida Lagstam, MD, PhD, +49196021000, ida.lagstam@regionorebrolan.se
Ida Lagstam, MD, PhD
- Recruiting
Karolinska University Hospital
Stockholm, 171 76
Lisa Liu Burström, MD, PhD, +46 8 123 700 00, lisa.liu-burstrom@regionstockholm.se
Lisa Liu Burström, MD, PhD
- Recruiting
Uppsala University Hospital
Uppsala, SE-751 85
Tanweera Khan, MD, PhD, +46186110000, tanweera.khan@akademiska.se
Tanweera Khan, MD, PhD
Italy1 site, 1 recruiting
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Maria Bencivenga, MD, PhD, +390458121111, maria.bencivenga@univr.it
Bencivenga, maria.bencivenga@univr.it
Netherlands1 site, 1 recruiting
- Not yet recruiting
Amsterdam University Medical Center
Amsterdam, 1081
Hanneke W.M van Laarhoven, MD, PhD, +31 20 444 4444, h.vanlaarhoven@amsterdamumc.nl
Hanneke W.M. van Laarhoven, MD, PhD
About this study
Official title: Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastases - IPa-Gastric
The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.
- Conditions
- Gastric Cancer Peritoneal Metastases
- Being tested
- Intraperitoneal Paclitaxel, Standard systemic therapy
- Keywords
- Gastric cancer, Peritoneal metastasis, Intraperitoneal administration
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal PaclitaxelDrug
Intraperitoneally administered Paclitaxel
Standard systemic therapyDrug
Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting
| Study group | Role | What they receive |
|---|---|---|
| Standard systemic therapy | Active comparator | The control arm treatment in the study will consist of standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting Receives: Drug: Standard systemic therapy |
| Intraperitoneal paclitaxel + Standard systemic therapy | Experimental | The experimental arm treatment will consist of the same standard systemic investigator's choice treatment described above combined with IP paclitaxel. Receives: Drug: Intraperitoneal Paclitaxel; Drug: Standard systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (OS), defined as time from randomisation to death from any cause. For subjects who are still alive at the End of Study (EoS), or who are lost to follow up, OS time will be censored at the last recorded date that the subject was known to be alive.
Measured: Assessed every second month from randomization until study completion, during a maximum of 60 months.
Secondary outcomes (8)
Treatment-related toxicity
Incidence of Adverse Events (AE) as assessed by CTCAE v5.0
Measured: Assessed continously from start of treatment until 4 weeks after end of treatment for respective participant, during a maximum of 61 months.
General Health Related Quality of Life (HR QoL)
General Health Related Quality of Life (HR QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30. Two types of scores will be calculated: raw scores and linearly transformed scores.
Measured: Assessed at baseline and 2, 4, 6, 12 and 24 months after randomisation
Progression free survival (PFS)
PFS is defined as time from randomisation to first documentation of progression according to RECIST1.1, progression of peritoneal carcinomatosis index (PCI), radiological progression of ascites, need for drainage of ascites or death, whichever occurs first.
Measured: Assessed from randomization until study completion, during a maximum of 60 months.
Radiological response of treatment on ascites present at baseline.
Observed and change from baseline values will be summarized descriptively at planned visits by treatment. A mixed-effects model repeated measures (MMRM) analysis will evaluate longitudinal change from baseline. The baseline score will be included as a covariate.
Measured: Assessed from baseline visit until study completion, during a maximum of 60 months.
Paracentesis of ascites
Time from randomisation to first paracentesis of ascites
Measured: Assessed from randomization until study completion, during a maximum of 60 months.
Amount of ascites drained
The sum of the volume drained from each patient from the date of randomisation to date of death, censoring or end of study
Measured: Assessed from time of randomisation to study completion, during a maximum of 60 months.
Proportion of patients fulfilling the criteria for curative intent conversion surgery.
Criteria for conversion surgery are 1. CYT- at two consecutive sampling occasions, 2. No signs of progression on radiology, 3. No macroscopic peritoneal disease visible at new staging laparoscopy, 4. Discussion at MDT with conversion surgery considered feasible.
Measured: Assessed from randomisation until study completion, during a maximum of 60 months.
The proportion of patients undergoing conversion surgery
The proportion of patients actually undergoing conversion surgery
Measured: Assessed from randomisation until study completion, during a maximum of 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start5 Nov 2025
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Peritoneal MetastasesStudies 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
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magnus Nilsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Magnus Nilsson, Karolinska University Hospital
- Investigators
- Magnus Nilsson, MD, Professor, Study director, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304271
- Sponsor's protocol ID
- 2024-514879-17-00
- Acronym
- IPa-Gastric
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A plan for IPD sharing will be added later
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastases - IPa-Gastric
- ClinicalTrials.gov ID
- NCT07304271
- Acronym / sponsor ID
- IPa-Gastric / 2024-514879-17-00
- Conditions
- Gastric Cancer Peritoneal Metastases
- Keywords
- Gastric cancer, Peritoneal metastasis, Intraperitoneal administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Magnus NilssonUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 26 Dec 2025 (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 most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard systemic therapy | Active comparator | Drug: Standard systemic therapyThe control arm treatment in the study will consist of standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting |
| Intraperitoneal paclitaxel + Standard systemic therapy | Experimental | Drug: Intraperitoneal Paclitaxel, Drug: Standard systemic therapyThe experimental arm treatment will consist of the same standard systemic investigator's choice treatment described above combined with IP paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
- Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
- Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.
- Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy.
- Adequate hematology assessment and serum chemistry
Key exclusion criteria (14 listed)
- Comorbidity that does not allow treatment with ST or IP paclitaxel
- Confirmed or suspected severe abdominal adhesions
- Severe coagulation disorder which precludes surgical interventions
- Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases
- Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term
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 |
|---|---|---|
| Intraperitoneal PaclitaxelIntraperitoneally administered Paclitaxel | Drug | Intraperitoneal paclitaxel + Standard systemic therapy |
| Standard systemic therapyStandard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting | Drug | Intraperitoneal paclitaxel + Standard systemic therapy, Standard systemic therapy |
Primary outcome
Overall survival (OS)
Time frame: Assessed every second month from randomization until study completion, during a maximum of 60 months.
Overall survival (OS), defined as time from randomisation to death from any cause. For subjects who are still alive at the End of Study (EoS), or who are lost to follow up, OS time will be censored at the last recorded date that the subject was known to be alive.
8 secondary outcomes
Treatment-related toxicity
Time frame: Assessed continously from start of treatment until 4 weeks after end of treatment for respective participant, during a maximum of 61 months.
General Health Related Quality of Life (HR QoL)
Time frame: Assessed at baseline and 2, 4, 6, 12 and 24 months after randomisation
Progression free survival (PFS)
Time frame: Assessed from randomization until study completion, during a maximum of 60 months.
Radiological response of treatment on ascites present at baseline.
Time frame: Assessed from baseline visit until study completion, during a maximum of 60 months.
Paracentesis of ascites
Time frame: Assessed from randomization until study completion, during a maximum of 60 months.
Amount of ascites drained
Time frame: Assessed from time of randomisation to study completion, during a maximum of 60 months.
Proportion of patients fulfilling the criteria for curative intent conversion surgery.
Time frame: Assessed from randomisation until study completion, during a maximum of 60 months.
The proportion of patients undergoing conversion surgery
Time frame: Assessed from randomisation until study completion, during a maximum of 60 months.
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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided. A plan for IPD sharing will be added later
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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.
Magnus Nilsson, MD, Professor study director
Karolinska University Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intraperitoneal Paclitaxel and Standard systemic therapy in people with Gastric Cancer Peritoneal Metastases, run by Magnus Nilsson at 7 sites in 3 countries.
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 9 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Italy, Netherlands. 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 Magnus Nilsson, MD, Professor (+46 8 123 800 00, magnus.nilsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Assessed every second month from randomization until study completion, during a maximum of 60 months.). 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 7 Jul 2026.