Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis (IPa-Gastric)

December 12, 2025 updated by: Magnus Nilsson

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
262

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lisa Liu Burström, MD, PhD
  • Phone Number: +46 8 123 700 00
  • Email: lisa.liu@ki.se

Study Locations

  • Italy
      • Verona, Italy, 37126
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Bencivenga, MD, PhD
  • Sweden
      • Gothenburg, Sweden, 413 46
        • Not yet recruiting
        • Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Mia Johansson, MD, PhD
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • Lisa Liu Burström, MD, PhD
      • Uppsala, Sweden, SE-751 85
        • Not yet recruiting
        • Uppsala University Hospital
        • Principal Investigator:
          • Jakob Hedberg, MD, PhD
        • Contact:
        • Contact:
      • Örebro, Sweden, SE-701 85
        • Not yet recruiting
        • Orebro University Hospital
        • Contact:
        • Principal Investigator:
          • Ida Lagstam, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard systemic therapy
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
Drug: Standard systemic therapy
Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting
Experimental: Intraperitoneal paclitaxel + Standard systemic therapy
The experimental arm treatment will consist of the same standard systemic investigator's choice treatment described above combined with IP paclitaxel.
Drug: Standard systemic therapy
Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting
Drug: Intraperitoneal Paclitaxel
Intraperitoneally administered Paclitaxel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Assessed every second month from randomization until study completion, during a maximum of 60 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Incidence of Adverse Events (AE) as assessed by CTCAE v5.0
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
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.
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.
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.
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.
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.
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.
Time from randomisation to first paracentesis of ascites
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.
The sum of the volume drained from each patient from the date of randomisation to date of death, censoring or end of study
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.
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.
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.
The proportion of patients actually undergoing conversion surgery
Assessed from randomisation until study completion, during a maximum of 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Magnus Nilsson

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Magnus Nilsson, MD, Professor, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-514879-17-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A plan for IPD sharing will be added later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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