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Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis

NCT ID: NCT07304271

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2031-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Peritoneal Metastases

Keywords

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Gastric cancer Peritoneal metastasis Intraperitoneal administration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Standard systemic therapy

Intervention Type DRUG

Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting

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.

Group Type EXPERIMENTAL

Intraperitoneal Paclitaxel

Intervention Type DRUG

Intraperitoneally administered Paclitaxel

Standard systemic therapy

Intervention Type DRUG

Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting

Interventions

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Intraperitoneal Paclitaxel

Intraperitoneally administered Paclitaxel

Intervention Type DRUG

Standard systemic therapy

Standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Magnus Nilsson

OTHER

Sponsor Role lead

Responsible Party

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Magnus Nilsson

Head of the Division of Surgery and Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Magnus Nilsson, MD, Professor

Role: STUDY_DIRECTOR

Karolinska University Hospital

Locations

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Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status NOT_YET_RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status NOT_YET_RECRUITING

Örebro University Hospital

Örebro, , Sweden

Site Status NOT_YET_RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Italy Sweden

Central Contacts

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Magnus Nilsson, MD, Professor

Role: CONTACT

Phone: +46 8 123 800 00

Email: [email protected]

Lisa Liu Burström, MD, PhD

Role: CONTACT

Phone: +46 8 123 700 00

Email: [email protected]

Facility Contacts

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Maria Bencivenga, MD, PhD

Role: primary

Bencivenga

Role: backup

Mia Johansson, MD, PhD

Role: primary

Ida Lagstam, MD, PhD

Role: primary

Lisa Liu Burström, MD, PhD

Role: primary

Jakob Hedberg, MD, PhD

Role: primary

Hedberg

Role: backup

Other Identifiers

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2024-514879-17-00

Identifier Type: -

Identifier Source: org_study_id