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Chemotherapy directly into the belly: a new hope for advanced stomach cancer?

NCT ID NCT07001748

Disease control Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study tests whether giving the chemotherapy drug paclitaxel directly into the abdominal cavity, along with standard intravenous chemo, can help people with stomach cancer that has spread to the lining of the abdomen. About 148 adults with this condition will be randomly assigned to receive either standard chemo alone or standard chemo plus intraperitoneal paclitaxel. The goal is to see if the combination delays cancer growth and helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
paclitaxel
What this could lead to
If successful, this approach could become a new standard treatment to delay cancer growth and extend survival for people with gastric cancer that has spread to the abdominal lining.
What could go wrong
This is an early-to-mid stage trial with only 148 participants, so results may not apply broadly. Adding intraperitoneal therapy carries risks like infection, catheter problems, and abdominal pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 148 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

STEP 0 REGISTRATION: * Patient must be at least 18 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H/dMMR) mismatch repair deficient disease are not eligible * Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment * Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic laparoscopy procedure followed by further systemic and intraperitoneal therapy * Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy * Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration * Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy * Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy * Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement * Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better * Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous * Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin * Leukocytes ≥ 2,000/uL (≤ 30 days prior to Step 0 registration) * Absolute neutrophil count (ANC) ≥ 1,500/uL (≤ 30 days prior to Step 0 registration) * Platelets ≥ 75,000/uL (≤ 30 days prior to Step 0 registration) * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be \< 2.0 mg/dL (≤ 30 days prior to Step 0 registration) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0 registration) * Creatinine clearance ≥ 30 mL/min (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration) * Hemoglobin ≥ 8 g/dL (≤ 30 days prior to Step 0 registration) * Serum albumin ≥ 2.5 g/dL (≤ 30 days prior to Step 0 registration) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible STEP 1 RANDOMIZATION: * Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained * The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available * Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal junction adenocarcinoma peritoneal carcinomatosis peritoneal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric adenocarcinoma Gastroesophageal junction adenocarcinoma Peritoneal carcinomatosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    78 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Drexel Town Square Health Center

    RECRUITING

    Oak Creek, Wisconsin, 53154, United States

  • Emory Saint Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Froedtert Menomonee Falls Hospital

    RECRUITING

    Menomonee Falls, Wisconsin, 53051, United States

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    RECRUITING

    West Bend, Wisconsin, 53095, United States

  • Froedtert and MCW Moorland Reserve Health Center

    RECRUITING

    New Berlin, Wisconsin, 53151, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    New York, New York, 10016, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center - Weston

    RECRUITING

    Weston, Wisconsin, 54476, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Hospital East

    RECRUITING

    Shiloh, Illinois, 62269, United States

  • Memorial Sloan Kettering Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    RECRUITING

    East White Plains, New York, 10604, United States

  • NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Old Irving Park

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Oak Brook

    RECRUITING

    Oak Brook, Illinois, 60523, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Parkland Memorial Hospital

    RECRUITING

    Dallas, Texas, 75235, United States

    Contact Email: •••••@•••••

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Sanford Roger Maris Cancer Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Christian Hospital

    RECRUITING

    St Louis, Missouri, 63136, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Saint Peters Hospital

    RECRUITING

    City of Saint Peters, Missouri, 63376, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center - Guilford

    RECRUITING

    Guilford, Connecticut, 06437, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center - Waterford

    RECRUITING

    Waterford, Connecticut, 06385, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center - Westerly

    RECRUITING

    Westerly, Rhode Island, 02891, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center at Greenwich

    RECRUITING

    Greenwich, Connecticut, 06830, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center at Long Ridge

    RECRUITING

    Stamford, Connecticut, 06902, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center-Fairfield

    RECRUITING

    Fairfield, Connecticut, 06824, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center-Trumbull

    RECRUITING

    Trumbull, Connecticut, 06611, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital-Derby Care Center

    RECRUITING

    Derby, Connecticut, 06418, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital-Torrington Care Center

    RECRUITING

    Torrington, Connecticut, 06790, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital-Waterbury Care Center

    RECRUITING

    Waterbury, Connecticut, 06708, United States

    Contact Email: •••••@•••••

  • Stanford Cancer Institute Palo Alto

    RECRUITING

    Palo Alto, California, 94304, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UCHealth University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    RECRUITING

    Irvine, California, 92612, United States

    Contact Email: •••••@•••••

  • UF Health Cancer Institute - Gainesville

    RECRUITING

    Gainesville, Florida, 32610, United States

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC-Passavant Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15237, United States

  • UT Southwestern Clinical Center at Richardson/Plano

    RECRUITING

    Richardson, Texas, 75080, United States

  • UT Southwestern Simmons Cancer Center - RedBird

    RECRUITING

    Dallas, Texas, 75237, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • University Medical Center New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Maryland/Greenebaum Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of North Carolina-Hillsborough Campus

    RECRUITING

    Hillsborough, North Carolina, 27278, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • West Michigan Cancer Center

    RECRUITING

    Kalamazoo, Michigan, 49007, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

  • Yale-New Haven Hospital North Haven Medical Center

    RECRUITING

    North Haven, Connecticut, 06473, United States

    Contact Email: •••••@•••••

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