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Stomach cancer trial combines Belly-Infused chemo with standard drugs

NCT ID NCT04762953

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests a combination of chemotherapy drugs for stomach cancer that has spread to the lining of the abdomen. About 40 adults will receive standard intravenous chemo plus paclitaxel infused directly into the abdomen. The goal is to see if this approach improves how long the cancer stays under control and to check for side effects.

What this could mean

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

Active substance
Paclitaxel (given into the abdomen and through a vein), plus leucovorin and fluorouracil (5-FU) through a vein
What this could lead to
If it works, this could offer a new treatment option for stomach cancer that has spread to the lining of the abdomen, potentially slowing the disease and improving survival.
What could go wrong
This is a small, early-phase (Phase II) trial with only 40 participants, so results may not apply to everyone. The treatment involves strong chemotherapy, which can cause serious side effects.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Started

Feb 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

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.

Inclusion Criteria: * Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma and have received a minimum of three months of first line systemic treatment without visceral metastatic progression * Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy * Age ≥ 18 -75 years * Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed is attributed to malignancy (rather than comorbidities) * Life expectancy of greater than 6 months * Adequate organ and marrow function as defined below: 1. Leukocytes: ≥ 2,000/mcL 2. Absolute Neutrophil Count: ≥ 1,500/mcL 3. Platelets: ≥ 80,000/mcL 4. Total Bilirubin: within normal institutional limits 5. AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal 6. Creatinine: \< 1.5 X institutional upper limit of normal 7. Hemoglobin: \> 8.0 g/dL (may be transfused) 8. Serum albumin: ≥ g/dL * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Systemic treatment for unresectable or metastatic disease for more than three months prior to enrollment * Any evidence of distant, solid organ metastases (visceral (liver, lung, brain), bone, extra-abdominal) * Any evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy * Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy * Uncontrolled intercurrent illness including, but not limited to, the following conditions: 1. Ongoing or active infection 2. Symptomatic congestive heart failure 3. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment 4. Unstable angina pectoris 5. Cardiac arrhythmia * History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy. * Inability to comply with study and follow-up procedures as judged by the Investigator * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Has an active infection requiring systemic therapy. * Prior surgery that would preclude safe diagnostic laparoscopy and port placement * Has a known history of active tuberculosis (TB; Bacillus tuberculosis). * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.