Stomach cancer trial combines Belly-Infused chemo with standard drugs
NCT ID NCT04762953
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
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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
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Feb 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868, United States
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Other studies related to the condition(s) this trial covers.
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