New way to deliver chemo for stomach cancer shows promise in early trial
NCT ID NCT04220827
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing the safety and best dose of the chemotherapy drug paclitaxel when given directly into the abdomen (intraperitoneal) for people with advanced stomach or gastroesophageal cancer that has spread to the lining of the abdomen. The study involves 27 participants and aims to find the highest safe dose while monitoring side effects. If successful, this approach could offer a more targeted treatment option for this hard-to-treat cancer.
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 could lead to a safer, more effective way to deliver chemotherapy directly to the abdomen for advanced gastric cancer patients.
- What could go wrong
- This is a very early phase I trial with only 27 participants, so the main goal is safety, not effectiveness. The cancer is advanced and hard to treat, so even if the drug is safe, it may not improve outcomes.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
27 people
The number who actually took part.
- Started
-
Dec 2019
- Expected to finish
-
Oct 2028
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 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 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: * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction * Leukocytes \>= 3,000/uL * Absolute neutrophil count \>= 1,500/uL * Platelets \>= 60,000/Ul * Serum creatinine =\< 1.5 mg/dL * Distant metastatic disease of peritoneum: * Positive peritoneal cytology * Carcinomatosis on diagnostic laparoscopy or laparotomy * Completion of preoperative systemic chemotherapy Exclusion Criteria: * Infections such as pneumonia or wound infections that would preclude protocol therapy * Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who are not postmenopausal defined as no menses in greater than or equal to 12 months, have not had a hysterectomy or bilateral salpingo-ophorectomy, do not have ovarian failure, or have not had a surgical sterilization procedure) must agree to refrain from breast-feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence. Men with reproductive potential must agree to an appropriate method of birth control, including abstinence or double barrier method (diaphragm plus condom) * Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure * Subjects deemed unable to comply with study and/or follow-up procedures * Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity * Previous surgery that would preclude safe diagnostic laparoscopy with port placement
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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
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Chemotherapy sprayed directly into the abdomen: a new attack on stubborn cancers
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