New combo therapy targets abdominal cancer spread in early trial
NCT ID NCT07453875
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new treatment plan for people with stomach or colorectal cancer that has spread to the lining of the abdomen. The approach combines low-dose radiation to the whole abdomen with chemotherapy and an immunotherapy drug. The main goal is to check if the treatment is safe and tolerable. About 9 to 18 participants will take part at one hospital in China.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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: 1. Age between18 and 75 years old. 2. Histologically confirmed gastric cancer/colon cancer, and diagnosed as peritoneal metastasis of tumor through laparoscopy/puncture (patients must have metastatic tumors located within the peritoneal cavity). 3. An Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, patients must have measurable disease within the irradiated area. 5. Expected survival period≥3 months 6. Adequate cardiac function (Left Ventricular Ejection Fractions \> 50%), hepatic function (total serum bilirubin ≤ 1.5 ×upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate \> 60 ml/min, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 109 cells per L). 7. Sign the informed consent and have good compliance. Exclusion Criteria: 1. Presence of distant metastasis other than peritoneal metastasis (ovarian metastasis is allowed); 2. Presence of uncontrolled clinical symptoms or diseases of the heart, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain uncontrolled after clinical intervention; 3. Upper gastrointestinal obstruction or physiological dysfunction, or suffering from malabsorption syndrome, which may affect the absorption of oral drugs; 4. Severe infection (CTCAE \> grade 2) or other concomitant diseases within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging shows active pulmonary inflammation, or symptoms and signs of infection within 14 days before the first use of the study drug, or requiring oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics; active pulmonary tuberculosis infection is found through medical history or CT examination, or there is a history of active pulmonary tuberculosis within 1 year before enrollment, or there is a history of active pulmonary tuberculosis more than 1 year ago but without regular treatment; 5. History of immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation or allogeneic bone marrow transplantation); 6. Moderate or severe renal impairment (creatinine clearance ≤ 50 ml/min); 7. Allergy to paclitaxel, oxaliplatin, monoclonal antibodies or any component of the study drug; 8. Pregnant or lactating women; 9. Presence of clinically detectable second primary malignancy, or a history of other malignancies within 5 years, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and superficial bladder tumors (non-invasive tumors, or carcinoma in situ, or T1); 10. Uncontrolled epilepsy, central nervous system disease or mental disorder, as judged by the investigator to be clinically significant enough to prevent signing the informed consent or affect the patient's compliance with drug treatment.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Army Medical Center
Chongqing, Chongqing Municipality, 400042, China
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Daping Hospital, Army Medical University
Chongqing, Chongqing Municipality, 400042, China
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