New combo shot targets stomach cancer belly fluid
NCT ID NCT06759064
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injecting two drugs directly into the belly can help control fluid buildup (ascites) caused by stomach cancer. The drugs are sintilimab, which helps the immune system fight cancer, and zoledronic acid, which may slow cancer growth. The trial involves 24 adults with advanced stomach cancer and aims to find a safe dose and see if it shrinks the fluid.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab (immune checkpoint inhibitor) plus zoledronic acid
- What this could lead to
- If it works, this could offer a new way to control malignant ascites in gastric cancer, potentially improving comfort and survival.
- What could go wrong
- This is an early phase I/II trial with only 24 participants, so results may not apply broadly. Side effects from the drug combination could be serious.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Sep 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: * Gastric adenocarcinoma diagnosed pathologically; * Malignant ascites confirmed by ascites cytology; * Presence of ascites confirmed by CT with ascites graded as 2nd and 3rd degree (EASL guidelines and ICA consensus); * Those aged 18-75 years; * Patients who had not undergone local administration of drugs in the abdominal cavity and systemic immunotherapy within the previous 4 weeks; * Vital signs are stable, Karnofsky score (≥70), and expected survival time is \>3 months; * Normal bone marrow haematopoietic function, blood routine: HGB ≥90g/L, WBC ≥2.5×10\^9/L (NEU ≥1.5×10\^9/L), PLT ≥90×10\^9/L; * Normal coagulation function without bleeding tendency (International normalised ratio of prothrombinogen INR\<1.5); * Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); AST and ALT ≤2 times the upper limit of normal (ULN) (or ≤5 times the upper limit of normal (ULN) if the abnormalities are mainly due to tumour infiltration); * Renal function: Cr ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥60mL/min. Exclusion Criteria: * Non-malignant ascites (e.g., portal hypertension ascites or infected ascites); * Presence of contraindications to immunotherapy (including long-term hormone use, history of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.); * Combination of other serious cardiopulmonary diseases that affect the treatment, etc; * Patients with extensive abdominal adhesions; encapsulated peritoneal fluid; history of intestinal obstruction; and malignant patients with extensive distant metastases in the terminal stage; * Women who are breastfeeding, pregnant, or preparing for pregnancy; * Patients with plasma albumin (ALB) \<30 g/L and severe hypoproteinemia; * Patients with known hypersensitivity to components of the test drug or its analogues; * Patients with other severe, acute or chronic diseases that may interfere with the interpretation of the study results and who, in the judgement of the investigator, are unsuitable for participation in the clinical trial; * Patients with cognitive dysfunction, or poor treatment compliance as judged by the investigator; * Participants in other clinical trials within 4 weeks; * Combination of other malignancies; * Those who, in the opinion of the investigator, are not suitable for participation in the clinical trial.
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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
1 site. 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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Qilu Hospital of Shandong University
RECRUITINGJinan, Shandong, 250012, China
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