Using immune checkpoint inhibitors and zoledronic acid to treat malignant ascites in gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of intraperitoneal injections of immune checkpoint inhibitors combined with zoledronic acid for treating malignant ascites in patients with gastric adenocarcinoma. The study consists of two phases: a Phase Ib safety study using a '3+3' drug-escalation design to determine the safe dosage, followed by a Phase II efficacy study designed using Simon's two-stage approach. The goal is to assess how well this combination therapy works in managing malignant ascites associated with gastric cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.