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

Efficacy and Safety of Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids in Gastric Cancer Malignant Ascites: a Phase I/II Clinical Study (IPIZA)

This study is testing a new treatment that combines immune checkpoint inhibitors with zoledronic acid to see if it helps people with gastric cancer who have fluid buildup in their abdomen.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Drugs / interventions: immunotherapy, radiation
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06759064 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed gastric adenocarcinoma and malignant ascites.

Not a fit: Patients who have undergone recent local drug administration in the abdominal cavity or systemic immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from malignant ascites due to gastric cancer.

How similar studies have performed: While this approach is innovative, similar studies exploring immune checkpoint inhibitors in cancer treatment have shown promising results.

Eligibility criteria

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 this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Conditions Cancer of Stomach, Adenocarcinoma; Ascites, Malignant; gastric cancer; malignant ascites; Immune checkpoint inhibitors; zoledronic acid; intraperitoneal injection