Safety and Effectiveness of Intraperitoneal Immune Checkpoint Inhibitors Combined with Zoledronic Acid for Malignant Ascites in Gastric Cancer Phase III Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining intraperitoneal injections of immune checkpoint inhibitors with zoledronic acid to treat malignant ascites in patients with gastric cancer. This phase IbII clinical trial aims to find a safe dose and then assess how well this treatment works for controlling malignant ascites, using a special two-stage design to guide the study phases. During the first phase phase Ib, patients receive increasing doses of the combination therapy using a 33 design to determine the highest safe and tolerable dose. After this, the second phase phase II evaluates the treatments effectiveness at the determined dose. Treatment involves draining ascites fluid before injections on days 1, 8, 15, and 22. The immune checkpoint inhibitor Sintilimab and zoledronic acid are dissolved in saline and injected into the abdominal cavity, followed by an additional saline injection based on patient tolerance. Participants will be closely monitored through a series of assessments including checking for dose-limiting toxicities within 28 days after the last treatment, measuring objective response rates four weeks after treatment, and tracking adverse events over three months. Long-term monitoring includes ascites control and quality of life assessments for up to one year, as well as immune cell changes four weeks after treatment. The total study duration and follow-up ensure detailed safety and effectiveness data collection for patients aged 18 to 75 with gastric cancer malignant ascites.

Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids for Gastric Cancer Malignant Ascites