RecruitingPhase 1Phase 2NCT06759064

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

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


Sponsor

Qilu Hospital of Shandong University

Enrollment

24 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitor combined with zoledronic acid for the treatment of malignant ascites in gastric cancer. This study is a phase Ib/II clinical study to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer, which consists of two phases, firstly, the phase Ib safety study, which adopts the '3+3' drug-escalation experimental design, and after determining the safe and tolerable dose, it will proceed to the second part of the phase II efficacy study. The Phase II study was designed by Simon's two-stage approach to evaluate the efficacy of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting immune checkpoint inhibitors and zoledronic acid (a bone-strengthening drug) directly into the abdominal cavity can help control malignant ascites — a build-up of fluid in the belly caused by stomach cancer that has spread. **You may be eligible if...** - You are between 18 and 75 years old - You have gastric (stomach) adenocarcinoma confirmed by biopsy - You have malignant ascites (fluid in your belly caused by cancer) confirmed by fluid analysis and CT scan - You are in reasonably good health (Karnofsky score of 70 or above) with at least 3 months expected survival - You have adequate blood count, liver, kidney, and clotting function **You may NOT be eligible if...** - Your fluid build-up is not cancer-related (e.g., from liver disease) - You have conditions that prevent immunotherapy use (such as autoimmune disease or long-term steroid use) - You are pregnant or breastfeeding - You have severe abdominal scarring or bowel blockage history - You are in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzoledronic acid plus Sintilimab intraperitoneal injection

At D-5\~D-1, drain the ascites by placing a tube in the abdominal cavity first, try to drain the ascites as much as possible according to the clinical routine, and record the amount of drainage.D1, D8, D15, D22 start the first immunocheckpoint inhibitor combined with zoledronic acid treatment, try to drain the ascites first, calculate the amount of drugs according to the patient's body weight, and then dissolve the corresponding dosage of immunocheckpoint inhibitor and zoledronic acid in 100 ml of saline and inject them into the abdominal cavity respectively, and then inject another 100 ml of saline according to the patient's tolerance. The corresponding dose of immune checkpoint inhibitor and zoledronic acid was dissolved in 100 ml of saline and injected into the abdominal cavity.


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06759064


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