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)
Qilu Hospital of Shandong University
24 participants
Sep 12, 2024
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
Plain Language Summary
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Interventions
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)
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NCT06759064