OncoMatch/Clinical Trials/NCT06759064
Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids for Gastric Cancer Malignant Ascites
Is NCT06759064 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies zoledronic acid plus Sintilimab intraperitoneal for cancer of stomach, adenocarcinoma.
Treatment: zoledronic acid plus Sintilimab intraperitoneal — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: local administration of drugs in the abdominal cavity
Cannot have received: systemic immunotherapy
Lab requirements
Blood counts
hgb ≥90g/l, wbc ≥2.5×10^9/l (neu ≥1.5×10^9/l), plt ≥90×10^9/l
Kidney function
cr ≤1.5x uln or creatinine clearance ≥60ml/min
Liver function
total bilirubin ≤1.5x uln; ast and alt ≤2x uln (or ≤5x uln if due to tumour infiltration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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