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OncoMatch/Clinical Trials/NCT06759064

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

Is NCT06759064 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies zoledronic acid plus Sintilimab intraperitoneal for cancer of stomach, adenocarcinoma.

Phase 1/2RecruitingQilu Hospital of Shandong UniversityNCT06759064Data as of Jun 2026Location: China

Treatment: zoledronic acid plus Sintilimab intraperitonealThis 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.

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Extracted eligibility criteria

Treatments studied

Other

zoledronic acid plus Sintilimab intraperitoneal

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06759064 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior local administration of drugs in the abdominal cavity, systemic immunotherapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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