Actively Recruiting
Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids for Gastric Cancer Malignant Ascites
Led by Qilu Hospital of Shandong University · Updated on 2025-11-19
24
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids for Gastric Cancer Malignant Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gastric adenocarcinoma diagnosed pathologically
- Malignant ascites confirmed by ascites cytology
- Presence of 2nd or 3rd degree ascites confirmed by CT according to EASL and ICA guidelines
- Age between 18 and 75 years
- No local abdominal drug administration or systemic immunotherapy within the previous 4 weeks
- Stable vital signs, Karnofsky score 60, expected survival time over 3 months
- Normal bone marrow function with hemoglobin 60 g/L, white blood cells 5 x10^9/L (neutrophils 1.5 x10^9/L), platelets 60 x10^9/L
- Normal coagulation with INR less than 1.5
- Liver function with total bilirubin 61.5 times ULN; AST and ALT 62 times ULN (or 5 times ULN if due to tumor infiltration)
- Renal function with creatinine 61.5 times ULN or creatinine clearance 60 mL/min
You will not qualify if you...
- Non-malignant ascites such as portal hypertension or infected ascites
- Contraindications to immunotherapy including long-term hormone use or history of radiation-induced lung, liver, or intestinal conditions
- Serious cardiopulmonary diseases affecting treatment
- Extensive abdominal adhesions, encapsulated peritoneal fluid, history of intestinal obstruction, or extensive distant metastases
- Women who are pregnant, breastfeeding, or planning pregnancy
- Plasma albumin less than 30 g/L or severe hypoproteinemia
- Known allergy to study drugs or similar compounds
- Severe acute or chronic diseases interfering with study results
- Cognitive dysfunction or poor treatment compliance
- Participation in other clinical trials within the last 4 weeks
- Presence of other malignancies
- Judged unsuitable for the trial by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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