About this trial
This prospective observational study aims to evaluate the efficacy and safety of anti-PD-1 therapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel as first-line treatment for patients with advanced gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites. The study will also explore potential predictive biomarkers of treatment response through longitudinal collection and multi-omics analysis of tumor tissue, peripheral blood, and ascites.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients with previously untreated, unresectable advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites. Eligible patients will receive first-line anti-PD-1 immunotherapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Ascites objective response rate (ORR)
The ascites objective response rate (ORR) was calculated as a summed ratio of patients with disappeared and decreased ascites to the total number of patients.
Secondary outcomes
Overall Survival (OS)
OS is calculated from diagnosis to death or last follow-up time
Progress free survival (PFS)
PFS is defined as the time from the date of treatment to the first date of disease
12 months os rate
The definition of 12-months OS rate is the percentage of patients who had NOT has an event before or at 12 months
Safety assessment
Number and percentage of participants with Adverse Events (any Grade and Grade 3/4)
Sponsors and contacts
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