Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Advanced GC/GEJ With Malignant Ascites

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

Overall Survival (OS)

OS is calculated from diagnosis to death or last follow-up time

Time frame
1 year
2

Progress free survival (PFS)

PFS is defined as the time from the date of treatment to the first date of disease

Time frame
1 year
3

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

Time frame
1 year
4

Safety assessment

Number and percentage of participants with Adverse Events (any Grade and Grade 3/4)

Time frame
1 year

Other outcomes

Sponsors and contacts

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