NCT07855640

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jul 2026Jul 2028

Study Start

First participant enrolled

July 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

October 2, 2026

Status Verified

August 1, 2026

Enrollment Period

2.1 years

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Gastric Cancer Peritoneal MetastasesGastric Cancer (GC)Ascites, Malignant

Keywords

Gastric CancerPeritoneal MetastasesMalignant ascites

Outcome Measures

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.

    1 year

Secondary Outcomes (7)

  • Overall Survival (OS)

    1 year

  • Progress free survival (PFS)

    1 year

  • 12 months os rate

    1 year

  • Safety assessment

    1 year

  • Dynamics of Peripheral Blood Biomarkers

    Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months

  • +2 more secondary outcomes

Study Arms (1)

Advanced GC/GEJ With Malignant Ascites

Patients with untreated advanced or metastatic GC/GEJ adenocarcinoma with malignant ascites receiving first-line anti-PD-1 therapy plus systemic chemotherapy and intraperitoneal nab-paclitaxel.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • \- Have fully understood the study and voluntarily signed the informed consent form (ICF); Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (GC/GEJ) adenocarcinoma with unresectable advanced or metastatic disease; HER2-negative and mismatch repair-proficient (pMMR); Moderate or greater volume of ascites at baseline; Peritoneal metastasis confirmed by ascites cytology or laparoscopy; Aged 18 to 75 years, regardless of sex; Receiving first-line anti-PD-1 immunotherapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel.

You may not qualify if:

  • \- History of or concurrent active malignancy other than gastric cancer within the past 5 years; Previous systemic treatment for unresectable advanced or metastatic GC/GEJ adenocarcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsAscites

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jieer Ying, Dr

CONTACT

13858195803jieerying@aliyun.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

October 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)