Gastric Cancer Peritoneal MetastasesNCT07855640
Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites
An observational study of Gastric Cancer Peritoneal Metastases and Gastric Cancer (GC), run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer Peritoneal Metastases, Gastric Cancer (GC), Ascites, Malignant
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jieer Ying, Dr, 13858195803, jieerying@aliyun.com
About this study
Official title: Anti-PD-1 Therapy Combined With Systemic Chemotherapy and Intraperitoneal Nab-paclitaxel as First-line Treatment for Advanced Gastric Cancer With Malignant Ascites: An Exploratory Study of Efficacy and Predictive Biomarkers
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.
Read the detailed description
Peritoneal metastasis is common in advanced gastric cancer and is associated with malignant ascites and poor prognosis. The efficacy of anti-PD-1 therapy combined with chemotherapy in this population remains insufficiently characterized, and reliable predictive biomarkers are lacking. This prospective, single-center, observational study conducted in China plans to enroll approximately 50 patients with previously untreated, unresectable advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites. Patients will receive anti-PD-1 therapy combined with systemic chemotherapy and intraperitoneal nab-paclitaxel as first-line treatment.
Clinical efficacy and safety will be evaluated using ascites objective response rate, progression-free survival, overall survival, 12-month overall survival rate, and treatment-related adverse events. Tumor tissue, peripheral blood, and ascites will be collected at baseline, prior to Cycle 2 or Cycle 3 of treatment, and at disease progression when available. Multi-omics analyses, including single-cell transcriptomics, spatial transcriptomics, proteomics, metabolomics, flow cytometry, and related assays, will be performed to identify potential predictive biomarkers and explore an integrated model for predicting treatment response.
- Keywords
- Gastric Cancer, Peritoneal Metastases, Malignant ascites
- Medical subject headings
- Stomach Neoplasms, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (7)
Overall Survival (OS)
OS is calculated from diagnosis to death or last follow-up time
Measured: 1 year
Progress free survival (PFS)
PFS is defined as the time from the date of treatment to the first date of disease
Measured: 1 year
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
Measured: 1 year
Safety assessment
Number and percentage of participants with Adverse Events (any Grade and Grade 3/4)
Measured: 1 year
Dynamics of Peripheral Blood Biomarkers
Changes in blood-based biomarker levels will be measured. Peripheral blood samples will be used for: 1) Immunophenotyping: The frequency of key immune cell subsets (e.g., CD4+/CD8+ T cells) in PBMCs will be analyzed by flow cytometry and single-cell transcriptome sequencing. 2) Plasma Multi-omics: Proteins and metabolites will be profiled using proteomics and metabolomics platforms, respectively. Metrics will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.
Measured: Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months
Biomarkers in Tumor Tissue
tumor tissue samples will be used for: 1) Immunophenotyping: The frequency of multiple cell subsets in fresh tumors will be analyzed by single-cell transcriptome sequencing. 2) Paraffin sections: used for immunohistochemistry and immunofluorescence. Data will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.3）Single-cell transcriptome sequencing.
Measured: Baseline; prior to Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months
Dynamics of Ascites Biomarkers
Changes in ascites-based biomarker levels will be measured. Ascites samples will be used for: 1) Cell clustering: The frequency of multiple cell subsets in ascites will be analyzed by flow cytometry and single-cell transcriptome sequencing. 2) ascites multi-omics: Proteins and metabolites of ascites supernatant will be profiled using ELISA, proteomics, metabolomics platforms, and etc. Metrics will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.
Measured: Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jul 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Peritoneal MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jieer, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855640
- Sponsor's protocol ID
- IRB-2026-929
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No