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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07855640
- Acronym / sponsor ID
- IRB-2026-929
- Keywords
- Gastric Cancer, Peritoneal Metastases, Malignant ascites
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ascites objective response rate (ORR)
Time frame: 1 year
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.
7 secondary outcomes
Overall Survival (OS)
Time frame: 1 year
Progress free survival (PFS)
Time frame: 1 year
12 months os rate
Time frame: 1 year
Safety assessment
Time frame: 1 year
Dynamics of Peripheral Blood Biomarkers
Time frame: Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months
Biomarkers in Tumor Tissue
Time frame: Baseline; prior to Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months
Dynamics of Ascites Biomarkers
Time frame: Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer Peritoneal Metastases and Gastric Cancer (GC), run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jieer Ying, Dr (13858195803, jieerying@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ascites objective response rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.