Anti-PD-1 with chemotherapy and intraperitoneal nab-paclitaxel for untreated advanced gastric cancer with ascites
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
Run by Zhejiang Cancer Hospital · NCT07855640 · Data updated 2026-11-12
This study tests whether adding anti-PD-1 therapy to standard chemotherapy plus intraperitoneal nab-paclitaxel can help patients with untreated advanced gastric cancer and malignant ascites.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07855640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with unresectable advanced or metastatic GC/GEJ adenocarcinoma, HER2-negative, pMMR, having moderate or greater ascites, and peritoneal metastasis, eligible for first-line anti-PD-1–based therapy with intraperitoneal nab-paclitaxel.
✕Probably not a fit
Patients whose disease does not respond to the therapy or who experience unacceptable toxicity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study conducted at Zhejiang Cancer Hospital in China, enrolling about 50 adults with unresectable or metastatic GC/GEJ adenocarcinoma and malignant ascites. Participants receive first-line anti-PD-1 therapy in combination with systemic chemotherapy and intraperitoneal nab-paclitaxel. Researchers will monitor efficacy using ascites objective response rate, progression-free survival, overall survival, and 12-month survival, along with treatment safety. Tumor tissue, blood, and ascites samples will be collected at multiple time points for multi-omics analyses to identify biomarkers and build a model to predict response. The study aims to better understand how this combination works in peritoneal metastasis and malignant ascites, a setting with limited evidence.
Why it matters
Potential benefit: If successful, patients may experience improved disease control and survival with a biomarker-driven approach to predict who benefits most.
How similar studies have gone: Data from similar immunotherapy plus chemotherapy regimens in gastric cancer are mixed; this exact combination with intraperitoneal nab-paclitaxel is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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. Exclusion Criteria: \- 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.
Where it's running
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jieer Ying, Dr
- Email: jieerying@aliyun.com
- Phone: 13858195803
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.