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Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis

Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Intraperitoneal Bevacizumab in Gastric Cancer With Peritoneal Metastasis

Status
Enrolling by invitation
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06487715
Enrollment
42
Registered
2024-07-05
Start date
2024-03-01
Completion date
2026-03-01
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer Peritoneal Metastases

Brief summary

It is an open label, phase II study involved receiving albumin-bound paclitaxel plus S-1 combined with sintilimab and bevacizumab in patients with gastric cancer peritoneal metastasis.

Interventions

DRUGalbumin-bound paclitaxel (260 mg/m2, d1)

260 mg/m2, d1)

DRUGS-1

80 mg/m2, d1-14

DRUGsintilimab

200 mg, d1

DRUGbevacizumab

First two cycles : intraperitoneally 7.5 mg/m2 Maintenance period: intravenously 7.5 mg/m2

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 18 to 75 years patients histologically or cytologically confirmed the presence of GC or gastroesophageal junction tumor with PM (HER2 negative). The ECOG performance status is 0-1 and the expected survival time is more than 3 months. Did not receive any therapy for GC within the last six months (chemotherapy, radiation therapy, or both).

Exclusion criteria

* Principal

Design outcomes

Primary

MeasureTime frame
Overall survival rate1 year

Secondary

MeasureTime frame
Progression free survival1 year
Ascites drainage-free survival1 year
Objective Response Rate1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026