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

Conditions

• Gastric Cancer Peritoneal Metastases

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• albumin-bound paclitaxel (260 mg/m2, d1) — DRUG
  260 mg/m2, d1)
• S-1 — DRUG
  80 mg/m2, d1-14
• sintilimab — DRUG
  200 mg, d1
• bevacizumab — DRUG
  First two cycles : intraperitoneally 7.5 mg/m2 Maintenance period: intravenously 7.5 mg/m2

Study Details

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.

Key Dates

First listed

Jul 5, 2024

Start date

Mar 1, 2024

Status verified

Mar 2024

Primary completion

Mar 1, 2025

Completion

Mar 1, 2026

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Albumin-bound paclitaxel plus S1 and sintilimab in combination with Bevacizumab
  Intraperitoneal period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intraperitoneally, 3-week cycle, 2 cycles; Maintenance period: Albumin-bound paclitaxel plus S-1 combined with sintilimab (200 mg, d1) and bevacizumab (7.5 mg/m2, d1) intravenously, 3-week cycle

Primary Outcome Measure

Overall survival rate [ Time Frame: 1 year ]