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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer Peritoneal Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

260 mg/m2, d1)

S-1

Intervention Type DRUG

80 mg/m2, d1-14

sintilimab

Intervention Type DRUG

200 mg, d1

bevacizumab

Intervention Type DRUG

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

Interventions

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

260 mg/m2, d1)

Intervention Type DRUG

S-1

80 mg/m2, d1-14

Intervention Type DRUG

sintilimab

200 mg, d1

Intervention Type DRUG

bevacizumab

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No