Efficacy and Safety of Fruquintinib in Combination With PD-1 Inhibitors as First-line Maintenance Therapy for Advanced HER-2 Negative Gastric Cancer: a Single-arm, Prospective, Exploratory Clinical Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 30, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2026

Conditions
Gastric Cancer
Interventions
DRUG

Fruquintinib+PD-1

"This is a one-arm, prospective, exploratory clinical study, including patients with advanced HER-2-negative gastric cancer (including gastroesophageal junction adenocarcinoma) who received first-line immunization combined with standard chemotherapy (RECIST 1.1 criteria) and were treated with fruquintinib(4mg orally, once daily for 3 wks on/1 wk off )combined with PD-1 antibody. Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first.~PD-1: Nivolumab(360mg IV d1, Q3W);Sintilimab(200mg IV d1, Q3W);Tislelizumab(200mg IV d1, Q3W) can be selected;"

Trial Locations (1)

213004

RECRUITING

The First People's Hospital of Changzhou, Changzhou

All Listed Sponsors
lead

Wu Jun

OTHER