NCT06939452

A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Yongxu Jia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression

Detailed description

Evaluation of the efficacy and safety of anlotinib in combination with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression. Additionally, real-world data were collected from hospital-based patients receiving immune checkpoint inhibitor (ICI)-combined chemotherapy as first-line therapy for PD-L1-low advanced gastric cancer to establish an external control cohort. The efficacy outcomes between the two treatment strategies were then compared.

Conditions

• Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Interventions

Type	Name	Description
DRUG	anlotinib +TQB2450 + Oxaliplatin+S-1	Anlotinib: 10mg, po, d1-14,q3w,until disease progression or unacceptable toxicity. TQB2450: 1200mg, iv, d1, q3w,until disease progression or unacceptable toxicity. Oxaliplatin: 130mg/㎡, iv, d1,6 cycles. S-1:40mg, po, bid, d1\~14,6 cycles.

Timeline

• Start date: 2023-06-07
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-04-22
• Last updated: 2026-04-07

Locations

1 site across 1 country: China