NCT06034964

Tislelizumab Combined With Chemotherapy in First-line Treatment of AGC

Retrospective Study of Tislelizumab Combined With Chemotherapy in First-line Treatment of HER2-negative Advanced Gastric Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, retrospective clinical study to evaluate the efficacy and safety of tislelizumab combined with first-line chemotherapy in the treatment of HER2-negative advanced gastric cancer.

Detailed description

This study aims to include 60 HER-2 negative advanced gastric cancer patients who received first-line treatment with tislelizumab combined with chemotherapy in our hospital from November 1, 2020 to November 1, 2021. Clinicopathological data, blood tests and imaging data of the patients were collected. The primary endpoints evaluated were PFS and OS, and the secondary endpoints were ORR and safety. At the same time, ctDNA and peripheral cytokine status of patients as well as second-generation sequencing of tumor tissues at baseline were collected for the exploration of therapeutic efficacy related biomarkers.

Conditions

• Tislelizumab
• Chemotherapy
• First-line
• Gastric Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab：200mg, iv, d1, 21 days per cycle, until disease progression or intolerable toxicity

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-11-01
• Completion: 2025-11-01
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study