NCT04963088

Tislelizumab Combined With Anlotinib and Chemotherapy (XELOX) in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (TALENT)

Tislelizumab Combined With Anlotinib and Chemotherapy (XELOX) in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (TALENT): a Single-arm, Open-label Phase I/IIa Trial.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multi-cohort study to investigate safety, anti-tumor activity of the monoclonal antibody BGB A317 in combination with Anlotinib and standard chemotherapy as first-line treatment in Gastric, or Gastroesophageal Junction Carcinoma. The study includes a screening (up to 28 days), treatment (until disease progression, intolerable toxicity, or treatment withdrawal for another reason), safety follow-up (up to 30 days following last study drug treatment), and survival follow-up phase.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	BGB-A317	Subjects will be treated with BGB A317 200 mg IV on Day 1 during each 21-day cycle. BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason
DRUG	Anlotinib	oral administration daily d1-d14, q3w;
DRUG	Oxaliplatin	30 mg/m² IV on Day 1 during each 21-day cycle. during each 21-day cycle
DRUG	Capecitabine	1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle. Capecitabine will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.

Timeline

• Start date: 2021-03-06
• Primary completion: 2024-03-15
• Completion: 2024-03-20
• First posted: 2021-07-15
• Last updated: 2025-06-26

Locations

1 site across 1 country: China