NCT05536102

The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)

A Single-arm, Open-label, Multicenter Phase 2 Study to Evaluate XELOX + Tislelizumab in Combination With Doxorubicin Hydrochloride Liposome Injection （XELOX+PD-1+PLD）as Neoadjuvant Therapy for Resectable Gastric Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a signle-arm, multi-center, open-lable, phase II study. The objective is to evaluate the effectiveness and safety of tislelizumab + oxaliplatin + capecitabine + PLD in the neoadjuvant treatment of resectable gastric adenocarcinoma.

Detailed description

This single-arm, multicenter, open-label study plan to enroll patients with resectable stage III gastric adenocarcinoma to recieve tislelizumab + oxaliplatin + capecitabine + PLD regimen for 2 or 4 cycles, radical resection will be performed after neoadjuvant therapy. Radiological evaluation will be performed every 2 cycles to evaluate the resectability of tumor. Survival follow-up will be performed after surgery, until patient's withdrawal of informed consent, loss to follow-up or death, whichever comes first.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	PLD	20mg/m2, day 1, q3w
DRUG	Oxaliplatin	130 mg/m2, day 1, q3w
DRUG	Capecitabine	1000 mg/m2, days 1-14, q3w
DRUG	Tislelizumab	200 mg, day 1, q3w

Timeline

• Start date: 2022-09-05
• Primary completion: 2023-09-30
• Completion: 2027-09-30
• First posted: 2022-09-10
• Last updated: 2023-03-09

Locations

1 site across 1 country: China