NCT05918094

Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.

Detailed description

Subjects will be randomized in a 1:1 ratio into either the modified XELOX plus sintilimab group or the standard XELOX plus sintilimab group. The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W. The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W. After 6 cycles of treatment, patients could choose capecitabine + sintilimab maintenance with a maximum treatment duration of 2 years. The primary endpoint of this study is the progression-free survival (PFS), defined as the time from random assignment of the subject to disease progression or death from any cause. All eligible patients will be randomly assigned to either the trial or control group in a 1:1 ratio based on the following stratification factors: Whether the PD-L1 CPS score \>= 5; Whether the age \>70 years old.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Experimental dose: modified XELOX + sintilimab	The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W.
DRUG	Standard dose: standard XELOX + sintilimab	The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W.

Timeline

• Start date: 2023-04-30
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2023-06-26
• Last updated: 2024-01-26

Locations

10 sites across 1 country: China