NCT06560528

Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Detailed description

This study included 40 patients with HER2 overexpression in locally advanced gastric cancer or gastroesophageal junction adenocarcinoma, who received treatment with Disitamab Vedotin combined with Tislelizumab and Capecitabine. The patient has not received any previous anti-tumor systemic therapy. HER2 expression is defined as immunohistochemistry (IHC) as 2+or 3+. Subjects who meet the inclusion criteria but do not meet the exclusion criteria will receive perioperative treatment after enrollment. Perioperative treatment includes neoadjuvant therapy and adjuvant therapy. Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles in the neoadjuvant phase and 5 cycles of treatment in the adjuvant phase.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	combination with Disitamab Vedotin and with Tislelizumab and Capecitabine	Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. 1. Disitamab Vedotin：2.5 mg/kg，Q3W； 2. Tislelizumab：200 mg，Q3W； 3. Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2024-08-19
• Last updated: 2024-08-19

Locations

2 sites across 1 country: China