NCT06487429

Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer

Prospective, Phase II Clinical Study of Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer.

Detailed description

This study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer. After signing informed consent and screening to meet the inclusion criteria, the patient received full course neoadjuvant therapy: short course radiotherapy, rest for 1 week, sequential 3 cycles of Disitamab Vedotin combined with S-1 and Sintilimab, and preoperative imaging examination within 3-4 weeks after the last medication to evaluate the efficacy of neoadjuvant therapy and the possibility of curative D2 resection. The decision to undergo adjuvant treatment after radical surgery for gastric cancer is made by the researcher.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Short range radiotherapy with sequential Disitamab Vedotin combined with S-1 and xindilizumab	Short range radiotherapy, PCTV (clinical planned target area) DT 25Gy/5F, once a day, for a total of 5 days, continuous irradiation, and IMRT (intensity modulated radiation therapy) technology; After a week of rest, radiotherapy and chemotherapy combined with immunotherapy will be performed * Disitamab Vedotin: 2.5 mg/kg, intravenous infusion, d1, Q3W; * Sintilimab: 200mg, iv; * S-1: 40 mg/dose, oral, bid, d1-14; Q3W Whether to undergo adjuvant therapy after surgery is determined by the researcher

Timeline

• Start date: 2024-05-08
• Primary completion: 2026-05-31
• Completion: 2028-05-31
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: China