NCT05586061

First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer

A Prospective, Multicenter, Phase II Clinical Study of First-line Treatment for HER2 (human Epidermal Growth Factor Receptor 2) Positive Advanced Gastric Cancer with Disitamab Vedotin in Combination with Tirelizumab and S-1

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Conditions

• HER2-positive Gastric Cancer

Interventions

Type	Name	Description
DRUG	Disitamab vedotin	Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, (every 3 weeks) Q3W
DRUG	Tislelizumab	Tislelizumab: 200mg, d1, ivdrip, (every 3 weeks) Q3W
DRUG	S1	S-1: 40-60mg (according to patients' body surface area), po, bid, d1-14, discontinued for 7 days.

Timeline

• Start date: 2023-02-10
• Primary completion: 2024-12-29
• Completion: 2025-12-31
• First posted: 2022-10-19
• Last updated: 2025-02-07

Locations

7 sites across 1 country: China