NCT06730373

First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions

• HER2-positive Gastric Cancer
• Metastatic Gastric Cancer
• Unresectable Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	2.5 mg/kg IV every 3 weeks
DRUG	Sintilimab	200 mg IV every 3 weeks
DRUG	S-1	40-60 mg BID for 14 days, every 3 weeks
DRUG	Trastuzumab	First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks
DRUG	Oxaliplatin	130 mg/m2 Q3W
DRUG	Capecitabine	1000 mg/m² Q3W
DRUG	5-FU	800 mg/m²
DRUG	Cisplatin	80 mg/m²

Timeline

• Start date: 2024-10-17
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-12-12
• Last updated: 2024-12-31

Locations

20 sites across 1 country: China