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RECRUITING
NCT06730373
PHASE2

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

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2024-10-17

Completion Date

2027-12-31

Last Updated

2024-12-31

Healthy Volunteers

No

Interventions

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

Locations (20)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Shengli Oilfield Central Hospital

Dongying, Shandong, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Shandong Provincial Third Hospital

Jinan, Shandong, China

Shandong Univerisity Qilu Hospital

Jinan, Shandong, China

Jinan Third People's Hospital

Jinan, Shandong, China

Affiliated Hospital of Jining Medical College

Jining, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Qilu Hospital of Shandong University(Qingdao)

Qingdao, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Taian City Central Hospital

Taian, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, China

Tengzhou Central People's Hospital

Tengzhou, Shandong, China

Weifang Hospital of Traditional Chinese Medicine

Weifang, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Yantaishan Hospital

Yantai, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

Zibo First People's Hospital

Zibo, Shandong, China