Actively Recruiting
First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
Led by Qilu Hospital of Shandong University · Updated on 2024-12-31
110
Participants Needed
20
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Pathologically confirmed locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that is inoperable
- HER2-Positive tumor confirmed by IHC3+ or IHC2+/FISH+
- At least one measurable lesion according to RECIST 1.1 criteria
- No prior systemic treatment, or progression/relapse more than 6 months after neoadjuvant/adjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Life expectancy of at least 3 months
You will not qualify if you...
- Allergy to any study drug or its ingredients, or serious allergy history
- Uncontrolled cardiovascular or cerebrovascular conditions
- Use of systemic Chinese patent medicine or immunomodulatory drugs within 2 weeks before first treatment
- History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases such as diabetes or hypertension
- Active immune deficiency, autoimmune diseases, HIV positive, organ transplantation, or similar conditions
- Severe or active infections requiring systemic treatment, including tuberculosis unless fully treated more than 1 year ago
- Brain or leptomeningeal metastases
- Clinically significant pleural, pericardial effusion, or ascites requiring frequent drainage within 2 weeks before treatment
- Presence of a second active primary cancer at recruitment or other cancers within past 5 years except certain skin or cervical cancers
- Major surgery within 28 days before first treatment
- History of allogeneic stem cell or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
2
Binzhou Medical University Hospital
Binzhou, Shandong, China
Not Yet Recruiting
3
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Actively Recruiting
4
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250012
Actively Recruiting
5
Shandong Provincial Third Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
6
Shandong Univerisity Qilu Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
7
Jinan Third People's Hospital
Jinan, Shandong, China
Actively Recruiting
8
Affiliated Hospital of Jining Medical College
Jining, Shandong, China
Actively Recruiting
9
Liaocheng People's Hospital
Liaocheng, Shandong, China
Actively Recruiting
10
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
11
Qilu Hospital of Shandong University(Qingdao)
Qingdao, Shandong, China, 250063
Actively Recruiting
12
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
13
Taian City Central Hospital
Taian, Shandong, China
Not Yet Recruiting
14
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
Actively Recruiting
15
Tengzhou Central People's Hospital
Tengzhou, Shandong, China, 277599
Actively Recruiting
16
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China
Not Yet Recruiting
17
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Actively Recruiting
18
Yantaishan Hospital
Yantai, Shandong, China
Actively Recruiting
19
Zibo Central Hospital
Zibo, Shandong, China
Actively Recruiting
20
Zibo First People's Hospital
Zibo, Shandong, China
Actively Recruiting
Research Team
L
Lian Liu, MD
CONTACT
S
Song Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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