Actively Recruiting
Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
Led by Sun Yat-sen University · Updated on 2024-01-26
540
Participants Needed
10
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.
CONDITIONS
Official Title
Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily agree to participate by signing consent
- Aged 18 to 75 years old
- Have locally advanced or metastatic HER2-negative gastric or gastroesophageal adenocarcinoma confirmed by pathology
- No prior systemic therapy, except completed neoadjuvant or adjuvant therapy with no recurrence for at least 6 months
- Agree to provide stored tumor tissue or biopsy sample
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months
- Adequate organ and bone marrow function within 7 days before enrollment with specified blood counts and liver, kidney function
- Agree to use effective contraception during treatment and for 6 months afterward
You will not qualify if you...
- Previous treatment with immune checkpoint inhibitors
- Receiving antitumor drugs, immunotherapy, or investigational treatments within 4 weeks before enrollment
- Radiotherapy within 4 weeks before first dose
- Major surgery within 4 weeks before enrollment or not fully recovered
- Symptomatic brain metastases or carcinomatous meningitis unless stable for 4 weeks with mild neurological symptoms
- History of other cancers unless in complete response for 2 years or certain treated skin or carcinoma in situ conditions
- Active autoimmune disease requiring systemic therapy in past 2 years
- History of gastrointestinal perforation or fistula in last 6 months
- Intestinal obstruction requiring parenteral nutrition
- HER2-positive gastric or gastroesophageal cancer
- Uncontrolled heart conditions including recent severe cardiac insufficiency, unstable angina, recent heart attack, or significant arrhythmias
- HIV infection
- Active hepatitis B or C infection
- Severe or uncontrolled infections within 4 weeks before first dose
- History of organ or stem cell transplantation
- Allergy or intolerance to study drugs
- Live vaccine within 4 weeks before first dose or planned during study
- Toxicity from previous cancer therapy not resolved to mild levels (grade 0-1)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
The Affliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
5
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
6
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
7
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
8
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
9
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
10
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Not Yet Recruiting
Research Team
R
Ruihua Xu, MD
CONTACT
F
Feng Wang, MD, PhD
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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