Actively Recruiting
Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer
Led by Zhejiang Cancer Hospital · Updated on 2026-01-08
60
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 2 study designed to evaluate the safety and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) or S-1 and oxaliplatin (SOX) in perioprative treatment of locally advanced MHC-II-negative gastric and gastroesophageal junction adenocarcinoma.
CONDITIONS
Official Title
Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily enrolled in this study and signed informed consent forms
- Age 18-75 years
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- MHC-II negative, with less than 5% tumor cells showing staining below grade 2+
- Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and/or laparoscopy according to AJCC 8th Edition staging
- No prior antineoplastic therapy for current disease including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Scheduled for surgery after completing neoadjuvant therapy
- Able to swallow tablets orally
- ECOG performance status 0-1
- Expected survival of 6 months or more
You will not qualify if you...
- Pregnant or breastfeeding women, or women planning pregnancy within 6 months before, during, or after the last dose of the study drug
- Known active bleeding from a lesion
- Patients with known dMMR/MSI-H status
- Esophageal or pyloric near-obstruction affecting eating or gastric emptying, or difficulty swallowing tablets
- Unresolved Grade greater than 1 toxicity from any prior antineoplastic therapy (except certain controlled and stable conditions)
- Known dihydropyrimidine dehydrogenase deficiency or prior fluorouracil therapy causing severe mucositis
- Known hypersensitivity to monoclonal antibodies or chemotherapy agents capecitabine or oxaliplatin causing severe reactions
- History of epileptic seizures, active or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases
- Clinically significant cardiovascular or cerebrovascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
X
Xiangdong Cheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here