Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer
Recruiting
Phase 2Interventional Study
IBI363 + Chemotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Zhejiang Cancer Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Key Inclusion Criteria:
1. Patients voluntarily enrolled in this study and signed informed consent forms;
2. Age 18-75 years;
3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
4. MHC-II negative, with \<5% tumour cells displaying staining \<2+ (grade 2 …
Key Inclusion Criteria:
1. Patients voluntarily enrolled in this study and signed informed consent forms;
2. Age 18-75 years;
3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
4. MHC-II negative, with \<5% tumour cells displaying staining \<2+ (grade 2 or stronger);
5. Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and/or laparoscopy (per AJCC 8th Edition staging);
6. No prior antineoplastic therapy for current disease (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy);
7. Scheduled for surgical intervention following completion of neoadjuvant therapy;
8. Able to swallow tablets orally;
9. ECOG performance status 0-1;
10. Expected survival ≥6 months.
Key Exclusion Criteria:
1. Pregnant or lactating women, or women planning to become pregnant within 6 months prior to, during, or after the last dose of the investigational medicinal product.
2. Known signs of active bleeding from a lesion.
3. Patients with known dMMR/MSI-H status.
4. Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets.
5. Subjects with unresolved Grade \>1 toxicity related to any prior antineoplastic therapy (excluding persistent Grade 2 alopecia, anaemia, peripheral neuropathy, electrolyte abnormalities correctable with treatment, or endocrine abnormalities controlled and stable with hormone replacement therapy).
6. Known dihydropyrimidine dehydrogenase (DPD) deficiency (or prior fluorouracil-containing therapy resulting in Grade 3 or higher mucositis).
7. Known hypersensitivity to any monoclonal antibody or component of the chemotherapy agents (capecitabine, oxaliplatin) (resulting in Grade 3 or higher hypersensitivity reaction).
8. History of epileptic seizures, active, newly diagnosed, or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases.
9. Clinically significant cardiovascular or cerebrovascular disease.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.