NCT07325630RecruitingPhase 2
IBI363 Combined Chemotherapy for Perioperative Treatment of MHC-II-Negative Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Single-Center, Single-Arm Phase II Clinical Study
Zhejiang Cancer Hospital1 site in 1 country60 target enrollmentStarted: November 3, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pathological Complete Response (pCR) rate of ITT population
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 <5% tumour cells displaying staining <2+ (grade 2 or stronger);
- •Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and/or laparoscopy (per AJCC 8th Edition staging);
- •No prior antineoplastic therapy for current disease (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy);
- •Scheduled for surgical intervention following completion of neoadjuvant therapy;
- •Able to swallow tablets orally;
- •ECOG performance status 0-1;
- •Expected survival ≥6 months.
Exclusion Criteria
- •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.
- •Known signs of active bleeding from a lesion.
- •Patients with known dMMR/MSI-H status.
- •Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets.
- •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).
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency (or prior fluorouracil-containing therapy resulting in Grade 3 or higher mucositis).
- •Known hypersensitivity to any monoclonal antibody or component of the chemotherapy agents (capecitabine, oxaliplatin) (resulting in Grade 3 or higher hypersensitivity reaction).
- •History of epileptic seizures, active, newly diagnosed, or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases.
- •Clinically significant cardiovascular or cerebrovascular disease.
Arms & Interventions
Experimental Arm
Experimental
IBI363 combination with oxaliplatin and capecitabine (XELOX) or S-1 and oxaliplatin (SOX) for perioprative treatment of locally advanced gastric and gastroesophageal junction adenocarcinoma
Intervention: IBI363 + chemotherapy (Drug)
Outcomes
Primary Outcomes
Pathological Complete Response (pCR) rate of ITT population
Time Frame: Up to 3 years
The proportion of subjects in the cohort defined as having no residual tumour cells detected microscopically and lymph node-negative following neoadjuvant therapy.
Secondary Outcomes
- Pathological Complete Response (pCR) Rate or surgical population(Up to 3 years)
- Major Pathologic Response (MPR) Rate of ITT Population(Up to 3 years)
- Major Pathologic Response (MPR) Rate of surgical population(Up to 3 years)
- R0 Resection Rate(Up to 3 years)
- Event-free Survival (EFS)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- AE(Up to 90 days post last dose)
Investigators
Xiangdong Cheng
Party Secretary of the Clinical Research Institute
Zhejiang Cancer Hospital
Study Sites (1)
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