IBI363 + Chemotherapy
Conditions
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.
Interventions
IBI363 Q3W +XELOX Q3W (Oxaliplatin 130 mg/m2, IV, Q3W, Capecitabine ,1000mg/ m2, PO, Bid, d1-14, Q3W) or IBI363 Q3W +SOX (Oxaliplatin 130 mg/m2, IV, Q3W, S-1, 40-60mg,PO, Bid, d1-14，Q3W )
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) rate of ITT population | 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
| Measure | Time frame | Description |
|---|---|---|
| Major Pathologic Response (MPR) Rate of ITT Population | Up to 3 years | The proportion of subjects in the enrolled population who achieved pathological residual tumour ≤10% as defined by tumour regression induced by neoadjuvant therapy. |
| Major Pathologic Response (MPR) Rate of surgical population | Up to 3 years | The proportion of subjects undergoing radical surgery who achieved pathological residual tumour ≤10% following neoadjuvant therapy-induced tumour regression. |
| R0 Resection Rate | Up to 3 years | The proportion of subjects defined as having undergone R0 resection within the radical resection population. |
| Pathological Complete Response (pCR) Rate or surgical population | Up to 3 years | The proportion of subjects undergoingvradical surgery who, following neoadjuvant therapy, were found to have no residual tumour cells under microscopic examination and negative lymph nodes. |
| Overall Survival (OS) | Up to 3 years | Defined as the time from randomization to death from any cause. |
| AE | Up to 90 days post last dose | Number of participants experiencing clinical adverse events (AEs) |
| Event-free Survival (EFS) | Up to 3 years | Defined as the time from randomization to the first occurrence of disease progression determined using RECIST v1.1, inoperable disease, local recurrence following surgery, distant metastasis, or death from any cause, whichever occurs first. |
Countries
China
Contacts
Primary ContactXiangdong Cheng
Outcome results
None listed