Perioprative Study of IBI363 in Patients With MHC-II-Nega... | NCT07325630

NCT07325630

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Drug: IBI363 + chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IBI363 + chemotherapy	Drug	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 )

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathological Complete Response (pCR) rate of ITT population	The proportion of subjects in the cohort defined as having no residual tumour cells detected microscopically and lymph node-negative following neoadjuvant therapy.	Up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Pathological Complete Response (pCR) Rate or surgical population	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.	Up to 3 years
Major Pathologic Response (MPR) Rate of ITT Population

Eligibility Module

Eligibility Criteria

Key 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.

Key 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.