Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer

Official title

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

Overview

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

• Drug IBI363 + chemotherapy
  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 )

Primary outcome measures

• Pathological Complete Response (pCR) rate of ITT population [Time frame: Up to 3 years]

Secondary outcome measures (7)

• Pathological Complete Response (pCR) Rate or surgical population [Time frame: Up to 3 years]
• Major Pathologic Response (MPR) Rate of ITT Population [Time frame: Up to 3 years]
• Major Pathologic Response (MPR) Rate of surgical population [Time frame: Up to 3 years]
• R0 Resection Rate [Time frame: Up to 3 years]
• Event-free Survival (EFS) [Time frame: Up to 3 years]
• Overall Survival (OS) [Time frame: Up to 3 years]
• AE [Time frame: Up to 90 days post last dose]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT07325630 · CIBI363Y122

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗