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

NCT07325630 | Recruiting Phase 2

• 1 other identifier: CIBI363Y122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

IBI363 + Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• 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

Study Arms (1)

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

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 )

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xiangdong Cheng

CONTACT

13968032995; chengxd516@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Party Secretary of the Clinical Research Institute

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

CN (1)