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Ipilimumab (N01) Plus Sintilimab and Modified XELOX as Conversion Therapy in Unresectable Locally Advanced Gastric Cancer

NCT07638631 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-10

No results posted yet for this study

Summary

This study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment.

Conditions

  • Locally Advanced Gastric Cancer

Interventions

DRUG

Ipilimumab injection N01

Ipilimumab injection N01 (R\&D Code: IBI310) is a recombinant fully human anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. It can specifically bind to CTLA-4 molecule, thereby blocking CTLA-4-mediated T cell suppression, promoting T cell activation and proliferation, and enhancing tumor immune response. To achieve anti-tumor effect.

DRUG

Sintilimab

Sintilimab is a recombinant fully human IgG4 PD-1 monoclonal antibody, which is a Class 1 new drug independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. Sintilimab can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1/PD-L1 pathway leading to tumor immune tolerance. To reactivate the anti-tumor activity of T lymphocytes and achieve the purpose of tumor treatment.

DRUG

Modified (60% standard dose) XELOX

Modified (60% standard dose) XELOX: (Oxaliplatin 78mg/m2,d1; capecitabine 600mg/m2,bid,d1-14,q3w)

Sponsors & Collaborators

  • Chen Lizhu

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-12-31
Completion
2030-06-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638631 on ClinicalTrials.gov