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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • IBI363 + chemotherapy

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators