IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Launched by RUIJIN HOSPITAL · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for people with a certain type of stomach cancer called gastric or gastroesophageal junction adenocarcinoma. The treatment combines three medicines: IBI343, Sintilimab, and chemotherapy. It is designed for patients whose cancer has a specific marker called CLDN18.2-positive and who do not have a different marker known as HER2-positive. This study is for patients whose cancer cannot be removed by surgery or has spread to other parts of the body, and who have not yet received any systemic treatment (treatment that affects the whole body).

People eligible for this trial are adults between 18 and 75 years old, with this specific type and stage of stomach cancer, and who are well enough to participate (meaning they have a good general health status). Participants will need to agree to the study’s procedures and visits. The trial is currently recruiting patients, and all genders are welcome. If you join the study, you can expect to receive the combination treatment, and doctors will closely monitor your health, side effects, and how well the treatment works. This study is important because it explores a new way to treat advanced stomach cancer that might improve outcomes for patients with this specific type of tumor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.
• • 2. Age was 18-75 years at the time of signing the ICF, and gender was unlimited.
• • 3. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
• • 4. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Exclusion Criteria:
• • 1. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease.
• • 2. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
• • 3. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).