Our hospital is conducting a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study to evaluate the efficacy and safety of M108 monoclonal antibody injection combined with CAPOX, compared to placebo, in patients with CLDN18.2-positive, HER2-negative, PD-L1 CPS <5 advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Study Drug

The investigational drug is M108 monoclonal antibody injection. M108 monoclonal antibody injection is an anti-tumor therapy that targets specific molecules on the surface of cancer cells, inducing immune cells to attack and destroy the tumor cells, thereby inhibiting tumor progression and metastasis.Treatment Groups

Study Group: M108 monoclonal antibody injection + capecitabine + oxaliplatin

Control Group: Placebo injection + capecitabine + oxaliplatin

Main Inclusion Criteria for Participation in this Study

1. Age 18-75 years (inclusive of boundaries).
2. Advanced gastric or gastroesophageal junction adenocarcinoma, with no prior systemic treatment (for those who have received neoadjuvant/adjuvant chemotherapy, please consult the contact person).
3. Availability of a certain number of archival tumor pathology tissue samples or fresh biopsy tissue for testing.
4. No significant organic diseases (if uncertain, please consult the contact person).

Please Note: Whether you meet the inclusion criteria will be determined by the final comprehensive examination results and evaluation by the study doctor.

Contact Us

If you are interested in participating in this study, please contact us. The study doctor will initially assess whether you meet the study’s inclusion criteria. We will strictly maintain the confidentiality of your personal information. We welcome your application and participation.

Add the study doctor on WeChat for preliminary screening.

Expert Introduction