SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients

Inclusion Criteria:

1. Age 18 to 75 years old (including boundary values)
2. Volunteer to participate in this clinical study and sign informed consent;
3. ECOG score 0-1;
4. Expected survival ≥3 months;
5. Gastric or Gastroesophageal Junction Adenocarcinoma;
6. positive CLDN18.2 expression in tumor tissue;
7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
8. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
2. HER2 posotive (IHC 3+ or IHC 2+/ISH +);
3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;
4. Individuals with Leptomeningeal metastasis or Active brain metastases;
5. Individuals with a history of GI perforation or fistula, unstable GI bleeding;
6. Individuals with a history of severe cardiovascular and cerebrovascular diseases;
7. The researcher determined that there are other situations that are not suitable for participation.