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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

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

Recruiting
18-75 years
All
Phase 3

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Overview

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

Eligibility

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.

Study details
    Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06649292

Shanghai Hengrui Pharmaceutical Co., Ltd.

15 October 2025

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