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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

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 criteria

Qualifiers

Age 18 to 75 years old (including boundary values)

Volunteer to participate in this clinical study and sign informed consent;

ECOG score 0-1;

Expected survival ≥3 months;

Disqualifiers

Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study

HER2 posotive (IHC 3+ or IHC 2+/ISH +);

Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;

Individuals with Leptomeningeal metastasis or Active brain metastases;

Trial design

Treatments tested in this trial

  • SHR-A1904
  • Paclitaxel, Docetaxel, Irinotecan

Treatment groups

524 Participants
are divided into 2 treatment groups