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

Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study ID
NCT06649292
Phase
PHASE3
Status
Recruiting
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Conditions

  • Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 22, 2024
Status verified
May 2026
Primary completion
Sep 20, 2027
Completion
Mar 20, 2028

Study Design

Enrollment
524 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A: SHR-A1904
  • Active Comparator: Treatment group B: Paclitaxel, Docetaxel, Irinotecan.

Primary Outcome Measure

Overall Survival [ Time Frame: Until death, assessed up to approximately 2 years ]

Central Contacts