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
Phase 3
Interventional Study
Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 524 (estimated)
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
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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
Trial Locations
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Eligibility Criteria
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…
Contacts