NCT06649292RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 524 (estimated)
- First submitted
- 17 Oct 2024
- Start date
- 22 Nov 2024
- Primary completion date
- 20 Sept 2027
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06649292
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 524
- From 22 Nov 2024 to the primary completion date, 20 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
- Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;
Other illness
- Individuals with a history of GI perforation or fistula, unstable GI bleeding;
- Individuals with a history of severe cardiovascular and cerebrovascular diseases;
Other
- HER2 posotive (IHC 3+ or IHC 2+/ISH +);
- Individuals with Leptomeningeal metastasis or Active brain metastases;
- The researcher determined that there are other situations that are not suitable for participation.
Who the study is looking for
- 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;
- Gastric or Gastroesophageal Junction Adenocarcinoma;
- positive CLDN18.2 expression in tumor tissue;
- There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
- Adequate bone marrow and organ function.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.