Comparing SHR-A1904 to standard treatments for advanced gastric cancer
Official title: 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
Run by Shanghai Hengrui Pharmaceutical Co., Ltd. · NCT06649292 · Data updated 2026-11-12
This study is testing a new treatment called SHR-A1904 to see if it helps people with advanced stomach cancer live longer compared to standard therapies they might usually receive.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 524 (estimated) |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | November 22, 2024 |
| Main results expected | September 20, 2027 |
| Study ends | March 20, 2028 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT06649292 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
✕Probably not a fit
Patients with HER2-positive tumors or those who have received recent anti-tumor therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of SHR-A1904 compared to investigator's choice of therapy in patients with second-line advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that express CLDN18.2. The study aims to determine overall survival rates among participants receiving SHR-A1904 versus those receiving standard treatments like Paclitaxel, Docetaxel, or Irinotecan. Eligible patients are those aged 18 to 75 with measurable disease and adequate organ function, who have not received certain prior therapies recently.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option that improves survival for patients with advanced gastric cancer.
How similar studies have gone: Other studies have shown promising results with targeted therapies in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 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.
Where it's running
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Qi Shi
- Email: shi.qi.qs16@hengrui.com
- Phone: 86-021-23511999
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.