Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaPhase 3NCT06649292
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
A Phase 3 study testing SHR-A1904 and Paclitaxel, Docetaxel, Irinotecan in people with Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- SHR-A1904 and Paclitaxel, Docetaxel, Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2024to 20 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Individuals with a history of GI perforation or fistula, unstable GI bleeding;
- Individuals with a history of severe cardiovascular and cerebrovascular diseases;
- The researcher determined that there are other situations that are not suitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu
About this study
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
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
- Being tested
- SHR-A1904, Paclitaxel, Docetaxel, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1904Drug
SHR-A1904
Paclitaxel, Docetaxel, IrinotecanDrug
Paclitaxel, Docetaxel, Irinotecan
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR-A1904 | Experimental | Not described Receives: Drug: SHR-A1904 |
| Treatment group B: Paclitaxel, Docetaxel, Irinotecan. | Active comparator | Not described Receives: Drug: Paclitaxel, Docetaxel, Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measure description: Defined as time from randomization until the date of death due to any cause
Measured: Until death, assessed up to approximately 2 years
Secondary outcomes (5)
Progression-free survival (PFS) by investigator assessment
Measure description: Defined as time from randomization until progression or death as assessed by the investigator
Measured: Until progression or death, assessed up to approximately 1 year
Objective response rate (ORR) by investigator assessment
Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator
Measured: Until progression, assessed up to approximately 1 year
Duration of response (DOR) by investigator assessment
Measure description: Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator
Measured: Until progression or death, assessed up to approximately 1 year
Disease control rate (DCR) by investigator assessment
Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator
Measured: Until progression, assessed up to approximately 1 year
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Measure description: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: until to 90 days after the last dose，assessed up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start22 Nov 2024
- Primary completion20 Sep 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649292
- Sponsor's protocol ID
- SHR-A1904-302
- Status last verified
- May 2026
- First submitted
- 17 Oct 2024
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06649292
- Acronym / sponsor ID
- SHR-A1904-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR-A1904 | Experimental | Drug: SHR-A1904 |
| Treatment group B: Paclitaxel, Docetaxel, Irinotecan. | Active comparator | Drug: Paclitaxel, Docetaxel, Irinotecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
- Individuals with a history of GI perforation or fistula, unstable GI bleeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1904SHR-A1904 | Drug | Treatment group A: SHR-A1904 |
| Paclitaxel, Docetaxel, IrinotecanPaclitaxel, Docetaxel, Irinotecan | Drug | Treatment group B: Paclitaxel, Docetaxel, Irinotecan. |
Primary outcome
Overall Survival
Time frame: Until death, assessed up to approximately 2 years
Measure description: Defined as time from randomization until the date of death due to any cause
5 secondary outcomes
Progression-free survival (PFS) by investigator assessment
Time frame: Until progression or death, assessed up to approximately 1 year
Objective response rate (ORR) by investigator assessment
Time frame: Until progression, assessed up to approximately 1 year
Duration of response (DOR) by investigator assessment
Time frame: Until progression or death, assessed up to approximately 1 year
Disease control rate (DCR) by investigator assessment
Time frame: Until progression, assessed up to approximately 1 year
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time frame: until to 90 days after the last dose，assessed up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A1904 and Paclitaxel, Docetaxel, Irinotecan in people with Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Shi (86-021-23511999, shi.qi.qs16@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Until death, assessed up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.