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

May 12, 2026 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

524

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Ruihua Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A: SHR-A1904
Drug: SHR-A1904
SHR-A1904
Active Comparator: Treatment group B: Paclitaxel, Docetaxel, Irinotecan.
Drug: Paclitaxel, Docetaxel, Irinotecan
Paclitaxel, Docetaxel, Irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until death, assessed up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) by investigator assessment
Time Frame: Until progression or death, assessed up to approximately 1 year
Measure description: Defined as time from randomization until progression or death as assessed by the investigator
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
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
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
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
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
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
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
Measure description: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
until to 90 days after the last dose，assessed up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

March 20, 2028

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1904-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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