Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
Location contact
Ruihua Xu
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06649292
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
The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
SHR-A1904
DrugSHR-A1904
Paclitaxel, Docetaxel, Irinotecan
DrugPaclitaxel, Docetaxel, Irinotecan
Primary outcomes
-
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
Secondary outcomes
-
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
-
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
-
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
-
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
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Oct 18, 2024
- Registry last updated
- May 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.