Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Brief 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
Interventions
DRUGSHR-A1904
SHR-A1904
DRUGPaclitaxel, Docetaxel, Irinotecan
Paclitaxel, Docetaxel, Irinotecan
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) by investigator assessment | 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 | 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 | 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 | 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) | 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 |
Countries
China
Contacts
Primary ContactQi Shi
Backup ContactLiang Hu
Outcome results
None listed