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The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR-A1904 | Experimental |
| |
| Treatment group B: Paclitaxel, Docetaxel, Irinotecan. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1904 | Drug | SHR-A1904 |
| |
| Paclitaxel, Docetaxel, Irinotecan |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Measure description: Defined as time from randomization until the date of death due to any cause | Until death, assessed up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) by investigator assessment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Shi | Contact | 86-021-23511999 | shi.qi.qs16@hengrui.com | |
| Liang Hu | Contact | 18036618148 | Liang.hu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Drug |
Paclitaxel, Docetaxel, Irinotecan |
|
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 | 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 | 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) | 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 doseļ¼assessed up to approximately 2 years |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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