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This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study,the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701、CAPOX | Drug | SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs in part 1 study | The number and proportion of subjects with dose limiting toxicity. The safety endpoints, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs). | up to 2 years |
| Overall survival in subjects with PD-L1 CPS ≥ 5 in part 2 study | up to 3 years | |
| OS in all subjects in part 2 study | Overall survival (OS) | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR in part 1 study | Objective response rate (ORR) as assessed by the investigator per RECIST 1.1 | up to 2 years |
| DCR in part 1 study | Disease control rate (DCR) as assessed by the investigator per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 1000000 | China |
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| Placebo、CAPOX |
| Drug |
Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine) |
|
| up to 2 years |
| PFS in part 1 study | Progression free survival (PFS) as assessed by the investigator per RECIST 1.1 | up to 2 years |
| DoR in part 1 study | Duration of response (DoR) as assessed by the investigator per RECIST 1.1 | up to 2 years |
| OS in part 1 study | Overall survival (OS) | up to 3 years |
| PFS in part 2 study | PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1 | up to 3 years |
| ORR in part 2 study | ORR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1 | up to 2 years |
| DCR in part 2 study | DCR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1 | up to 2 years |
| DoR in part2 study | DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1 | up to 2 years |
| PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator as per RECIST 1.1 | up to 2 years |
| ORR in part 2 study | ORR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1 | up to 2 years |
| DCR in part 2 study | DCR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1 | up to 2 years |
| DoR in part 2 study | DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1 | up to 2 years |
| AEs and SAEs in part 2 study | Safety endpoints, including incidence and severity of AEs and SAEs as per NCI-CTCAE v5.0 criteria | up to 2 years |
| EORTC QLQ-C30 score | up to 2 years |
| EORTC QLQ-STO22 score | up to 2 years |
| EQ-5D-5L score | up to 2 years |