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This study aims to evaluate the efficacy and safety of SHR-A1811 combined with chemotherapy and immune checkpoint inhibitor versus standard first-line therapy in gastric or gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: | Experimental | SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection |
|
| Treatment group B | Active Comparator | Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 + Adebrelimab Injection + Capecitabine Tablets or Fluorouracil Injection | Drug | SHR-A1811: intravenous infusion; Adebrelimab Injection: intravenous infusion; Capecitabine Tablets: oral administration Fluorouracil Injection: intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) per RECIST 1.1 assessed by BIRC(Blinded Independ Review Committee) | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. | UP to approximately 5 years |
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | UP to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 assessed by BIRC | ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) | UP to approximately 5 years |
| PFS per RECIST 1.1 assessed by investigator |
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Inclusion Criteria:
Exclusion Criteria:
11、14. History of immunodeficiency, including positive HIV test; active hepatitis B or hepatitis C.
12、Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
13、Severe cardiovascular or cerebrovascular diseases. 14、Active bleeding (CTCAE Grade ≥ 2). 15、Gastrointestinal perforation, gastrointestinal fistula or abdominal infection within 3 months before randomization.
16、Uncontrollable tumor-related pain or symptomatic hypercalcemia. 17、Patients with Grade > 1 peripheral neuropathy. 18、Vaccination of live attenuated vaccine within 28 days prior to randomization.
19、Previous use of anti-HER2 antibody-drug conjugates.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Wei SUN | Contact | +86 18036618554 | Shiwei.sun@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Trastuzumab + Pembrolizumab + CAPOX( Capecitabine Tablets + Oxaliplatin) or FP (Fluorouracil Injection+Cisplatin) | Drug | Trastuzumab : intravenous infusion; Pembrolizumab: intravenous infusion; Capecitabine Tablets: oral administration; Oxaliplatin: intravenous infusion; Fluorouracil Injection: intravenous infusion; Cisplatin: intravenous infusion; |
|
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
| UP to approximately 5 years |
| Disease Control Rate (DCR) per RECIST 1.1 | DCR is defined as the proportion of patients who exhibit no tumor progression (including shrinkage or stability) after treatment. | UP to approximately 5 years |
| Duration of Response (DOR) | DOR is defined as the time from the first achievement of complete response (CR) or partial response (PR) to the first occurrence of disease progression (PD) or death from any cause. | UP to approximately 5 years |
| Adverse events (AE) | An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. | UP to approximately 5 years |
| Zhongshan Hospital,Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000068878 | Trastuzumab |
| C582435 | pembrolizumab |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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