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This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | HER2 negative and PD-L1 CPS≥5, as first-line therapy |
|
| Arm B | Experimental | As third-line or above therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX07+HLX10+oxaliplatin+capecitabine | Drug | HLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate by IRRC assessment per RECIST 1.1 | Up to 2 years |
| PFS | Progression-free survival by IRRC assessment per RECIST 1.1 | From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | From the date of first dose unitl the date of death from any cause,assessed up to 2 years |
| ORR | Objective response rate by INV assessment per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dazhi Xu, MD | Contact | 021-64175590 | xudzh@shca.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gansu Wuwei Tumor Hospital | Recruiting | Wuwei | Gansu | 730000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000722210 | HLX07 |
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| HLX07 | Drug | HLX07 1500mg q3w |
|
| Up to 2 years |
| PFS | Objective response rate by INV assessment per RECIST 1.1 | From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years |
| DOR | Duration of response by IRRC/INV assessment per RECIST 1.1 | From the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years |
| Fudan University shanghai cancer center | Recruiting | Shanghai | 200000 | China |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |