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This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 + XELOX chemotherapy | Experimental | Iparomlimab and Tuvonralimab+XELOX |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706) | Drug | 5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity. |
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| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1). | 12 months after the last subject participating in |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | The time from the starting date of study drug to the date of death due to any cause. | 12 months after the last subject participating in |
| objective response rate (ORR) | The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lian Liu, MD, PHD | Contact | 0531-82169851 | tounao@126.com | |
| Song Li, MD, PHD | Contact | 0531-82169851 |
| Name | Affiliation | Role |
|---|---|---|
| Lian Liu, MD, PHD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Oxallplation | Drug | 130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles. |
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| Capectitabine Tablets | Drug | 1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity. |
|
| 6 months after the last subject participating in |
| duration of response (DOR) | The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. | 12 months after the last subject participating in |
| disease control rate (DCR) | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects | 12 months after the last subject participating in |
| Safety (adverse event) | The rates of adverse events. | Up to approximately 2 years |
| Binzhou Medical University Hospital | Recruiting | Binzhou | Shandong | China |
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| Dezhou People's Hospital | Recruiting | Dezhou | Shandong | China |
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| Shengli Oilfield Central Hospital | Recruiting | Dongying | Shandong | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | 250012 | China |
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| Shandong Provincial Third Hospital | Recruiting | Jinan | Shandong | 250012 | China |
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| Jinan Central Hospital | Recruiting | Jinan | Shandong | China |
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| Jinan Third People's Hospital | Recruiting | Jinan | Shandong | China |
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| Shandong Qianfoshan Hospital | Recruiting | Jinan | Shandong | China |
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| Affiliated Hospital of Jining Medical College | Recruiting | Jining | Shandong | China |
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| Liaocheng People's Hospital | Recruiting | Liaocheng | Shandong | China |
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| Linyi Cancer Hospital | Recruiting | Linyi | Shandong | China |
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| Linyi People's Hospital | Recruiting | Linyi | Shandong | China |
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| Qilu Hospital of Shandong University(Qingdao) | Recruiting | Qingdao | Shandong | 250063 | China |
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| Qingdao Municipal Hospital | Recruiting | Qingdao | Shandong | China |
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| Qingdao Municipal Hospital | Recruiting | Qingdao | Shandong | China |
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| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
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| Taian City Central Hospital | Recruiting | Tai’an | Shandong | China |
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| The Second Affiliated Hospital of Shandong First Medical University | Recruiting | Tai’an | Shandong | China |
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| Tengzhou Central People's Hospital | Recruiting | Tengzhou | Shandong | 277599 | China |
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| Weifang Hospital of Traditional Chinese Medicine | Recruiting | Weifang | Shandong | China |
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| Weihai Central Hospital | Recruiting | Weihai | Shandong | China |
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| Yantai Yuhuangding Hospital | Recruiting | Yantai | Shandong | China |
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| Yantai Yuhuangding Hospital | Recruiting | Yantai | Shandong | China |
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| Yantaishan Hospital | Recruiting | Yantai | Shandong | China |
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| Zibo Central Hospital | Recruiting | Zibo | Shandong | China |
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| Zibo First People's Hospital | Recruiting | Zibo | Shandong | China |
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| Jining First People's Hospital | Recruiting | Jining | China |
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