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This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group | Experimental |
| |
| Durvalumab + Cisplatin and Gemcitabine Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068 Injection | Drug | SHR-8068 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 15 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Up to 7 months. | |
| Duration of Response (DoR) | Up to 7 months. | |
| Progression free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Shi | Contact | +86-0518-82342973 | xin.shi.xs3@hengrui.com | |
| Xin Xu | Contact | +86-0518-82342973 | xin.xu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Adebrelimab Injection |
| Drug |
Adebrelimab injection. |
|
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine Hydrochloride for injection. |
|
| Cisplatin Injection | Drug | Cisplatin injection. |
|
| Durvalumab Injection | Drug | Durvalumab injection. |
|
| Up to 7 months. |
| Objective Response Rate (ORR) | Up to 7 months. |
| Time to Progression (TTP) | Up to 7 months. |
| Time to Response (TTR) | Up to 7 months. |
| Adverse events (AEs) | Up to approximately 15 months. |
| Serious adverse events (SAEs) | Up to approximately 15 months. |
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D007267 | Injections |
| D002945 | Cisplatin |
| C000613593 | durvalumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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