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The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-4642 monotherapy arm | Experimental | Patients will receive HRS-4642 monotherapy at a fixed dose. |
|
| combination therapy arm | Experimental | Patients will receive HRS-4642 and adebrelimab combination therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4642 monotherapy | Drug | HRS-4642 will be administrated per dose level in which the patients are assigned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) by RECIST V1.1 | The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1. | up 2 years |
| Adverse events(AEs), serious adverse events(SAEs) | AEs and SAEs occurred from the first dose of treatment to 30 days after the last dose of HRS-4642 or 90 days after the last dose of adebrelimab (whichever comes late). | up 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD). | up 2 years |
| Progression-free survival (PFS) | PFS is defined as Time from the date of enrollment to of disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoming Shi, M.D | Contact | 13916969578 | shi.guoming@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jia Fan, M.D | Shanghai Zhongshan Hospital | Principal Investigator |
| Guoming Shi, M.D | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200020 | China |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| HRS-4642 and adebrelimab combination therapy | Drug | HRS-4642 and adebrelimab will be administrated per dose level in which the patients are assigned. |
|
| up 2 years |
| Overall survival (OS) | OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. | up 2 years |
| D004066 |
| Digestive System Diseases |