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The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.
After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Neoadjuvant Treatment | Drug | Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Overall survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as time interval from recruitment to tumor progression or censoring | 2 years |
| Pathological Complete Response Rate (pCR) | pathological complete response rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangcheng Li | Contact | 18951999088 | drlixc@163.com | |
| Xiaofeng Chen | Contact | 13585172066 |
| Name | Affiliation | Role |
|---|---|---|
| Xiangcheng Li | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Xiaofeng Chen | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
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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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|
| 18 weeks |
| Major Pathological Response Rate (MPR) | MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%) | 18 weeks |
| D004066 |
| Digestive System Diseases |