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Cohort A and B: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in combination with Cisplatin plus Gemcitabine (CisGem), compared with Adebrelimab in combination with CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer. Cohort C: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab and Bevacizumab in combination with Cisplatin Plus Gemcitabine (CisGem) as first-line treatment in patients with Advanced Biliary Tract cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine | Experimental |
| |
| Arm B: Adebrelimab, Cisplatin and Gemcitabine | Experimental |
| |
| Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068 | Drug | SHR-8068 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the investigator according to RECIST v1.1. | From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the investigator according to RECIST v1.1. | From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)] (up to approximately 14 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University) | Nanjing | Jiangsu | 210029 | China | ||
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This study is a randomized and exploratory cohort, open-label, multicenter, Phase II clinical trial aimed at evaluating the efficacy and safety of SHR-8068 in combination with Adebrelimab, Bevacizumab, and Platinum-based chemotherapy as first-line treatment for advanced biliary tract cancer. The primary endpoint of the study is the Objective Response Rate (ORR), assessed by investigators based on RECIST v1.1 criteria.
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| Adebrelimab | Drug | Adebrelimab |
|
| Cisplatin | Drug | Cisplatin |
|
| Gemcitabine | Drug | Gemcitabine |
|
| Bevacizumab Injection | Drug | Bevacizumab injection. |
|
| Progression-Free-Survival (PFS) | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). | From randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months) |
| Duration of Response (DoR) | DoR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). | From the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months) |
| The First Affiliated Hospital，Zhejiang University School of Medicine |
| Hangzhou |
| Zhejiang |
| 310000 |
| China |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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