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This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.
This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Patients initially received GP/GEMOX regimen. |
| |
| Experimental group | Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine combined with cisplatin or oxaliplatin | Drug | Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from the start of treatment until disease progression or the emergence of new lesions. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients were histologically or radiologically confirmed intrahepatic cholangiocarcinoma, with initial treatment consisting of GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weilin Wang, PHD | Contact | +86 057187783820 | wam@zju.edu.cn | |
| Yuan Ding, PHD | Contact | +86 18858101960 | dingyuan@zju.edu |
| Name | Affiliation | Role |
|---|---|---|
| Weilin Wang, PHD | Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors | Drug | Gemcitabine (1000 mg/m², day 1 and 8), cisplatin (75 mg/m²; day 1) or oxaliplatin (85 mg/m²; day 1), PD-1/L1 agents (200 mg; day 1), and TKI inhibitors (8 mg; per day) |
|
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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