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The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | GEMOX+Lenvatinib+Toripalimab |
|
| group 2 | Experimental | GEMOX+Toripalimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEMOX Regimen | Drug | Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR | up to 90 days after last treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD | up to 90 days after last treatment administration |
| Progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Liu, MD | Contact | +86 22-27468682 | mail4luwei@163.com | |
| Ningning Zhang, MD | Contact | 15822153931 | mail4ningning@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C508870 | gemcitabine-oxaliplatin regimen |
| C531958 | lenvatinib |
| C000656314 | toripalimab |
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| Lenvatinib | Drug | 8/12mg PO QD continuously |
|
| Toripalimab | Drug | 240mg IV d1 Q3W |
|
the time period from randomization of the participants to objective tumor progression or death
| up to 3 years |
| Overall survival (OS) | the time period from the randomization of the participants to the death event due to any reason | up to 3 years |
| The frequency, duration, and severity of adverse events | Safety is assessed by the frequency, duration, and severity of adverse events | up to 30 days after last treatment administration |
| D009369 | Neoplasms |