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Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat | Experimental | Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day. Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information. Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bile duct cancer cohort | Drug | Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day. Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information. Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade ≥ 3 thrombocytopenia | through study completion, an average of 1 year | |
| The incidence of FN | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Throughout the Entire Chemotherapy Course | 2 years |
| PFS | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu E Miao, Doctor | Contact | 17553832219 | miaoyue0626@126.com |
| Name | Affiliation | Role |
|---|---|---|
| yan hai Liu | The Second Affiliated Hospital of Shandong First Medical University | Principal Investigator |
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|
| Pancreatic cancer cohort | Drug | rilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day. Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information. Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment. |
|
| 1 year |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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