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This study will investigate the safety and effectiveness of a new combination treatment for patients with advanced bile duct cancer. The treatment combines standard chemotherapy drugs (gemcitabine and cisplatin) with two additional medications: adebrelimab and simvastatin.
All participants in this study will receive the same four-drug combination. Researchers will closely monitor patients to see how well the tumors shrink, how long the treatment keeps the cancer from growing, and what side effects occur. The study is exploratory, meaning it aims to gather initial data on whether this four-drug combination is a promising approach for treating advanced biliary tract cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group Intervention | Experimental | All participants receive the combination therapy of adebrelimab, gemcitabine, cisplatin, and simvastatin for up to 8 cycles (21-day/cycle), followed by maintenance therapy with adebrelimab and simvastatin until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab is an anti-PD-L1 monoclonal antibody. During the initial combination phase (up to 8 cycles), it is administered intravenously at 1200 mg on Day 1 of each 21-day cycle. During the subsequent maintenance phase, it is administered at 1200 mg intravenously every 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Tumor assessments will be performed by investigators via contrast-enhanced CT or MRI scans. | From enrollment until the first documented disease progression or completion of study treatment, whichever occurs first, assessed up to approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the start of study treatment to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first. | From enrollment until the first documented progression or death from any cause, assessed up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang WU, M.D. | Contact | 13636076910 | 255001907@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Wanguang Zhang, M.D. | Tongji Hospital | Principal Investigator |
| Zeyang Ding, M.D. | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine + Cisplatin | Drug | Standard gemcitabine and cisplatin chemotherapy regimen. This combination is administered intravenously only during the initial treatment phase for a maximum of 8 cycles (21-day cycles). |
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| Simvastatin 20mg | Drug | Simvastatin is an HMG-CoA reductase inhibitor (statin). It is administered orally at a dose of 20 mg once daily continuously throughout both the initial combination phase and the subsequent maintenance phase until treatment completion criteria are met. |
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| Overall Survival (OS) |
OS is defined as the time from the start of study treatment to death from any cause. |
| From enrollment until death from any cause, assessed up to approximately 3 years. |
| Disease Control Rate (DCR) | DCR is defined as the proportion of participants achieving a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (lasting for at least 6 weeks) according to RECIST 1.1. | From enrollment until the first documented disease progression or completion of study treatment, assessed up to approximately 2 years. |
| Duration of Response (DOR) | DOR is defined as the time from the first documentation of objective response (CR or PR) to the first documented disease progression or death from any cause, whichever occurs first, in participants who achieve a confirmed response. | From the first documented response until disease progression or death, assessed up to approximately 2 years. |
| Incidence of Treatment-Related Adverse Events (TRAEs) | The proportion of participants experiencing any adverse event determined by the investigator to be related to the study treatment regimen. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | From the first dose of study treatment until 30 days after the last dose, assessed up to approximately 2 years. |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |