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The purpose of this clinical trial is to evaluate the safety and effectiveness of a new combination therapy for patients with biliary tract cancer that cannot be removed by surgery. Participants will receive an immunotherapy drug called adebrelimab combined with two chemotherapy drugs (gemcitabine and albumin-bound paclitaxel) as their first-line treatment. This is an open-label, single-arm study, meaning all enrolled patients will receive this same combination treatment. The main goal of the study is to determine the Objective Response Rate (ORR), which measures the proportion of patients whose tumors shrink in response to the treatment. Researchers will also evaluate how long patients live without the disease getting worse (Progression-Free Survival), overall survival, quality of life, and any side effects experienced. The study plans to enroll 30 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Participants in this single arm will receive Adebrelimab (1200 mg, IV, Day 1), Gemcitabine (800 mg/m^2, IV, Days 1 and 8), and albumin-bound paclitaxel (100 mg/m^2, IV, Days 1 and 8) every 3 weeks (21 days) for 6 to 8 cycles. Adebrelimab is administered first, followed by chemotherapy after an interval of at least 30 minutes. Maintenance phase: After 6-8 cycles of initial treatment, Adebrelimab will be continued for up to 2 years, while Gemcitabine and albumin-bound paclitaxel will be administered alternately every cycle. Treatment continues until disease progression/recurrence, unacceptable toxicity, withdrawal of consent, or other specified discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Biological | 1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The proportion of patients whose tumor volume shrinks to a predefined value and maintains the minimum time requirement, defined as the sum of Complete Response (CR) and Partial Response (PR). Assessed by investigators according to RECIST 1.1 criteria. | From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from the start of treatment to the first observation of disease progression or death from any cause. Assessed according to RECIST 1.1 criteria. | From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months. |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongxiang Xia, Doctor | Contact | +8613815893869 | yx_xia@njmu.edu.cn | |
| Yongxiang Xia | Contact | +8613815893869 | yx_xia@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| gemcitabine | Drug | 800 mg/m^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle. |
|
| Albumin-Bound Paclitaxel /nab-Paclitaxel | Drug | 100 mg/m^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle. |
|
The time from the start of treatment to death from any cause. |
| From the first dose of study treatment until death from any cause, assessed up to approximately 36 months. |
| Disease Control Rate (DCR) | The proportion of patients who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after treatment. Assessed according to RECIST 1.1 criteria. | From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months. |
| Duration of Response (DoR) | The time from the first confirmed disease response to the first confirmed disease progression or termination of the response status due to any cause (such as disease recurrence or patient death). | From the first confirmed response until disease progression or death, assessed up to approximately 24 months. |
| Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Evaluated based on the incidence and severity of AEs and SAEs according to the NCI-CTCAE v5.0 standard. | From the signing of informed consent up to 90 days after the last dose of study medication. |
| 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 |
|---|---|
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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