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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle.
800 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.
100 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGObjective 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.
Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
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.
Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: From the signing of informed consent up to 90 days after the last dose of study medication.
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