Biliary Tract Neoplasms
Conditions
Brief summary
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.
Interventions
BIOLOGICALAdebrelimab
1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle.
DRUGgemcitabine
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 years, male or female. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. No prior local or systemic treatment for biliary tract malignancy. Histologically or cytologically confirmed initially unresectable or inoperable biliary tract cancer; recurrent biliary tract tumor after surgery; or patients who received post-operative adjuvant therapy must have been off treatment for more than 6 months. Adequate organ and hematological function. Life expectancy of ≥ 3 months. Laboratory results within 7 days prior to the first dose meeting the following criteria:Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, Platelets ≥ 75 × 10\^9/L, Hemoglobin ≥ 90 g/L (without blood transfusion or G-CSF within 2 weeks prior to screening); Serum albumin ≥ 30 g/L, Total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Serum creatinine ≤ 1.5 × ULN or Creatinine clearance \> 50 mL/min; INR ≤ 1.2 or PT exceeding the normal control range by ≤ 2 seconds; Urine protein \< 2+ (if ≥ 2+, 24-hour urine protein quantification must be \< 1.0 g). Women of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must not be lactating. Male subjects with female partners of childbearing potential must agree to abstain from sexual intercourse or use a reliable and effective method of contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug, and must not donate sperm during this period.
Exclusion criteria
* Pathological diagnosis of mixed hepatocellular carcinoma or containing other non-cholangiocarcinoma malignant components. Prior systemic therapy. History of or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer. Active pulmonary tuberculosis infection within 1 year prior to enrollment; or history of active tuberculosis infection over 1 year ago without formal anti-tuberculosis treatment or with tuberculosis still in the active phase. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. Requiring long-term systemic corticosteroid therapy (dose equivalent to \> 10 mg/day prednisone) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are allowed. Severe cardiopulmonary or renal dysfunction. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); history of hypertensive crisis or hypertensive encephalopathy. HBV DNA \> 2000 IU/ml, or active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection). Active infection requiring systemic therapy. Human immunodeficiency virus (HIV 1/2 antibody) positive. History of psychotropic drug abuse, alcoholism, or drug addiction. History of allergy to study drugs. Other factors that, in the judgment of the investigator, may affect the safety of the subject or compliance with the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months. | 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. |
| Overall Survival (OS) | From the first dose of study treatment until death from any cause, assessed up to approximately 36 months. | The time from the start of treatment to death from any cause. |
| Disease Control Rate (DCR) | From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months. | 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. |
| Duration of Response (DoR) | From the first confirmed response until disease progression or death, assessed up to approximately 24 months. | 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). |
| Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the signing of informed consent up to 90 days after the last dose of study medication. | Evaluated based on the incidence and severity of AEs and SAEs according to the NCI-CTCAE v5.0 standard. |
Countries
China
Contacts
CONTACTYongxiang Xia, Doctor
CONTACTYongxiang Xia
Outcome results
None listed