An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies

Overview

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

• Biological Adebrelimab
  1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle.
• Drug gemcitabine
  800 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.
• Drug Albumin-Bound Paclitaxel /nab-Paclitaxel
  100 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.]

Secondary outcome measures (5)

• Progression-Free Survival (PFS) [Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.]
• Overall Survival (OS) [Time frame: From the first dose of study treatment until death from any cause, assessed up to approximately 36 months.]
• Disease Control Rate (DCR) [Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.]
• Duration of Response (DoR) [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) [Time frame: From the signing of informed consent up to 90 days after the last dose of study medication.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Jiangsu Provincial People's Hospital — Nanjing

Identifiers

NCT: NCT07668453 · 26-OBU-JS-BTC-II-010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗