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

NCT07668453 | Recruiting Phase 2

• 1 other identifier: 26-OBU-JS-BTC-II-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.

• Overall Survival (OS)

  From the first dose of study treatment until death from any cause, assessed up to approximately 36 months.

• Disease Control Rate (DCR)

  From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.

• Duration of Response (DoR)

  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)

  From the signing of informed consent up to 90 days after the last dose of study medication.

Study Arms (1)

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.

Biological: Adebrelimab; Drug: gemcitabine; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel

Interventions

Adebrelimab BIOLOGICAL

1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle.

Experimental Arm

gemcitabine DRUG

800 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.

Experimental Arm

Albumin-Bound Paclitaxel /nab-Paclitaxel DRUG

100 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yongxiang Xia, Doctor

CONTACT

＋8613815893869; yx_xia@njmu.edu.cn

Yongxiang Xia

CONTACT

＋8613815893869; yx_xia@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 25, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)