OncoMatch/Clinical Trials/NCT07668453
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
Is NCT07668453 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies multiple treatments including Adebrelimab and gemcitabine for biliary tract neoplasms.
Treatment: Adebrelimab · gemcitabine · Albumin-Bound Paclitaxel /nab-Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic therapy
No prior local or systemic treatment for biliary tract malignancy
Cannot have received: systemic therapy
Prior systemic therapy
Lab requirements
Blood counts
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)
Kidney function
Serum creatinine ≤ 1.5 × ULN or Creatinine clearance > 50 mL/min; Urine protein < 2+ (if ≥ 2+, 24-hour urine protein quantification must be < 1.0 g)
Liver function
Serum albumin ≥ 30 g/L, Total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN
Adequate organ and hematological function. Laboratory results within 7 days prior to the first dose meeting the following criteria: 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07668453 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages