This prospective, single-center, single-arm phase II clinical trial was designed to evaluate the efficacy and safety of bevacizumab plus nab-paclitaxel and S-1 as second-line treatment for patients with advanced biliary tract adenocarcinoma who experienced disease progression or intolerance after first-line systemic therapy. Participants received bevacizumab in combination with nab-paclitaxel and oral S-1 in 21-day treatment cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, or other protocol-defined discontinuation criteria. The primary outcome was objective response rate assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary outcomes included progression-free survival, disease control rate, duration of response, overall survival, quality of life, and safety. Exploratory analyses were conducted to investigate potential predictive biomarkers of treatment efficacy.
Inclusion Criteria:
Aged ≥18 years at the time of signing the informed consent form (ICF).
Histologically confirmed or clinically diagnosed biliary tract adenocarcinoma.
Unresectable disease and not suitable for locoregional therapy, or disease progression after locoregional therapy.
Child-Pugh class A or class B with a score of 7.
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
Radiographic disease progression or intolerance after first-line treatment.
Adequate bone marrow, hepatic, and renal function, as defined by:
For patients with hepatitis B virus (HBV) infection, HBV deoxyribonucleic acid (DNA) <500 IU/mL (or <2,500 copies/mL).
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Women of childbearing potential must use highly effective contraception during the study and for at least 120 days after the last dose of study treatment and must have a negative urine or serum pregnancy test within 7 days before the first dose of study treatment. Non-sterilized male participants must agree to use highly effective contraception during the study and for at least 120 days after the last dose of study treatment.
Exclusion Criteria:
Beijing, 100021, China
The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
Anlotinib Plus Nab-Paclitaxels and S-1 for Patients with Advanced Biliary Tract Cancer As Second-Line Treatment
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract Cancer
Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer
IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer
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
Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer