Bevacizumab Plus Nab-paclitaxel and Tegafur Gimeracil Oteracil Potassium Capsule (S-1) as Second-line Treatment for Advanced Biliary Tract Cancer: a Phase Ⅱ Clinical Trial

NCT07719738 | Completed Phase 2 DMC

• 1 other identifier: SH-202521
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) according to RECIST Version 1.1

  Percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1.

  Every 6 weeks until disease progression, up to 24 months

Secondary Outcomes (6)

• Progression-Free Survival According to RECIST Version 1.1

  Up to 24 months

• Disease Control Rate (DCR)

  Every 6 weeks from first dose until disease progression, up to 24 months

• Duration of Response (DoR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From first dose through 90 days after last dose

Other Outcomes (1)

• Expression of predefined predictive biomarkers associated with treatment response

  Every 6 weeks until disease progression, up to 24 months

Study Arms (1)

Bevacizumab plus nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1)

EXPERIMENTAL

Drug: Bevacizumab+nab-paclitaxel+tegafur gimeracil oteracil potassium capsule (S-1)

Interventions

Bevacizumab+nab-paclitaxel+tegafur gimeracil oteracil potassium capsule (S-1) DRUG

Patients received intravenous nab-paclitaxel at a dose of 125 mg/m2 on day 1 and 8, intravenous bevacizumab at a dose of 7.5 mg/kg on day 1, and oral S-1, 80 to 120 mg/day on days 1-14 of a 21-day cycle.

Bevacizumab plus nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1)

Eligibility Criteria

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

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L, platelet count ≥75 × 10\^9/L, and hemoglobin ≥85 g/L;
• Serum total bilirubin ≤1.5 × the upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN;
• Estimated glomerular filtration rate (eGFR) \>30 mL/min/1.73 m²;
• International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5 × ULN;
• Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
• 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).

You may not qualify if:

• Histologically or cytologically confirmed fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma.
• Active autoimmune disease or a history of autoimmune disease with the potential for recurrence.
• Any condition requiring systemic treatment with corticosteroids at a dose of \>10 mg/day of prednisone or equivalent, or other immunosuppressive agents, within 14 days before the first dose of study treatment.
• Inadequately controlled hypertension despite medical therapy, defined as systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg.
• Active gastrointestinal disorders, including active gastric or duodenal ulcer or ulcerative colitis; active bleeding from an unresected tumor; or any other condition considered by the investigator to pose a risk of gastrointestinal bleeding or perforation. Patients with a history of gastrointestinal perforation or gastrointestinal fistula that had not healed after surgical treatment were also excluded.
• A history of arterial thrombosis or deep vein thrombosis within 6 months before enrollment, or evidence or a history of bleeding tendency within 2 months before enrollment, regardless of severity.
• Any clinical or laboratory abnormality or compliance issue that, in the investigator's judgment, made the participant unsuitable for participation in the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Beijing, 100021, China

Location

MeSH Terms

Interventions

S 1 (combination)

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 22, 2026
• Study Start: February 23, 2026
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)