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

July 19, 2026 updated by: YONGKUN SUN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Efficacy and Safety of Bevacizumab With Nab-paclitaxel and Tegafur Gimeracil Oteracil Potassium Capsule (S-1) in Advanced Biliary Tract Adenocarcinoma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

    1. Absolute neutrophil count (ANC) ≥1.5 × 10^9/L, platelet count ≥75 × 10^9/L, and hemoglobin ≥85 g/L;
    2. Serum total bilirubin ≤1.5 × the upper limit of normal (ULN);
    3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN;
    4. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m²;
    5. International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5 × ULN;
    6. 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).
  • 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bevacizumab plus nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1)
Drug: Bevacizumab+nab-paclitaxel+tegafur gimeracil oteracil potassium capsule (S-1)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) according to RECIST Version 1.1
Time Frame: Every 6 weeks until disease progression, up to 24 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival According to RECIST Version 1.1
Time Frame: Up to 24 months
Time from first dose until disease progression according to RECIST version 1.1 or death.
Up to 24 months
Disease Control Rate (DCR)
Time Frame: Every 6 weeks from first dose until disease progression, up to 24 months
Percentage of participants achieving CR, PR or stable disease according to RECIST version 1.1.
Every 6 weeks from first dose until disease progression, up to 24 months
Duration of Response (DoR)
Time Frame: Up to 24 months
Time from first documented response until disease progression or death.
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 24 months
Time from enrollment to the patient's death for any cause
Up to 24 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose through 90 days after last dose
Incidence and severity of treatment-emergent adverse events assessed according to CTCAE version 5.0.
From first dose through 90 days after last dose
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Time Frame: Baseline through 24 months
Quality of life assessed using the EORTC QLQ-C30 questionnaire.
Baseline through 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expression of predefined predictive biomarkers associated with treatment response
Time Frame: Every 6 weeks until disease progression, up to 24 months
Assessment of predefined tumor and blood biomarkers associated with treatment response.
Every 6 weeks until disease progression, up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SH-202521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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