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Biliary Cancer MetastaticPhase 2NCT07719738

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

A Phase 2 study testing Bevacizumab+nab-paclitaxel+tegafur gimeracil oteracil potassium capsule (S-1) in people with Biliary Cancer Metastatic, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Cancer Metastatic
What is being tested?
Bevacizumab+nab-paclitaxel+tegafur gimeracil oteracil potassium capsule (S-1)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
23 Feb 2026to 23 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Beijing, 100021

Other trials in China

About this study

Official title: 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07719738
Study groupRoleWhat they receive
Bevacizumab plus nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1)ExperimentalNot described
Receives: Drug: Bevacizumab+nab-paclitaxel+tegafur gimeracil oteracil potassium capsule (S-1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Every 6 weeks until disease progression, up to 24 months

Secondary outcomes (6)

  1. Progression-Free Survival According to RECIST Version 1.1

    Time from first dose until disease progression according to RECIST version 1.1 or death.

    Measured: Up to 24 months

  2. Disease Control Rate (DCR)

    Percentage of participants achieving CR, PR or stable disease according to RECIST version 1.1.

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

  3. Duration of Response (DoR)

    Time from first documented response until disease progression or death.

    Measured: Up to 24 months

  4. Overall Survival (OS)

    Time from enrollment to the patient's death for any cause

    Measured: Up to 24 months

  5. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Incidence and severity of treatment-emergent adverse events assessed according to CTCAE version 5.0.

    Measured: From first dose through 90 days after last dose

  6. Change From Baseline in EORTC QLQ-C30 Global Health Status Score

    Quality of life assessed using the EORTC QLQ-C30 questionnaire.

    Measured: Baseline through 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start23 Feb 2026
  3. Primary completion23 Feb 2026
  4. Study completion23 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07719738
Sponsor's protocol ID
SH-202521
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab+nab-paclitaxel+tegafur gimeracil oteracil potassium capsule (S-1) in people with Biliary Cancer Metastatic, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) according to RECIST Version 1.1 (time frame: Every 6 weeks until disease progression, up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07719738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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