Can a three-drug cocktail shrink advanced bile-duct tumors?
NCT ID NCT07719738
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether combining bevacizumab (a blood-vessel growth blocker) with nab-paclitaxel and an oral chemotherapy called S-1 can shrink tumors in people with advanced biliary tract adenocarcinoma that has worsened after initial treatment. About 32 participants will receive the drug combination in 21-day cycles. The main goal is to see how many patients experience tumor shrinkage, while also tracking side effects and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bevacizumab plus nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1)
- What this could lead to
- If effective, this combination could offer a new second-line treatment option for people with advanced biliary tract cancer who have not responded to initial therapy.
- What could go wrong
- This is a small, single-arm phase 2 trial, so results may not be generalizable. The combination may cause significant side effects, and there is no control group to compare against.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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32 people
The number who actually took part.
- Started
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Feb 2026
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, 100021, China
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