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BTCPhase 2NCT07890506

Chidamide Combined With Benmelstobart, Nab-paclitaxel, and SBRT as Second-Line Treatment for Advanced BTC

A Phase 2 study testing chidamide+benmelstobart+nab-paclitaxel+SBRT in people with BTC, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of chidamide combined with benmelstobart, nab-paclitaxel, and immunogenic radiotherapy (SBRT) as second-line treatment in patients with advanced biliary tract cancer (BTC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
BTC
What is being tested?
chidamide+benmelstobart+nab-paclitaxel+SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteChina
Study dates
1 Nov 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 1.Voluntarily sign the informed consent form (ICF); fully understand and be informed about this study and sign the ICF; be willing to comply with and capable of completing all study procedures.
  • 2.Male or female; aged 18 years or older.
  • 3. Histologically or cytologically confirmed unresectable or metastatic biliary tract cancer (BTC).
  • 4.Patients who have failed prior standard first-line therapy (gemcitabine plus cisplatin, gemcitabine plus oxaliplatin, or either regimen combined with a PD-1 monoclonal antibody). Failure of first-line therapy is defined as: disease progression during treatment or within 6 months after the last dose of treatment; or intolerance due to toxicity during treatment. Prior neoadjuvant or adjuvant chemotherapy is permitted. If disease progression or recurrence occurs during neoadjuvant/adjuvant therapy or within 6 months after completion of such therapy, the neoadjuvant/adjuvant therapy is considered to constitute failure of first-line therapy for progressive disease.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
  • 6. Life expectancy ≥ 12 weeks.
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  • 7. At least 2 tumor lesions, of which at least 1 lesion must be a measurable lesion according to RECIST v1.1.
  • 8. At least one tumor lesion is suitable for hypofractionated immunogenic radiotherapy at 5-8 Gy × 3 fractions, as assessed by a radiation oncologist.
  • 9. Laboratory test values obtained within 7 days prior to initiation of treatment must meet the following criteria: a) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; b) Platelets ≥ 50 × 10⁹/L; c) Hemoglobin ≥ 90 g/L (no packed red blood cell transfusion within 2 weeks); d) Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL/min; e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; f) Serum albumin ≥ 30 g/L; g) For patients not receiving anticoagulant therapy: INR or aPTT ≤ 1.5 × ULN. If the patient is receiving prophylactic anticoagulant therapy, enrollment is acceptable provided that INR ≤ 2 × ULN and aPTT is within the normal range within 14 days prior to initiation of study treatment; h) Serum bilirubin ≤ 1.25 × ULN.
  • 10. Subjects with controlled hepatitis B are eligible to participate provided they meet the following criteria: HBV antiviral therapy must have been administered for at least 4 weeks, and the HBV viral load must be < 100 IU/mL prior to the first dose of study drug. For subjects with a viral load below 100 IU/mL who are receiving anti-HBV therapy, the same treatment should be maintained throughout the study treatment period. Subjects who are positive for hepatitis B core antibody (anti-HBc), negative for hepatitis B surface antigen (HBsAg), negative or positive for hepatitis B surface antibody (anti-HBs), and have an HBV viral load below 100 IU/mL do not require prophylactic anti-HBV therapy.
  • 11. Subjects must have good compliance.

Who cannot join

  • 1. Prior receipt of HDAC inhibitor therapy or PD-L1-targeted therapy.
  • 2. Active autoimmune disease (except psoriasis) requiring systemic therapy (i.e., use of corticosteroids or immunosuppressive agents) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is permitted.
  • 3. Anticipated major surgery during the study period, including the 28-day screening period (diagnostic surgical procedures are excluded). Major surgery is defined as surgery requiring at least 3 weeks of postoperative recovery before the subject is able to receive study treatment.
  • 4. Known interstitial lung disease or presence of non-infectious pneumonitis requiring corticosteroid therapy.
  • 5. History of human immunodeficiency virus (HIV) infection, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or stem cell transplantation.
  • 6. Known clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis or other hepatitis, severe cirrhosis, hepatic steatosis (fatty liver), hereditary liver disease, hepatic atrophy, portal hypertension, uncontrolled major seizure disorder, or superior vena cava syndrome.
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  • 7. Known prior hypersensitivity to macromolecular protein preparations, monoclonal antibodies, or to any chemotherapeutic agent used in this trial.
  • 8. Participation in another clinical trial of an investigational agent within 4 weeks prior to the first dose (calculated from the date of last administration of the investigational agent).
  • 9. Receipt of a live vaccine within 30 days prior to the first dose. Injected inactivated viral vaccines for seasonal influenza are permitted; however, intranasally administered live attenuated influenza vaccines are not permitted.
  • 10. Receipt of liver-directed local therapy (transcatheter arterial chemoembolization [TACE], transcatheter embolization [TAE], hepatic arterial infusion [HAI], radiotherapy, radioembolization, or ablation) within 4 weeks prior to the first dose of study drug. Note: subjects must show evidence of disease progression following local therapy in order to be eligible.
  • 11. Receipt of prior radiotherapy to non-hepatic regions within 2 weeks prior to the first dose of study drug. Subjects must have recovered from all radiotherapy-related toxicities, must not require corticosteroids, and must not have experienced radiation pneumonitis. Palliative radiotherapy for non-CNS disease (≤ 2 weeks of radiotherapy) is permitted with a 2-week washout period.
  • 12. Known additional malignancy that is currently progressing or has required active treatment within the past 3 years. Note: subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma in situ, cervical carcinoma in situ) that has received potentially curative therapy are permitted.
  • 13. Alcohol dependence, or a history of drug abuse or substance abuse within the past 1 year.
  • 14. Pregnancy or breastfeeding during the study period, i.e., from the screening visit until 120 days after the last dose of study treatment, or planning to become pregnant or to father a child.
  • 15. Medical history or evidence of disease, treatment, or abnormal laboratory values that may interfere with the interpretation of study results or prevent the subject from participating in the entire study, or situations in which the investigator considers participation not to be in the subject's best interest.
  • 16. Subjects considered by the investigator to be unsuitable for participation in this trial for any other reason.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juan Du, Dr contact

+86 13951826526

dujuanglyy@163.com

China1 site

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing, Jiangsu, 210008

    Juan Du, +86 13951826526, dujuanglyy@163.com

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Phase II Clinical Study of Chidamide Combined With Benmelstobart, Nab-paclitaxel, and Immunogenic Radiotherapy as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer

This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of chidamide combined with benmelstobart, nab-paclitaxel, and immunogenic radiotherapy (SBRT) as second-line treatment in patients with advanced biliary tract cancer (BTC). The study plans to enroll 41 BTC patients who have previously received first-line systemic therapy, and these patients will receive chidamide, benmelstobart, nab-paclitaxel, and SBRT. The primary endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), duration of response (DoR), overall survival (OS), and safety.

Conditions
BTC
Being tested
chidamide+benmelstobart+nab-paclitaxel+SBRT
Keywords
HDACi, PD-L1, SBRT, BTC

What participants receive

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

  • chidamide+benmelstobart+nab-paclitaxel+SBRTDrug

    1. Chidamide: 20mg, biw, administered 30 minutes after a meal.
    2. Benmelstobart: 1200 mg, q3w
    3. Nab-paclitaxel: 125 mg/m², q3w
    4. SBRT: 5-8Gy*3f
Study groups in NCT07890506
Study groupRoleWhat they receive
chidamide+benmelstobart+nab-paclitaxel+SBRTExperimentalNot described
Receives: Drug: chidamide+benmelstobart+nab-paclitaxel+SBRT

What is being measured

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

  1. PFS

    Measured: from treatment initiation to disease progression at 6 months

Secondary outcomes (4)

  1. ORR

    Measured: from treatment initiation to disease progression at 6 months

  2. DoR

    Measured: from treatment initiation to disease progression at 6 months

  3. OS

    Measured: from treatment initiation to death at 12 months

  4. AE

    Measured: from treatment initiation to disease progression at 6 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 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

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
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07890506
Sponsor's protocol ID
2026-1216-01
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing chidamide+benmelstobart+nab-paclitaxel+SBRT in people with BTC, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 11 inclusion and 16 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: opening soon, as of the sponsor's last update on 22 Oct 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Juan Du, Dr (+86 13951826526, dujuanglyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: from treatment initiation to disease progression at 6 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 NCT07890506.

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 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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