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Biliary Tract CancerPhase 2NCT05254847

Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With BTC

A Phase 2 study testing Capecitabine combined with lenvatinib and tislelizumab in people with Biliary Tract Cancer, run by Fudan University 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 is a prospective, open-label, single-center clinical study, to evaluate the efficacy and safety of Capecitabine combined with Lenvatinib and Tislelizumab as adjuvant treatment after resection in patients with biliary tract cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Capecitabine combined with lenvatinib and tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteChina
Study dates
24 Feb 2022to 31 Dec 2025
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

  • Ages 18 and above
  • Pathological reported showed Biliary tract cancer (include intrahepatic cholangiocarcinoma (IHCC), extrahepatic/hilar cholangiocarcinoma, muscle infiltrated gallbladder carcinoma or distal cholangiocarcinoma)，patients received R0 resection(including liver resection, pancreatectomy, or both).
  • ECOG PS 0-1
  • Patients can tolerate the combination therapy and survive longer than 6 months.
  • Organ function(Exclude use blood components and cell growth factors for 14 days): Neutrophils (ANC) ≥1,500/mm3, Platelet count (PLT)≥100,000/mm3, Hemoglobin (Hb) ≥9g/dL; Serum creatinine(SCR) ≤1.5*upper limit of normal(ULN),or creatinine clearance rate≥50 ml/min(Cockcroft-Gault Formula),Total bilirubin(TBIL)≤ 2*ULN,Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3*ULN, urine protein≤2+(if urine protein≥2+, 24-hour urinary protein quantity must ≤1g), Adequate surgical biliary drainage and no infection signal.
  • The coagulation function was normal (without active bleeding and thrombotic disease): International normalized ratio(INR)≤1.5*ULN, activated partial thromboplastin time(APTT)≤1.5×ULN, prothrombin time(PT)≤1.5*ULN.
  • Women without surgical sterilization or childbearing age who are required to use a medically approved contraceptive method (such as an intrauterine device, birth control pill or condom) during the study period and for 3 months after the study period; Women are of reproductive age and not undergoing surgical sterilization whose the serum or urine HCG test must be negative within 7 days prior to study enrollment and must be non lactation period. Male patients without surgical sterilization or reproductive age are required to consent with their spouse to use a medically approved contraceptive method during the study treatment period and for 3 months after the study treatment period.
  • The patients are voluntarily enrolled in the study, with good compliance and coordinate the follow-up for safety and survival

Who cannot join

  • Patients with pancreatic/ampullary carcinoma
  • Patients with mucous gallbladder carcinoma
  • Patients who had received radiotherapy or chemotherapy previously
  • Incomplete surgery recovery or biliary obstruction exist
  • Patients with radiographs confirmed distant metastases
  • Patients with prior or concurrent malignancy(excluded Cured basal cell carcinoma of the skin and Carcinoma in situ elsewhere)
Show all 22Show fewer
  • Patients are allergy to macromolecular protein preparation(including anti-PD-1 antibody, uracil, cytosine pharmaceutical ingredients)
  • There are significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
  • Patients had any active autoimmune disease or had experience of autoimmune disease.
  • Patients are receiving immunosuppressant and continue using within 2 weeks before enrollment
  • Patients with ascites or pleural effusion requiring therapeutic puncture or drainage
  • Patients with disease of the heart that are not well controlled
  • Abnormal coagulation(have tendency to bleed or receiving thrombolytic or anticoagulant therapy)
  • Patients had active infection or unexplained fever during screening and before first dose
  • Patients had abdominal fistula, gastrointestinal perforation, or abdominal abscess less than 4 weeks before first dose.
  • Patients past or present with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc
  • Patients have congenital or acquired immune deficiency; Hepatitis B patients: HBV DNA≥10^3/ml, Hepatitis C patients: HCV RNA≥10^3/ml, Chronic hepatitis B virus carriers: HBV DNA<2000 IU/ml（<10^4 copies/ml), patients must receive antiviral therapy during the trial
  • Patients are participating in other relevant clinical studies or it has been less than 1 month since the end of the previous clinical study; Patients maybe receive other systemic antitumor therapy during the study period;
  • Patients received live vaccination less than 4 weeks before administration or possibly receive during the study period.
  • Patients had history of psychotropic substance abuse, alcohol abuse, or drug abuse.
  • Patients cannot or does not agree to pay the cost of examination and treatment expense
  • The researchers concluded the patients should be excluded from this study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With Biliary Tract Cancer: A Single-arm, Phase II Study

This is a prospective, open-label, single-center clinical study, to evaluate the efficacy and safety of Capecitabine combined with Lenvatinib and Tislelizumab as adjuvant treatment after resection in patients with biliary tract cancer.

Being tested
Capecitabine combined with lenvatinib and tislelizumab
Medical subject headings
Biliary Tract Neoplasms

What participants receive

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

  • Capecitabine combined with lenvatinib and tislelizumabDrug

    Capecitabine combined with lenvatinib and tislelizumab

Study groups in NCT05254847
Study groupRoleWhat they receive
combined treatment groupExperimentalCapecitabine combined with lenvatinib and tislelizumab: Lenvatinib,8mg po. qd.Tislelizumab,200mg iv. q3w. Capecitabine 1250mg/m^2 bid.d1-d14 q3w
Receives: Drug: Capecitabine combined with lenvatinib and tislelizumab

What is being measured

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

  1. 1 year DFS rate

    one year disease free survival rate

    Measured: 12 month

Secondary outcomes (4)

  1. 2 years DFS rate

    two years disease free survival rate

    Measured: 24 month

  2. 1 year OS rate

    one year overall survival rate

    Measured: 12 month

  3. 3 years OS rate

    three years overall survival rate

    Measured: 36 month

  4. AE

    adverse event

    Measured: 30 days from the beginning of treatment to the last treatment

Timeline

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

  1. First posted24 Feb 2022
  2. Study start24 Feb 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2025

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254847
Sponsor's protocol ID
BTC-CaLenT
Status last verified
Jan 2026
First submitted
15 Feb 2022
Last updated
20 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Feng Y, Zhang N, Zhao YM, Pan Q, Mao AR, Zhu WP, Zhang T, Wang L. Adjuvant tislelizumab, lenvatinib, and capecitabine for resected biliary tract cancer: a prospective phase II trial. BMC Med. 2026 Jan 23;24(1):104. doi: 10.1186/s12916-026-04650-0.

    PubMed 41578300

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine combined with lenvatinib and tislelizumab in people with Biliary Tract Cancer, run by Fudan University 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 8 inclusion and 22 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 20 Jan 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?

1 year DFS rate (time frame: 12 month). 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 NCT05254847, which also lists 1 linked publication.

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 20 Jan 2026.

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