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

NCT05254847 | Completed Phase 2

• 1 other identifier: BTC-CaLenT
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• 1 year DFS rate

  one year disease free survival rate

  12 month

Secondary Outcomes (4)

• 2 years DFS rate

  24 month

• 1 year OS rate

  12 month

• 3 years OS rate

  36 month

• AE

  30 days from the beginning of treatment to the last treatment

Study Arms (1)

combined treatment group

EXPERIMENTAL

Capecitabine combined with lenvatinib and tislelizumab: Lenvatinib,8mg po. qd.Tislelizumab,200mg iv. q3w. Capecitabine 1250mg/m\^2 bid.d1-d14 q3w

Drug: Capecitabine combined with lenvatinib and tislelizumab

Interventions

Capecitabine combined with lenvatinib and tislelizumab DRUG

Capecitabine combined with lenvatinib and tislelizumab

combined treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 41578300 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

lenvatinib; tislelizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver surgery department

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: February 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)