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

Fudan University1 site in 1 country65 target enrollmentFebruary 24, 2022

ConditionsBiliary Tract Cancer

InterventionsCapecitabine combined with lenvatinib and tislelizumab

DrugsCapecitabine combined with lenvatinib and tislelizumab

Overview

Phase: Phase 2
Intervention: Capecitabine combined with lenvatinib and tislelizumab
Conditions: Biliary Tract Cancer
Sponsor: Fudan University
Enrollment: 65
Locations: 1
Primary Endpoint: 1 year DFS rate
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 24, 2022

End Date

December 31, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Lu Wang, MD, PhD

Head of liver surgery department

Fudan University

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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