Brief Title
Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With BTC
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
1 year DFS rate
Secondary Outcome
2 years DFS rate
Condition
Biliary Tract Cancer
Intervention
Capecitabine combined with lenvatinib and tislelizumab
Study Arms / Comparison Groups
combined treatment group
Description: Capecitabine combined with lenvatinib and tislelizumab: Lenvatinib,8mg po. qd.Tislelizumab,200mg iv. q3w. Capecitabine 1250mg/m^2 bid.d1-d14 q3w
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
75
Start Date
December 30, 2021
Completion Date
December 2024
Primary Completion Date
December 2022
Eligibility Criteria
Inclusion Criteria:
1. Ages 18 and above
2. 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).
3. ECOG PS 0-1
4. Patients can tolerate the combination therapy and survive longer than 6 months.
5. 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.
6. 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.
7. 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.
8. The patients are voluntarily enrolled in the study, with good compliance and
coordinate the follow-up for safety and survival
Exclusion Criteria:
1. Patients with pancreatic/ampullary carcinoma
2. Patients with mucous gallbladder carcinoma
3. Patients who had received radiotherapy or chemotherapy previously
4. Incomplete surgery recovery or biliary obstruction exist
5. Patients with radiographs confirmed distant metastases
6. Patients with prior or concurrent malignancy(excluded Cured basal cell carcinoma of
the skin and Carcinoma in situ elsewhere)
7. Patients are allergy to macromolecular protein preparation(including anti-PD-1
antibody, uracil, cytosine pharmaceutical ingredients)
8. There are significant factors affecting oral drug absorption, such as inability to
swallow, chronic diarrhea, and intestinal obstruction
9. Patients had any active autoimmune disease or had experience of autoimmune disease.
10. Patients are receiving immunosuppressant and continue using within 2 weeks before
enrollment
11. Patients with ascites or pleural effusion requiring therapeutic puncture or drainage
12. Patients with disease of the heart that are not well controlled
13. Abnormal coagulation(have tendency to bleed or receiving thrombolytic or anticoagulant
therapy)
14. Patients had active infection or unexplained fever during screening and before first
dose
15. Patients had abdominal fistula, gastrointestinal perforation, or abdominal abscess
less than 4 weeks before first dose.
16. Patients past or present with pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung
function, etc
17. 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
18. 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;
19. Patients received live vaccination less than 4 weeks before administration or possibly
receive during the study period.
20. Patients had history of psychotropic substance abuse, alcohol abuse, or drug abuse.
21. Patients cannot or does not agree to pay the cost of examination and treatment expense
22. The researchers concluded the patients should be excluded from this study
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +86-18121299357, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05254847
Organization ID
BTC-CaLenT
Responsible Party
Principal Investigator
Study Sponsor
Fudan University
Study Sponsor
, ,
Verification Date
March 2022