Status:
UNKNOWN
Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With BTC
Lead Sponsor:
Fudan University
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05254847
Start Date
December 30 2021
End Date
December 1 2024
Last Update
April 4 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China