Biliary Tract Tumor
Conditions
Brief summary
This study is a single-center, single-arm, open-label clinical study. All patients with advanced and unresectable biliary tract tumors will be treated with the combination of tisleizumab, lenvatinib and XELOX regimen (oxaliplatin plus capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. Patients will be closely monitored for safety and tolerability throughout the study.
Interventions
DRUGTislelizumab
Tisleizumab 200 mg intravenously (IV) every 3 weeks (Q3W) ,D1
DRUGLenvatinib
Lenvatinib 8 mg (for patient weight \< 60 kg) or 12 mg (for patient weight ≥ 60 kg), orally, QD, D1-21, Q3W
DRUGOxaliplatin
Oxaliplatin 130 mg/m2, IV， D1，Q3W Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years.
DRUGCapecitabine
Capecitabine 1000 mg/m2, orally, BID, D1-14, Q3W Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* To be eligible to participate in this study, a patient must meet all of the following criteria: 1. Able to provide written informed consent and able to understand and agree to comply with study requirements and assessment schedules 2. Histologically or cytologically confirmed unresectable or postoperative recurrent locally advanced or metastatic biliary tract tumors, including cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; 3. Aged 18-75 years old, male or female; 4. Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1; 5. Expected survival ≥ 3 months; 6. At least one measurable lesion according to RECIST V1.1; 7. No previous systemic therapy, including chemotherapy, targeted therapy, immunotherapy; 8. Adequate organ function as indicated by the following laboratory values ≤ 7 days prior to the first dose of study drug: a. Patients must not have required a transfusion of blood product or growth factor support within the 14 days before sample collection during the Screening Period and met all of the following criteria: i. Absolute neutrophil count（ANC）≥ 1.5 × 10\^9/L ii. Platelets ≥ 75 × 10\^9/L iii. Hemoglobin ≥ 90 g/L b. Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance \> 50 μmol/L c. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × ULN; if there is a lesion in liver, ALT or AST ≤ 5 × ULN; d. Serum total bilirubin ≤ 1.5 × ULN; e. International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN f. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN g. Cardiac Doppler ultrasound evaluation score (LVEF) ≥ 50%. 9. Patients with positive hepatitis B surface antigen (HBsAg) or previous history of HBV infection must receive antiviral agents before the first dose of study drug and continue treatment during the study. 10. Females of childbearing potential must agree to practice highly effective contraception during the study and for ≥ 120 days after the last dose of study drug and have a negative serum pregnancy test ≤ 7 days of the first study drug administration 11. Nonsterilized male patients must agree to practice highly effective contraception for the duration of the study and for ≥ 120 days after study drug administration 12. Good compliance and family agrees to cooperate with survival follow-up.
Exclusion criteria
* To be eligible to participate in this study, a patient cannot meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) per RECIST v1.1 assessed by investigator | 12months | It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR. |
| Safety as measured by the rate of AEs | 12months | Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of response (DOR) | 12months | DOR assessed by the investigator according to RECIST v1.1 and iRECIST |
| ORR per iRECIST by the investigator | 12months | ORR assessed by the investigator according to iRECIST |
| Overall survival (OS) | 24months | Overall survival (OS) |
| progression-free survival (PFS) | 12months | progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 and iRECIST |
| Disease control rate (DCR) | 12months | Disease control rate (DCR) assessed by the investigator according to RECIST v1.1 and iRECIST |
Countries
China
Contacts
Primary ContactYongxiang Xia, Doctor
Backup ContactJie Zhao, Doctor
Outcome results
None listed