Cholangiocarcinoma
Conditions
Interventions
single-arm:regorafenib + tislelizumab
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male or female patients aged 18-75 years; 2) Patients with cholangiocarcinoma that cannot be resected or has recurred or metastasized after resection are included, including intrahepatic cholangiocarcinoma (iCCA), hilar cholangiocarcinoma (pCCA) or extrahepatic distal cholangiocarcinoma (dCCA); 3) Patients who refused chemotherapy; 4) ECOG score 0-1.
Exclusion criteria
Exclusion criteria: 1) Neutrophil count (ANC) upper limit of normal, the total bilirubin (TB) > 2 ULN, TB > 3 ULN in patients with obstructive jaundice; INR and PT > 1.5 ULN; 3) Renal function indexes: serum creatinine > 1.5 ULN; creatinine clearance rate < 45 ml / min; 4) Severe cardiovascular and cerebrovascular diseases; 5) Participated in other clinical trials 30 days before screening; 6) The researchers did not consider it appropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate;Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Time to disease progression (TTP);Objective response rate (ORR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactZhiyong Huang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed