ALPPS Combined With Tislelizumab in Liver Malignancy
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
Study design: Prospective, single-center, phase IIa clinical trial; Primary endpoint:
Recurrence free survival; Secondary endpoints: Safety, overall survival; Main characteristics
of patients: Liver malignancy, required (extended) hemihepatectomy, insufficient liver
reserve; Study approaches: The experimental group is treated with ALPPS combined with
Tislelizumab, and the control group was treated with ALPPS; Sample size: 20 (10:10); Study
process: In experimental group, patients who meet the inclusion criteria will receive ALPPS
stage I surgery, treated with Tislelizumab 2-4 weeks after stage I surgery, and receive ALPPS
stage II surgery 2-4 weeks after Tislelizumab treatment, and treated with Tislelizumab q3W
6-12 months after stage II surgery; In control group, patients who meet the inclusion
criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 3-6 weeks
after stage I surgery.