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. 2023 Apr 30;35(2):92–107. doi: 10.21147/j.issn.1000-9604.2023.02.02

Table 4. Clinical trials of immunotherapy for LT.

No. of NCT PI Intervention model description Intervention/treatment Primary outcomes measures Secondary outcome measures Status
LT, liver transplantation; PI, principal investigator; RFS, recurrence-free survival; OS, overall survival; I.V., intravenous; AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; ORR, objective response rate; PFS, progression-free survival; TTP, time to progression; SAE, serious adverse event; GR, graft rejection; NK, nature killer.
NCT05027425 Davendra Sohal et al. Single-arm, open-label, multicenter clinical trial, phase II Four months durvalumab plus tremelimumab, after 72 d undergo LT Cellular rejection rates 1. AEs during treatment, and graft loss and mortality rates2. Radiologic responses via RECIST 1.1 and/or mRECIST3. Pathologic responses via explanted liver assessment4. RFS and OS outcomes based on survival follow-up reporting Not yet recruiting
NCT03966209 Huang et al. Single group assignment, open label, phase I JS001(PD-1 inhibitor) 240 mg I.V. Q3W 1. Serious AEs rate2. Acute graft rejection rate ORR, PFS, OS Recruiting
NCT04564313 Wang et al. Single group assignment, open label, phase I Camrelizumab (SHR-1210), 200 mg, I.V., Q3W ORR OS, PFS, TTP, SAE, GR Recruiting
NCT01147380 Seigo Nishida et al. Non-randomized, parallel assignment, open label, phase I Small dose: inoculation NK cells between 10 and 100 million cellsLarge dose: inoculation cells between 100 and 1,000 million cells Side effects of cadaveric donor liver NK cell infusion 1. NK cell infusion-related toxicity2. Anti-HCC effect of this treatment3. Anti-HCV effect of this treatment (if applicable) Completed
NCT02849015 Chen et al. Randomized, parallel assignment, open label phase I, phase II Device: CryosurgeryBiological: NK immunotherapy No. of participants with treatment-related AEs as assessed by CTCAE v4.0 (Time frame: 3 months) PFS, OS Completed