PMID- 37139154
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230505
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 13
DP  - 2023
TI  - TIDE: adjuvant tislelizumab plus donafenib combined with transarterial 
      chemoembolization for high-risk hepatocellular carcinoma after surgery: protocol 
      for a prospective, single-arm, phase II trial.
PG  - 1138570
LID - 10.3389/fonc.2023.1138570 [doi]
LID - 1138570
AB  - BACKGROUND: The high recurrence rate of hepatocellular carcinoma (HCC) after 
      surgery negatively affects the prognosis of patients. There is currently no 
      widely accepted adjuvant therapy strategy for patients with HCC. A clinical study 
      of effective adjuvant therapy is still needed. METHODS: In this prospective, 
      single-arm, phase II clinical trial, an adjuvant regimen of donafenib plus 
      tislelizumab combined with transarterial chemoembolization (TACE) will be used to 
      treat enrolled HCC patients after surgery. Briefly, patients newly diagnosed with 
      HCC by pathological examination who underwent curative resection and had a single 
      tumor more than 5 cm in diameter with microvascular invasion as detected by 
      pathological examination are eligible. The primary endpoint of the study is the 
      recurrence-free survival (RFS) rate at 3 years, and secondary endpoints are the 
      overall survival (OS) rate and the incidence of adverse events (AEs). The planned 
      sample size, 32 patients, was calculated to permit the accumulation of sufficient 
      RFS events in 3 years to achieve 90% power for the RFS primary endpoint. 
      DISCUSSION: Vascular endothelial growth factor (VEGF) and programmed cell death 
      protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathways regulate the 
      relevant immunosuppressive mechanisms of HCC recurrence. Our trial will evaluate 
      the clinical benefit of adding donafenib plus tislelizumab to TACE in patients 
      with early-stage HCC and a high risk of recurrence. CLINICAL TRIAL REGISTRATION: 
      www.chictr.org.cn, identifier ChiCTR2200063003.
CI  - Copyright (c) 2023 Qi, Peng, Qi, Qiu, Wen and Li.
FAU - Qi, Weili
AU  - Qi W
AD  - Department of Liver Surgery, West China Hospital, Sichuan University, Chengdu, 
      China.
FAU - Peng, Wei
AU  - Peng W
AD  - Department of Liver Surgery, West China Hospital, Sichuan University, Chengdu, 
      China.
AD  - Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, 
      Chengdu, China.
FAU - Qi, Xin
AU  - Qi X
AD  - West China School of Medicine, Sichuan University, Chengdu, China.
FAU - Qiu, Zhancheng
AU  - Qiu Z
AD  - Department of Liver Surgery, West China Hospital, Sichuan University, Chengdu, 
      China.
FAU - Wen, Tianfu
AU  - Wen T
AD  - Department of Liver Surgery, West China Hospital, Sichuan University, Chengdu, 
      China.
FAU - Li, Chuan
AU  - Li C
AD  - Department of Liver Surgery, West China Hospital, Sichuan University, Chengdu, 
      China.
LA  - eng
PT  - Journal Article
DEP - 20230417
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC10149831
OTO - NOTNLM
OT  - PD-1
OT  - TACE
OT  - VEGF
OT  - adjuvant therapy
OT  - hepatocellular carcinoma
COIS- WP reports receiving grant support from Zelgen and lecture fees from Bayer, Merk, 
      Roche, Hengrui, SciClone. TW reports receiving grant support from AstraZeneca, 
      Zelgen, Merk, Roche, Eisai and Innovent, advisory board fees and lecture fees 
      from Bayer, Merk, Roche, Hengrui. CL, receiving grant support from Eisai, Merk, 
      and advisor board fees from Bayer, Merk, Roche. The remaining authors declare 
      that the research was conducted in the absence of any commercial or financial 
      relationships that could be construed as a potential conflict of interest.
EDAT- 2023/05/04 06:41
MHDA- 2023/05/04 06:42
PMCR- 2023/01/01
CRDT- 2023/05/04 02:14
PHST- 2023/01/05 00:00 [received]
PHST- 2023/04/03 00:00 [accepted]
PHST- 2023/05/04 06:42 [medline]
PHST- 2023/05/04 06:41 [pubmed]
PHST- 2023/05/04 02:14 [entrez]
PHST- 2023/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2023.1138570 [doi]
PST - epublish
SO  - Front Oncol. 2023 Apr 17;13:1138570. doi: 10.3389/fonc.2023.1138570. eCollection 
      2023.