Evaluating the effectiveness and safety of adjuvant transcatheter arterial chemoembolisation (TACE) after curative resection for Barcelona Clinic Liver Cancer (BCLC) stage 0-B hepatocellular carcinoma: protocol for a target trial emulation study.
According to Chinese clinical practice guidelines, patients with hepatocellular carcinoma (HCC) at high risk of recurrence after curative hepatectomy should have adjuvant transcatheter arterial chemoembolisation (TACE). However, the National Comprehensive Cancer Network and the European Association for the Study of the Liver guidelines take a more conservative stance on the routine use of adjuvant TACE. A recent randomised controlled trial (RCT) found no benefit of adjuvant TACE for patients with early-stage HCC. Given the potential ethical concerns, it is impractical to conduct another RCT. Therefore, we plan to use a target trial emulation (TTE) framework to estimate the effectiveness and safety of adjuvant TACE in patients with resectable HCC, classified as Barcelona Clinic Liver Cancer stage 0-B, with subgroup analyses to identify potential effect-modifying subpopulations.
A TTE framework using the cloning-censoring-weighting approach with a 4-week grace period will be implemented. Eligible patients will be cloned into the adjuvant TACE and active surveillance groups and artificially censored on deviation from their assigned treatment strategy. Potential confounders will be identified using a directed acyclic graph and inverse probability of censoring weights will be applied to adjust for bias arising from artificial censoring. Subgroup analyses will be prespecified based on the potential sources of treatment-effect heterogeneity.
The institutional review board of West China Hospital, Sichuan University, approved this study (Approval No. 2025(1790)). Given the study's retrospective design and the use of de-identified data, informed consent was waived. The results of this research will be disseminated through publication in a peer-reviewed journal and presentation at scientific conferences.
ChiCTR2600121012.
A TTE framework using the cloning-censoring-weighting approach with a 4-week grace period will be implemented. Eligible patients will be cloned into the adjuvant TACE and active surveillance groups and artificially censored on deviation from their assigned treatment strategy. Potential confounders will be identified using a directed acyclic graph and inverse probability of censoring weights will be applied to adjust for bias arising from artificial censoring. Subgroup analyses will be prespecified based on the potential sources of treatment-effect heterogeneity.
The institutional review board of West China Hospital, Sichuan University, approved this study (Approval No. 2025(1790)). Given the study's retrospective design and the use of de-identified data, informed consent was waived. The results of this research will be disseminated through publication in a peer-reviewed journal and presentation at scientific conferences.
ChiCTR2600121012.