Table 1.
Characteristics of neoadjuvant immunotherapy studies in patients with hepatocellular carcinoma. N/A, not applicable; HCC, hepatocellular carcinoma; NI, neoadjuvant immunotherapy; ICIs, immune checkpoint inhibitor.
| Source (Author/Year) |
Trial Indentifier |
Region | Sample Size | Study Phase | Intervention Model | Masking | Study Type | Randomization Method | Main Inclusion Criteria |
Article Type | Neoadjuvant Immuotherapy |
Cycles of NI |
ICIs Post-Surgery | pCR | MPR | Grade3–4 TRAEs | Surgical Delay |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shi, Y.H. et al., 2021 [30] |
NCT03867370 | China | 18 | 1b/2 | Sequential Assignment |
Open Label | Clinical Trial | Randomized | Surgically resectable; has not received local treatment | Conference abstract | Toripalimab (n = 14) or Toripalimab+ Lenvatinib (n = 4) |
1 | Yes | 6.3% (1/16) | NA | 16.7% (3/18) | 0% (0/16) |
| Su, Y. et al., 2021 [31] |
NCT03510871 | China | 29 | 2 | Single Group Assignment | Open Label | Clinical Trial | N/A | Potentially eligible for curative surgery (AJCC T3/T2) | Conference abstract | Nivolumab+ ipilimumab | 2/4 | N/A | NA | 33.3%(5/15) | 41.4% (12/29) | NA |
| Ho, W.J. et al., 2021 [32] |
NCT03299946 | USA | 15 | 1 | Single Group Assignment | Open Label | Clinical Trial | N/A | Locally advanced/borderline resectable; high-risk tumor features | Full text | Nivolumab+ Cabozantinib | 4 | N/A | 8.3% (1/12) | 33.3% (4/12) | 13.3% (2/15) | 0% (0/14) |
| Marron, T.U. et al., 2022 [33] |
NCT03916627 | USA | 21 | 2 | Single Group Assignment | Open Label | Clinical Trial | N/A | Surgical candidate for resection | Full text | Cemiplimab | 2 | Yes | 15% (3/20) | NA | 10% (2/21) | 5.8% (1/21) |
| Xia, Y. et al., 2022 [34] |
NCT04297202 | China | 20 | 2 | Single Group Assignment | Open Label | Clinical Trial | N/A | Systemic treatment-naive resectable HCC in intermediate/advanced stage. | Full text | Camrelizumab+ Apatinib | 3 | Yes | 5.9% (1/17) | 17.6%(3/17) | 16.7% (3/18) | 0% (0/17) |
| Kaseb, A.O. et al., 2022 [35] | NCT03222076 | USA | 30 | 2 | Parallel Assignment | Open Label | Clinical Trial | Randomized | Patients with HCC who are eligible for surgical resection | Full text | Nivolumab (n = 13) or Nivolumab +Ipilimumab (n = 14) | 3 | Yes | 25% (5/20) | NA | 33.3% (9/27) | 0% (0/20) |
| Chen, S. et al., 2022 [36] |
NCT04615143 | China | 11 | 2 | Sequential Assignment | Open Label | Clinical Trial | Non-Randomized | Resectable recurrent HCC after curative ablation | Conference abstract |
Tislelizumab | 2 | Yes | 9.1% (1/11) | NA | NA | 0% (0/11) |
| D’Alessio, A. et al., 2022 [37] | NCT03682276 | UK | 17 | 1b | Single Group Assignment | Open Label | Clinical Trial | N/A | HCC medically fit to undergo surgery; ineligible for liver transplantation | Conference abstract |
Nivolumab+ Ipilimumab | 2 | N/A | 22% (2/9) | NA | 7% (1/15) | 11% (1/9) |
| Bai, X. et al., 2022 [38] |
NCT04930315 | China | 32 | 2 | Parallel Assignment | Open Label | Clinical Trial | Randomized | BCLC stage B/C, or CNLC stage was IIa-IIIb, technically resectable | Conference abstract |
Camrelizumab+ Apatinib (n = 16) | 4 | Yes | 9.1% (1/11) | 27.3%(3/11) | NA | 0% (0/11) |