Table 2.
Selected Ongoing Trials of Adjuvant and Neoadjuvant Therapies in HCC
| ClinicalTrials.Gov Identifier | Interventions (Mechanism) | Phase, Setting | Primary Outcome | |
|---|---|---|---|---|
| (No. of Patients) | Measures | Study Completion | ||
| Neoadjuvant therapy | ||||
| NCT04615143 (43) | Tislelizumab(PD-1 mAb) | II, resectable recurrent HCC | DFS | Jun. 2022 |
| NCT03510871 (40) | Nivolumab(PD-1 mAb)+ipilimumab(CTLA-4 mAb) | II, potential resectable HCC | ORR | Dec. 2022 |
| NCT03867370 (40) | Toripalimab(PD-1 mAb)+lenvatinib(TKI) vs toripalimab | II, resectable HCC | PRR | Oct. 2022 |
| NCT04174781 (61) | Sintilimab(PD-L1 mAb) +DEB-TACE | II, early and intermediate HCC | PFS | May. 2022 |
| Adjuvant therapy | ||||
| NCT04168944 (108) | Lenvatinib(TKI) vs placebo | III, HCC at high risk of recurrence after liver transplantation | TFSR | Sep. 2022 |
| NCT02738697 (290) | FOLFOX | III, HCC with solitary tumor more than 5cm and MVI after radical hepatectomy | OS | Dec. 2021 |
| NCT04143191 (158) | Sorafenib(TKI)+TACE vs sorafenib | III, HCC after curative hepatic resection | RFS | Sep. 2023 |
| NCT03867084 (950) | Pembrolizumab(PD-1 mAb) vs placebo | III, HCC at complete radiological response after surgical resection or local ablation | RFS | Jun. 2025 |
| NCT03847428 (888) | Durvalumab(PD-L1 mAb)+bevacizumab(VEGF mAb) vs durvalumab | III, HCC at high risk of recurrence after curative treatment | RFS | May. 2024 |
| NCT04102098 (662) | Atezolizumab(PD-L1 mAb)+bevacizumab(VEGF mAb) vs active surveillance | III, HCC at high risk of recurrence after surgical resection or ablation | RFS | Jul. 2027 |
| NCT04639180 (674) | Camrelizumab(PD-1 mAb)+apatinib(TKI) vs active surveillance | III, HCC at high risk of recurrence after curative resection or ablation | RFS | Jul. 2024 |
Abbreviations: OS, overall survival; DFS, disease-free survival; ORR, overall response rate; RFS, recurrence-free Survival; PFS, progression-free survival; PRR, pathological response rate; TFSR, tumor free survival rate; mAb, monoclonal antibody; VEGF,vascular endothelial growth factor;PD-1, programmed cell death protein 1; PD-L1, programmed death 1 ligand 1; MVI, microvessels invasion; CTLA-4, cytotoxic T lymphocyte-associated protein 4; FOLFOX, fluorouracil, leucovorin, and oxaliplatin; TKI, tyrosine kinase inhibitor; mAb, monoclonal antibody; DEB-TACE, drug-eluting bead transarterial chemoembolization; HCC, hepatocellular carcinoma; aHCC, advanced HCC.