Table 2.
Ongoing clinical trial investigating the use of TMB as a biomarker for prediction of HCC progression and therapy outcome (downloaded from https://www.clinicaltrials.gov/ accessed on 2 February 2023).
| NCT Number | Status | Outcome Measures | Study Population | Type of Study | Number of Enrolled Patients |
|---|---|---|---|---|---|
| NCT03236935 | Active, not recruiting | Maximum tolerated dose (MTD); dose-limiting toxicities (DLTs) and other adverse events; recommended interventional phase 2 dose (RP2D) of L-NMMA in combination with pembrolizumab; antitumor activity; plasma concentrations of L-NMMA when combined with pembrolizumab | 18 years and older | Interventional phase 1b study | 12 |
| NCT04042805 | Recruiting | TMB performed by NSG in association with ORR and survival after treatment with Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) | 18 to 100 years | Interventional single-arm, single-center, unrandomized, open-label phase II study | 36 |
| NCT04484636 | Recruiting | Distribution of mutations in HCC Evaluation of relative frequency of targetable mutations (incl. TMB and MSI status) per disease group Number of patients receiving therapies in accordance with their genomic profiles |
18 years and older | Prospective, multicenter, observational cohort study with biobanking | 200 |
| NCT05240404 | Recruiting | Evaluation of TMB in patients undergoing adjuvant toripalimab therapy after curative-intent ablation for HCC recurrence | 18 to 75 years | Interventional phase 2 | 116 |
| NCT04523493 | Recruiting | Evaluation of the correlation between TMB and therapy efficacy in advanced HCC patients undergoing toripalimab combined with lenvatinib vs. lenvatinib | 18 to 75 years | Prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study | 519 |
| NCT04605731 | Recruiting | Evaluation of TMB, response, and survival outcomes in patients treated with durvalumab and tremelimumab after radioembolization | 18 years and older | Interventional phase 1b | 32 |
| NCT04723004 | Active, not recruiting | Correlation between TMB and the efficacy of toripalimab combined with bevacizumab in advanced HCC | 18 to 75 years | Prospective, randomized, open-label, parallel-group, active controlled, multi-center phase III | 326 |