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. 2023 May 15;10:745–752. doi: 10.2147/JHC.S406902

Table 1.

Currently Recruiting Clinical Trials for Fibrolamellar Carcinoma

Trial Title Phase Trial Drugs Estimated Enrollment Patient No. Primary Objective
DNAJB1-PRKACA fusion kinase peptide vaccine combined with nivolumab and ipilimumab for patients with fibrolamellar hepatocellular carcinoma (NCT04248569) 1 1. DNAJB1-PRKACA peptide vaccine
2. Nivolumab
3. Ipilimumab		 12 Safety and interferon-producing DNAJB1-PRKACA-specific T-cell response at 10 weeks
Nivolumab, 5-Fluorouracil and Interferon-α2b for the treatment of unresectable fibrolamellar carcinoma (NCT04380545) 1/2 1. Fluorouracil
2. Nivolumab
3. Recombinant Interferon Alpha 2b-like protein		 15 Safety
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) (NCT03017326) 3 1. Carboplatin
2. Cisplatin
3. Doxorubicin
4. Etoposide
5. Flourouracil
6. Gemcitabine
7. Irinotecan
8. Oxaliplatin
9. Sorafenib
10. Vincristine Sulfate		 450 Event-free survival
Fc-engineering anti-CTLA-4 monoclonal antibody in advanced cancer (NCT03860272) 1 1. Botensilimab
2. Balstilimab		 195 Incidence of treatment-emergent adverse events, dose-limited toxicity of botensilimab, recommended Phase 2 dose of botensilimab
Safety and efficacy of cyclophosphamide, sorafenib, bevacizumab, and atezolizumab in pediatric solid tumor patients (NCT05468359) 1/2

  1. Atezolizumab

  2. Sorafenib

  3. Bevacizumab

  4. Cyclophosphamide

 64 Recommended phase 2 dose, pharmacokinetics of sorafenib, response rate, intratumoral T cell infiltration of CD8+CD45RO+ cells
Checkpoint inhibition in pediatric hepatocellular carcinoma (NCT04134559) 2 Pembrolizumab 18 Immune-related best overall response
A study of DT2216 in Relapsed/Refractory Malignancies (NCT04886622) 1 DT2216 24 Safety and dose limiting toxicity

Note: Data gathered from clinicaltrials.gov.