Table 3.
Ongoing Trials Involving Systemic Approaches With Radiotherapy
| Clinical Trial Identifier | Cancer Type | Regimen | Agent and Target | Outcomes of Interest |
|---|---|---|---|---|
| NCT01196390; ongoing, but no longer recruiting | HER-2 (+) esophageal ACA | Neoadjuvant paclitaxel, carboplatin, and 50.4 Gy (28 fractions)with or without trastuzumab | Trastuzumab, anti-HER-2/Neu MAB | Disease-free survival, pCR, and toxicity over 8 years. Estimated 591 people enrolled. |
| NCT02530437; not yet recruiting | Esophageal and GEJ ACA | Paclitaxel, carboplatin, and 50.4 Gy (28 fractions) with either concurrent or preceding taladegib | Taladegib, Hedgehog inhibitor | Toxicity and pCR over 10 weeks. Goal enrollment 66 patients. |
| NCT02375581; currently recruiting | Esophageal SCC and ACA | Concurrent icotinib with 50–60 Gy (25–30 fractions) | Icotinib, anti-EGFR TKI | Mortality and toxicity over 2 years. Goal enrollment 130 patients. |
| NCT02545751; not yet recruiting | Metastatic esophageal SCC and ACA | Concurrent thymalfasin with 25 Gy (5 fractions) | Thymalfasin, stimulates immune system proliferation and differentiation | Tumor response over 8 weeks and toxicity and OS over 2 years. Goal enrollment 29 patients. |
| NCT02381561; not yet recruiting | Advanced UGI and lower GI cancers | Ropidoxuridine with concurrent radiotherapy (dosing dependent on cancer site) | Ropidoxuridine, prodrug for nucleoside analog idoxuridine | MTD over 28 days. Goal enrollment 30 patients. |
| NCT02425605; currently recruiting | Advanced HCC | Intra-arterial 5-FU with 45 Gy (25 fractions) followed by sorafenib | Sorafenib, anti-VEGF-R TKI | OS, PFS, and pCR over 36 months. Goal enrollment 47 patients. |
| NCT01342224; active, but no longer recruiting | Locally advanced pancreatic ACA | Neoadjuvant telomerase vaccine (GV1001), followed by GM-CSF with gemcitabine and 50.4 Gy (28 fractions). Tadalaf l given throughout treatment and after surgery. | Telomerase vaccine (GV1001), peptide subunit of telomerase reverse transcriptase that can generate T-cell response to telomerase Tadalafl, phosphodiesterase inhibitor | Toxicity and tumor response over 180 days. 11 enrolled. |
| NCT02439593; not yet recruiting | Locally advanced pancreatic ACA | Neoadjuvant FOLFIRINOX followed by concurrent gemcitabine and 50.4 Gy (28 fractions) with or without weekly hyperthermia (40–41C) | Localized hyperthermia to 40–41C | 1-year OS and safety. Goal 39 patients in each arm. |
| NCT02405585; currently recruiting | Borderline resectable pancreatic ACA | Neoadjuvant FOLFIRINOX followed by concurrent gemcitabine and 50.4 Gy (28 fractions) with monthly algenpantucel-l immunotherapy | Algenpantucel-L, immunotherapy with human pancreatic cancer cells that contain mouse gene, thereby inducing immune system to recognize and attack cancer cells as foreign | 18-month OS, PFS, CR, and safety. Goal 48 patients total. |
| NCT02349867; currently recruiting | Untreated pancreatic ACA | Neoadjuvant gemcitabine and nab-paclitaxel followed by concurrent gemcitabine, vorinostat, sorafenib, and 50.4 Gy (28 fractions) | Vorinostat, histone deacetylase inhibitor Sorafenib, anti-VEGF-R TKI | Determine optimal dose and schedule of vorinostat and sorafenib over 18–36 months. Goal 36 patients total. |