Table 6.
Current trials involving the immune system in BTC registered on clinicaltrials.gov
| NCT | Study | Phase | Status | Recruiting countries | Comment |
|---|---|---|---|---|---|
| NCT02829918190 | Nivolumab in patients with aBTC which is refractory | II | Recruiting | USA | PD-1 antibody |
| NCT03110328191 | Pembrolizumab in mBTC as second-line treatment after failing one cytotoxic chemo | II | Not yet open | Korea | PD-1 antibody |
| NCT03046862192 | Durvalumab/tremelimumab in combination with GC in chemo-naïve BTC patients | II | Recruiting | Korea | Durvalumab = PD-L1 antibody Tremelimumab = CTLA-4 antibody |
| NCT03101566193 | Nivolumab in combination with GC or ipilimumab in aBTC | II | Not yet open | USA | Nivolumab = PD-1 antibody Ipilimumab = CTLA4 antibody |
| NCT02632019194 | Immunotherapy using precision T cells specific to neo-antigens for the treatment of advanced BTC | I/II | Recruiting | China | Dendritic cell precision T cells against neoantigen |
| NCT02586987173 | Study to assess the safety and tolerability of ascending doses of selumetinib with MEDI4736 and selumetinib, MEDI4736, tremelimumab in advanced solid tumors | I | Recruiting | Multinational | Selumetinib = MEK inhibitor MEDI4736= PD-L1 antibody Tremelimumab = CTLA4 antibody |
| NCT01938612195 | Phase I, open-label, multicentre study to evaluate MEDI4736 in advanced solid tumors | I | Recruiting | Multinational | PD-L1 antibody |
| NCT02628067196 | Pembrolizumab in patients with advanced solid tumors, KEYNOTE-158 | II | Recruiting | Multinational | PD-1 antibody |
| NCT02821754197 | Pilot study of combined immune check point inhibitors with ablative therapy in HCC and BTC | I/II | Recruiting | USA | Durvalumab = PD-L1 antibody Tremelimumab = CTLA4 antibody |
| NCT01853618198 | Tremelimumab with chemoembolization or ablation for liver ca | I | Active, not recruiting | USA | CTLA4 antibody |
| NCT02662348199 | T cell-mediated adaptive therapy for Her2- positive digestive system ca | I | Enrolling by invitation | China | HER2 Bi-armed T cells |
| NCT03482102200 | Durvalumab (MEDI4736) and tremelimumab and radiation therapy in HCC and BTC | II | Recruiting | USA | PD-L1 antibody and anti- CTLA4 |
| NCT03111732201 | Pembrolizumab with CapeOx in aBTC | II | Recruiting | USA | PD-1 antibody |
| NCT03260712202 | Pembrolizumab in BTC | II | Not yet recruiting | Germany | PD-1 antibody |
| NCT03358849203 | Evaluation of the safety of allogeneic NKC (SMT-NK) cell therapy in aBTC | I | Recruiting | South Korea | Human NKC therapy designated as SMT 01 |
Notes: Tariq NU, Vogel A, McNamara MG, Valle JW. Biliary tract cancer: implicated immune-mediated pathways and their associated potential targets. Oncol Res Treat. 2018;41(5):298–304. Copyright © 2018 Karger Publishers, Basel, Switzerland.203
Abbreviations: aBTC, advanced biliary tract cancer; aCCA, advanced cholangiocarcinoma; BTC, biliary tract cancer; ca, carcinoma; CapeOx, capecitabine and oxaliplatin; CCA, cholangiocarcinoma; chemo, chemotherapy; CTLA4, cytotoxic T-lymphocyte-associated antigen 4; GBC, gallbladder cancer; GC, gemcitabine and cisplatin; HCC, hepatocellular carcinoma; HER, human EGF receptor; mBTC, metastatic biliary tract cancer; MEK, mitogen-activated protein kinase; NKC, natural killer cell; PD-1, programmed death 1; PD-L1, programmed cell death ligand-1; TKI, tyrosine kinase inhibitor.