Table 1.
Clinical trials of various adoptive immunotherapies in gastrointestinal (GI) cancer.
| Cancer Type | Start Year | No of Participants | Site of Trial | Agents | Phase | Clinical Trials Gov Number | Recruitment Status |
|---|---|---|---|---|---|---|---|
| CAR-T Therapies | |||||||
| Liver neoplasms | 2015 | 25 | China | EPCAM CAR-T cells | N/A | NCT02729493 | Yes |
| Metastatic cancer | 2012 | 15 | US | Mesothelin CAR-T | I/II | NCT01583686 | Terminated |
| HCC | 2018 | 50 | China | c-Met/PD-L1 CAR-T | Ia | NCT03672305 | Not yet |
| Advanced HCC | 2015 | 13 | China | Anti-GPC3 CAR-T | I | NCT02395250 | Completed |
| Malignancies | 2018 | 73 | China | Autologous CAR-T/TCR | I/II | NCT03638206 | Yes |
| PC | 2017 | 18 | US | huCART-meso cells | I | NCT03323944 | Yes |
| HCC | 2019 | 14 | US | GPC3-CAR-T + Cytoxan + Fludarabine | I | NCT02905188 | Yes |
| Malignant solid tumor | 2019 | 30 | China | Nectin 4/FAP CAR-T | I | NCT03932565 | Yes |
| PC | 2018 | 10 | China | CAR-T-meso cells | N/A | NCT03638193 | Yes |
| PC CEA + liver metastases |
2019 | 6 | US | CAR2Anti-CEA CAR-T | Ib | NCT03818165 | Yes |
| HCC/Metastatic colorectal and PC | 2016 | 20 | China | CAR-T | I/II | NCT02959151 | Unknown |
| EPCAM + cancer | 2017 | 60 | China | CAR-T | I/II | NCT03013712 | Yes |
| HCC | 2017 | 18 | China | ET1402L1-CAR-T | I | NCT03888859 | Yes |
| Metastatic CRC | 2018 | 20 | China | EGFR/CAR-T | I | NCT03542799 | Not yet |
| Advanced malignancies | 2015 | 20 | China | Anti-CD133 CAR-T | I | NCT02541370 | Unknown |
| Tumor-Infiltrating Lymphocyte Therapies | |||||||
| Metastatic cancer | 2010 | 332 | US | TIL + Aldesleukin + Cyclophosphamide + Fludarabine + Pembrolizumab | II | NCT01174121 | Yes |
| Colorectal cancer | 2019 | 20 | China | Anti-PD-1 activated TIL + Xelox | I/II | NCT03904537 | Yes |
| Advanced refractory solid tumor | 2017 | 40 | China | Neoantigen Reactive T Cells (NRTs) + PD-1 | I/II | NCT03171220 | Yes |
| Advanced solid cancer | 2019 | 240 | US | TIL + Cyclophosphamide + Fludarabine | II | NCT03935893 | Not yet |
| CIK Therapies | |||||||
| PC | 2013 | 47 | China | DC/CIK + S1 | I/II | NCT01781520 | Completed |
| PC | 2018 | 90 | China | CIK + Anti- CD3-MUC1 bispecific antibody | II | NCT03509298 | Yes |
| CRC | 2012 | 46 | China | CIK + Folfox4 | IV | NCT03084809 | Completed |
| Colon cancer | 2019 | 20 | Iran | Autologous CIK | I/II | NCT03329664 | Not yet |
| Metastatic CRC | 2017 | 28 | Korea | Immuncell-LC | II | NCT03220984 | Enrolling by invitation |
| HCC | 2015 | 55 | China | Autologous CIK | I/II | NCT03124498 | Unknown |
| Resected liver cancer | 2008 | 200 | China | CIK | III | NCT00769106 | Completed |
| Liver transplant in HCC | 2019 | 18 | Korea | Immuncell-LC | I/II | NCT03983967 | Yes |
| iNKT Therapies | |||||||
| Advanced solid tumor | 2017 | 40 | China | iNKT cells + CD8+ T cells | I/II | NCT03093688 | Yes |
| HCC | 2017 | 18 | Adoptive iNKT therapy | I | NCT03175679 | Yes | |
| Bispecific T cell engager | |||||||
| PC | 2015 | 2 | US | anti-CD3 × anti-EGFR, IL-2 + GM-CSF | I/II | NCT02620865 | Active, NR |
Abbreviations: EGFR, epidermal growth factor receptor; iNKT, invariant natural killer-T cell; CIK, cytokine induced killer cell; GM-CSF, granulocyte macrophage-colony stimulating factor; NRT, Neoantigen Reactive T Cells; MUC-1, mucin-1; TIL, tumor infiltrating lymphocyte; GPC3, glypican-3; DC, dendritic cell; EPCAM, epithelia cell adhesion molecule; NR, not recruiting; CEA, Carcinoembryonic Antigen; CART-T, chimeric antigen receptor-T cell; TCR, T cell receptor.