Table 3.
Clinical trials of gut microbiome as biomarker of immunotherapy
| Type | Conditions | Interventions | Phases | Enrollment | Funder type | Start date | Completion date | Locations | Study status | NCT number |
|---|---|---|---|---|---|---|---|---|---|---|
| Response | Gastric cancer, stomach neoplasm | JS001 + chemotherapy (XELOX or SOX) | Phase2 | 110 | Other | 2021/3/12 | 2024/12/30 | China | Recruiting | NCT04744649 |
| Response | ESCC | Sintilimab + chemotherapy | – | 30 | Other | 2021/12/1 | 2023/6/1 | China | Recruiting | NCT05199649 |
| Response | Colorectal adenocarcinoma | Fruquintinib + PD-1 inhibitors; fruquintinib + PD-1 inhibitors + radiotherapy | – | 100 | Other | 2022/1/1 | 2023/9/30 | China | Recruiting | NCT05635149 |
| Response | CRC | CAP + pembrolizumab + bevacizumab | – | 50 | Other | 2018/4/13 | 2022/6/30 | US | Completed | NCT04054908 |
| Response | Upper GI cancer | Immunotherapy | – | 40 | Other | 2021/10/1 | 2023/12/1 | China | Recruiting | NCT05065515 |
| Response | Metastatic carcinoma, CRC | Chemotherapy/immunotherapy | – | 21 | Other | 2016/10/20 | 2022/4/13 | US | Terminated | NCT02960282 |
| Response | NSCLC | PD-1/PD-L1 inhibitors | – | 50 | Other | 2021/8/12 | 2022/12/30 | China | Recruiting | NCT04682327 |
| Response | Metastatic NSCLC | ICI; ICI + chemotherapy | – | 24 | Other | 2021/5/3 | 2025/11/1 | France | Active not recruiting | NCT04804137 |
| Response | NSCLC, CRC, TNBC, pancreas cancer | Immunotherapy; chemotherapy | – | 5000 | Industry | 2022/7/1 | 2025/12/31 | US | Recruiting | NCT04638751 |
| Response | NSCLC, malignant melanoma, RCC, TNBC | ICI | – | 800 | Industry | 2021/11/22 | 2028/9/14 | US | Recruiting | NCT05037825 |
| Response | Carcinoma | Pembrolizumab | – | 100 | Industry | 2019/6/28 | 2022/12/31 | US | Unknown | NCT04291755 |
| Response | Melanoma | ICI | – | 450 | Other_gov | 2018/4/4 | 2023/5/2 | UK | Unknown | NCT03643289 |
| Response | Urothelial carcinoma | Atezolizumab; pembrolizumab | – | 40 | Other | 2020/12/2 | 2023/6/1 | France | Recruiting | NCT04566029 |
| Response | Advanced cancer | ICI | – | 150 | Other | 2016/11/29 | 2024/9/1 | US | Recruiting | NCT04204434 |
| Response | Diffuse large B cell lymphoma | Chemo-immunotherapy | – | 50 | Other | 2019/4/2 | 2023/12/20 | Italy | Active not recruiting | NCT03797170 |
| Response | Gynecologic cancer | Immunotherapy | – | 30 | Industry | 2021/6/29 | 2023/6/1 | US | Recruiting | NCT04957511 |
| Response | Melanoma | Pembrolizumab; lenvatinib | Phase2 | 44 | Other | 2023/5/1 | 2030/10/1 | Australia | Not yet recruiting | NCT05545969 |
| Response | Solid carcinoma | Immunotherapy | – | 60 | Other | 2018/6/4 | 2023/4/30 | Korea | Unknown | NCT04264975 |
| Response and irAEs | Melanoma, renal cancer, lung cancer | Nivolumab; pembrolizumab; ipilimumab; durvalumab; tremelimumab; atezolizumab; bevacizumab | – | 1800 | Other | 2020/7/8 | 2025/7/8 | UK | Recruiting | NCT04107168 |
| Response and irAEs | Non-squamous NSCLC | Pembrolizumab; pembrolizumab + pemetrexed + carboplatin | – | 150 | Other | 2021/5/18 | 2024/12/31 | US | Recruiting | NCT04954885 |
| Response and irAEs | Advanced solid tumor | ICI | – | 60 | Other | 2018/4/1 | 2024/12/1 | Canada | Recruiting | NCT04579978 |
| Response and irAEs | Lung cancer | ICI | – | 44 | Other | 2018/8/30 | 2022/5/9 | US | Completed | NCT03688347 |
| irAEs | Melanoma | Ipilimumab; nivolumab; pembrolizumab | – | 123 | Other | 2013/8/1 | 2019/4/1 | Netherlands | Completed | NCT02600143 |
| irAEs | NSCLC | ICI | – | 150 | Other | 2021/1/21 | 2023/3/3 | US | Recruiting | NCT04913311 |
US United States, UK United Kingdom, GI gastrointestinal, ESCC esophageal squamous cell carcinoma, NSCLC non-small cell lung cancer, TNBC triple negative breast cancer, CRC colorectal cancer, CAP capecitabine, RCC renal cell carcinoma, ICI immune checkpoint inhibitor