Table 3.
Clinical trials of gut-microbiome-based therapies in HCC.
| Clinical Trial | Official Title | Intervention | Research Purpose | Primary Outcome | Status |
|---|---|---|---|---|---|
| NCT03785210 | Phase II Study of Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in Patients With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers | Vancomycin | To investigate if nivolumab given with tadalafil and vancomycin causes liver cancer to shrink. | Best overall response | Completed |
| NCT05032014 | Probiotics Enhance the Treatment of PD-1 Inhibitors in Patients With Liver Cancer |
Probio-M9 | To assess whether probiotics can improve the efficacy of ICI |
Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit |
Recruiting |
| NCT04264975 | Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology | FMT | To evaluate whether the fecal microbiota transplantation (FMT) could help overcome resistance in pts with advanced solid cancer refractory to anti-PD-(L)1 inhibitors | Overall response rate | Unknown |
| NCT05690048 | Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab | FMT | To assess safety and immunogenicity of fecal microbiota transfer in combination with standard of care immunotherapy in advanced hepatocellular carcinoma | Differential tumoral CD8 T-cell infiltration Adverse event documentation of FMT in advanced HCC |
Not yet recruiting |
| NCT05750030 | Fecal Microbiota Transplant (FMT) Combined With Atezolizumab Plus Bevacizumab in Patients With HepatoCellular Carcinoma Who Failed to Respond to Prior Immunotherapy—the FAB-HCC Pilot Study | FMT | To assess the safety of FMT combined with atezolizumab plus bevacizumab, as measured by incidence and severity of treatment-related adverse events | Safety of atezolizumab/bevacizumab in combination with FMT, measured by incidence and severity of treatment-related adverse events, determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | Not yet recruiting |