Clinical trial · Observational
Relationship Between Microbiota and Prognosis of Hepatocellular Carcinoma(HCC) After Systemic Treatments
Intestinal and Oral Microbiota Signatures of Clinical Response and Adverse Events in HCC Treated With Systemic Therapies
NCT05443217CI-TRIAL-00069562unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
By tracking the short-term and long-term results of HCC patients treated with systemic therapies,the difference of microbiota between responded patients and non-responded patients was analyzed, and the correlation between gut and oral microbiota and short-term and long-term results was explored, so as to improve people's awareness of microbiota and pay attention to its prevention and treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Event | — | UNRESOLVED | — |
| Efficacy | — | UNRESOLVED | — |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Microbiota | — | UNRESOLVED | — |
| Prognosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaire survey | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients with response to systemic therapies
- interventionNames
- Diagnostic Test: questionnaire survey
- label
- patients with no response to systemic therapies
- interventionNames
- Diagnostic Test: questionnaire survey
Primary outcomes (2)
- measure
- Post-treatment adverse events
- timeFrame
- 3 months
- description
- Post-treatment complications are recorded
- measure
- Long-term outcomes after treatment
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * clinically or pathologically diagnosed HCC * didn't receive prior anti-tumor treatments * didn't receive prior antibiotics * Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1 * Child-Pugh score of ≤7 * complete clinical and follow-up information. Exclusion Criteria: * combined with other malignancies * receive surgical treatment * lost follow-up * Child-Pugh score of\>7 * uncompleted clinical and follow-up information * overall survival less than 1 month * receive prior antibiotics
References
Publications (2)
- BACKGROUNDMcCulloch JA, Davar D, Rodrigues RR, Badger JH, Fang JR, Cole AM, Balaji AK, Vetizou M, Prescott SM, Fernandes MR, Costa RGF, Yuan W, Salcedo R, Bahadiroglu E, Roy S, DeBlasio RN, Morrison RM, Chauvin JM, Ding Q, Zidi B, Lowin A, Chakka S, Gao W, Pagliano O, Ernst SJ, Rose A, Newman NK, Morgun A, Zarour HM, Trinchieri G, Dzutsev AK. Intestinal microbiota signatures of clinical response and immune-related adverse events in melanoma patients treated with anti-PD-1. Nat Med. 2022 Mar;28(3):545-556. doi: 10.1038/s41591-022-01698-2. Epub 2022 Feb 28. PMID 35228752
- BACKGROUNDZheng Y, Wang T, Tu X, Huang Y, Zhang H, Tan D, Jiang W, Cai S, Zhao P, Song R, Li P, Qin N, Fang W. Gut microbiome affects the response to anti-PD-1 immunotherapy in patients with hepatocellular carcinoma. J Immunother Cancer. 2019 Jul 23;7(1):193. doi: 10.1186/s40425-019-0650-9. PMID 31337439