Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC) (NCT07143955) | Clinical Trial Compass
CompletedNot Applicable
Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)
China100 participantsStarted 2022-05-01
Plain-language summary
This prospective, randomized controlled trial investigates the efficacy of a targeted dietary intervention in patients with hepatocellular carcinoma (HCC). The study aims to compare a structured diet including probiotics and prebiotics against routine dietary care. The primary goal is to assess the impact on clinical outcomes (survival), gut microbiota composition, systemic lipid metabolism, and anti-tumor immune responses, to determine if this intervention can serve as an effective adjunctive therapy for HCC.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 80 years.
* Pathologically confirmed primary Hepatocellular Carcinoma (HCC).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Adequate organ function (e.g., liver, renal, and bone marrow).
* Life expectancy of at least 3 months.
* Willingness to provide informed consent and adhere to study procedures.
Exclusion Criteria:
* Concurrent malignancies other than HCC.
* Severe, uncontrolled comorbidities (e.g., congestive heart failure, renal failure).
* Known history of severe intestinal diseases such as inflammatory bowel disease.
* Use of antibiotics, probiotics, or other microbiota-altering agents within 4 weeks prior to enrollment.
* Cognitive impairment precluding understanding of the study.
* Refusal to provide consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Through study completion, an average of 12 months
2
Overall Survival (OS)
Timeframe: Through study completion, an average of 12 months
Trial details
NCT IDNCT07143955
SponsorThe First Hospital of Hebei Medical University