Dietary Intervention and Gut Microbiota in Hepatocellular Carcinoma (HCC)

A Randomized Controlled Trial of a Targeted Dietary Intervention to Reshape Gut Microbiota and Lipid Metabolism for Enhancing Anti-Tumor Immunity and Prognosis in Patients With Hepatocellular Carcinoma

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.

Hepatocellular carcinoma (HCC) is associated with gut microbiota dysbiosis, which contributes to a pro-inflammatory and immunosuppressive tumor microenvironment via the "gut-liver axis." This study hypothesizes that modulating the gut microbiota through a targeted dietary intervention can rebalance systemic immunity and improve clinical outcomes. This single-center, prospective trial randomized 100 patients with HCC into two groups. The experimental group (n=50) received a structured dietary plan including high-fiber foods, probiotics (Bifidobacterium, Lactobacillus), and prebiotics. The control group (n=50) received routine dietary counseling. The study evaluates the intervention's effects on progression-free survival (PFS), overall survival (OS), gut microbiota diversity, serum lipid profiles, peripheral immune cell populations (CD8+ T cells, Tregs), and quality of life. The findings aim to provide robust clinical evidence for integrating microbiota-targeted dietary therapy into the standard management of HCC.

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.