The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperat… (NCT07306481) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant/Conversion Immunotherapy in Patients With Primary Resectable Liver Cancer
40 participantsStarted 2025-12-20
Plain-language summary
On the basis of previous studies, this study intends to explore the efficacy of preoperative oral administration of Lactobacillus reuteri (Lr) combined with preoperative neoadjuvant/conversion therapy in patients with primary resectable hepatocellular carcinoma (HCC). We hypothesize that this combination represents a novel, microbiota-based therapeutic strategy to facilitate perioperative hepatic recovery and improve long-term survival outcomes.
This study is an open-label, randomized, blank-controlled clinical trial. Patients undergoing liver resection were randomly allocated to one of two groups. The intervention group received preoperative oral Lactobacillus reuteri (Lr) supplementation alongside neoadjuvant/conversion immunotherapy. The control group received preoperative neoadjuvant/conversion immunotherapy alone. Fecal and peripheral blood samples will be collected at baseline (pre-medication), 3 days prior to surgery, and at 5 days, 1, 3, 6, 9, 12, 18, and 24 months postoperatively. Intraoperative liver tissue samples will also be obtained. Statistical analyses will be performed to compare intergroup differences in postoperative liver function recovery, overall survival, hepatic and peripheral immune markers, and gut microbiota composition.
This study aims to develop adjuvant strategies to enhance therapeutic outcomes for HCC patients undergoing preoperative neoadjuvant/conversion immunotherapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Understanding and voluntarily signing the informed consent form for this study;
✓. Age≥18 years and ≤75 years; gender not restricted;
✓. Histologically (pathologically), cytologically, or radiologically confirmed hepatocellular carcinoma (HCC);
✓. Patients who require preoperative immune checkpoint inhibitor (ICI) combination therapy followed by potentially curative hepatectomy;
✓. No prior systemic therapy for HCC, including chemotherapy, targeted therapy, or immunotherapy had been administered before enrollment.;
✓. Patients with a history of prior curative surgery or curative ablation are allowed, except for those with recurrence within 2 years post-curative treatment or prior receipt of other local therapies;
✓. At least one measurable lesion meets RECIST v1.1 criteria;
✓. Child-Pugh liver function rating: grade A or B;
Exclusion criteria
✕
What they're measuring
1
Comparison of liver function recovery with ALT and AST
Timeframe: 5 days, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery
2
Comparison of liver function recovery with total bilirubin
Timeframe: 5 days, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery
3
Comparison of liver function recovery with prothrombin activity
Timeframe: 5 days, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery
. Inability to comply with the study protocols or procedures;
✕. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma (ICC more than 30%) and fibrolaminar cell carcinoma
✕. Hepatic encephalopathy, hepatorenal syndrome, or severe decompensated cirrhosis;
✕. Planned use of probiotics, yogurt, or bacterial-fortified foods during the treatment period;
✕. Use of probiotics or antibiotic within 2 months before the trial;
✕. Patients with severe mental illness;
✕. Patients under fasting or fluid restriction (e.g., complete bowel obstruction, active gastrointestinal bleeding, etc.);
✕. Patients with chronic digestive system diseases, such as irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease, or ileostomy;