NCT07306481

The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant/Conversion Immunotherapy in Patients With Primary Resectable Liver Cancer

The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant/Conversion Immunotherapy in Patients With Primary Resectable Liver Cancer: a Prospective Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC - Hepatocellular Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement: L. reuteri DSM 17938	1 \* 10\^8 CFU of L. reuteri DSM 17938 two capsules per day for 3 months

Timeline

• Start date: 2025-12-20
• Primary completion: 2028-06-20
• Completion: 2028-12-20
• First posted: 2025-12-29
• Last updated: 2025-12-29