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HCC - Hepatocellular CarcinomaNCT07306481

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

A study testing Dietary Supplement: L. reuteri DSM 17938 in people with HCC - Hepatocellular Carcinoma, run by Fujian Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC - Hepatocellular Carcinoma
What is being tested?
Dietary Supplement: L. reuteri DSM 17938
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
20 Dec 2025to 20 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • At least one measurable lesion meets RECIST v1.1 criteria;
  • Child-Pugh liver function rating: grade A or B;
  • The expected survival period is greater than 3 months;
  • Patients must be able to take food orally independently;
  • Preoperative ECOG physical condition score 0-1 points;
  • Normal coagulation function, no activebleeding or thrombotic diseases; A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN;
  • Has adequate organ and bone marrow function, laboratory test values within 7 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin, or other corrective drugs are allowed within 14 days prior to laboratory test), as follows: 1) Blood routine: absolute neutrophil count≥1.5×109/L; platelet count≥75×109/L; hemoglobin conten≥9.0 g/dL. 2) Liver function: serum total bilirubin≤2× upper limit of normal value (ULN); alanine aminotransferase and aspartate transferas≤5×ULN; Serum albumin ≥28 g/L; alkaline phosphatase≤5×ULN. 3) Renal function: serum creatinine≤1.5×ULN or clearance of creatinine≥50mL/min(Cockcroft-Gault formula); Urine routine results showed that urine protein <2+; For patients with urine protein ≥2+ on routine urine tests at baseline, 24-hour urine collection and 24-hour protein quantification <1g should be performed.

Who cannot join

  • 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;
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  • 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;
  • Allergy to the trial product or its components, inability to swallow tablets, unwillingness or inability to receive intravenous administration, or a history of severe infusion-related reactions to monoclonal antibodies or any other active malignancies during the initial study treatment administration;
  • Participants in other drug, dietary supplement, probiotic, or prebiotic clinical studies within the past 1 months prior to enrollment
  • Pregnant or lactating women;
  • History of other malignancies within the past 5 years, except for completely resected basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ;
  • Any medical or non-medical condition that the researcher deems unsuitable for participation.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Meimei Chen contact

0591-62752500

1145805830@qq.com

About this study

Official title: 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

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.

Being tested
Dietary Supplement: L. reuteri DSM 17938
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary Supplement: L. reuteri DSM 17938Dietary supplement

    1 * 10^8 CFU of L. reuteri DSM 17938 two capsules per day for 3 months

Study groups in NCT07306481
Study groupRoleWhat they receive
Lr groupExperimentalNot described
Receives: Dietary Supplement: Dietary Supplement: L. reuteri DSM 17938
Con groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of liver function recovery with ALT and AST

    The levels of the alanine aminotransferase (ALT) and aspartate aminotransferase (ALT) after surgery will be compared.

    Measured: 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

    The levels of the total bilirubin after surgery will be compared.

    Measured: 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

    The levels of the prothrombin after surgery will be compared.

    Measured: 5 days, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery

  4. Incidence of postoperative complications

    The postoperative complication rates including surgical site infection, hemorrhage, and bile leakage.

    Measured: 30 days after the surgery

Secondary outcomes (6)

  1. Analysis of hepatic tissue microbiota

    Postoperative liver specimens will be collected to compare or quantitatively detect microbial content (e.g., Lactobacillus reuteri) in liver tissues (tumor and peritumoral regions) through culture-based methods, or to assess microbial community diversity changes via microbiome sequencing.

    Measured: During surgery

  2. Alterations in gut microbiota

    16S rRNA sequencing will be used to measure fecal sample. The alpha and beta diversity of gut microbiota between two groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.

    Measured: Before intervention, 3 days before surgery, and 5 days, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery

  3. Differences among hepatic immune cell subsets

    Single-cell sequencing will be used to analyzed the immune cell subsets in tumor tissues and paired normal tissues. The immune cell clusters comprised: 9 clusters of CD4+ T cells (CD3+CD4+), 8 clusters of CD8+ T cells (CD3+CD8+), 3 clusters of B cells (CD3-CD19+), 2 clusters of monocytes (CD3-CD19-CD14+) and 10 clusters of other subsets, such as dendritic cells (DCs, CD3-CD19-CD14-CD20-HLA-DR+), and NK cells (CD3-CD19-CD14-C-D20-CD56+).

    Measured: During surgery

  4. The alterations of peripheral immune cell subsets

    Single-cell sequencing will be used to analyze the immune cell subsets in peripheral blood. The peripheral immune cell subsets comprised: 9 clusters of CD4+ T cells (CD3+CD4+), 8 clusters of CD8+ T cells (CD3+CD8+), 3 clusters of B cells (CD3-CD19+), 2 clusters of monocytes (CD3-CD19-CD14+) and 10 clusters of other subsets, such as dendritic cells (DCs, CD3-CD19-CD14-CD20-HLA-DR+), and NK cells (CD3-CD19-CD14-C-D20-CD56+).

    Measured: 3 days before surgery, and 1, 3, 6, 9, 12, 18, and 24 months after surgery

  5. The alterations of immune cytokines

    Standardized luminex-based multiplex bead technology or elisa assay will be used to assess the dynamic changes of immune cytokines at key time points. The immune cytokines included TNF-α, IFN-γ, CXCL10, G-CSF, IL-1β, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17, PDGF-BB, MCP-1, MIP-1α, MIP-1β, GM-CSF, eotaxin, FGF, and RANTES.

    Measured: 3 days before surgery, and 1, 3, 6, 9, 12, 18, and 24 months after surgery

  6. Potential impact on long-term postoperative survival

    1-year and 2-year recurrence-free survival (RFS) and overall survival (OS) rate。

    Measured: 1year and 2year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start20 Dec 2025 (estimated)
  3. Primary completion20 Jun 2028 (estimated)
  4. Study completion20 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07306481
Sponsor's protocol ID
LRHCC-2025
Status last verified
Dec 2025
First submitted
22 Nov 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Supplement: L. reuteri DSM 17938 in people with HCC - Hepatocellular Carcinoma, run by Fujian Cancer Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meimei Chen (0591-62752500, 1145805830@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of liver function recovery with ALT and AST (time frame: 5 days, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07306481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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