Gut bacteria boosts immunotherapy for liver cancer?
NCT ID NCT07306481
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking a probiotic (Lactobacillus reuteri) before surgery can improve the effects of immunotherapy in people with liver cancer. About 40 adults with resectable liver cancer will either receive the probiotic plus immunotherapy or immunotherapy alone before surgery. Researchers will compare liver recovery, survival, and side effects between the two groups.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Understanding and voluntarily signing the informed consent form for this study; 2. Age≥18 years and ≤75 years; gender not restricted; 3. Histologically (pathologically), cytologically, or radiologically confirmed hepatocellular carcinoma (HCC); 4. Patients who require preoperative immune checkpoint inhibitor (ICI) combination therapy followed by potentially curative hepatectomy; 5. No prior systemic therapy for HCC, including chemotherapy, targeted therapy, or immunotherapy had been administered before enrollment.; 6. 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; 7. At least one measurable lesion meets RECIST v1.1 criteria; 8. Child-Pugh liver function rating: grade A or B; 9. The expected survival period is greater than 3 months; 10. Patients must be able to take food orally independently; 11. Preoperative ECOG physical condition score 0-1 points; 12. Normal coagulation function, no activebleeding or thrombotic diseases; A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN; 13. 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. Exclusion Criteria: 1. Inability to comply with the study protocols or procedures; 2. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma (ICC more than 30%) and fibrolaminar cell carcinoma 3. Hepatic encephalopathy, hepatorenal syndrome, or severe decompensated cirrhosis; 4. Planned use of probiotics, yogurt, or bacterial-fortified foods during the treatment period; 5. Use of probiotics or antibiotic within 2 months before the trial; 6. Patients with severe mental illness; 7. Patients under fasting or fluid restriction (e.g., complete bowel obstruction, active gastrointestinal bleeding, etc.); 8. Patients with chronic digestive system diseases, such as irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease, or ileostomy; 9. 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; 10. Participants in other drug, dietary supplement, probiotic, or prebiotic clinical studies within the past 1 months prior to enrollment 11. Pregnant or lactating women; 12. 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; 13. Any medical or non-medical condition that the researcher deems unsuitable for participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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The official record
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