New drug combo may shield liver during cancer surgery
NCT ID NCT07150624
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called polyene phosphatidylcholine, given before and after surgery, can protect the liver in people with liver cancer. About 96 participants will receive either the drug combo or standard care. The goal is to see if it reduces liver injury after laparoscopic liver removal.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2026
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 70 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. Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection. 2. Surgical scope (defined by randomization stratification):Stratum 1: Major hepatectomy, involving the resection of at least 3 Couinaud liver segments, including right hemihepatectomy and extended right hemihepatectomy, etc.Stratum 2: Minor hepatectomy, involving the resection of no more than 2 Couinaud liver segments. This includes right posterior sectorectomy, right anterior sectorectomy, left lateral sectionectomy, single segmentectomy, etc. 3. During the operation, the Pringle method is used to block the first hepatic portal. Each block lasts ≤ 15 minutes, and the blocking procedure is performed 2 to 4 times. 4. Age: 18 - 80 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg/m². 5. Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III. 6. Preoperative ICG R15 \< 10%, and the residual liver volume/standard liver volume \> 40%. 7. A single HCC (hepatocellular carcinoma), with a tumor diameter of less than 10 cm, without distant metastasis or invasion of the portal vein system. 8. Preoperative ALT \< 2x ULN (upper limit of normal). 9. No history of portal vein embolization prior to enrollment. If TACE treatment was previously received, it must have been completed \> 6 months ago; if systemic anti-tumor drug therapy was previously received, it must have been completed \> 4 weeks ago. 10. No liver-damaging treatment drugs were used within two weeks prior to enrollment. Exclusion Criteria: 1. Reserve liver vascular damage, including: reconstruction after severance, ligation, embolization, thrombosis, etc 2. Combined with abnormal coagulation function (prothrombin time prolonged by more than 3 seconds) 3. Combining obstructive jaundice, severe heart disease, severe kidney disease and other serious illnesses 4. During the operation, microwave treatment or a combination of microwave treatment was adopted 5. More than 4 times of blocking at the first hepatic hilum, or a single blocking duration longer than 15 minutes 6. Non-anatomic liver resection, where the remaining liver contains large areas of ischemic/edematous regions 7. More than 1000ml of blood transfusion during the operation 8. During the operation, an extra-hepatic disease was discovered. Other organs except the gallbladder needed to be removed simultaneously 9. During the operation, other intrahepatic lesions were discovered, which required combination with other surgeries, such as ablation or choledochojejunostomy 10. Diseases that have previously received systemic treatment with glucocorticoids, such as chronic kidney disease, inflammatory diseases, or other immune system-related disorders 11. Psychosis, severe neurosis, those who cannot cooperate with this experiment 12. Participated in other clinical trials within the previous 3 months before enrollment 13. Allergy or intolerance to benzoic acid, or to the study drug 14. Pregnant and lactating women 15. The researchers believe that any participants who have any other factors that would make them unsuitable for this trial should not be included
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Provincial Hospital
RECRUITINGHefei, Anhui, 230000, China
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