Hepatocellular Carcinoma (HCC)Phase 4NCT07150624
The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine
A Phase 4 study testing Experimental Group in people with Hepatocellular Carcinoma (HCC) and Liver Diseases, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Liver Diseases
- What is being tested?
- Experimental Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 31 Dec 2026
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection.
- 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.
- 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.
- Age: 18 - 80 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg/m².
- Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III.
- Preoperative ICG R15 < 10%, and the residual liver volume/standard liver volume > 40%.
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- A single HCC (hepatocellular carcinoma), with a tumor diameter of less than 10 cm, without distant metastasis or invasion of the portal vein system.
- Preoperative ALT < 2x ULN (upper limit of normal).
- 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.
- No liver-damaging treatment drugs were used within two weeks prior to enrollment.
Who cannot join
- Reserve liver vascular damage, including: reconstruction after severance, ligation, embolization, thrombosis, etc
- Combined with abnormal coagulation function (prothrombin time prolonged by more than 3 seconds)
- Combining obstructive jaundice, severe heart disease, severe kidney disease and other serious illnesses
- During the operation, microwave treatment or a combination of microwave treatment was adopted
- More than 4 times of blocking at the first hepatic hilum, or a single blocking duration longer than 15 minutes
- Non-anatomic liver resection, where the remaining liver contains large areas of ischemic/edematous regions
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- More than 1000ml of blood transfusion during the operation
- During the operation, an extra-hepatic disease was discovered. Other organs except the gallbladder needed to be removed simultaneously
- During the operation, other intrahepatic lesions were discovered, which required combination with other surgeries, such as ablation or choledochojejunostomy
- Diseases that have previously received systemic treatment with glucocorticoids, such as chronic kidney disease, inflammatory diseases, or other immune system-related disorders
- Psychosis, severe neurosis, those who cannot cooperate with this experiment
- Participated in other clinical trials within the previous 3 months before enrollment
- Allergy or intolerance to benzoic acid, or to the study drug
- Pregnant and lactating women
- The researchers believe that any participants who have any other factors that would make them unsuitable for this trial should not be included
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
Lianxin LIU L LIU, 0551-96512, liulx@ustc.edu.cn
About this study
Official title: Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hepatectomy in Hepatocellular Carcinoma: a Multicenter Randomized Controlled Study
A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hepatectomy for hepatocellular carcinoma were compared.
- Conditions
- Hepatocellular Carcinoma (HCC), Liver Diseases
- Being tested
- Experimental Group, control group
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving 930mg of polyene phosphatidylcholine injection one day before the operation,twice a day. And 930mg of polyene phosphatidylcholine injection,twice a day, combined with 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation.
control groupDrug
Receiving 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Experimental Group |
| control group | Active comparator | Not described Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average change of ALT on the 5th day after the operation
Measured: The 5th day after the operation
Secondary outcomes (5)
The average change of ALT on the 1th day after the operation
Measured: The 1th day after the operation
The average change of ALT on the 3th day after the operation
Measured: The 3th day after the operation
The rate of ALT returning to normal on the 5th day after the operation
Measured: The 5th day after the operation
The rate of AST returning to normal on the 5th day after the operation
Measured: The 5th day after the operation
AEs
Measured: Observation period 5 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start10 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, First Affiliated Hospital of Wannan Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150624
- Sponsor's protocol ID
- CXPJJH125002-2503
- Status last verified
- May 2026
- First submitted
- 21 Aug 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hepatectomy in Hepatocellular Carcinoma: a Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07150624
- Acronym / sponsor ID
- CXPJJH125002-2503
- Conditions
- Hepatocellular Carcinoma (HCC), Liver Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, First Affiliated Hospital of Wannan Medical College
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hepatectomy for hepatocellular carcinoma were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Experimental Group |
| control group | Active comparator | Drug: control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection.
- 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.
- 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.
- Age: 18 - 80 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg/m².
- Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III.
Key exclusion criteria (15 listed)
- Reserve liver vascular damage, including: reconstruction after severance, ligation, embolization, thrombosis, etc
- Combined with abnormal coagulation function (prothrombin time prolonged by more than 3 seconds)
- Combining obstructive jaundice, severe heart disease, severe kidney disease and other serious illnesses
- During the operation, microwave treatment or a combination of microwave treatment was adopted
- More than 4 times of blocking at the first hepatic hilum, or a single blocking duration longer than 15 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupReceiving 930mg of polyene phosphatidylcholine injection one day before the operation,twice a day. And 930mg of polyene phosphatidylcholine injection,twice a day, combined with 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation. | Drug | Experimental group |
| control groupReceiving 100mg of magnesium isoglycyrrhizinate injection once a day，from the 1st to the 5th day after the operation. | Drug | control group |
Primary outcome
The average change of ALT on the 5th day after the operation
Time frame: The 5th day after the operation
5 secondary outcomes
The average change of ALT on the 1th day after the operation
Time frame: The 1th day after the operation
The average change of ALT on the 3th day after the operation
Time frame: The 3th day after the operation
The rate of ALT returning to normal on the 5th day after the operation
Time frame: The 5th day after the operation
The rate of AST returning to normal on the 5th day after the operation
Time frame: The 5th day after the operation
AEs
Time frame: Observation period 5 days after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental Group in people with Hepatocellular Carcinoma (HCC) and Liver Diseases, run by Anhui Provincial Hospital at 1 site in China.
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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lianxin Liu (0551-96512, liulx@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average change of ALT on the 5th day after the operation (time frame: The 5th day after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.