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New treatment option for Hepatocellular Carcinoma (HCC)
Official title The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine
ClinicalTrials.gov ID: NCT07150624
What this study is testing
What is Experimental Group?
Experimental Group is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- During the operation, the Pringle method is used to block the first hepatic portal. Each block lasts ≤ 15 minutes, and the blocking procedure is...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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 \ 40%.
- 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...
- No liver-damaging treatment drugs were used within two weeks prior to enrollment.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.