Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury
Recruiting · NCT07760038 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this study is to find out whether phycocyanin, a natural protein from spirulina, can help protect the liver and support recovery in adults having part of their liver removed. The study will also look at whether phycocyanin is safe to take.The main questions are: Does phycocyanin reduce liver injury after surgery? Does it help the liver grow back and recover? What side effects or medical problems happen while taking it? Researchers will compare phycocyanin with a placebo, which looks similar but does not contain phycocyanin. About 30 people will take part. Each person will be randomly placed into one of the two groups, and neither the participants nor the researchers will know which treatment each person receives during the study. Participants will: Take 1.5 grams of phycocyanin or placebo every day for 3 weeks before surgery and 3 weeks after surgery Receive the usual care for liver surgery Give blood and stool samples before and after treatment Allow researchers to study a small piece of liver tissue removed during surgery Return for follow-up for up to 90 days after surgery The samples will be used to check liver function, inflammation, gut bacteria, and changes linked to liver healing. Possible side effects include an allergic reaction or stomach discomfort. The study has been approved by an ethics committee.
Who can take part
Inclusion criteria
- Diagnosis of intrahepatic cholangiocarcinoma
- Child-Pugh class A liver function
- Planned neoadjuvant treatment with gemcitabine plus oxaliplatin, lenvatinib, and a PD-1 inhibitor
- Planned anatomical hemihepatectomy with an expected future liver remnant greater than 40%
- Age 18 to 75 years
- Willing and able to participate and provide written informed consent
- No acute illness or significant worsening of symptoms within 4 weeks before enrollment
Exclusion criteria
- Serious coexisting medical conditions
- Known allergy to phycocyanin
- Other malignant tumors
- Previous liver resection
- History of severe psychiatric illness that may affect treatment adherence
Where it is running
1 location listed.
- The Second Affiliated Hospital of Zhejiang University - Hangzhou, Zhejiang, China