Recruiting

Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury

ClinicalTrials.gov IDNCT07760038

PhaseNA

Enrollment30

SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Intrahepatic Cholangiocarcinoma (Icc), Liver Injury

About this study

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.

Interventions

Dietary Supplement: Phycocyanin — Participants will take 1.5 grams of phycocyanin by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. Phycocyanin is a natural protein from spirulina.
Dietary Supplement: Maltodextrin — Participants will take 1.5 grams of maltodextrin placebo by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. The placebo does not contain phycocyanin.

Primary outcomes

Change in Serum Aspartate Aminotransferase (AST) Level (Baseline and Week 3 after surgery)
Change in Serum Alanine Aminotransferase (ALT) Level (Baseline and Week 3 after surgery)
Change in Serum Total Bilirubin (TBIL) Level (Baseline and Week 3 after surgery)

Eligibility information

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

Study locations

The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.