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NCT Number: NCT07760038

Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Xiaopeng Cai

CONTACT

[email protected]

+86 18768161626

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phycocyanin

Dietary Supplement

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.

Maltodextrin

Dietary Supplement

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

  1. Change in Serum Aspartate Aminotransferase (AST) Level

    Time frame: Baseline and Week 3 after surgery

  2. Change in Serum Alanine Aminotransferase (ALT) Level

    Time frame: Baseline and Week 3 after surgery

  3. Change in Serum Total Bilirubin (TBIL) Level

    Time frame: Baseline and Week 3 after surgery

Secondary outcomes

  1. Change in Blood Inflammatory Marker Levels

    Time frame: Baseline and Week 3 after surgery

  2. Liver Cell Proliferation Assessed by Ki-67 Expression

    Time frame: Baseline and Week 3 after surgery

  3. Liver Cell Proliferation Assessed by PCNA Expression

    Time frame: Baseline and Week 3 after surgery

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaopeng Cai

CONTACT

[email protected]

+86 18768161626

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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