Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury

NCT07760038 | Recruiting

• 1 other identifier: 2026-0597
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc); Liver Injury

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Change in Blood Inflammatory Marker Levels

  Baseline and Week 3 after surgery

• Liver Cell Proliferation Assessed by Ki-67 Expression

  Baseline and Week 3 after surgery

• Liver Cell Proliferation Assessed by PCNA Expression

  Baseline and Week 3 after surgery

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  through study completion, an average of 1 year

Study Arms (2)

Phycocyanin Group

EXPERIMENTAL

Participants will take 1.5 grams of phycocyanin by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. They will also receive the usual medical care for partial liver removal surgery.

Dietary Supplement: Phycocyanin

Placebo Group

PLACEBO COMPARATOR

Participants will take 1.5 grams of maltodextrin placebo by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. The placebo does not contain phycocyanin. Participants will also receive the usual medical care for partial liver removal surgery.

Dietary Supplement: Maltodextrin

Interventions

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.

Phycocyanin Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious coexisting medical conditions
• Known allergy to phycocyanin
• Other malignant tumors
• Previous liver resection
• History of severe psychiatric illness that may affect treatment adherence

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

Phycocyanin; maltodextrin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phycobiliproteins; Phycobilisomes; Light-Harvesting Protein Complexes; Photosynthetic Reaction Center Complex Proteins; Multienzyme Complexes; Multiprotein Complexes; Macromolecular Substances; Enzymes; Enzymes and Coenzymes; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Pigments, Biological; Biological Factors

Central Study Contacts

Xiaopeng Cai

CONTACT

+86 18768161626; cxpeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-07

Locations

CN (1)