Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury

The goal of this clinical trial is to learn if spirulina can help protect the liver and promote recovery after partial hepatectomy (surgery to remove part of the liver). It will also learn about the safety of spirulina in patients undergoing liver surgery.

The main questions it aims to answer are:

Does spirulina help improve liver function after surgery? Does spirulina promote liver regeneration and reduce inflammation? What side effects, if any, occur when participants take spirulina? Researchers will compare spirulina tablets to a placebo (a look-alike tablet that contains no spirulina) to see if spirulina helps protect the liver and support recovery after surgery.

Participants will:

Take spirulina or placebo tablets daily for 3 weeks before and 3 weeks after surgery.

Provide blood and stool samples before and after treatment. Allow the collection of a small piece of liver tissue (from surgical waste) for analysis.

Have regular clinic visits for checkups, blood tests, and safety monitoring.

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Dietary supplement: Spirulina; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaopeng Cai; Phone Number: +86 18768161626; Email: cxpeng@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University
    • Contact: Xiaopeng Cai; Phone Number: +86 18768161626; Email: cxpeng@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with cholangiocarcinoma (bile duct cell carcinoma).
• Child-Pugh Class A liver function.
• Planned to receive neoadjuvant therapy with gemcitabine + oxaliplatin, combined with lenvatinib and a PD-1 inhibitor, followed by anatomical hemihepatectomy (remaining liver volume > 40%).
• Age 18-75 years, male or female. Willing and able to comply with the study protocol, including oral administration of spirulina or placebo for 3 weeks before and 3 weeks after surgery.
• Voluntarily agrees to participate and signs written informed consent.
• Has had no acute illness or significant symptom worsening within 4 weeks before enrollment.

Exclusion Criteria:

• Presence of severe comorbidities (e.g., uncontrolled cardiovascular, respiratory, renal, or hematologic diseases).
• Known allergy to spirulina or its components.
• Concurrent malignant tumors other than the target disease.
• History of previous liver resection surgery.
• Severe psychiatric disorders that could affect compliance or the ability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spirulina treatment group; participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery.	Dietary supplement: Spirulina; participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery
Placebo Comparator: Placebo control group; participants take placebo tablets (maltodextrin, same dosage and schedule).	Dietary supplement: Maltodextrin; Participants take placebo tablets (maltodextrin, same dosage and schedule).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Alanine Aminotransferase (ALT) Level	Serum ALT will be measured at baseline and after the 6-week perioperative intervention. The outcome is the change from baseline compared between spirulina and placebo groups.	Day 0 (pre-treatment, ~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Aspartate Aminotransferase (AST) Level	Serum AST will be measured at baseline and after the intervention. The analysis compares change from baseline between study arms.	Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Total Bilirubin (TBIL) Level	Serum TBIL will be measured pre- and post-intervention. The change from baseline will be compared between groups.	Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Inflammatory Cytokine Concentrations	Serum inflammatory cytokines (e.g., IL-6, TNF-α) will be quantified using immunoassays before and after intervention. Analysis will compare changes from baseline.	Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Gut Microbial Species Abundance Measured by Fecal Metagenomic Sequencing	Fecal metagenomic sequencing will assess gut microbial species abundance and alpha-diversity indices. The outcome is change in microbial composition from baseline to post-treatment.	Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Gene Expression Profiles from Liver Tissue Assessed by Single-cell and/or Bulk Transcriptomic Sequencing	Single-cell RNA sequencing and/or bulk RNA sequencing will be performed on liver tissue collected during partial hepatectomy to characterize cellular and molecular pathways related to liver injury and regeneration.	During liver surgery (partial hepatectomy)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abnormal Hematology Laboratory Values	Complete blood count parameters will be assessed at baseline, during intervention, and at end of treatment. The outcome is the number of participants exhibiting abnormal values defined by institutional reference ranges.	Day 0 (baseline) Perioperative period (during hospitalization) End of 6-week treatment (~3 weeks after surgery)
Number of Participants With Abnormal Renal Function Test Results	Renal function parameters including serum creatinine and blood urea nitrogen will be assessed. The number of participants with abnormal values will be reported.	Day 0 Perioperative period End of 6-week treatment
Number of Participants With Abnormal Coagulation Function Test Results	Coagulation parameters including prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) will be collected. Abnormal findings will be counted.	Day 0 Perioperative period End of 6-week treatment
Number of Participants With Abnormal Urine Routine Test Results	Routine urinalysis including leukocytes, nitrites, protein, glucose, ketones, and microscopic examination will be performed. Abnormal results will be recorded.	Day 0 Perioperative period End of 6-week treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma; maltodextrin
• Other Study ID Numbers: 2025-0805

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No