CholangiocarcinomaNCT07263217
Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury
A study testing Spirulina and Maltodextrin in people with Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Spirulina and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou
Xiaopeng Cai, +86 18768161626, cxpeng@zju.edu.cn
About this study
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:
Read more
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.
- Conditions
- Cholangiocarcinoma
- Being tested
- Spirulina, Maltodextrin
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirulinaDietary supplement
participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery
MaltodextrinDietary supplement
Participants take placebo tablets (maltodextrin, same dosage and schedule).
| Study group | Role | What they receive |
|---|---|---|
| Spirulina treatment group | Experimental | participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery. Receives: Dietary Supplement: Spirulina |
| Placebo control group | Placebo comparator | participants take placebo tablets (maltodextrin, same dosage and schedule). Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: During liver surgery (partial hepatectomy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263217
- Sponsor's protocol ID
- 2025-0805
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury
- ClinicalTrials.gov ID
- NCT07263217
- Acronym / sponsor ID
- 2025-0805
- Conditions
- Cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirulina treatment group | Experimental | Dietary Supplement: Spirulinaparticipants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery. |
| Placebo control group | Placebo comparator | Dietary Supplement: Maltodextrinparticipants take placebo tablets (maltodextrin, same dosage and schedule). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulinaparticipants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery | Dietary supplement | Spirulina treatment group |
| MaltodextrinParticipants take placebo tablets (maltodextrin, same dosage and schedule). | Dietary supplement | Placebo control group |
Primary outcome
Change in Alanine Aminotransferase (ALT) Level
Time frame: Day 0 (pre-treatment, ~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
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.
Change in Aspartate Aminotransferase (AST) Level
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Serum AST will be measured at baseline and after the intervention. The analysis compares change from baseline between study arms.
Change in Total Bilirubin (TBIL) Level
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Serum TBIL will be measured pre- and post-intervention. The change from baseline will be compared between groups.
3 secondary outcomes
Change in Serum Inflammatory Cytokine Concentrations
Time frame: 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
Time frame: 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
Time frame: During liver surgery (partial hepatectomy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina and Maltodextrin in people with Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaopeng Cai (+86 18768161626, cxpeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alanine Aminotransferase (ALT) Level (time frame: Day 0 (pre-treatment, ~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.