Spirulina to protect the liver and help recovery after partial hepatectomy
Official title: Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07263217 · Data updated 2026-11-12
This trial will test whether taking spirulina tablets before and after surgery helps people with cholangiocarcinoma protect their liver and recover faster after a partial hepatectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | lenvatinib |
| Locations | 1 site (Hangzhou) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07263217 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with cholangiocarcinoma, Child-Pugh A liver function, planned neoadjuvant gemcitabine + oxaliplatin with lenvatinib and a PD-1 inhibitor, and scheduled anatomical hemihepatectomy with remaining liver volume >40% are ideal candidates.
✕Probably not a fit
Patients with poorer liver function (Child-Pugh B/C), prior liver resection, other active malignancies, severe uncontrolled comorbidities, or a known allergy to spirulina are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants are given either spirulina tablets or a placebo daily for three weeks before and three weeks after planned anatomical hemihepatectomy. The trial collects blood and stool samples, and a small piece of surgical liver tissue, to measure liver function, regeneration markers, and inflammation while monitoring for side effects. Regular clinic visits include blood tests and safety checks to track recovery and any adverse events. The design compares outcomes between the spirulina and placebo groups to determine whether spirulina provides protective or regenerative effects in the perioperative period.
Why it matters
Potential benefit: If successful, spirulina could reduce liver injury, support regeneration, and lower post-operative complications to improve recovery after hepatectomy.
How similar studies have gone: Spirulina has shown hepatoprotective effects in preclinical models and limited clinical settings, but perioperative use around hepatectomy for cholangiocarcinoma is novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China Recruiting
Study contacts
- Study coordinator: Xiaopeng Cai
- Email: cxpeng@zju.edu.cn
- Phone: +86 18768161626
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SumMET: Targeted radioligand therapy for c-MET–positive solid tumors
This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.
-
68Ga-SorB PET/CT imaging for solid tumors
This study tests a new PET tracer called 68Ga-SorB to see if it can safely and accurately detect tumors in adults with melanoma, liver, lung, breast, pancreatic, ovarian cancer, or cholangiocarcinoma.
-
Breath test to help detect gastrointestinal cancers early
A breath test that looks for signals in exhaled air to see if someone with gut cancer symptoms might have oesophageal, stomach, pancreatic, liver, or colorectal cancer and need urgent testing.
-
Can an imaging tracer help predict if cholangiocarcinoma patients will respond to standard therapy
This study tests whether an imaging tracer called [18F]FTT used with PET/CT can predict how newly diagnosed cholangiocarcinoma patients will respond to the standard treatment of gemcitabine, cisplatin, and durvalumab.
-
Dual-target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
This trial tests a ready-to-use CAR-NK cell therapy that targets HER2 and CEACAM5 in adults with unresectable or metastatic biliary tract cancers after standard therapy to see if it can help control the disease.
-
KRAS G12V cancer patients get TCR1188-ABC cell therapy
This early-phase trial tests whether TCR1188-ABC cells can safely be given to adults with KRAS G12V-mutated metastatic cancers to see if it can help some types of pancreatic, biliary, colorectal, or lung cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.