Intrahepatic Cholangiocarcinoma (Icc), Liver Injury
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPhycocyanin
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.
DIETARY_SUPPLEMENTMaltodextrin
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.
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTXiaopeng Cai
Outcome results
None listed